Viewing Study NCT02763566

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Ignite Creation Date: 2025-12-24 @ 4:32 PM
Ignite Modification Date: 2026-02-01 @ 4:41 AM
Study NCT ID: NCT02763566
Status: ACTIVE_NOT_RECRUITING
Last Update Posted: 2025-09-11
First Post: 2016-05-04
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: A Study of Abemaciclib (LY2835219) in Participants With 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': 'D000077384', 'term': 'Anastrozole'}, {'id': 'D000077289', 'term': 'Letrozole'}, {'id': 'D000077267', 'term': 'Fulvestrant'}], 'ancestors': [{'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D004958', 'term': 'Estradiol'}, {'id': 'D004963', 'term': 'Estrenes'}, {'id': 'D004962', 'term': 'Estranes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D045166', 'term': 'Estradiol Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov@lilly.com', 'phone': '800-545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 28 Months', 'description': 'All randomized participants who received at least one dose of study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'Abemaciclib + Nonsteroidal Aromatase Inhibitor (NSAI)', 'description': 'Participants received Abemaciclib orally every 12 hours (Q12H) plus anastrozole or letrozole given orally every 24 hours (Q24H) on days 1 to 28 of a 28 day cycle.', 'otherNumAtRisk': 205, 'deathsNumAtRisk': 205, 'otherNumAffected': 204, 'seriousNumAtRisk': 205, 'deathsNumAffected': 20, 'seriousNumAffected': 40}, {'id': 'EG001', 'title': 'Placebo + NSAI', 'description': 'Participants received Placebo orally Q12H plus anastrozole or letrozole given orally Q24H on days 1 to 28 of a 28 day cycle.', 'otherNumAtRisk': 99, 'deathsNumAtRisk': 99, 'otherNumAffected': 85, 'seriousNumAtRisk': 99, 'deathsNumAffected': 10, 'seriousNumAffected': 9}, {'id': 'EG002', 'title': 'Abemaciclib + Fulvestrant', 'description': 'Participants received Abemaciclib orally Q12H on days 1 to 28 of a 28 day cycle plus fulvestrant intramuscularly (IM) on days 1 and 15 of cycle 1, then on day 1 of cycle 2 and beyond.', 'otherNumAtRisk': 104, 'deathsNumAtRisk': 104, 'otherNumAffected': 103, 'seriousNumAtRisk': 104, 'deathsNumAffected': 8, 'seriousNumAffected': 16}, {'id': 'EG003', 'title': 'Placebo + Fulvestrant', 'description': 'Participants received Placebo orally Q12H on days 1 to 28 of a 28 day cycle plus fulvestrant IM on days 1 and 15 of cycle 1, then on day 1 of cycle 2 and beyond.', 'otherNumAtRisk': 53, 'deathsNumAtRisk': 53, 'otherNumAffected': 39, 'seriousNumAtRisk': 53, 'deathsNumAffected': 9, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 462, 'numAffected': 127}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 39, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 206, 'numAffected': 73}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 14, 'numAffected': 8}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Lacrimation increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 13, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 10, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 101, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 21, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 32, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 35, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 10, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 31, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 11, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 12, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 960, 'numAffected': 164}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 45, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 449, 'numAffected': 82}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 75, 'numAffected': 54}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 30, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 25, 'numAffected': 19}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 17, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 44, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 18, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 11, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 38, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 19, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 29, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 87, 'numAffected': 60}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 41, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 35, 'numAffected': 24}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 11, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 42, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 18, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 6, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Localised oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 14, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 38, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 11, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 28, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 26, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 10, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 14, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 25, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 15, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 39, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 31, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 17, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 143, 'numAffected': 71}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 40, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 68, 'numAffected': 36}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 17, 'numAffected': 12}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 142, 'numAffected': 71}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 35, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 53, 'numAffected': 32}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 19, 'numAffected': 14}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 39, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 17, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Blood cholesterol increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 23, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 52, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 7, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 38, 'numAffected': 22}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 18, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 14, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 91, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 7, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 56, 'numAffected': 22}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Monocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 29, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 17, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 953, 'numAffected': 164}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 44, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 392, 'numAffected': 84}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 29, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 247, 'numAffected': 90}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 15, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 100, 'numAffected': 43}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 13, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 64, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 22, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 28, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 15, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 891, 'numAffected': 156}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 58, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 374, 'numAffected': 86}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 24, 'numAffected': 12}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 70, 'numAffected': 48}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 18, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 34, 'numAffected': 23}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Hypertriglyceridaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 18, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Hypoalbuminaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 12, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 18, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 6, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 56, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 18, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 21, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 19, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 10, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 18, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 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procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Hypertriglyceridaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Cerebral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Facial nerve disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Iiird nerve disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': "Parkinson's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Chronic kidney disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Progression Free Survival (PFS) (Abemaciclib + NSAI & Placebo NSAI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abemaciclib + Nonsteroidal Aromatase Inhibitor (NSAI)', 'description': 'Participants received Abemaciclib orally every 12 hours (Q12H) plus anastrozole or letrozole given orally every 24 hours (Q24H) on days 1 to 28 of a 28 day cycle.'}, {'id': 'OG001', 'title': 'Placebo + NSAI', 'description': 'Participants received Placebo orally Q12H plus anastrozole or letrozole given orally Q24H on days 1 to 28 of a 28 day cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median and Upper bound were not estimable due to Immature data.', 'groupId': 'OG000', 'lowerLimit': '22.32', 'upperLimit': 'NA'}, {'value': '14.73', 'groupId': 'OG001', 'lowerLimit': '11.21', 'upperLimit': '18.87'}]}]}], 'analyses': [{'pValue': '0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.499', 'ciLowerLimit': '0.346', 'ciUpperLimit': '0.719', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Randomization to Measured Progressive Disease or Death (up to 26 Months)', 'description': 'Progression-free survival time was measured from randomization until the date of objective progression as defined by Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1), or death from any cause. 