Ignite Creation Date:
2025-12-24 @ 2:23 PM
Ignite Modification Date:
2025-12-28 @ 4:10 AM
Study NCT ID:
NCT01446159
Status:
COMPLETED
Last Update Posted:
2020-06-02
First Post:
2011-09-12
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of MEDI-573 Plus Standard Endocrine Therapy for Women With Hormone-sensitive Metastatic Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'C000601324', 'term': 'dusigitumab'}, {'id': 'D047072', 'term': 'Aromatase Inhibitors'}], 'ancestors': [{'id': 'D065088', 'term': 'Steroid Synthesis Inhibitors'}, {'id': 'D004791', 'term': 'Enzyme Inhibitors'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D004965', 'term': 'Estrogen Antagonists'}, {'id': 'D006727', 'term': 'Hormone Antagonists'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'information.center@astrazeneca.com', 'phone': '+1-800-236-9933', 'title': 'Shahram Rahimian', 'organization': 'MedImmune, LLC'}, 'certainAgreement': {'otherDetails': 'MedImmune has 60 days to review results communications prior to public release and may delete information that compromises on-going studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From the start of study treatment (Day 1) through 60 days after the last dose of treatment or until the participants started another anticancer therapy, whichever occurs first (approximately 8 years)', 'description': 'An AE is any unfavourable and unintended sign, symptoms, or diseases temporally associated with use of study drug, whether or not considered related to study drug. An SAE is an AE that results in death, initial or prolonged inpatient hospitalization, life-threatening, persistent or significant disability/incapacity, congenital anomaly/birth defect, or an important medical event.', 'eventGroups': [{'id': 'EG000', 'title': 'MEDI-573 10 mg/kg + Aromatase Inhibitor (AI)', 'description': "Participants enrolled in Phase 1b of the study and received intravenous infusion of MEDI-573 10 mg/kg on Day 1 of each 21-day cycle and AI of the investigator's choice (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.", 'otherNumAtRisk': 3, 'deathsNumAtRisk': 6, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 2, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'MEDI-573 30 mg/kg + AI', 'description': 'Participants enrolled in Phase 1 b of the study and received intravenous infusion of MEDI-573 30 mg/kg on Day 1 of each 21-day cycle and AI (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 6, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 3, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'MEDI-573 45 mg/kg + AI', 'description': 'Participants received intravenous infusion of MEDI-573 45 mg/kg on Day 1 of each 21-day cycle and AI (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons. Three participants were enrolled in Phase 1b and 89 were enrolled in Phase 2 of the study.', 'otherNumAtRisk': 92, 'deathsNumAtRisk': 184, 'otherNumAffected': 86, 'seriousNumAtRisk': 92, 'deathsNumAffected': 43, 'seriousNumAffected': 21}, {'id': 'EG003', 'title': 'Aromatase Inhibitor', 'description': 'Participants enrolled in Phase 2 of the study and received oral AI (letrozole, anastrozole, or exemestane) once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.', 'otherNumAtRisk': 85, 'deathsNumAtRisk': 170, 'otherNumAffected': 79, 'seriousNumAtRisk': 85, 'deathsNumAffected': 36, 'seriousNumAffected': 16}], 'otherEvents': [{'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Sinus bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 9, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 50, 'numAffected': 30}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 39, 'numAffected': 22}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 13, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Haematochezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 11, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 9, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 20, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 21, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 33, 'numAffected': 19}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 18, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 16, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 20, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 11, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Fungal skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Nail infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 13, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Gamma-glutamyltransferase decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 41, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Granulocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Protein total decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 10, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hyperuricaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 15, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 9, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 49, 'numAffected': 29}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 33, 'numAffected': 21}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Bone loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 11, 'numAffected': 9}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 14, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and 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{'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Gastric ulcer perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Biliary dilatation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Acetabulum fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Cervical vertebral fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Flank pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Breast cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Intraductal proliferative breast lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Lung adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Ovarian cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Rectal neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Uterine cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Altered state of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Partial seizures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Mental status changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Psychotic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hydronephrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Ovarian cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Emphysema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Phase 1b and Phase 2: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '92', 'groupId': 'OG002'}, {'value': '85', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI-573 10 mg/kg + Aromatase Inhibitor (AI)', 'description': "Participants enrolled in Phase 1b of the study and received intravenous infusion of MEDI-573 10 mg/kg on Day 1 of each 21-day cycle and AI of the investigator's choice (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons."}, {'id': 'OG001', 'title': 'MEDI-573 30 mg/kg + AI', 'description': 'Participants enrolled in Phase 1 b of the study and received intravenous infusion of MEDI-573 30 mg/kg on Day 1 of each 21-day cycle and AI (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.'}, {'id': 'OG002', 'title': 'MEDI-573 45 mg/kg + AI', 'description': 'Participants received intravenous infusion of MEDI-573 45 mg/kg on Day 1 of each 21-day cycle and AI (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons. Three participants were enrolled in Phase 1b and 89 were enrolled in Phase 2 of the study.'}, {'id': 'OG003', 'title': 'Aromatase Inhibitor', 'description': 'Participants enrolled in Phase 2 of the study and received oral AI (letrozole, anastrozole, or exemestane) once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.'}], 'classes': [{'title': 'Any TEAEs', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '90', 'groupId': 'OG002'}, {'value': '82', 'groupId': 'OG003'}]}]}, {'title': 'Any TESAEs', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the start of study treatment (Day 1) through 60 days after the last dose of treatment or until the participants started another anticancer therapy, whichever occurs first (approximately 8 years)', 'description': 'An Adverse Event (AE) is any unfavourable and unintended sign, symptoms, or diseases temporally associated with use of study drug, whether or not considered related to study drug. A serious adverse event (SAE) is an AE that results in death, initial or prolonged inpatient hospitalization, life-threatening, persistent or significant disability/incapacity, congenital anomaly/birth defect, or an important medical event. TEAEs and TESAEs are defined as AEs and SAEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug, up to 60 days after the last study drug or until the participants started another anticancer therapy, whichever occurs first (approximately 8 years).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received any study therapy and were analyzed per the treatment they actually received.'}, {'type': 'PRIMARY', 'title': 'Phase 1b: Number of Participants With Dose-limiting Toxicities (DLTs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI-573 10 mg/kg + Aromatase Inhibitor (AI)', 'description': "Participants enrolled in Phase 1b of the study and received intravenous infusion of MEDI-573 10 mg/kg on Day 1 of each 21-day cycle and AI of the investigator's choice (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons."}, {'id': 'OG001', 'title': 'MEDI-573 30 mg/kg + AI', 'description': 'Participants enrolled in Phase 1 b of the study and received intravenous infusion of MEDI-573 30 mg/kg on Day 1 of each 21-day cycle and AI (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.'}, {'id': 'OG002', 'title': 'MEDI-573 45 mg/kg + AI', 'description': 'Participants received intravenous infusion of MEDI-573 45 mg/kg on Day 1 of each 21-day cycle and AI (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons. Three participants were enrolled in Phase 1b and 89 were enrolled in Phase 2 of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Day 21 of Cycle 1', 'description': 'The AEs that occurred during Cycle 1 (Days 1 to 21) and were suspected of having a causal relationship to MEDI-573 and were \\>= Grade 3 in severity were considered as DLTs.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable population included all participants in Phase 1b of the study, who received at least 1 full cycle of MEDI-573 and completed the safety follow-up through the DLT evaluation period (Days 1 to 21 of Cycle 1).'}, {'type': 'PRIMARY', 'title': 'Phase 1b: Number of DLTs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI-573 10 mg/kg + Aromatase Inhibitor (AI)', 'description': "Participants enrolled in Phase 1b of the study and received intravenous infusion of MEDI-573 10 mg/kg on Day 1 of each 21-day cycle and AI of the investigator's choice (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons."}, {'id': 'OG001', 'title': 'MEDI-573 30 mg/kg + AI', 'description': 'Participants enrolled in Phase 1 b of the study and received intravenous infusion of MEDI-573 30 mg/kg on Day 1 of each 21-day cycle and AI (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.'}, {'id': 'OG002', 'title': 'MEDI-573 45 mg/kg + AI', 'description': 'Participants received intravenous infusion of MEDI-573 45 mg/kg on Day 1 of each 21-day cycle and AI (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons. Three participants were enrolled in Phase 1b and 89 were enrolled in Phase 2 of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Day 21 of Cycle 1', 'description': 'The AEs that occurred during Cycle 1 (Days 1 to 21) and were suspected of having a causal relationship to MEDI-573 and were \\>= Grade 3 in severity were considered as DLTs.', 'unitOfMeasure': 'DLT events', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable population included all participants in Phase 1b of the study, who received at least 1 full cycle of MEDI-573 and completed the safety follow-up through the DLT evaluation period (Days 1 to 21 of Cycle 1).'}, {'type': 'PRIMARY', 'title': 'Phase 2: Progression-free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI-573 45 mg/kg + AI', 'description': 'Participants received intravenous infusion of MEDI-573 45 mg/kg on Day 1 of each 21-day cycle and AI (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons. Three participants were enrolled in Phase 1b and 89 were enrolled in Phase 2 of the study.'}, {'id': 'OG001', 'title': 'Aromatase Inhibitor', 'description': 'Participants enrolled in Phase 2 of the study and received oral AI (letrozole, anastrozole, or exemestane) once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.65', 'groupId': 'OG000', 'lowerLimit': '8.15', 'upperLimit': '15.54'}, {'value': '11.33', 'groupId': 'OG001', 'lowerLimit': '8.54', 'upperLimit': '15.54'}]}]}], 'analyses': [{'pValue': '0.86', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.991', 'ciLowerLimit': '0.689', 'ciUpperLimit': '1.429', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From Day 1 until disease progression or death due to any cause, whichever occurred first (Approximately 8 years)', 'description': 'Progression-free survival (PFS) was defined as the time from the randomization until the first documentation of disease progression or death due to any cause, whichever occurred first.\n\nThe PFS was censored on the date of the last tumor assessment documenting absence of tumor progression for participants who had no documented progression and were still alive prior to data cut-off, dropout, or the initiation of alternate anticancer treatment. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as \\>= 20% increase in the sum of diameters of target lesions and an absolute increase in sum of diameters of \\>=5mm (compared to the previous minimum sum) or progression of non-target lesions or a new lesion.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included all participants who received any study therapy and were analyzed per their randomized treatment group. Participants enrolled in Phase 2 of the study were analyzed.'}, {'type': 'SECONDARY', 'title': 'Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '92', 'groupId': 'OG002'}, {'value': '85', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI-573 10 mg/kg + Aromatase Inhibitor (AI)', 'description': "Participants enrolled in Phase 1b of the study and received intravenous infusion of MEDI-573 10 mg/kg on Day 1 of each 21-day cycle and AI of the investigator's choice (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons."}, {'id': 'OG001', 'title': 'MEDI-573 30 mg/kg + AI', 'description': 'Participants enrolled in Phase 1 b of the study and received intravenous infusion of MEDI-573 30 mg/kg on Day 1 of each 21-day cycle and AI (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.'}, {'id': 'OG002', 'title': 'MEDI-573 45 mg/kg + AI', 'description': 'Participants received intravenous infusion of MEDI-573 45 mg/kg on Day 1 of each 21-day cycle and AI (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons. Three participants were enrolled in Phase 1b and 89 were enrolled in Phase 2 of the study.'}, {'id': 'OG003', 'title': 'Aromatase Inhibitor', 'description': 'Participants enrolled in Phase 2 of the study and received oral AI (letrozole, anastrozole, or exemestane) once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.'}], 'classes': [{'title': 'Anemia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}]}, {'title': 'Eosinophilia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Leukopenia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Lymphopenia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Neutropenia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'Pancytopenia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Thrombocytopenia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Granulocyte count decreased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Hemoglobin decreased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Lymphocyte count decreased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Monocyte count decreased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Neutrophil count decreased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Neutrophil count increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Platelet count decreased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'White blood cell count decreased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Alanine aminotransferase increased', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'Aspartate aminotransferase increased', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'Blood albumin decreased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Blood albumin increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Blood alkaline phosphatase increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}, {'title': 'Blood bicarbonate decreased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Blood bilirubin increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Blood chloride decreased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Blood creatine increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Blood creatinine decreased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Blood creatinine increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Blood glucose increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Blood lactate dehydrogenase increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Blood magnesium decreased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Blood potassium decreased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Blood sodium decreased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Blood triglycerides increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Blood urea increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Blood uric acid increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Gamma-glutamyl transferase decreased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Gamma-glutamyl transferase increased', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'Protein total decreased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Leukocytosis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Neutrophilia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the start of study treatment (Day 1) through 60 days after the last dose of treatment or until the participants started another anticancer therapy, whichever occurs first (approximately 8 years)', 'description': 'An abnormal laboratory finding which required an action or intervention by the investigator, or a finding judged by the investigator to represent a change beyond the range of normal physiologic fluctuation were reported as AEs. The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug, up to 60 days after the last study drug or until the participants started another anticancer therapy, whichever occurs first (approximately 8 years).