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Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug

Ignite Creation Date: 2025-12-24 @ 9:16 PM

Ignite Modification Date: 2026-01-07 @ 9:30 AM

Study NCT ID: NCT02747004

Status: ACTIVE_NOT_RECRUITING

Last Update Posted: 2025-04-20

First Post: 2016-04-19

Is Gene Therapy: True

Has Adverse Events: True

Brief Title: A Study of Abemaciclib (LY2835219) Plus Tamoxifen or Abemaciclib Alone in Women With Metastatic Breast Cancer

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000590451', 'term': 'abemaciclib'}, {'id': 'D013629', 'term': 'Tamoxifen'}], 'ancestors': [{'id': 'D013267', 'term': 'Stilbenes'}, {'id': 'D001597', 'term': 'Benzylidene Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov@lilly.com', 'phone': '800-545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 21 Months', 'description': 'All randomized participants who received at least one dose of study drug.', 'eventGroups': [{'id': 'EG000', 'title': '150mg Abemaciclib + 20mg Tamoxifen', 'description': 'Participants received oral dose of 150 milligrams (mg) Abemaciclib every 12 hours (Q12H) along with 20mg Tamoxifen every 24 hours (QD) on days 1 to days 28 of a 28 day cycle.', 'otherNumAtRisk': 78, 'deathsNumAtRisk': 78, 'otherNumAffected': 73, 'seriousNumAtRisk': 78, 'deathsNumAffected': 18, 'seriousNumAffected': 16}, {'id': 'EG001', 'title': '150mg Abemaciclib', 'description': 'Participants received oral dose of 150 milligrams (mg) Abemaciclib every 12 hours (Q12H) on days 1 to days 28 of a 28 day cycle.', 'otherNumAtRisk': 79, 'deathsNumAtRisk': 79, 'otherNumAffected': 77, 'seriousNumAtRisk': 79, 'deathsNumAffected': 28, 'seriousNumAffected': 16}, {'id': 'EG002', 'title': '200mg Abemaciclib + 2mg Prophylactic Loperamide', 'description': "Participants received oral dose of 200 milligrams (mg) Abemaciclib every 12 hours (Q12H) along with 2mg Prophylactic Loperamide on days 1 to days 28 of a 28 day cycle.\n\nNote: During Cycle 1, 2mg prophylactic loperamide was administered orally with the first dose of abemaciclib daily. During Cycle 2 and beyond, loperamide was administered at investigator's discretion and/or if clinically indicated.", 'otherNumAtRisk': 77, 'deathsNumAtRisk': 77, 'otherNumAffected': 75, 'seriousNumAtRisk': 77, 'deathsNumAffected': 29, 'seriousNumAffected': 21}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 63, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 36, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 68, 'numAffected': 31}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 24, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 23, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 9, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 64, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 46, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 51, 'numAffected': 18}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 18, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Lacrimation increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 21, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 17, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 21, 'numAffected': 19}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 16, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 13, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 28, 'numAffected': 25}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 161, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 244, 'numAffected': 53}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 140, 'numAffected': 47}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 48, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 47, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 50, 'numAffected': 33}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 7, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 34, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 62, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 34, 'numAffected': 20}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 26, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 20, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 32, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 30, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 41, 'numAffected': 21}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 8, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 10, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 8, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 12, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 10, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 35, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 15, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 11, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 13, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 7, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 20, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 22, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 71, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 81, 'numAffected': 22}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 14, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 22, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 49, 'numAffected': 22}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 9, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 26, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 56, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 52, 'numAffected': 15}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 29, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 21, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 27, 'numAffected': 17}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hypertriglyceridaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 22, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hypoalbuminaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 9, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 11, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 11, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 7, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hypophosphataemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 14, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective 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{'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Cerebral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Monoparesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Spinal cord compression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Glomerulonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Progression Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '150mg Abemaciclib + 20mg Tamoxifen', 'description': 'Participants received oral dose of 150 milligrams (mg) Abemaciclib every 12 hours (Q12H) along with 20mg Tamoxifen every 24 hours (QD) on days 1 to days 28 of a 28 day cycle.'