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. Patients 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 in Abemaciclib + NSAI \\& Placebo NSAI arms. Censored participants: 141 in Abemaciclib + NSAI, 46 in Placebo + NSAI.'}, {'type': 'SECONDARY', 'title': 'Progression Free Survival (PFS) (Abemaciclib + Fulvestrant and Placebo + Fulvestrant Arms)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abemaciclib + Fulvestrant', 'description': 'Participants received Abemaciclib orally Q12H on days 1 to 28 of a 28 day cycle plus fulvestrant intramuscularly (IM) on days 1 and 15 of cycle 1, then on day 1 of cycle 2 and beyond.'}, {'id': 'OG001', 'title': 'Placebo + Fulvestrant', 'description': 'Participants received Placebo orally Q12H on days 1 to 28 of a 28 day cycle plus fulvestrant IM on days 1 and 15 of cycle 1, then on day 1 of cycle 2 and beyond.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.47', 'comment': 'Upper bound was not estimable due to Immature data.', 'groupId': 'OG000', 'lowerLimit': '9.53', 'upperLimit': 'NA'}, {'value': '5.59', 'groupId': 'OG001', 'lowerLimit': '3.65', 'upperLimit': '7.69'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.376', 'ciLowerLimit': '0.240', 'ciUpperLimit': '0.588', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Randomization to Measured Progressive Disease or Death (up to 26 Months)', 'description': 'Progression-free survival time was measured from randomization until the date of objective progression as defined by Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1), or death from any cause. 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. Patients 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 in Abemaciclib + Fulvestrant and Placebo + Fulvestrant arms.\n\nCensored participants: 58 in Abemaciclib + Fulvestrant, 17 in Placebo + Fulvestrant.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'timeFrame': 'Randomization to Date of Death from Any Cause (Estimated up to 38 Months)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '104', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Abemaciclib + Nonsteroidal Aromatase Inhibitor (NSAI)', 'description': 'Participants received Abemaciclib orally every 12 hours (Q12H) plus anastrozole or letrozole given orally every 24 hours (Q24H) on days 1 to 28 of a 28 day cycle.'}, {'id': 'OG001', 'title': 'Placebo + NSAI', 'description': 'Participants received Placebo orally Q12H plus anastrozole or letrozole given orally Q24H on days 1 to 28 of a 28 day cycle.'}, {'id': 'OG002', 'title': 'Abemaciclib + Fulvestrant', 'description': 'Participants received Abemaciclib orally Q12H on days 1 to 28 of a 28 day cycle plus fulvestrant intramuscularly (IM) on days 1 and 15 of cycle 1, then on day 1 of cycle 2 and beyond.'}, {'id': 'OG003', 'title': 'Placebo + Fulvestrant', 'description': 'Participants received Placebo orally Q12H on days 1 to 28 of a 28 day cycle plus fulvestrant IM on days 1 and 15 of cycle 1, then on day 1 of cycle 2 and beyond.'}], 'classes': [{'categories': [{'measurements': [{'value': '56.0', 'groupId': 'OG000', 'lowerLimit': '49.3', 'upperLimit': '62.8'}, {'value': '30.3', 'groupId': 'OG001', 'lowerLimit': '21.3', 'upperLimit': '39.4'}, {'value': '38.5', 'groupId': 'OG002', 'lowerLimit': '29.1', 'upperLimit': '47.8'}, {'value': '7.5', 'groupId': 'OG003', 'lowerLimit': '0.4', 'upperLimit': '14.7'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG002', 'OG003'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Randomization to Measured Progressive Disease (up to 26 Months)', 'description': 'Objective response rate is the percentage of participants with a BOR of CR or PR as defined by RECIST v1.1. CR is defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR is 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': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants.'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DoR)', 'timeFrame': 'Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Estimated up to 38 Months)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Exhibit Stable Disease (SD) or CR or PR [Disease Control Rate (DCR)]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '104', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Abemaciclib + Nonsteroidal Aromatase Inhibitor (NSAI)', 'description': 'Participants received Abemaciclib orally every 12 hours (Q12H) plus anastrozole or letrozole given orally every 24 hours (Q24H) on days 1 to 28 of a 28 day cycle.'}, {'id': 'OG001', 'title': 'Placebo + NSAI', 'description': 'Participants received Placebo orally Q12H plus anastrozole or letrozole given orally Q24H on days 1 to 28 of a 28 day cycle.'}, {'id': 'OG002', 'title': 'Abemaciclib + Fulvestrant', 'description': 'Participants received Abemaciclib orally Q12H on days 1 to 28 of a 28 day cycle plus fulvestrant intramuscularly (IM) on days 1 and 15 of cycle 1, then on day 1 of cycle 2 and beyond.'