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received any study therapy and were analyzed per the treatment they actually received.'}, {'type': 'SECONDARY', 'title': 'Phase 1b and Phase 2: Number of Participants With Abnormal Vital Signs Reported as TEAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '92', 'groupId': 'OG002'}, {'value': '85', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI-573 10 mg/kg + Aromatase Inhibitor (AI)', 'description': "Participants enrolled in Phase 1b of the study and received intravenous infusion of MEDI-573 10 mg/kg on Day 1 of each 21-day cycle and AI of the investigator's choice (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons."}, {'id': 'OG001', 'title': 'MEDI-573 30 mg/kg + AI', 'description': 'Participants enrolled in Phase 1 b of the study and received intravenous infusion of MEDI-573 30 mg/kg on Day 1 of each 21-day cycle and AI (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.'}, {'id': 'OG002', 'title': 'MEDI-573 45 mg/kg + AI', 'description': 'Participants received intravenous infusion of MEDI-573 45 mg/kg on Day 1 of each 21-day cycle and AI (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons. Three participants were enrolled in Phase 1b and 89 were enrolled in Phase 2 of the study.'}, {'id': 'OG003', 'title': 'Aromatase Inhibitor', 'description': 'Participants enrolled in Phase 2 of the study and received oral AI (letrozole, anastrozole, or exemestane) once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.'}], 'classes': [{'title': 'Bradycardia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Palpitations', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Pyrexia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}, {'title': 'Temperature intolerance', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Body temperature increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Aspiration', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Dyspnoea', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}]}, {'title': 'Hypertension', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}]}, {'title': 'Hypotension', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Orthostatic hypotension', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the start of study treatment (Day 1) through 60 days after the last dose of treatment or until the participants started another anticancer therapy, whichever occurs first (approximately 8 years)', 'description': 'An abnormal vital signs that were judged by the investigator to be medically significant were reported as AEs. The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug, up to 60 days after the last study drug or until the participants started another anticancer therapy, whichever occurs first (approximately 8 years).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received any study therapy and were analyzed per the treatment they actually received.'}, {'type': 'SECONDARY', 'title': 'Phase 1b and Phase 2: Number of Participants With Abnormal Electrocardiogram (ECG) Reported as TEAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '92', 'groupId': 'OG002'}, {'value': '85', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI-573 10 mg/kg + Aromatase Inhibitor (AI)', 'description': "Participants enrolled in Phase 1b of the study and received intravenous infusion of MEDI-573 10 mg/kg on Day 1 of each 21-day cycle and AI of the investigator's choice (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons."}, {'id': 'OG001', 'title': 'MEDI-573 30 mg/kg + AI', 'description': 'Participants enrolled in Phase 1 b of the study and received intravenous infusion of MEDI-573 30 mg/kg on Day 1 of each 21-day cycle and AI (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.'}, {'id': 'OG002', 'title': 'MEDI-573 45 mg/kg + AI', 'description': 'Participants received intravenous infusion of MEDI-573 45 mg/kg on Day 1 of each 21-day cycle and AI (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons. Three participants were enrolled in Phase 1b and 89 were enrolled in Phase 2 of the study.'}, {'id': 'OG003', 'title': 'Aromatase Inhibitor', 'description': 'Participants enrolled in Phase 2 of the study and received oral AI (letrozole, anastrozole, or exemestane) once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.'}], 'classes': [{'title': 'Sinus bradycardia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Sinus tachycardia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Supraventricular tachycardia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Tachycardia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Angina pectoris', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Arrhythmia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Atrial fibrillation', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Atrial flutter', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Atrioventricular block first degree', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Bradycardia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Cardiac failure', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Cardiac valve disease', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Palpitation', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Ventricular extrasystoles', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the start of study treatment (Day 1) through 60 days after the last dose of treatment or until the participants started another anticancer therapy, whichever occurs first (approximately 8 years)', 'description': 'An abnormal ECG findings that were judged by the investigator to be medically significant were reported as AEs. The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug, up to 60 days after the last study drug or until the participants started another anticancer therapy, whichever occurs first (approximately 8 years).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received any study therapy and were analyzed per the treatment they actually received.'}, {'type': 'SECONDARY', 'title': 'Phase 2: Number of Participants With Best Overall Tumor Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI-573 45 mg/kg + AI', 'description': 'Participants received intravenous infusion of MEDI-573 45 mg/kg on Day 1 of each 21-day cycle and AI (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons. Three participants were enrolled in Phase 1b and 89 were enrolled in Phase 2 of the study.'}, {'id': 'OG001', 'title': 'Aromatase Inhibitor', 'description': 'Participants enrolled in Phase 2 of the study and received oral AI (letrozole, anastrozole, or exemestane) once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.'}], 'classes': [{'title': 'CR', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'PR', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'SD', 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}]}, {'title': 'PD', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'NE', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 1 until disease progression or death due to any cause, whichever occurred first (Approximately 8 years)', 'description': 'Tumor evaluation was based on RECIST v1.1 by CT or MRI scan as: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): \\>= 30% decrease in the sum of diameters of target lesions (compared to baseline) and no new lesions; Stable disease (SD): Neither sufficient shrinkage to qualify as a response nor sufficient growth to qualify as progression; Progressive Disease (PD): \\>= 20% increase in the sum of diameters of target lesions and an absolute increase in sum of diameters of \\>=5mm (compared to the previous minimum sum) or progression of non-target lesions or a new lesion; not evaluable (NE): either no or only a subset of lesion measurements are made at an assessment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included all participants who received any study therapy and were analyzed per their randomized treatment group. Participants enrolled in Phase 2 of the study were analyzed.'}, {'type': 'SECONDARY', 'title': 'Phase 2: Objective Response Rate (ORR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI-573 45 mg/kg + AI', 'description': 'Participants received intravenous infusion of MEDI-573 45 mg/kg on Day 1 of each 21-day cycle and AI (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons. Three participants were enrolled in Phase 1b and 89 were enrolled in Phase 2 of the study.'}, {'id': 'OG001', 'title': 'Aromatase Inhibitor', 'description': 'Participants enrolled in Phase 2 of the study and received oral AI (letrozole, anastrozole, or exemestane) once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.'}], 'classes': [{'categories': [{'measurements': [{'value': '27.0', 'groupId': 'OG000', 'lowerLimit': '18.1', 'upperLimit': '37.4'}, {'value': '27.1', 'groupId': 'OG001', 'lowerLimit': '18.0', 'upperLimit': '37.