}, {'id': 'OG001', 'title': '150mg Abemaciclib', 'description': 'Participants received oral dose of 150 milligrams (mg) Abemaciclib every 12 hours (Q12H) on days 1 to days 28 of a 28 day cycle.'}, {'id': 'OG002', 'title': '200mg Abemaciclib + 2mg Prophylactic Loperamide', 'description': 'Participants received oral dose of 150 milligrams (mg) Abemaciclib every 12 hours (Q12H) along with 2mg Prophylactic Loperamide on days 1 to days 28 of a 28 day cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.07', 'groupId': 'OG000', 'lowerLimit': '6.90', 'upperLimit': '10.95'}, {'value': '6.48', 'groupId': 'OG001', 'lowerLimit': '4.77', 'upperLimit': '9.21'}, {'value': '7.43', 'groupId': 'OG002', 'lowerLimit': '5.42', 'upperLimit': '9.17'}]}]}], 'analyses': [{'pValue': '0.2930', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'Two-sided P-value.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by the randomization factors of presence of liver metastases and prior use of Tamoxifen in the advanced/metastatic setting.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.045', 'ciLowerLimit': '0.711', 'ciUpperLimit': '1.535', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Stratified by the randomization factors of presence of liver metastases and prior use of Tamoxifen in the advanced/metastatic setting.', 'nonInferiorityComment': 'Informal phase 2 non-inferiority.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to Objective Disease Progression or Death from Any Cause (Up to 21 Months)', 'description': 'Progression-free survival time was measured from the date of randomization to the date of investigator-determined objective progression as defined by RECIST v1.1, or death from any cause, whichever occurred first. Progressive disease (PD) is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. Participants who have neither progressed nor died were censored at the day of their last radiographic tumor assessment (if available) or date of randomization if no post baseline radiographic assessment is available.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug. Censored participants: 21 in Abemaciclib 150 mg + Tamoxifen 20mg; 25 in Abemaciclib 150 mg; 22 in Abemaciclib 200mg.'}, {'type': 'SECONDARY', 'title': 'Objective Response Rate (ORR): Percentage of Participants With a Complete Response (CR) or Partial Response (PR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '150mg Abemaciclib + 20mg Tamoxifen', 'description': 'Participants received oral dose of 150 milligrams (mg) Abemaciclib every 12 hours (Q12H) along with 20mg Tamoxifen every 24 hours (QD) on days 1 to days 28 of a 28 day cycle.'}, {'id': 'OG001', 'title': '150mg Abemaciclib', 'description': 'Participants received oral dose of 150 milligrams (mg) Abemaciclib every 12 hours (Q12H) on days 1 to days 28 of a 28 day cycle.'}, {'id': 'OG002', 'title': '200mg Abemaciclib + 2mg Prophylactic Loperamide', 'description': 'Participants received oral dose of 150 milligrams (mg) Abemaciclib every 12 hours (Q12H) along with 2mg Prophylactic Loperamide on days 1 to days 28 of a 28 day cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '34.6', 'groupId': 'OG000', 'lowerLimit': '24.1', 'upperLimit': '45.2'}, {'value': '24.1', 'groupId': 'OG001', 'lowerLimit': '14.6', 'upperLimit': '33.5'}, {'value': '32.5', 'groupId': 'OG002', 'lowerLimit': '22', 'upperLimit': '42.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Objective Disease Progression (Up to 21 Months)', 'description': 'Objective response rate was defined as the percentage of participants with CR or PR according to RECIST v1.1. CR was defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR was defined as at least a 30% decrease in the sum of the LD (longest diameter) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and had PR/CR data.'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DoR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '150mg Abemaciclib + 20mg Tamoxifen', 'description': 'Participants received oral dose of 150 milligrams (mg) Abemaciclib every 12 hours (Q12H) along with 20mg Tamoxifen every 24 hours (QD) on days 1 to days 28 of a 28 day cycle.'}, {'id': 'OG001', 'title': '150mg Abemaciclib', 'description': 'Participants received oral dose of 150 milligrams (mg) Abemaciclib every 12 hours (Q12H) on days 1 to days 28 of a 28 day cycle.'}, {'id': 'OG002', 'title': '200mg Abemaciclib + 2mg Prophylactic Loperamide', 'description': 'Participants received oral dose of 150 milligrams (mg) Abemaciclib every 12 hours (Q12H) along with 2mg Prophylactic Loperamide on days 1 to days 28 of a 28 day cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.40', 'groupId': 'OG000', 'lowerLimit': '3.88', 'upperLimit': '9.27'}, {'value': '9.21', 'comment': 'Upper bound not estimable.', 'groupId': 'OG001', 'lowerLimit': '3.72', 'upperLimit': 'NA'}, {'value': '7.46', 'groupId': 'OG002', 'lowerLimit': '5.56', 'upperLimit': '10.92'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Up to 21 Months)', 'description': 'DoR is defined as the time from the date of first evidence of a CR or PR to the date of objective progression or death from any cause, whichever is earlier as defined by Recist v1.1. CR was defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR was defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and achieved CR or PR.\n\nCensored participants: 9 in Abemaciclib 150 mg + Tamoxifen 20mg; 9 in Abemaciclib 150 mg; 11 in Abemaciclib 200mg.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'timeFrame': 'Baseline to Death from Any Cause (Approximately 36 Months)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics (PK): Mean Single Dose Concentration of Abemaciclib and Its Metabolites', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '150mg Abemaciclib + 20mg Tamoxifen', 'description': 'Participants received oral dose of 150 milligrams (mg) Abemaciclib every 12 hours (Q12H) along with 20mg Tamoxifen every 24 hours (QD) on days 1 to days 28 of a 28 day cycle.'