}, {'id': 'OG003', 'title': 'Placebo + Fulvestrant', 'description': 'Participants received Placebo orally Q12H on days 1 to 28 of a 28 day cycle plus fulvestrant IM on days 1 and 15 of cycle 1, then on day 1 of cycle 2 and beyond.'}], 'classes': [{'categories': [{'measurements': [{'value': '91.3', 'groupId': 'OG000', 'lowerLimit': '87.5', 'upperLimit': '95.1'}, {'value': '82.8', 'groupId': 'OG001', 'lowerLimit': '75.4', 'upperLimit': '90.3'}, {'value': '92.3', 'groupId': 'OG002', 'lowerLimit': '87.2', 'upperLimit': '97.4'}, {'value': '69.8', 'groupId': 'OG003', 'lowerLimit': '57.5', 'upperLimit': '82.2'}]}]}], 'analyses': [{'pValue': '0.0456', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0004', 'groupIds': ['OG002', 'OG003'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Randomization to Measured Progressive Disease (up to 26 Months)', 'description': 'Disease control rate (DCR) is the percentage of participants with a best overall response of CR, PR or SD as defined by RECIST v1.1. CR is defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) for target lesions, no progression of non-target lesions, and no appearance of new lesions. 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.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Best Overall Response of CR, PR, or SD With Duration of SD for at Least 6 Months [Clinical Benefit Rate (CBR)]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '104', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Abemaciclib + Nonsteroidal Aromatase Inhibitor (NSAI)', 'description': 'Participants received Abemaciclib orally every 12 hours (Q12H) plus anastrozole or letrozole given orally every 24 hours (Q24H) on days 1 to 28 of a 28 day cycle.'}, {'id': 'OG001', 'title': 'Placebo + NSAI', 'description': 'Participants received Placebo orally Q12H plus anastrozole or letrozole given orally Q24H on days 1 to 28 of a 28 day cycle.'}, {'id': 'OG002', 'title': 'Abemaciclib + Fulvestrant', 'description': 'Participants received Abemaciclib orally Q12H on days 1 to 28 of a 28 day cycle plus fulvestrant intramuscularly (IM) on days 1 and 15 of cycle 1, then on day 1 of cycle 2 and beyond.'}, {'id': 'OG003', 'title': 'Placebo + Fulvestrant', 'description': 'Participants received Placebo orally Q12H on days 1 to 28 of a 28 day cycle plus fulvestrant IM on days 1 and 15 of cycle 1, then on day 1 of cycle 2 and beyond.'}], 'classes': [{'categories': [{'measurements': [{'value': '82.6', 'groupId': 'OG000', 'lowerLimit': '77.4', 'upperLimit': '87.8'}, {'value': '62.6', 'groupId': 'OG001', 'lowerLimit': '53.1', 'upperLimit': '72.2'}, {'value': '77.9', 'groupId': 'OG002', 'lowerLimit': '69.9', 'upperLimit': '85.9'}, {'value': '45.3', 'groupId': 'OG003', 'lowerLimit': '31.9', 'upperLimit': '58.7'}]}]}], 'analyses': [{'pValue': '0.0003', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG002', 'OG003'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Randomization to Measured Progressive Disease (up to 26 Months)', 'description': 'Clinical benefit rate (CBR) is the percentage of participants with a BOR of CR or PR, or SD for at least 6 months. CR is defined as the disappearance of all target and non-target lesions \\& no appearance of new lesions. PR is 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. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, no progression of non-target lesions, and no appearance of new lesions. 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.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants'}, {'type': 'SECONDARY', 'title': 'Change From Randomization 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': '202', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}, {'value': '97', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Abemaciclib + Nonsteroidal Aromatase Inhibitor (NSAI)', 'description': 'Participants received Abemaciclib orally every 12 hours (Q12H) plus anastrozole or letrozole given orally every 24 hours (Q24H) on days 1 to 28 of a 28 day cycle.'}, {'id': 'OG001', 'title': 'Placebo + NSAI', 'description': 'Participants received Placebo orally Q12H plus anastrozole or letrozole given orally Q24H on days 1 to 28 of a 28 day cycle. Participants receiving benefit may continue until disease progression.'}, {'id': 'OG002', 'title': 'Abemaciclib + Fulvestrant', 'description': 'Participants received Abemaciclib orally Q12H on days 1 to 28 of a 28 day cycle plus fulvestrant intramuscularly (IM) on days 1 and 15 of cycle 1, then on day 1 of cycle 2 and beyond.'}, {'id': 'OG003', 'title': 'Placebo + Fulvestrant', 'description': 'Participants received Placebo orally Q12H on days 1 to 28 of a 28 day cycle plus fulvestrant IM on days 1 and 15 of cycle 1, then on day 1 of cycle 2 and beyond.'