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Day 1 until disease progression or death due to any cause, whichever occurred first (Approximately 8 years)', 'description': 'The ORR was defined as percentage of participants with confirmed complete response or confirmed partial response, where CR was defined as disappearance of all target and non-target lesions and no new lesions and PR was definded as \\>= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included all participants who received any study therapy and were analyzed per their randomized treatment group. Participants enrolled in Phase 2 of the study were analyzed.'}, {'type': 'SECONDARY', 'title': 'Phase 2: Time to Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI-573 45 mg/kg + AI', 'description': 'Participants received intravenous infusion of MEDI-573 45 mg/kg on Day 1 of each 21-day cycle and AI (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons. Three participants were enrolled in Phase 1b and 89 were enrolled in Phase 2 of the study.'}, {'id': 'OG001', 'title': 'Aromatase Inhibitor', 'description': 'Participants enrolled in Phase 2 of the study and received oral AI (letrozole, anastrozole, or exemestane) once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.22', 'groupId': 'OG000', 'lowerLimit': '1.7', 'upperLimit': '18.0'}, {'value': '3.98', 'groupId': 'OG001', 'lowerLimit': '1.9', 'upperLimit': '16.8'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From Day 1 until disease progression or death due to any cause, whichever occurred first (Approximately 8 years)', 'description': 'Time to response was measured from treatment start to the first documentation of disease response and was evaluated only in participants who achieved objective response (confirmed CR or confirmed PR. The CR was defined as disappearance of all target and non-target lesions and no new lesions and PR was defined as \\>= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions.', 'unitOfMeasure': 'Months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included all participants who received any study therapy and were analyzed per their randomized treatment group. Participants enrolled in Phase 2 of the study were analyzed.'}, {'type': 'SECONDARY', 'title': 'Phase 2: Duration of Response (DR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI-573 45 mg/kg + AI', 'description': 'Participants received intravenous infusion of MEDI-573 45 mg/kg on Day 1 of each 21-day cycle and AI (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons. Three participants were enrolled in Phase 1b and 89 were enrolled in Phase 2 of the study.'}, {'id': 'OG001', 'title': 'Aromatase Inhibitor', 'description': 'Participants enrolled in Phase 2 of the study and received oral AI (letrozole, anastrozole, or exemestane) once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.55', 'groupId': 'OG000', 'lowerLimit': '4.5', 'upperLimit': '58.8'}, {'value': '17.18', 'groupId': 'OG001', 'lowerLimit': '2.1', 'upperLimit': '45.1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From Day 1 until disease progression or death due to any cause, whichever occurred first (Approximately 8 years)', 'description': 'Duration of response (DR) is measured from the first documentation of disease response to the first documented progressive disease and was evaluated only in participants who achieved objective response (confirmed CR or confirmed PR). The CR was defined as disappearance of all target and non-target lesions and no new lesions and PR was defined as \\>= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions.', 'unitOfMeasure': 'Months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included all participants who received any study therapy and were analyzed per their randomized treatment group. Participants enrolled in Phase 2 of the study were analyzed.'}, {'type': 'SECONDARY', 'title': 'Phase 2: Time to Progression (TTP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI-573 45 mg/kg + AI', 'description': 'Participants received intravenous infusion of MEDI-573 45 mg/kg on Day 1 of each 21-day cycle and AI (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons. Three participants were enrolled in Phase 1b and 89 were enrolled in Phase 2 of the study.'}, {'id': 'OG001', 'title': 'Aromatase Inhibitor', 'description': 'Participants enrolled in Phase 2 of the study and received oral AI (letrozole, anastrozole, or exemestane) once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.39', 'groupId': 'OG000', 'lowerLimit': '8.34', 'upperLimit': '18.69'}, {'value': '11.33', 'groupId': 'OG001', 'lowerLimit': '8.54', 'upperLimit': '17.97'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From Day 1 until disease progression or death due to any cause, whichever occurred first (Approximately 8 years)', 'description': 'Time to progression was measured from treatment start until the first documentation of disease progression. The PD was defined as \\>= 20% increase in the sum of diameters of TLs and an absolute increase in sum of diameters of \\>=5mm (compared to the previous minimum sum) or progression of non-target lesions or a new lesion.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included all participants who received any study therapy and were analyzed per their randomized treatment group. Participants enrolled in Phase 2 of the study were analyzed.'}, {'type': 'SECONDARY', 'title': 'Phase 2: Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI-573 45 mg/kg + AI', 'description': 'Participants received intravenous infusion of MEDI-573 45 mg/kg on Day 1 of each 21-day cycle and AI (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons. Three participants were enrolled in Phase 1b and 89 were enrolled in Phase 2 of the study.'}, {'id': 'OG001', 'title': 'Aromatase Inhibitor', 'description': 'Participants enrolled in Phase 2 of the study and received oral AI (letrozole, anastrozole, or exemestane) once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.'}], 'classes': [{'categories': [{'measurements': [{'value': '39.39', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '73.2'}, {'value': '38.34', 'groupId': 'OG001', 'lowerLimit': '0.3', 'upperLimit': '51.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From Day 1 until disease progression or death due to any cause, whichever occurred first (Approximately 8 years)', 'description': 'Overall survival (OS) was measured from treatment start until death.', 'unitOfMeasure': 'Months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included all participants who received any study therapy and were analyzed per their randomized treatment group. Participants enrolled in Phase 2 of the study were analyzed.'}, {'type': 'SECONDARY', 'title': 'Phase 2: Change in Tumor Size', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI-573 45 mg/kg + AI', 'description': 'Participants received intravenous infusion of MEDI-573 45 mg/kg on Day 1 of each 21-day cycle and AI (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons. Three participants were enrolled in Phase 1b and 89 were enrolled in Phase 2 of the study.'}, {'id': 'OG001', 'title': 'Aromatase Inhibitor', 'description': 'Participants enrolled in Phase 2 of the study and received oral AI (letrozole, anastrozole, or exemestane) once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.'}], 'classes': [{'categories': [{'measurements': [{'value': '-36.2', 'spread': '35.8', 'groupId': 'OG000'}, {'value': '-26.8', 'spread': '37.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Day 1 until disease progression or death due to any cause, whichever occurred first (Approximately 8 years)', 'description': 'Mean change in tumor size is reported.', 'unitOfMeasure': 'Centimeters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included all participants who received any study therapy and were analyzed per their randomized treatment group. Participants enrolled in Phase 2 of the study were analyzed.'}, {'type': 'SECONDARY', 'title': 'Phase 1b and Phase 2: Area Under the Serum Concentration-time Curve From Time Zero to Day 21 (AUC0-day21) of MEDI-573 for Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '92', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI-573 10 mg/kg + Aromatase Inhibitor (AI)', 'description': "Participants enrolled in Phase 1b of the study and received intravenous infusion of MEDI-573 10 mg/kg on Day 1 of each 21-day cycle and AI of the investigator's choice (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons."}, {'id': 'OG001', 'title': 'MEDI-573 30 mg/kg + AI', 'description': 'Participants enrolled in Phase 1 b of the study and received intravenous infusion of MEDI-573 30 mg/kg on Day 1 of each 21-day cycle and AI (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.'}, {'id': 'OG002', 'title': 'MEDI-573 45 mg/kg + AI', 'description': 'Participants received intravenous infusion of MEDI-573 45 mg/kg on Day 1 of each 21-day cycle and AI (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons. Three participants were enrolled in Phase 1b and 89 were enrolled in Phase 2 of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '1430', 'spread': '867', 'groupId': 'OG000'}, {'value': '4500', 'spread': '725', 'groupId': 'OG001'}, {'value': '7990', 'spread': '1590', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 Days 1, 2, 8, 15, and 21 (Cycle 2 Day 1, pre-dose)', 'description': 'AUC0-day21 of MEDI-573 for Cycle 1 is reported.', 'unitOfMeasure': 'μg·day/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was considered for this analysis. Participants who received MEDI-573 were analyzed.'