}, {'id': 'OG001', 'title': '150mg Abemaciclib', 'description': 'Participants received oral dose of 150 milligrams (mg) Abemaciclib every 12 hours (Q12H) on days 1 to days 28 of a 28 day cycle.'}, {'id': 'OG002', 'title': '200mg Abemaciclib + 2mg Prophylactic Loperamide', 'description': 'Participants received oral dose of 150 milligrams (mg) Abemaciclib every 12 hours (Q12H) along with 2mg Prophylactic Loperamide on days 1 to days 28 of a 28 day cycle.'}], 'classes': [{'title': 'Abemaciclib (C1D1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '10.9', 'spread': '231', 'groupId': 'OG000'}, {'value': '3.05', 'spread': '95.4', 'groupId': 'OG001'}, {'value': '8.59', 'spread': '440', 'groupId': 'OG002'}]}]}, {'title': 'M2 (C1D1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6.05', 'spread': '123', 'groupId': 'OG000'}, {'value': '2.14', 'spread': '60.1', 'groupId': 'OG001'}, {'value': '6.85', 'spread': '237', 'groupId': 'OG002'}]}]}, {'title': 'M20 (C1D1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6.50', 'spread': '132', 'groupId': 'OG000'}, {'value': '2.54', 'spread': '54.5', 'groupId': 'OG001'}, {'value': '7.91', 'spread': '220', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle (C) 1 Day (D) 1 post dose', 'description': 'Mean single dose concentrations of Abemaciclib and its metabolites (M2 \\& M20) are reported.', 'unitOfMeasure': 'Nanogram per Millilitre (ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and had evaluable PK samples.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics (PK): Steady State Concentration of Abemaciclib and Its Metabolites', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '150mg Abemaciclib + 20mg Tamoxifen', 'description': 'Participants received oral dose of 150 milligrams (mg) Abemaciclib every 12 hours (Q12H) along with 20mg Tamoxifen every 24 hours (QD) on days 1 to days 28 of a 28 day cycle.'}, {'id': 'OG001', 'title': '150mg Abemaciclib', 'description': 'Participants received oral dose of 150 milligrams (mg) Abemaciclib every 12 hours (Q12H) on days 1 to days 28 of a 28 day cycle.'}, {'id': 'OG002', 'title': '200mg Abemaciclib + 2mg Prophylactic Loperamide', 'description': 'Participants received oral dose of 150 milligrams (mg) Abemaciclib every 12 hours (Q12H) along with 2mg Prophylactic Loperamide on days 1 to days 28 of a 28 day cycle.'}], 'classes': [{'title': 'Abemaciclib (C1D15)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '214', 'spread': '66.4', 'groupId': 'OG000'}, {'value': '256', 'spread': '58.8', 'groupId': 'OG001'}, {'value': '314', 'spread': '74.3', 'groupId': 'OG002'}]}]}, {'title': 'M2 (C1D15)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '96.5', 'spread': '53.9', 'groupId': 'OG000'}, {'value': '108', 'spread': '45.6', 'groupId': 'OG001'}, {'value': '147', 'spread': '47.1', 'groupId': 'OG002'}]}]}, {'title': 'M20 (C1D15)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '180', 'spread': '51.1', 'groupId': 'OG000'}, {'value': '199', 'spread': '41.0', 'groupId': 'OG001'}, {'value': '251', 'spread': '48.5', 'groupId': 'OG002'}]}]}, {'title': 'Abemaciclib (C2D1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '98.9', 'spread': '196', 'groupId': 'OG000'}, {'value': '182', 'spread': '129', 'groupId': 'OG001'}, {'value': '220', 'spread': '154', 'groupId': 'OG002'}]}]}, {'title': 'M2 (C2D1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '56.1', 'spread': '88.0', 'groupId': 'OG000'}, {'value': '85.4', 'spread': '62.1', 'groupId': 'OG001'}, {'value': '105', 'spread': '98.5', 'groupId': 'OG002'}]}]}, {'title': 'M20 (C2D1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '100', 'spread': '103', 'groupId': 'OG000'}, {'value': '149', 'spread': '78.9', 'groupId': 'OG001'}, {'value': '164', 'spread': '171', 'groupId': 'OG002'}]}]}, {'title': 'Abemaciclib (C2D15)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '135', 'spread': '115', 'groupId': 'OG000'}, {'value': '157', 'spread': '173', 'groupId': 'OG001'}, {'value': '175', 'spread': '136', 'groupId': 'OG002'}]}]}, {'title': 'M2 (C2D15)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '62.3', 'spread': '79.0', 'groupId': 'OG000'}, {'value': '71.7', 'spread': '97.9', 'groupId': 'OG001'}, {'value': '95.4', 'spread': '73.9', 'groupId': 'OG002'}]}]}, {'title': 'M20 (C2D15)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '120', 'spread': '76.2', 'groupId': 'OG000'}, {'value': '128', 'spread': '121', 'groupId': 'OG001'}, {'value': '154', 'spread': '101', 'groupId': 'OG002'}]}]}, {'title': 'Abemaciclib (C3D1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '125', 'spread': '64.3', 'groupId': 'OG000'}, {'value': '177', 'spread': '42.0', 'groupId': 'OG001'}, {'value': '207', 'spread': '49', 'groupId': 'OG002'}]}]}, {'title': 'M2 (C3D1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '60.6', 'spread': '39.6', 'groupId': 'OG000'}, {'value': '78.4', 'spread': '38.2', 'groupId': 'OG001'}, {'value': '95.8', 'spread': '44.2', 'groupId': 'OG002'}]}]}, {'title': 'M20 (C3D1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '109', 'spread': '39.4', 'groupId': 'OG000'}, {'value': '146', 'spread': '37.7', 'groupId': 'OG001'}, {'value': '171', 'spread': '36.6', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Cycle 3 Day 1 post dose', 'description': 'Mean steady state concentrations of Abemaciclib and its metabolites (M2 \\& M20) are reported.\n\nC=Cycle D= Day', 'unitOfMeasure': 'Nanogram per Millilitre (ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and had evaluable PK samples.'}, {'type': 'SECONDARY', 'title': 'PK: Mean Single Dose Concentration of Tamoxifen and Endoxifen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '150mg Abemaciclib + 20mg Tamoxifen', 'description': 'Participants received oral dose of 150 milligrams (mg) Abemaciclib every 12 hours (Q12H) along with 20mg Tamoxifen every 24 hours (QD) on days 1 to days 28 of a 28 day cycle.'}], 'classes': [{'title': 'Tamoxifen (C1D1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.47', 'spread': '116', 'groupId': 'OG000'}]}]}, {'title': 'Endoxifen (C1D1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Geometric Mean was not able to be calculated due to small sample size (2 Participants). Individual values = 0.653 ng/mL, 3.8 ng/mL.', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 1 post dose', 'description': 'Mean single dose concentrations of Tamoxifen and its metabolite (Endoxifen) were reported.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug along with Tamoxifen and had evaluable PK samples.'