}], 'classes': [{'title': 'Global Health Status', 'categories': [{'measurements': [{'value': '2.38', 'spread': '0.99', 'groupId': 'OG000'}, {'value': '4.26', 'spread': '1.47', 'groupId': 'OG001'}, {'value': '-0.35', 'spread': '1.41', 'groupId': 'OG002'}, {'value': '3.12', 'spread': '2.07', 'groupId': 'OG003'}]}]}, {'title': 'Functional Scales - Physical Functioning', 'categories': [{'measurements': [{'value': '-0.78', 'spread': '0.82', 'groupId': 'OG000'}, {'value': '-0.01', 'spread': '1.21', 'groupId': 'OG001'}, {'value': '-1.11', 'spread': '1.06', 'groupId': 'OG002'}, {'value': '-2.70', 'spread': '1.54', 'groupId': 'OG003'}]}]}, {'title': 'Functional Scales - Role Functioning', 'categories': [{'measurements': [{'value': '-1.69', 'spread': '1.20', 'groupId': 'OG000'}, {'value': '-1.38', 'spread': '1.79', 'groupId': 'OG001'}, {'value': '-3.76', 'spread': '1.35', 'groupId': 'OG002'}, {'value': '-2.04', 'spread': '1.95', 'groupId': 'OG003'}]}]}, {'title': 'Functional Scales - Emotional Functioning', 'categories': [{'measurements': [{'value': '1.57', 'spread': '0.98', 'groupId': 'OG000'}, {'value': '-0.10', 'spread': '1.44', 'groupId': 'OG001'}, {'value': '0.43', 'spread': '1.27', 'groupId': 'OG002'}, {'value': '0.18', 'spread': '1.85', 'groupId': 'OG003'}]}]}, {'title': 'Functional Scales - Cognitive Functioning', 'categories': [{'measurements': [{'value': '-2.89', 'spread': '0.90', 'groupId': 'OG000'}, {'value': '-0.72', 'spread': '1.35', 'groupId': 'OG001'}, {'value': '-3.52', 'spread': '1.35', 'groupId': 'OG002'}, {'value': '-1.10', 'spread': '1.96', 'groupId': 'OG003'}]}]}, {'title': 'Functional Scales - Social Functioning', 'categories': [{'measurements': [{'value': '-2.45', 'spread': '1.19', 'groupId': 'OG000'}, {'value': '-1.57', 'spread': '1.75', 'groupId': 'OG001'}, {'value': '-2.03', 'spread': '1.71', 'groupId': 'OG002'}, {'value': '-2.67', 'spread': '2.44', 'groupId': 'OG003'}]}]}, {'title': 'Symptom Scales - Fatigue', 'categories': [{'measurements': [{'value': '1.63', 'spread': '0.95', 'groupId': 'OG000'}, {'value': '0.06', 'spread': '1.40', 'groupId': 'OG001'}, {'value': '4.19', 'spread': '1.44', 'groupId': 'OG002'}, {'value': '1.46', 'spread': '2.08', 'groupId': 'OG003'}]}]}, {'title': 'Symptom Scales - Nausea and Vomiting', 'categories': [{'measurements': [{'value': '0.62', 'spread': '0.60', 'groupId': 'OG000'}, {'value': '-0.33', 'spread': '0.88', 'groupId': 'OG001'}, {'value': '4.26', 'spread': '1.10', 'groupId': 'OG002'}, {'value': '1.67', 'spread': '1.65', 'groupId': 'OG003'}]}]}, {'title': 'Symptom Scales - Pain', 'categories': [{'measurements': [{'value': '-5.44', 'spread': '0.91', 'groupId': 'OG000'}, {'value': '-4.90', 'spread': '1.35', 'groupId': 'OG001'}, {'value': '-2.82', 'spread': '1.36', 'groupId': 'OG002'}, {'value': '-0.17', 'spread': '2.01', 'groupId': 'OG003'}]}]}, {'title': 'Symptom Scales - Dyspnoea', 'categories': [{'measurements': [{'value': '2.51', 'spread': '1.02', 'groupId': 'OG000'}, {'value': '0.35', 'spread': '1.53', 'groupId': 'OG001'}, {'value': '-1.66', 'spread': '1.27', 'groupId': 'OG002'}, {'value': '0.83', 'spread': '1.92', 'groupId': 'OG003'}]}]}, {'title': 'Symptom Scales - Insomnia', 'categories': [{'measurements': [{'value': '-0.87', 'spread': '1.07', 'groupId': 'OG000'}, {'value': '-0.05', 'spread': '1.60', 'groupId': 'OG001'}, {'value': '1.53', 'spread': '1.59', 'groupId': 'OG002'}, {'value': '-0.44', 'spread': '2.42', 'groupId': 'OG003'}]}]}, {'title': 'Symptom Scales - Appetite', 'categories': [{'measurements': [{'value': '4.19', 'spread': '0.97', 'groupId': 'OG000'}, {'value': '-1.47', 'spread': '1.44', 'groupId': 'OG001'}, {'value': '8.67', 'spread': '1.63', 'groupId': 'OG002'}, {'value': '1.21', 'spread': '2.42', 'groupId': 'OG003'}]}]}, {'title': 'Symptom Scales - Constipation', 'categories': [{'measurements': [{'value': '-3.05', 'spread': '0.98', 'groupId': 'OG000'}, {'value': '-1.49', 'spread': '1.46', 'groupId': 'OG001'}, {'value': '-1.63', 'spread': '1.31', 'groupId': 'OG002'}, {'value': '0.65', 'spread': '1.88', 'groupId': 'OG003'}]}]}, {'title': 'Symptom Scales - Diarrhoea', 'categories': [{'measurements': [{'value': '15.72', 'spread': '0.85', 'groupId': 'OG000'}, {'value': '-0.10', 'spread': '1.27', 'groupId': 'OG001'}, {'value': '16.03', 'spread': '1.26', 'groupId': 'OG002'}, {'value': '-1.80', 'spread': '1.95', 'groupId': 'OG003'}]}]}, {'title': 'Symptom Scales - Financial Difficulties', 'categories': [{'measurements': [{'value': '-3.02', 'spread': '1.65', 'groupId': 'OG000'}, {'value': '-1.27', 'spread': '2.46', 'groupId': 'OG001'}, {'value': '-6.36', 'spread': '1.76', 'groupId': 'OG002'}, {'value': '-9.35', 'spread': '2.59', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.287', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSMean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.89', 'ciLowerLimit': '-5.36', 'ciUpperLimit': '1.59', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.77', 'groupDescription': 'Global Health Status', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.597', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSMean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.77', 'ciLowerLimit': '-3.64', 'ciUpperLimit': '2.10', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.46', 'groupDescription': 'Functional Scales - Physical functioning', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.885', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSMean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.31', 'ciLowerLimit': '-4.55', 'ciUpperLimit': '3.93', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.15', 