}, {'type': 'SECONDARY', 'title': 'Phase 1b and Phase 2: Area Under the Serum Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of MEDI-573 for Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '92', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI-573 10 mg/kg + Aromatase Inhibitor (AI)', 'description': "Participants enrolled in Phase 1b of the study and received intravenous infusion of MEDI-573 10 mg/kg on Day 1 of each 21-day cycle and AI of the investigator's choice (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons."}, {'id': 'OG001', 'title': 'MEDI-573 30 mg/kg + AI', 'description': 'Participants enrolled in Phase 1 b of the study and received intravenous infusion of MEDI-573 30 mg/kg on Day 1 of each 21-day cycle and AI (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.'}, {'id': 'OG002', 'title': 'MEDI-573 45 mg/kg + AI', 'description': 'Participants received intravenous infusion of MEDI-573 45 mg/kg on Day 1 of each 21-day cycle and AI (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons. Three participants were enrolled in Phase 1b and 89 were enrolled in Phase 2 of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '1500', 'spread': '955', 'groupId': 'OG000'}, {'value': '4930', 'spread': '691', 'groupId': 'OG001'}, {'value': '9570', 'spread': '2310', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 Days 1, 2, 8, 15, and 21 (Cycle 2 Day 1, pre-dose)', 'description': 'AUC0-info of MEDI-573 for Cycle 1 is reported.', 'unitOfMeasure': 'μg·day/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was considered for this analysis. Participants who received MEDI-573 were analyzed.'}, {'type': 'SECONDARY', 'title': 'Phase 1b and Phase 2: Dose-Normalised Area Under the Serum Concentration-time Curve From Time Zero to Infinity (DN AUC0-inf) of MEDI-573 for Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '92', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI-573 10 mg/kg + Aromatase Inhibitor (AI)', 'description': "Participants enrolled in Phase 1b of the study and received intravenous infusion of MEDI-573 10 mg/kg on Day 1 of each 21-day cycle and AI of the investigator's choice (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons."}, {'id': 'OG001', 'title': 'MEDI-573 30 mg/kg + AI', 'description': 'Participants enrolled in Phase 1 b of the study and received intravenous infusion of MEDI-573 30 mg/kg on Day 1 of each 21-day cycle and AI (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.'}, {'id': 'OG002', 'title': 'MEDI-573 45 mg/kg + AI', 'description': 'Participants received intravenous infusion of MEDI-573 45 mg/kg on Day 1 of each 21-day cycle and AI (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons. Three participants were enrolled in Phase 1b and 89 were enrolled in Phase 2 of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '150', 'spread': '95.5', 'groupId': 'OG000'}, {'value': '164', 'spread': '23.0', 'groupId': 'OG001'}, {'value': '213', 'spread': '51.3', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 Days 1, 2, 8, 15, and 21 (Cycle 2 Day 1, pre-dose)', 'description': 'DN AUC0-inf of MEDI-573 for Cycle 1 is reported.', 'unitOfMeasure': 'day·kg·μg/mL/mg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was considered for this analysis. Participants who received MEDI-573 were analyzed.'}, {'type': 'SECONDARY', 'title': 'Phase 1b and Phase 2: Maximum Observed Serum Concentration (Cmax) of MEDI-573 for Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '92', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI-573 10 mg/kg + Aromatase Inhibitor (AI)', 'description': "Participants enrolled in Phase 1b of the study and received intravenous infusion of MEDI-573 10 mg/kg on Day 1 of each 21-day cycle and AI of the investigator's choice (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons."}, {'id': 'OG001', 'title': 'MEDI-573 30 mg/kg + AI', 'description': 'Participants enrolled in Phase 1 b of the study and received intravenous infusion of MEDI-573 30 mg/kg on Day 1 of each 21-day cycle and AI (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.'}, {'id': 'OG002', 'title': 'MEDI-573 45 mg/kg + AI', 'description': 'Participants received intravenous infusion of MEDI-573 45 mg/kg on Day 1 of each 21-day cycle and AI (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons. Three participants were enrolled in Phase 1b and 89 were enrolled in Phase 2 of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '269', 'spread': '74.1', 'groupId': 'OG000'}, {'value': '624', 'spread': '210', 'groupId': 'OG001'}, {'value': '1070', 'spread': '253', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 Days 1, 2, 8, 15, and 21 (Cycle 2 Day 1, pre-dose)', 'description': 'Cmax of MEDI-573 for Cycle 1 is reported.', 'unitOfMeasure': 'μg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was considered for this analysis. Participants who received MEDI-573 were analyzed.'}, {'type': 'SECONDARY', 'title': 'Phase 1b and Phase 2: Time to Reach Maximum Observed Serum Concentration (Tmax) of MEDI-573 for Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '92', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI-573 10 mg/kg + Aromatase Inhibitor (AI)', 'description': "Participants enrolled in Phase 1b of the study and received intravenous infusion of MEDI-573 10 mg/kg on Day 1 of each 21-day cycle and AI of the investigator's choice (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons."}, {'id': 'OG001', 'title': 'MEDI-573 30 mg/kg + AI', 'description': 'Participants enrolled in Phase 1 b of the study and received intravenous infusion of MEDI-573 30 mg/kg on Day 1 of each 21-day cycle and AI (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.'}, {'id': 'OG002', 'title': 'MEDI-573 45 mg/kg + AI', 'description': 'Participants received intravenous infusion of MEDI-573 45 mg/kg on Day 1 of each 21-day cycle and AI (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons. Three participants were enrolled in Phase 1b and 89 were enrolled in Phase 2 of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.04', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0.09'}, {'value': '0.07', 'groupId': 'OG001', 'lowerLimit': '0.06', 'upperLimit': '0.08'}, {'value': '0.07', 'groupId': 'OG002', 'lowerLimit': '0.03', 'upperLimit': '0.17'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cycle 1 Days 1, 2, 8, 15, and 21 (Cycle 2 Day 1, pre-dose)', 'description': 'Tmax of MEDI-573 for Cycle 1 is reported.', 'unitOfMeasure': 'Day', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was considered for this analysis. Participants who received MEDI-573 were analyzed.'}, {'type': 'SECONDARY', 'title': 'Phase 1b and Phase 2: Systemic Clearance (CL) of MEDI-573 for Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '92', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI-573 10 mg/kg + Aromatase Inhibitor (AI)', 'description': "Participants enrolled in Phase 1b of the study and received intravenous infusion of MEDI-573 10 mg/kg on Day 1 of each 21-day cycle and AI of the investigator's choice (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons."}, {'id': 'OG001', 'title': 'MEDI-573 30 mg/kg + AI', 'description': 'Participants enrolled in Phase 1 b of the study and received intravenous infusion of MEDI-573 30 mg/kg on Day 1 of each 21-day cycle and AI (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.'}, {'id': 'OG002', 'title': 'MEDI-573 45 mg/kg + AI', 'description': 'Participants received intravenous infusion of MEDI-573 45 mg/kg on Day 1 of each 21-day cycle and AI (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons. Three participants were enrolled in Phase 1b and 89 were enrolled in Phase 2 of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.29', 'spread': '3.86', 'groupId': 'OG000'}, {'value': '6.17', 'spread': '0.889', 'groupId': 'OG001'}, {'value': '4.96', 'spread': '1.13', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 Days 1, 2, 8, 15, and 21 (Cycle 2 Day 1, pre-dose)', 'description': 'The CL is a quantitative measure of the rate at which a drug substance is removed from the body. The total systemic clearance after intravenous dose was estimated by dividing the total administered dose by AUC(0-infinity).', 'unitOfMeasure': 'mL/day/kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was considered for this analysis. Participants who received MEDI-573 were analyzed.'}, {'type': 'SECONDARY', 'title': 'Phase 1b and Phase 2: Terminal Half Life (t1/2) of MEDI-573 for Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '92', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI-573 10 mg/kg + Aromatase Inhibitor (AI)', 'description': "Participants enrolled in Phase 1b of the study and received intravenous infusion of MEDI-573 10 mg/kg on Day 1 of each 21-day cycle and AI of the investigator's choice (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons."}, {'id': 'OG001', 'title': 'MEDI-573 30 mg/kg + AI', 'description': 'Participants enrolled in Phase 1 b of the study and received intravenous infusion of MEDI-573 30 mg/kg on Day 1 of each 21-day cycle and AI (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.'}, {'id': 'OG002', 'title': 'MEDI-573 45 mg/kg + AI', 'description': 'Participants received intravenous infusion of MEDI-573 45 mg/kg on Day 1 of each 21-day cycle and AI (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons. Three participants were enrolled in Phase 1b and 89 were enrolled in Phase 2 of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.38', 'spread': '1.07', 'groupId': 'OG000'}, {'value': '5.91', 'spread': '2.09', 'groupId': 'OG001'}, {'value': '8.45', 'spread': '2.23', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 Days 1, 2, 8, 15, and 21 (Cycle 2 Day 1, pre-dose)', 'description': 'The elimination half-life (t1/2) is the time measured for the serum concentration of MEDI-573 to decrease by 1 half to its original concentration.', 'unitOfMeasure': 'Day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was considered for this analysis. Participants who received MEDI-573 were analyzed.'