}, {'type': 'SECONDARY', 'title': 'PK: Multiple Dose Concentration of Tamoxifen and Endoxifen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '150mg Abemaciclib + 20mg Tamoxifen', 'description': 'Participants received oral dose of 150 milligrams (mg) Abemaciclib every 12 hours (Q12H) along with 20mg Tamoxifen every 24 hours (QD) on days 1 to days 28 of a 28 day cycle.'}], 'classes': [{'title': 'Tamoxifen (C1D15)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '84.5', 'spread': '41.6', 'groupId': 'OG000'}]}]}, {'title': 'Endoxifen (C1D15)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.76', 'spread': '99.7', 'groupId': 'OG000'}]}]}, {'title': 'Tamoxifen (C2D1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '98.7', 'spread': '50.2', 'groupId': 'OG000'}]}]}, {'title': 'Endoxifen (C2D1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.41', 'spread': '89.5', 'groupId': 'OG000'}]}]}, {'title': 'Tamoxifen (C2D15)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '109', 'spread': '51.9', 'groupId': 'OG000'}]}]}, {'title': 'Endoxifen (C2D15)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.17', 'spread': '73.7', 'groupId': 'OG000'}]}]}, {'title': 'Tamoxifen (C3D1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '112', 'spread': '60.2', 'groupId': 'OG000'}]}]}, {'title': 'Endoxifen (C3D1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10.3', 'spread': '84.8', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Cycle 3 Day 1 post dose', 'description': 'Mean multiple dose concentrations of Tamoxifen and its metabolite (Endoxifen) were reported.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug along with Tamoxifen and had evaluable PK samples.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '150mg Abemaciclib + 20mg Tamoxifen', 'description': 'Participants received oral dose of 150 milligrams (mg) Abemaciclib every 12 hours (Q12H) along with 20mg Tamoxifen every 24 hours (QD) on days 1 to days 28 of a 28 day cycle.'}, {'id': 'OG001', 'title': '150mg Abemaciclib', 'description': 'Participants received oral dose of 150 milligrams (mg) Abemaciclib every 12 hours (Q12H) on days 1 to days 28 of a 28 day cycle.'}, {'id': 'OG002', 'title': '200mg Abemaciclib + 2mg Prophylactic Loperamide', 'description': 'Participants received oral dose of 150 milligrams (mg) Abemaciclib every 12 hours (Q12H) along with 2mg Prophylactic Loperamide on days 1 to days 28 of a 28 day cycle.'}], 'classes': [{'title': 'Global Health Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.56', 'spread': '1.83', 'groupId': 'OG000'}, {'value': '4.56', 'spread': '1.90', 'groupId': 'OG001'}, {'value': '-2.77', 'spread': '1.91', 'groupId': 'OG002'}]}]}, {'title': 'Functional Scales (Physical Functioning)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-2.01', 'spread': '1.59', 'groupId': 'OG000'}, {'value': '-1.05', 'spread': '1.68', 'groupId': 'OG001'}, {'value': '-2.65', 'spread': '1.68', 'groupId': 'OG002'}]}]}, {'title': 'Functional Scales (Role Functioning)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.44', 'spread': '2.18', 'groupId': 'OG000'}, {'value': '-3.95', 'spread': '2.30', 'groupId': 'OG001'}, {'value': '-5.87', 'spread': '2.29', 'groupId': 'OG002'}]}]}, {'title': 'Functional Scales (Emotional Functioning)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.40', 'spread': '1.88', 'groupId': 'OG000'}, {'value': '2.58', 'spread': '1.95', 'groupId': 'OG001'}, {'value': '1.86', 'spread': '1.95', 'groupId': 'OG002'}]}]}, {'title': 'Functional Scale (Cognitive Functioning)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.14', 'spread': '1.37', 'groupId': 'OG000'}, {'value': '-1.31', 'spread': '1.44', 'groupId': 'OG001'}, {'value': '-2.39', 'spread': '1.43', 'groupId': 'OG002'}]}]}, {'title': 'Functional Scales (Social Functioning)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.23', 'spread': '2.08', 'groupId': 'OG000'}, {'value': '-0.53', 'spread': '2.16', 'groupId': 'OG001'}, {'value': '-0.94', 'spread': '2.16', 'groupId': 'OG002'}]}]}, {'title': 'Symptom Scales (Fatigue)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.39', 'spread': '2.05', 'groupId': 'OG000'}, {'value': '2.77', 'spread': '2.15', 'groupId': 'OG001'}, {'value': '4.0', 'spread': '2.16', 'groupId': 'OG002'}]}]}, {'title': 'Symptom Scales (Nausea and Vomiting)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.59', 'spread': '1.63', 'groupId': 'OG000'}, {'value': '5.30', 'spread': '1.73', 'groupId': 'OG001'}, {'value': '5.09', 'spread': '1.71', 'groupId': 'OG002'}]}]}, {'title': 'Symptom Scales (Pain)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-3.09', 'spread': '2.20', 'groupId': 'OG000'}, {'value': '-1.43', 'spread': '2.30', 'groupId': 'OG001'}, {'value': '-2.01', 'spread': '2.29', 'groupId': 'OG002'}]}]}, {'title': 'Symptom Scales (Dyspnoea)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.21', 'spread': '1.79', 'groupId': 'OG000'}, {'value': '-3.49', 'spread': '1.89', 'groupId': 'OG001'}, {'value': '-2.0', 'spread': '1.87', 'groupId': 'OG002'}]}]}, {'title': 'Symptom Scales (Insomnia)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-5.02', 'spread': '2.21', 'groupId': 'OG000'}, {'value': '-3.43', 'spread': '2.36', 'groupId': 'OG001'}, {'value': '-2.98', 'spread': '2.35', 'groupId': 'OG002'}]}]}, {'title': 'Symptom Scales (Appetite Loss)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.82', 'spread': '2.38', 'groupId': 'OG000'}, {'value': '1.87', 'spread': '2.50', 'groupId': 'OG001'}, {'value': '7.76', 'spread': '2.50', 'groupId': 'OG002'}]}]}, {'title': 'Symptom Scales (Constipation)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.28', 'spread': '1.57', 'groupId': 'OG000'}, {'value': '-6.29', 'spread': '1.71', 'groupId': 'OG001'}, {'value': '0.08', 'spread': '1.67', 'groupId': 'OG002'}]}]}, {'title': 'Symptom Scales (Diarrhoea)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '13.31', 'spread': '1.97', 'groupId': 'OG000'}, {'value': '20.17', 'spread': '2.10', 'groupId': 'OG001'}, {'value': '17.43', 'spread': '2.09', 'groupId': 'OG002'}]}]}, {'title': 'Symptom Scales (Functional Difficulties)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-7.56', 'spread': '2.00', 'groupId': 'OG000'}, {'value': '-3.81', 'spread': '2.08', 'groupId': 'OG001'}, {'value': '-0.09', 'spread': '2.07', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 21 Months', 'description': 'The EORTC QLQ-C30 self-reported general cancer instrument consists of 30 items covered by 1 of 3 dimensions:\n\n1. Global health status/quality of life (2 items) with scores ranging from 1 (Very Poor) to 7 (Excellent).