'groupDescription': 'Functional Scales - Role Functioning', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.340', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSMean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.67', 'ciLowerLimit': '-1.77', 'ciUpperLimit': '5.10', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.74', 'groupDescription': 'Functional Scales - Emotional Functioning', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.182', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSMean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.17', 'ciLowerLimit': '-5.37', 'ciUpperLimit': '1.03', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.62', 'groupDescription': 'Functional Scales - Cognitive Functioning', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.678', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSMean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.88', 'ciLowerLimit': '-5.05', 'ciUpperLimit': '3.29', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.12', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.355', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSMean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.57', 'ciLowerLimit': '-1.77', 'ciUpperLimit': '4.91', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.70', 'groupDescription': 'Symptom Scales - Fatigue', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.372', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSMean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.95', 'ciLowerLimit': '-1.14', 'ciUpperLimit': '3.03', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.06', 'groupDescription': 'Symptom Scales - Nausea and Vomiting', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.740', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSMean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.740', 'ciLowerLimit': '-3.75', 'ciUpperLimit': '2.66', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.63', 'groupDescription': 'Symptom Scales - Pain', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.240', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSMean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.16', 'ciLowerLimit': '-1.46', 'ciUpperLimit': '5.78', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.84', 'groupDescription': 'Symptom Scales - Dyspnoea', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.673', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSMean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.81', 'ciLowerLimit': '-4.60', 'ciUpperLimit': '2.97', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.92', 'groupDescription': 'Symptom scales - Insomnia', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSMean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.65', 'ciLowerLimit': '2.23', 'ciUpperLimit': '9.07', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.74', 'groupDescription': 'Symptom Scales - Appetite', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.375', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSMean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.57', 'ciLowerLimit': '-5.04', 'ciUpperLimit': '1.91', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.76', 'groupDescription': 'Symptom Scales - Constipation', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSMean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '15.82', 'ciLowerLimit': '12.81', 'ciUpperLimit': '18.84', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.53', 'groupDescription': 'Symptom Scales - Diarrhoea', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.557', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSMean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.75', 'ciLowerLimit': '-7.59', 'ciUpperLimit': '4.10', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.97', 'groupDescription': 'Symptom Scales - Financial Difficulties', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.169', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LSMean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.47', 'ciLowerLimit': '-8.43', 'ciUpperLimit': '1.49', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.51', 'groupDescription': 'Global Health Status', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.400', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LSMean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.58', 'ciLowerLimit': '-2.12', 'ciUpperLimit': '5.29', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.87', 'groupDescription': 'Functional Scales - Physical Functioning', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.472', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LSMean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.72', 'ciLowerLimit': '-6.42', 'ciUpperLimit': '2.99', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.38', 'groupDescription': 'Functional Scales - Role functioning', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.310', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LSMean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.42', 'ciLowerLimit': '-7.12', 'ciUpperLimit': '2.28', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.310', 