}, {'type': 'SECONDARY', 'title': 'Phase 1b and Phase 2: Concentration of Insulin-like Growth Factor (IGF) I and IGF-II', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '92', 'groupId': 'OG002'}, {'value': '85', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI-573 10 mg/kg + Aromatase Inhibitor (AI)', 'description': "Participants enrolled in Phase 1b of the study and received intravenous infusion of MEDI-573 10 mg/kg on Day 1 of each 21-day cycle and AI of the investigator's choice (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons."}, {'id': 'OG001', 'title': 'MEDI-573 30 mg/kg + AI', 'description': 'Participants enrolled in Phase 1 b of the study and received intravenous infusion of MEDI-573 30 mg/kg on Day 1 of each 21-day cycle and AI (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.'}, {'id': 'OG002', 'title': 'MEDI-573 45 mg/kg + AI', 'description': 'Participants received intravenous infusion of MEDI-573 45 mg/kg on Day 1 of each 21-day cycle and AI (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons. Three participants were enrolled in Phase 1b and 89 were enrolled in Phase 2 of the study.'}, {'id': 'OG003', 'title': 'Aromatase Inhibitor', 'description': 'Participants enrolled in Phase 2 of the study and received oral AI (letrozole, anastrozole, or exemestane) once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.'}], 'classes': [{'title': 'Baseline: Free IGF-I Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.57', 'spread': '0.712', 'groupId': 'OG000'}, {'value': '1.25', 'spread': '0.635', 'groupId': 'OG001'}, {'value': '3.49', 'spread': '4.39', 'groupId': 'OG002'}, {'value': '1.89', 'spread': '1.24', 'groupId': 'OG003'}]}]}, {'title': 'Baseline: Free IGF-II Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.81', 'spread': '1.66', 'groupId': 'OG000'}, {'value': '3.07', 'spread': '0.709', 'groupId': 'OG001'}, {'value': '3.01', 'spread': '1.20', 'groupId': 'OG002'}, {'value': '3.03', 'spread': '1.12', 'groupId': 'OG003'}]}]}, {'title': 'EOT: Free IGF-I Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '38', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.724', 'spread': '0.421', 'groupId': 'OG000'}, {'value': '0.313', 'spread': '0.0', 'groupId': 'OG001'}, {'value': '0.346', 'spread': '0.130', 'groupId': 'OG002'}, {'value': '2.32', 'spread': '3.64', 'groupId': 'OG003'}]}]}, {'title': 'EOT: Free IGF-II Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '38', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.625', 'spread': '0.0', 'groupId': 'OG000'}, {'value': '0.625', 'spread': '0.0', 'groupId': 'OG001'}, {'value': '0.641', 'spread': '0.102', 'groupId': 'OG002'}, {'value': '3.12', 'spread': '1.22', 'groupId': 'OG003'}]}]}, {'title': '60 days post last dose: Free IGF-I Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.54', 'spread': 'NA', 'comment': 'Not applicable as only one participant was evaluable for the specified time point.', 'groupId': 'OG000'}, {'value': '1.33', 'spread': '0.3', 'groupId': 'OG001'}, {'value': '1.02', 'spread': '1.29', 'groupId': 'OG002'}, {'value': '4.62', 'spread': '8.52', 'groupId': 'OG003'}]}]}, {'title': '60 days post last dose: Free IGF-II Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.49', 'spread': 'NA', 'comment': 'Not applicable as only one participant was evaluable for the specified time point.', 'groupId': 'OG000'}, {'value': '0.625', 'spread': '0.0', 'groupId': 'OG001'}, {'value': '0.984', 'spread': '0.734', 'groupId': 'OG002'}, {'value': '3.38', 'spread': '1.51', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Cycle1 Day1 pre-dose), end of treatment (EOT), and 60 days post last dose (Approximately 8 years)', 'description': 'The mean concentration profiles of both IGF-I and IGF-II post administration of MEDI-573 in plasma were evaluated during treatment.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received any study therapy and were analyzed per the treatment they actually received. Participants with free IGF concentration were analyzed.'}, {'type': 'SECONDARY', 'title': 'Phase 1b and Phase 2: Number of Participants With Positive Anti-drug Antibodies (ADA) to MEDI-573', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '92', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI-573 10 mg/kg + Aromatase Inhibitor (AI)', 'description': "Participants enrolled in Phase 1b of the study and received intravenous infusion of MEDI-573 10 mg/kg on Day 1 of each 21-day cycle and AI of the investigator's choice (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons."}, {'id': 'OG001', 'title': 'MEDI-573 30 mg/kg + AI', 'description': 'Participants enrolled in Phase 1 b of the study and received intravenous infusion of MEDI-573 30 mg/kg on Day 1 of each 21-day cycle and AI (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.'}, {'id': 'OG002', 'title': 'MEDI-573 45 mg/kg + AI', 'description': 'Participants received intravenous infusion of MEDI-573 45 mg/kg on Day 1 of each 21-day cycle and AI (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons. Three participants were enrolled in Phase 1b and 89 were enrolled in Phase 2 of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Pre-infusion on Day 1 of each cycle, End of Treatment, Day 30, 60 and 90 post treatment (approximately 8 years)', 'description': 'Participants With Positive ADA to MEDI-573 are reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received MEDI-573 and were analyzed per the treatment they actually received were analyzed for this outcome measure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'MEDI-573 10 mg/kg + Aromatase Inhibitor (AI)', 'description': "Participants enrolled in Phase 1b of the study and received intravenous infusion of MEDI-573 10 mg/kg on Day 1 of each 21-day cycle and AI of the investigator's choice (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons."}, {'id': 'FG001', 'title': 'MEDI-573 30 mg/kg + AI', 'description': 'Participants enrolled in Phase 1 b of the study and received intravenous infusion of MEDI-573 30 mg/kg on Day 1 of each 21-day cycle and AI (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.'}, {'id': 'FG002', 'title': 'MEDI-573 45 mg/kg + AI', 'description': 'Participants received intravenous infusion of MEDI-573 45 mg/kg on Day 1 of each 21-day cycle and AI (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons. Three participants were enrolled in Phase 1b and 89 were enrolled in Phase 2 of the study.'}, {'id': 'FG003', 'title': 'Aromatase Inhibitor', 'description': 'Participants enrolled in Phase 2 of the study and received oral AI (letrozole, anastrozole, or exemestane) once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '92'}, {'groupId': 'FG003', 'numSubjects': '85'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '21'}, {'groupId': 'FG003', 'numSubjects': '23'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '71'}, {'groupId': 'FG003', 'numSubjects': '62'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '14'}, {'groupId': 'FG003', 'numSubjects': '11'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '43'}, {'groupId': 'FG003', 'numSubjects': '36'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '13'}, {'groupId': 'FG003', 'numSubjects': '13'}]}]}], 'recruitmentDetails': 'The study was conducted across 10 countries (Belgium, Canada, France, Germany, Hungary, Israel, Spain, Poland, United Kingdom, USA).', 'preAssignmentDetails': 'A total of 187 participants were screened in the study. Of which, 183 participants were treated with study drugs.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}, {'value': '85', 'groupId': 'BG003'}, {'value': '183', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'MEDI-573 10 mg/kg + Aromatase Inhibitor (AI)', 'description': "Participants enrolled in Phase 1b of the study and received intravenous infusion of MEDI-573 10 mg/kg on Day 1 of each 21-day cycle and AI of the investigator's choice (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons."}, {'id': 'BG001', 'title': 'MEDI-573 30 mg/kg + AI', 'description': 'Participants enrolled in Phase 1 b of the study and received intravenous infusion of MEDI-573 30 mg/kg on Day 1 of each 21-day cycle and AI (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.'}, {'id': 'BG002', 'title': 'MEDI-573 45 mg/kg + AI', 'description': 'Participants received intravenous infusion of MEDI-573 45 mg/kg on Day 1 of each 21-day cycle and AI (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons. Three participants were enrolled in Phase 1b and 89 were enrolled in Phase 2 of the study.'