\n2. Functional scales (15 total items addressing either physical, role, emotional, cognitive, or social functioning), each item scores ranging from 1 (not at all) to 4 (very much)\n3. Symptom scales (13 total items addressing either fatigue, nausea/vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, or financial impact), each item scores ranging from 1 (not at all) to 4 (very much).\n\nRaw scores are linearly converted to a 0-100 scale with higher scores reflecting higher levels of function/QOL or higher levels of symptom burden.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug with baseline and post-baseline EORTC QLQ-C30 score.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Pain and Symptom Burden Assessment on the Modified Brief Pain Inventory-Short Form (mBPI-sf)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '150mg Abemaciclib + 20mg Tamoxifen', 'description': 'Participants received oral dose of 150 milligrams (mg) Abemaciclib every 12 hours (Q12H) along with 20mg Tamoxifen every 24 hours (QD) on days 1 to days 28 of a 28 day cycle.'}, {'id': 'OG001', 'title': '150mg Abemaciclib', 'description': 'Participants received oral dose of 150 milligrams (mg) Abemaciclib every 12 hours (Q12H) on days 1 to days 28 of a 28 day cycle.'}, {'id': 'OG002', 'title': '200mg Abemaciclib + 2mg Prophylactic Loperamide', 'description': 'Participants received oral dose of 150 milligrams (mg) Abemaciclib every 12 hours (Q12H) along with 2mg Prophylactic Loperamide on days 1 to days 28 of a 28 day cycle.'}], 'classes': [{'title': 'Pain at its Worst in Last 24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.53', 'spread': '0.20', 'groupId': 'OG000'}, {'value': '-0.43', 'spread': '0.21', 'groupId': 'OG001'}, {'value': '-0.43', 'spread': '0.21', 'groupId': 'OG002'}]}]}, {'title': 'Pain at its Least in Last 24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.09', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '-0.01', 'spread': '0.16', 'groupId': 'OG001'}, {'value': '0.14', 'spread': '0.16', 'groupId': 'OG002'}]}]}, {'title': 'Pain on the Average', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.34', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '-0.20', 'spread': '0.17', 'groupId': 'OG001'}, {'value': '-0.11', 'spread': '0.17', 'groupId': 'OG002'}]}]}, {'title': 'Pain Right Now', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.28', 'spread': '0.17', 'groupId': 'OG000'}, {'value': '-0.18', 'spread': '0.17', 'groupId': 'OG001'}, {'value': '-0.04', 'spread': '0.17', 'groupId': 'OG002'}]}]}, {'title': 'Mean Interference Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.09', 'spread': '0.18', 'groupId': 'OG000'}, {'value': '0.03', 'spread': '0.18', 'groupId': 'OG001'}, {'value': '0.16', 'spread': '0.18', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 21 Months', 'description': 'mBPI-sf is an 11-item instrument used as a multiple-item measure of cancer pain intensity. In addition to pain intensity (4 items), the mBPI-sf is designed for participants to record the presence of pain in general, pain relief, and pain interference with function (general activity, mood, ability to walk, ability to perform normal work, relations with others, sleep, enjoyment of life). Responses for the mBPI-sf items are captured through the use of 11-point numeric rating scales anchored at 0 (no pain or does not interfere) and 10 (pain as bad as you can imagine or completely interferes). The mBPI-sf recall period is 24 hours and typical completion time for this instrument is less than 5 minutes.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and had baselines and post baseline mBPI-sf measurement.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '150mg Abemaciclib + 20mg Tamoxifen', 'description': 'Participants received oral dose of 150 milligrams (mg) Abemaciclib every 12 hours (Q12H) along with 20mg Tamoxifen every 24 hours (QD) on days 1 to days 28 of a 28 day cycle.'}, {'id': 'FG001', 'title': '150mg Abemaciclib', 'description': 'Participants received oral dose of 150 milligrams (mg) Abemaciclib every 12 hours (Q12H) on days 1 to days 28 of a 28 day cycle.'}, {'id': 'FG002', 'title': '200mg Abemaciclib + 2mg Prophylactic Loperamide', 'description': "Participants received oral dose of 200 milligrams (mg) Abemaciclib every 12 hours (Q12H) along with 2mg Prophylactic Loperamide on days 1 to days 28 of a 28 day cycle.\n\nNote: During Cycle 1, 2mg prophylactic loperamide was administered orally with the first dose of abemaciclib daily. During Cycle 2 and beyond, loperamide was administered at investigator's discretion and/or if clinically indicated."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '78'}, {'groupId': 'FG001', 'numSubjects': '79'}, {'groupId': 'FG002', 'numSubjects': '77'}]}, {'type': 'Received at Least One Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '78'}, {'groupId': 'FG001', 'numSubjects': '79'}, {'groupId': 'FG002', 'numSubjects': '77'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '30'}, {'groupId': 'FG002', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '57'}, {'groupId': 'FG001', 'numSubjects': '49'}, {'groupId': 'FG002', 'numSubjects': '47'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'on study treatment/follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '48'}, {'groupId': 'FG001', 'numSubjects': '42'}, {'groupId': 'FG002', 'numSubjects': '41'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}, {'value': '234', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': '150mg Abemaciclib + 20mg Tamoxifen', 'description': 'Participants received oral dose of 150 milligrams (mg) Abemaciclib every 12 hours (Q12H) along with 20mg Tamoxifen every 24 hours (QD) on days 1 to days 28 of a 28 day cycle.'}, {'id': 'BG001', 'title': '150mg Abemaciclib', 'description': 'Participants received oral dose of 150 milligrams (mg) Abemaciclib every 12 hours (Q12H) on days 1 to days 28 of a 28 day cycle.'}, {'id': 'BG002', 'title': '200mg Abemaciclib + 2mg Prophylactic Loperamide', 'description': "Participants received oral dose of 200 milligrams (mg) Abemaciclib every 12 hours (Q12H) along with 2mg Prophylactic Loperamide on days 1 to days 28 of a 28 day cycle.\n\nNote: During Cycle 1, 2mg prophylactic loperamide was administered orally with the first dose of abemaciclib daily. During Cycle 2 and beyond, loperamide was administered at investigator's discretion and/or if clinically indicated."}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.28', 'spread': '12.47', 'groupId': 'BG000'}, {'value': '56.18', 'spread': '12.24', 'groupId': 'BG001'}, {'value': '55.86', 'spread': '11.03', 'groupId': 'BG002'}, {'value': '55.44', 'spread': '11.91', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '78', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}, {'value': '234', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '57', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}, {'value': '146', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '187', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-01-29', 'size': 4313714, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-04-02T05:16', 'hasProtocol': True}, {'date': '2016-06-29', 'size': 458908, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-04-02T05:17', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 234}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-09-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'nctId': 'NCT03763604', 'statusForNctId': 'APPROVED_FOR_MARKETING', 'hasExpandedAccess': True}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-17', 'studyFirstSubmitDate': '2016-04-19', 'resultsFirstSubmitDate': '2019-06-14', 'studyFirstSubmitQcDate': '2016-04-19', 'lastUpdatePostDateStruct': {'date': '2025-04-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-06-14', 'studyFirstPostDateStruct': {'date': '2016-04-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-07-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression Free Survival (PFS)', 'timeFrame': 'Baseline to Objective Disease Progression or Death from Any Cause (Up to 21 Months)', 'description': 'Progression-free survival time was measured from the date of randomization to the date of investigator-determined objective progression as defined by RECIST v1.1, or death from any cause, whichever occurred first. Progressive disease (PD) is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. Participants who have neither progressed nor died were censored at the day of their last radiographic tumor assessment (if available) or date of randomization if no post baseline radiographic assessment is available.'}], 'secondaryOutcomes': [{'measure': 'Objective Response Rate (ORR): Percentage of Participants With a Complete Response (CR) or Partial Response (PR)', 'timeFrame': 'Baseline to Objective Disease Progression (Up to 21 Months)', 'description': 'Objective response rate was defined as the percentage of participants with CR or PR according to RECIST v1.1. CR was defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR was defined as at least a 30% decrease in the sum of the LD (longest diameter) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions.'}, {'measure': 'Duration of Response (DoR)', 'timeFrame': 'Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Up to 21 Months)', 'description': 'DoR is defined as the time from the date of first evidence of a CR or PR to the date of objective progression or death from any cause, whichever is earlier as defined by Recist v1.1. CR was defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR was defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'Baseline to Death from Any Cause (Approximately 36 Months)'}, {'measure': 'Pharmacokinetics (PK): Mean Single Dose Concentration of Abemaciclib and Its Metabolites', 'timeFrame': 'Cycle (C) 1 Day (D) 1 post dose', 'description': 'Mean single dose concentrations of Abemaciclib and its metabolites (M2 \\& M20) are reported.'}, {'measure': 'Pharmacokinetics (PK): Steady State Concentration of Abemaciclib and Its Metabolites', 'timeFrame': 'Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Cycle 3 Day 1 post dose', 'description': 'Mean steady state concentrations of Abemaciclib and its metabolites (M2 \\& M20) are reported.\n\nC=Cycle D= Day'}, {'measure': 'PK: Mean Single Dose Concentration of Tamoxifen and Endoxifen', 'timeFrame': 'Cycle 1 Day 1 post dose', 'description': 'Mean single dose concentrations of Tamoxifen and its metabolite (Endoxifen) were reported.'}, {'measure': 'PK: Multiple Dose Concentration of Tamoxifen and Endoxifen', 'timeFrame': 'Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Cycle 3 Day 1 post dose', 'description': 'Mean multiple dose concentrations of Tamoxifen and its metabolite (Endoxifen) were reported.'}, {'measure': 'Change From Baseline in Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)', 'timeFrame': 'Baseline, 21 Months', 'description': 'The EORTC QLQ-C30 self-reported general cancer instrument consists of 30 items covered by 1 of 3 dimensions:\n\n1. Global health status/quality of life (2 items) with scores ranging from 1 (Very Poor) to 7 (Excellent).\n2. Functional scales (15 total items addressing either physical, role, emotional, cognitive, or social functioning), each item scores ranging from 1 (not at all) to 4 (very much)\n3. Symptom scales (13 total items addressing either fatigue, nausea/vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, or financial impact), each item scores ranging from 1 (not at all) to 4 (very much).\n\nRaw scores are linearly converted to a 0-100 scale with higher scores reflecting higher levels of function/QOL or higher levels of symptom burden.'}, {'measure': 'Change From Baseline in Pain and Symptom Burden Assessment on the Modified Brief Pain Inventory-Short Form (mBPI-sf)', 'timeFrame': 'Baseline, 21 Months', 'description': 'mBPI-sf is an 11-item instrument used as a multiple-item measure of cancer pain intensity. In addition to pain intensity (4 items), the mBPI-sf is designed for participants to record the presence of pain in general, pain relief, and pain interference with function (general activity, mood, ability to walk, ability to perform normal work, relations with others, sleep, enjoyment of life). Responses for the mBPI-sf items are captured through the use of 11-point numeric rating scales anchored at 0 (no pain or does not interfere) and 10 (pain as bad as you can imagine or completely interferes). The mBPI-sf recall period is 24 hours and typical completion time for this instrument is less than 5 minutes.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Metastatic Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '35829935', 'type': 'DERIVED', 'citation': 'Hamilton E, Cortes J, Ozyilkan O, Chen SC, Petrakova K, Manikhas A, Jerusalem G, Hegg R, Huober J, Zhang W, Chen Y, Martin M. nextMONARCH Phase 2 randomized clinical trial: overall survival analysis of abemaciclib monotherapy or in combination with tamoxifen in patients with endocrine-refractory HR + , HER2- metastatic breast cancer. Breast Cancer Res Treat. 2022 Aug;195(1):55-64. doi: 10.1007/s10549-022-06662-9. Epub 2022 Jul 12.'