}, {'id': 'BG003', 'title': 'Aromatase Inhibitor', 'description': 'Participants enrolled in Phase 2 of the study and received oral AI (letrozole, anastrozole, or exemestane) once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66.3', 'spread': '12.3', 'groupId': 'BG000'}, {'value': '61.0', 'spread': '8.7', 'groupId': 'BG001'}, {'value': '63.2', 'spread': '10.5', 'groupId': 'BG002'}, {'value': '63.3', 'spread': '11.0', 'groupId': 'BG003'}, {'value': '63.2', 'spread': '10.7', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}, {'value': '85', 'groupId': 'BG003'}, {'value': '183', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}, {'value': '79', 'groupId': 'BG003'}, {'value': '170', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}, {'value': '82', 'groupId': 'BG003'}, {'value': '171', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Intent-to-Treat (ITT) population included all participants who received any study therapy and were analysed per their randomized treatment group.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-07-25', 'size': 1577269, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-06-06T03:33', 'hasProtocol': True}, {'date': '2011-06-14', 'size': 838627, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-06-06T03:34', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 188}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2019-06-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-22', 'studyFirstSubmitDate': '2011-09-12', 'resultsFirstSubmitDate': '2018-05-30', 'studyFirstSubmitQcDate': '2011-10-04', 'lastUpdatePostDateStruct': {'date': '2020-06-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-07-31', 'studyFirstPostDateStruct': {'date': '2011-10-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Phase 1b and Phase 2: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)', 'timeFrame': 'From the start of study treatment (Day 1) through 60 days after the last dose of treatment or until the participants started another anticancer therapy, whichever occurs first (approximately 8 years)', 'description': 'An Adverse Event (AE) is any unfavourable and unintended sign, symptoms, or diseases temporally associated with use of study drug, whether or not considered related to study drug. A serious adverse event (SAE) is an AE that results in death, initial or prolonged inpatient hospitalization, life-threatening, persistent or significant disability/incapacity, congenital anomaly/birth defect, or an important medical event. TEAEs and TESAEs are defined as AEs and SAEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug, up to 60 days after the last study drug or until the participants started another anticancer therapy, whichever occurs first (approximately 8 years).'}, {'measure': 'Phase 1b: Number of Participants With Dose-limiting Toxicities (DLTs)', 'timeFrame': 'Up to Day 21 of Cycle 1', 'description': 'The AEs that occurred during Cycle 1 (Days 1 to 21) and were suspected of having a causal relationship to MEDI-573 and were \\>= Grade 3 in severity were considered as DLTs.'}, {'measure': 'Phase 1b: Number of DLTs', 'timeFrame': 'Up to Day 21 of Cycle 1', 'description': 'The AEs that occurred during Cycle 1 (Days 1 to 21) and were suspected of having a causal relationship to MEDI-573 and were \\>= Grade 3 in severity were considered as DLTs.'}, {'measure': 'Phase 2: Progression-free Survival (PFS)', 'timeFrame': 'From Day 1 until disease progression or death due to any cause, whichever occurred first (Approximately 8 years)', 'description': 'Progression-free survival (PFS) was defined as the time from the randomization until the first documentation of disease progression or death due to any cause, whichever occurred first.\n\nThe PFS was censored on the date of the last tumor assessment documenting absence of tumor progression for participants who had no documented progression and were still alive prior to data cut-off, dropout, or the initiation of alternate anticancer treatment. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as \\>= 20% increase in the sum of diameters of target lesions and an absolute increase in sum of diameters of \\>=5mm (compared to the previous minimum sum) or progression of non-target lesions or a new lesion.'}], 'secondaryOutcomes': [{'measure': 'Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs', 'timeFrame': 'From the start of study treatment (Day 1) through 60 days after the last dose of treatment or until the participants started another anticancer therapy, whichever occurs first (approximately 8 years)', 'description': 'An abnormal laboratory finding which required an action or intervention by the investigator, or a finding judged by the investigator to represent a change beyond the range of normal physiologic fluctuation were reported as AEs. The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug, up to 60 days after the last study drug or until the participants started another anticancer therapy, whichever occurs first (approximately 8 years).'}, {'measure': 'Phase 1b and Phase 2: Number of Participants With Abnormal Vital Signs Reported as TEAEs', 'timeFrame': 'From the start of study treatment (Day 1) through 60 days after the last dose of treatment or until the participants started another anticancer therapy, whichever occurs first (approximately 8 years)', 'description': 'An abnormal vital signs that were judged by the investigator to be medically significant were reported as AEs. The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug, up to 60 days after the last study drug or until the participants started another anticancer therapy, whichever occurs first (approximately 8 years).'}, {'measure': 'Phase 1b and Phase 2: Number of Participants With Abnormal Electrocardiogram (ECG) Reported as TEAEs', 'timeFrame': 'From the start of study treatment (Day 1) through 60 days after the last dose of treatment or until the participants started another anticancer therapy, whichever occurs first (approximately 8 years)', 'description': 'An abnormal ECG findings that were judged by the investigator to be medically significant were reported as AEs. The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug, up to 60 days after the last study drug or until the participants started another anticancer therapy, whichever occurs first (approximately 8 years).'}, {'measure': 'Phase 2: Number of Participants With Best Overall Tumor Response', 'timeFrame': 'From Day 1 until disease progression or death due to any cause, whichever occurred first (Approximately 8 years)', 'description': 'Tumor evaluation was based on RECIST v1.1 by CT or MRI scan as: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): \\>= 30% decrease in the sum of diameters of target lesions (compared to baseline) and no new lesions; Stable disease (SD): Neither sufficient shrinkage to qualify as a response nor sufficient growth to qualify as progression; Progressive Disease (PD): \\>= 20% increase in the sum of diameters of target lesions and an absolute increase in sum of diameters of \\>=5mm (compared to the previous minimum sum) or progression of non-target lesions or a new lesion; not evaluable (NE): either no or only a subset of lesion measurements are made at an assessment.'}, {'measure': 'Phase 2: Objective Response Rate (ORR)', 'timeFrame': 'From Day 1 until disease progression or death due to any cause, whichever occurred first (Approximately 8 years)', 'description': 'The ORR was defined as percentage of participants with confirmed complete response or confirmed partial response, where CR was defined as disappearance of all target and non-target lesions and no new lesions and PR was definded as \\>= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions.'}, {'measure': 'Phase 2: Time to Response', 'timeFrame': 'From Day 1 until disease progression or death due to any cause, whichever occurred first (Approximately 8 years)', 'description': 'Time to response was measured from treatment start to the first documentation of disease response and was evaluated only in participants who achieved objective response (confirmed CR or confirmed PR. The CR was defined as disappearance of all target and non-target lesions and no new lesions and PR was defined as \\>= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions.'}, {'measure': 'Phase 2: Duration of Response (DR)', 'timeFrame': 'From Day 1 until disease progression or death due to any cause, whichever occurred first (Approximately 8 years)', 'description': 'Duration of response (DR) is measured from the first documentation of disease response to the first documented progressive disease and was evaluated only in participants who achieved objective response (confirmed CR or confirmed PR). The CR was defined as disappearance of all target and non-target lesions and no new lesions and PR was defined as \\>= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions.'}, {'measure': 'Phase 2: Time to Progression (TTP)', 'timeFrame': 'From Day 1 until disease progression or death due to any cause, whichever occurred first (Approximately 8 years)', 'description': 'Time to progression was measured from treatment start until the first documentation of disease progression. The PD was defined as \\>= 20% increase in the sum of diameters of TLs and an absolute increase in sum of diameters of \\>=5mm (compared to the previous minimum sum) or progression of non-target lesions or a new lesion.'}, {'measure': 'Phase 2: Overall Survival (OS)', 'timeFrame': 'From Day 1 until disease progression or death due to any cause, whichever occurred first (Approximately 8 years)', 'description': 'Overall survival (OS) was measured from treatment start until death.'}, {'measure': 'Phase 2: Change in Tumor Size', 'timeFrame': 'From Day 1 until disease progression or death due to any cause, whichever occurred first (Approximately 8 years)', 'description': 'Mean change in tumor size is reported.'