}], 'seeAlsoLinks': [{'url': 'https://trials.lillytrialguide.com/en-US/trial/11MY3TKjOeIWgmIkemWkyM', 'label': 'A Study of Abemaciclib (LY2835219) Plus Tamoxifen or Abemaciclib Alone in Women With Metastatic Breast Cancer (nextMONARCH 1)'}]}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to evaluate the safety and efficacy of abemaciclib plus tamoxifen or abemaciclib alone in women with previously treated hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2-), metastatic breast cancer.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have a diagnosis of HR+, HER2- breast cancer.\n* Relapsed or progressed following endocrine therapy.\n* Have received prior treatment with at least 2 chemotherapy regimens, of which at least 1 but no more than 2 have been administered in the metastatic setting.\n* Have the presence of measureable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1).\n* Have a performance status ≤1 on the Eastern Cooperative Oncology Group (ECOG) scale.\n* Have discontinued previous therapies for cancer (including specifically, aromatase inhibitors, anti-estrogens, chemotherapy, radiotherapy, and immunotherapy) for at least 21 days for myelosuppressive agents or 14 days for nonmyelosuppressive agents prior to receiving study drug, and recovered from the acute effects of therapy (until the toxicity resolves to either baseline or at least Grade 1) except for residual alopecia or peripheral neuropathy.\n* Have adequate organ function.\n* Have negative serum pregnancy test within 7 days prior to the first dose of study treatment and agree to use highly effective precautions to prevent pregnancy during the study and for 3 weeks following last dose of study treatment.\n* Are able to swallow oral medication.\n\nExclusion Criteria:\n\n* Have clinical evidence or history of central nervous system metastasis.\n* Have a personal history of any of the following conditions: syncope of either unexplained or cardiovascular etiology, ventricular tachycardia, ventricular fibrillation, or sudden cardiac arrest.\n* Have active bacterial or fungal infection (that is, requiring intravenous antibiotics at the time of initiating study treatment) and/or detectable viral infection.\n* Have received treatment with a prior cyclin-dependent kinase (CDK4) and CDK 6 inhibitor.\n* Have a preexisting chronic condition resulting in persistent diarrhea.\n* Have a history of any other cancer (except nonmelanoma skin cancer or carcinoma in-situ of the cervix or breast), unless in complete remission with no therapy for a minimum of 3 years.'}, 'identificationModule': {'nctId': 'NCT02747004', 'acronym': 'Next MONARCH 1', 'briefTitle': 'A Study of Abemaciclib (LY2835219) Plus Tamoxifen or Abemaciclib Alone in Women With Metastatic Breast Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Randomized, Open-Label, Phase 2 Study of Abemaciclib Plus Tamoxifen or Abemaciclib Alone, in Women With Previously Treated Hormone Receptor-Positive, HER2-Negative, Metastatic Breast Cancer', 'orgStudyIdInfo': {'id': '16339'}, 'secondaryIdInfos': [{'id': 'I3Y-MC-JPCG', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}, {'id': '2016-000288-18', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Abemaciclib + Tamoxifen', 'description': 'Abemaciclib given orally every 12 hours (Q12H) in combination with tamoxifen given orally every day. Participants may continue to receive treatment until discontinuation criteria are met.', 'interventionNames': ['Drug: Abemaciclib', 'Drug: Tamoxifen']}, {'type': 'EXPERIMENTAL', 'label': 'Abemaciclib', 'description': 'Abemaciclib given orally Q12H. Participants may continue to receive treatment until discontinuation criteria are met.', 'interventionNames': ['Drug: Abemaciclib']}, {'type': 'EXPERIMENTAL', 'label': 'Abemaciclib + Prophylactic Loperamide', 'description': 'Abemaciclib given orally Q12H in combination with prophylactic loperamide given orally. Participants may continue to receive treatment until discontinuation criteria are met.', 'interventionNames': ['Drug: Abemaciclib', 'Drug: Prophylactic Loperamide']}], 'interventions': [{'name': 'Abemaciclib', 'type': 'DRUG', 'otherNames': ['LY2835219'], 'description': 'Administered orally', 'armGroupLabels': ['Abemaciclib', 'Abemaciclib + Prophylactic Loperamide', 'Abemaciclib + Tamoxifen']}, {'name': 'Tamoxifen', 'type': 'DRUG', 'description': 'Administered orally', 'armGroupLabels': ['Abemaciclib + Tamoxifen']}, {'name': 'Prophylactic Loperamide', 'type': 'DRUG', 'description': 'Administered orally', 'armGroupLabels': ['Abemaciclib + Prophylactic Loperamide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85724', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'The University of Arizona Cancer Center', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '03766', 'city': 'Lebanon', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Dartmouth Hitchcock Medical Center', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Tennessee Oncology PLLC', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '76104', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'The Center for Cancer and Blood Disorders', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '53705', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin Clinical Research Center', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}, {'zip': 'C1125ABD', 'city': 'CABA', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'CENIT Centro de Neurociencias, Investigación y Tratamiento'}, {'zip': 'Y4600APW', 'city': 'San Salvador de Jujuy', 'state': 'Jujuy Province', 'country': 'Argentina', 'facility': 'Fundacion Ars Medica', 'geoPoint': {'lat': -24.1928, 'lon': -65.29342}}, {'zip': 'R8500ACE', 'city': 'Viedma', 'state': 'Río Negro Province', 'country': 'Argentina', 'facility': 'Clinica Viedma', 'geoPoint': {'lat': -40.81519, 'lon': -63.0004}}, {'zip': 'S2000KZE', 'city': 'Rosario', 'state': 'Santa Fe Province', 'country': 'Argentina', 'facility': 'Instituto de Oncología de Rosario', 'geoPoint': {'lat': -32.94682, 'lon': -60.63932}}, {'zip': '4000', 'city': 'San Miguel de Tucumán', 'state': 'Tucumán Province', 'country': 'Argentina', 'facility': 'Centro Para la Atención Integral del Paciente Oncologico (CAIPO)', 'geoPoint': {'lat': -26.81601, 'lon': -65.21051}}, {'zip': '4400', 'city': 'Salta', 'country': 'Argentina', 'facility': 'Sanatorio Parque', 'geoPoint': {'lat': -24.80645, 'lon': -65.41999}}, {'zip': '8036', 'city': 'Graz', 'state': 'Styria', 'country': 'Austria', 'facility': 'Medizinische Universitaet Graz', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'zip': '6020', 