}, {'measure': 'Phase 1b and Phase 2: Area Under the Serum Concentration-time Curve From Time Zero to Day 21 (AUC0-day21) of MEDI-573 for Cycle 1', 'timeFrame': 'Cycle 1 Days 1, 2, 8, 15, and 21 (Cycle 2 Day 1, pre-dose)', 'description': 'AUC0-day21 of MEDI-573 for Cycle 1 is reported.'}, {'measure': 'Phase 1b and Phase 2: Area Under the Serum Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of MEDI-573 for Cycle 1', 'timeFrame': 'Cycle 1 Days 1, 2, 8, 15, and 21 (Cycle 2 Day 1, pre-dose)', 'description': 'AUC0-info of MEDI-573 for Cycle 1 is reported.'}, {'measure': 'Phase 1b and Phase 2: Dose-Normalised Area Under the Serum Concentration-time Curve From Time Zero to Infinity (DN AUC0-inf) of MEDI-573 for Cycle 1', 'timeFrame': 'Cycle 1 Days 1, 2, 8, 15, and 21 (Cycle 2 Day 1, pre-dose)', 'description': 'DN AUC0-inf of MEDI-573 for Cycle 1 is reported.'}, {'measure': 'Phase 1b and Phase 2: Maximum Observed Serum Concentration (Cmax) of MEDI-573 for Cycle 1', 'timeFrame': 'Cycle 1 Days 1, 2, 8, 15, and 21 (Cycle 2 Day 1, pre-dose)', 'description': 'Cmax of MEDI-573 for Cycle 1 is reported.'}, {'measure': 'Phase 1b and Phase 2: Time to Reach Maximum Observed Serum Concentration (Tmax) of MEDI-573 for Cycle 1', 'timeFrame': 'Cycle 1 Days 1, 2, 8, 15, and 21 (Cycle 2 Day 1, pre-dose)', 'description': 'Tmax of MEDI-573 for Cycle 1 is reported.'}, {'measure': 'Phase 1b and Phase 2: Systemic Clearance (CL) of MEDI-573 for Cycle 1', 'timeFrame': 'Cycle 1 Days 1, 2, 8, 15, and 21 (Cycle 2 Day 1, pre-dose)', 'description': 'The CL is a quantitative measure of the rate at which a drug substance is removed from the body. The total systemic clearance after intravenous dose was estimated by dividing the total administered dose by AUC(0-infinity).'}, {'measure': 'Phase 1b and Phase 2: Terminal Half Life (t1/2) of MEDI-573 for Cycle 1', 'timeFrame': 'Cycle 1 Days 1, 2, 8, 15, and 21 (Cycle 2 Day 1, pre-dose)', 'description': 'The elimination half-life (t1/2) is the time measured for the serum concentration of MEDI-573 to decrease by 1 half to its original concentration.'}, {'measure': 'Phase 1b and Phase 2: Concentration of Insulin-like Growth Factor (IGF) I and IGF-II', 'timeFrame': 'Baseline (Cycle1 Day1 pre-dose), end of treatment (EOT), and 60 days post last dose (Approximately 8 years)', 'description': 'The mean concentration profiles of both IGF-I and IGF-II post administration of MEDI-573 in plasma were evaluated during treatment.'}, {'measure': 'Phase 1b and Phase 2: Number of Participants With Positive Anti-drug Antibodies (ADA) to MEDI-573', 'timeFrame': 'Pre-infusion on Day 1 of each cycle, End of Treatment, Day 30, 60 and 90 post treatment (approximately 8 years)', 'description': 'Participants With Positive ADA to MEDI-573 are reported.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['MEDI-573, breast cancer, metastatic, aromatase inhibitor, anti-IGF'], 'conditions': ['Hormone-sensitive, HER-2 Negative Metastatic Breast Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=50&filename=CD-ON-MEDI-573-1030-Protocol_amendment%203_redaction-PDF-A.pdf', 'label': 'CD-ON-MEDI-573-1030-Protocol\\_amendment 3\\_redaction-PDF-A'}, {'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=50&filename=CD-ON-MEDI-573-1030-SAP-V1_and_V2_Final_Redacted_PDF-A.pdf', 'label': 'CD-ON-MEDI-573-1030-SAP-V1\\_and\\_V2\\_Final\\_Redacted\\_PDF-A'}]}, 'descriptionModule': {'briefSummary': 'Study to evaluate the safety, tolerability, antitumor activity, and pharmacology of MEDI-573 in combination with an aromatase inhibitor (AI) in adult subjects with HR+, HER2-negative MBC.', 'detailedDescription': 'This is a Phase 1b/2, multicenter, open-label study to evaluate the safety, tolerability, antitumor activity, and pharmacology of MEDI-573 in combination with an AI in adult subjects with HR+, HER2-negative MBC. This study has 2 phases: a dose-evaluation phase (Phase 1b) and a randomization phase (Phase 2).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically-confirmed MBC not deemed amenable to curative surgery or curative radiation therapy\n* Tumors are positive for ER, PgR, or both\n* Tumors must be negative for HER2 (by FISH, CISH or IHC)\n* Female gender and age ≥ 18 years at time of study entry\n* Postmenopausal\n* Karnofsky Performance Status ≥ 70\n* Life expectancy of ≥ 6 months\n\nExclusion Criteria:\n\n* Subjects who received prior chemotherapy, hormonal therapy, immunotherapy or biologic therapy for advanced or metastatic disease with the following exceptions:\n\n * Prior adjuvant therapy with an AI and/or tamoxifen is allowed, provided treatment ended at least 2 weeks prior to the first dose of MEDI-573\n * Prior neoadjuvant and/or adjuvant chemotherapy for breast cancer is allowed\n* Extensive symptomatic visceral disease including hepatic involvement and pulmonary lymphangitic spread of tumor, or disease that is considered by the investigator to be rapidly progressing or life threatening (eg, subjects who are intended for chemotherapy)\n* Active brain metastases with the exception of subject has been treated and are asymptomatic and there has been no evidence of CNS progression for at least 4 weeks of first dose of MEDI-573\n* Evidence of ongoing spinal cord compression or leptomeningeal carcinomatosis\n* Unresolved toxicities from prior therapy with the exception of alopecia that have not resolved to ≤ Grade 1 at the time of starting study treatment\n* Previous treatment with agents that target the IGF receptor\n* History of allergy or reaction attributed to compounds of chemical or biologic composition similar to those of MEDI-573 or AI\n* History of another invasive malignancy within 5 years except for curatively resected nonmelanoma skin cancer or carcinoma in situ of the cervix\n* Poorly controlled diabetes mellitus'}, 'identificationModule': {'nctId': 'NCT01446159', 'briefTitle': 'Study of MEDI-573 Plus Standard Endocrine Therapy for Women With Hormone-sensitive Metastatic Breast Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'MedImmune LLC'}, 'officialTitle': 'A Phase 1b/2 Randomized Study of MEDI-573 in Combination With an Aromatase Inhibitor (AI) Versus AI Alone in Women With Metastatic Breast Cancer (MBC)', 'orgStudyIdInfo': {'id': 'CD-ON-MEDI-573-1030'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MEDI-573 10 mg/kg + AI', 'description': "Participants who will be enrolled in Phase 1b Cohort A of the study will receive intravenous infusion of MEDI-573 10 mg/kg on Day 1 of each 21-day cycle and AI of the investigator's choice (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.", 'interventionNames': ['Drug: MEDI-573', 'Drug: Aromatase Inhibitor']}, {'type': 'EXPERIMENTAL', 'label': 'MEDI-573 30 mg/kg + AI', 'description': "Participants who will be enrolled in Phase 1b Cohort B of the study will receive intravenous infusion of MEDI-573 30 mg/kg on Day 1 of each 21-day cycle and AI of the investigator's choice (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.", 'interventionNames': ['Drug: MEDI-573', 'Drug: Aromatase Inhibitor']}, {'type': 'EXPERIMENTAL', 'label': 'MEDI-573 45 mg/kg + AI', 'description': "Participants who will be enrolled in Phase 1b Cohort C and Phase 2 Arm 1 of the study will receive intravenous infusion of MEDI-573 45 mg/kg on Day 1 of each 21-day cycle and AI of the investigator's choice (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.", 'interventionNames': ['Drug: MEDI-573', 'Drug: Aromatase Inhibitor']}, {'type': 'EXPERIMENTAL', 'label': 'Aromatase Inhibitor', 'description': "Participants who will be enrolled in Phase 2 Arm 2 of the study will receive oral AI of the investigator's choice (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.", 'interventionNames': ['Drug: Aromatase Inhibitor']}], 'interventions': [{'name': 'MEDI-573', 'type': 'DRUG', 'description': 'Intravenous infusion of MEDI-573 (10 or 30 or 45 mg/kg) will be administered on Day 1 of each 21-day cycle until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.', 'armGroupLabels': ['MEDI-573 10 mg/kg + AI', 'MEDI-573 30 mg/kg + AI', 'MEDI-573 45 mg/kg + AI']}, {'name': 'Aromatase Inhibitor', 'type': 'DRUG', 'description': "Aromatase inhibitor of the investigator's choice (letrozole, anastrozole, or exemestane) will be provided orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.", 'armGroupLabels': ['Aromatase Inhibitor', 'MEDI-573 10 mg/kg + AI', 'MEDI-573 30 mg/kg + AI', 'MEDI-573 45 mg/kg + AI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85259', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '93309', 'city': 'Bakersfield', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 35.37329, 'lon': -119.01871}}, {'zip': '94523', 'city': 'Pleasant Hill', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 37.94798, 'lon': -122.0608}}, {'zip': '06904', 'city': 'Stamford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 41.05343, 'lon': -73.53873}}, {'zip': '33901', 'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'zip': '32804', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '34952-7596', 'city': 'Port Saint Lucie', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 27.29393, 'lon': -80.35033}}, {'zip': '33705', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '30607', 'city': 'Athens', 'state': 'Georgia', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.96095, 'lon': -83.37794}}, {'zip': '30901', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 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