'city': 'Innsbruck', 'state': 'Tyrol', 'country': 'Austria', 'facility': 'Universitätsklinik Innsbruck', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}, {'zip': '1090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'AKH', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '9000', 'city': 'Ghent', 'state': 'Oost-Vlaanderen', 'country': 'Belgium', 'facility': 'Universitair Ziekenhuis Gent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '9100', 'city': 'Sint-Niklaas', 'state': 'Oost-Vlaanderen', 'country': 'Belgium', 'facility': 'VITAZ', 'geoPoint': {'lat': 51.16509, 'lon': 4.1437}}, {'zip': '6000', 'city': 'Charleroi', 'country': 'Belgium', 'facility': 'Grand Hopital de Charleroi-Site Notre-Dame', 'geoPoint': {'lat': 50.41136, 'lon': 4.44448}}, {'zip': '4000', 'city': 'Liège', 'country': 'Belgium', 'facility': 'Centre Hospitalier Universitaire Sart Tilman', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'zip': '90610-000', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Hospital São Lucas - 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Krc', 'country': 'Czechia', 'facility': 'Thomayerova nemocnice'}, {'zip': '59020', 'city': 'Lille', 'state': 'Hauts-de-France', 'country': 'France', 'facility': 'Centre Oscar Lambret', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '13273', 'city': 'Marseille', 'state': "Provence-Alpes-Côte d'Azur Region", 'country': 'France', 'facility': 'Institut Paoli-Calmettes', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '89081', 'city': 'Ulm', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'Universitätsklinikum Ulm', 'geoPoint': {'lat': 48.39841, 'lon': 9.99155}}, {'zip': '22087', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Kath. Marienkrankenhaus gGmbH', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '00161', 'city': 'Roma', 'state': 'Rome', 'country': 'Italy', 'facility': 'Polic.Umberto I -Univ. La Sapienza', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '37024', 'city': 'Negrar', 'state': 'Verona', 'country': 'Italy', 'facility': 'Ospedale Sacro Cuore Don G. Calabria', 'geoPoint': {'lat': 45.52918, 'lon': 10.93899}}, {'zip': '40139', 'city': 'Bologna', 'country': 'Italy', 'facility': 'Ospedale Bellaria - Azienda USL di Bologna', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'zip': '80131', 'city': 'Napoli', 'country': 'Italy', 'facility': 'Azienda Ospedaliera Universitaria Federico II', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'zip': '80020', 'city': 'Culiacán', 'state': 'Sinaloa', 'country': 'Mexico', 'facility': 'Neurociencias Estudios Clinicos', 'geoPoint': {'lat': 24.80209, 'lon': -107.39421}}, {'zip': '50080', 'city': 'San Bernardino', 'state': 'Toluca', 'country': 'Mexico', 'facility': 'Centro Hemato Oncologico Privado', 'geoPoint': {'lat': 19.47667, 'lon': -98.89635}}, {'zip': '03310', 'city': 'Mexico City', 'country': 'Mexico', 'facility': 'Grupo Medico Camino Sc', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'zip': '68000', 'city': 'Oaxaca City', 'country': 'Mexico', 'facility': 'Oaxaca Site Management Organization', 'geoPoint': {'lat': 17.06025, 'lon': -96.72544}}, {'zip': '420029', 'city': "Kazan'", 'country': 'Russia', 'facility': 'Republic Oncology Dispensary of MoH of Republic Tatarstan', 'geoPoint': {'lat': 55.78874, 'lon': 49.12214}}, {'zip': '197758', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'St-Petersburg scientifical practical center of specialized medical care', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '198255', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Saint-Petersburg city clinical oncology dispensary', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '08035', 'city': 'Barcelona', 'state': 'Barcelona [Barcelona]', 'country': 'Spain', 'facility': "Hospital Universitari Vall d'Hebron", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28034', 'city': 'Madrid', 'state': 'Madrid, Comunidad de', 'country': 'Spain', 'facility': 'Hospital Universitario Ramón y Cajal', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '08036', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Clinic I Provincial', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28007', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital General Universitario Gregorio Marañon', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28040', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Clinico San Carlos', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28041', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario 12 de Octubre', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '46010', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Hospital Clínico Universitario de Valencia', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '235', 'city': 'New Taipei City', 'country': 'Taiwan', 'facility': 'Taipei Medical University Shuang Ho Hospital', 'geoPoint': {'lat': 25.06199, 'lon': 121.45703}}, {'zip': '40447', 'city': 'Taichung', 'country': 'Taiwan', 'facility': 'China Medical University Hospital', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}, {'zip': '10449', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Mackay Memorial Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '11217', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Taipei Veterans General Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '33305', 'city': 'Taoyuan', 'country': 'Taiwan', 'facility': 'Chang Gung Memorial Hospital - Linkou', 'geoPoint': {'lat': 24.99368, 'lon': 121.29696}}, {'zip': '38039', 'city': 'Kayseri', 'state': 'Melikgazi', 'country': 'Turkey (Türkiye)', 'facility': 'Erciyes University Faculty of Medicine', 'geoPoint': {'lat': 38.73222, 'lon': 35.48528}}, {'zip': '1250', 'city': 'Adana', 'country': 'Turkey (Türkiye)', 'facility': 'Baskent University Dr. Turgut Noyan Research and Training Center', 'geoPoint': {'lat': 36.98615, 'lon': 35.32531}}, {'zip': '06100', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Hacettepe University Faculty of Medicine', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}, {'zip': '34214', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Medipol Mega University Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'zip': '34668', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Marmara University Medical Faculty', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.', 'ipdSharing': 'YES', 'description': 'Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.', 'accessCriteria': 'A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}