'groupDescription': 'Functional Scales - Emotional Functioning', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.830', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LSMean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.64', 'ciLowerLimit': '-5.26', 'ciUpperLimit': '6.55', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.98', 'groupDescription': 'Functional Scales - Social Functioning', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.281', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LSMean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.73', 'ciLowerLimit': '-2.26', 'ciUpperLimit': '7.72', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.52', 'groupDescription': 'Symptom Scales - Fatigue', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.194', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LSMean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.59', 'ciLowerLimit': '-1.33', 'ciUpperLimit': '6.52', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.99', 'groupDescription': 'Symptom Scales - Nausea and Vomiting', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.275', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LSMean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.66', 'ciLowerLimit': '-7.45', 'ciUpperLimit': '2.14', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.42', 'groupDescription': 'Symptom Scales - Pain', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.280', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LSMean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.49', 'ciLowerLimit': '-7.04', 'ciUpperLimit': '2.06', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.39', 'groupDescription': 'Symptom Scales - Dyspnoea', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.499', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LSMean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.97', 'ciLowerLimit': '-3.78', 'ciUpperLimit': '7.72', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.90', 'groupDescription': 'Symptom Scales - Insomnia', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.012', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LSMean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.46', 'ciLowerLimit': '1.68', 'ciUpperLimit': '13.23', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.92', 'groupDescription': 'Symptom Scales - Appetite', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.321', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LSMean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.28', 'ciLowerLimit': '-6.83', 'ciUpperLimit': '2.27', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.29', 'groupDescription': 'Symptom Scales - Constipation', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LSMean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '17.83', 'ciLowerLimit': '13.25', 'ciUpperLimit': '22.41', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.32', 'groupDescription': 'Symptom Scales - Diarrhoea', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.342', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LSMean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.99', 'ciLowerLimit': '-3.21', 'ciUpperLimit': '9.19', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.14', 'groupDescription': 'Symptom Scales - Financial DIfficulties', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.310', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LSMean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.42', 'ciLowerLimit': '-7.12', 'ciUpperLimit': '2.28', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.38', 'groupDescription': 'Functional Scales - Cognitive functioning', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline through 19 Months', 'description': '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 Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and had baseline EORTC-QLQ-C30 measurement.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics (PK): Area Under the Concentration Curve of Abemaciclib, Its Metabolites (M2 & M20)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '204', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abemaciclib + Nonsteroidal Aromatase Inhibitor (NSAI)', 'description': 'Participants received Abemaciclib orally every 12 hours (Q12H) plus anastrozole or letrozole given orally every 24 hours (Q24H) on days 1 to 28 of a 28 day cycle.'}, {'id': 'OG001', 'title': 'Abemaciclib + Fulvestrant', 'description': 'Participants received Abemaciclib orally Q12H on days 1 to 28 of a 28 day cycle plus fulvestrant intramuscularly (IM) on days 1 and 15 of cycle 1, then on day 1 of cycle 2 and beyond.'}], 'classes': [{'title': 'Abemaciclib', 'categories': [{'measurements': [{'value': '2720', 'spread': '40', 'groupId': 'OG000'}, {'value': '2740', 'spread': '57', 'groupId': 'OG001'}]}]}, {'title': 'LSN2839567 (M2)', 'categories': [{'measurements': [{'value': '1080', 'spread': '84', 'groupId': 'OG000'}, {'value': '861', 'spread': '120', 'groupId': 'OG001'}]}]}, {'title': 'LSN3106726 (M20)', 'categories': [{'measurements': [{'value': '1970', 'spread': '81', 'groupId': 'OG000'}, {'value': '1570', 'spread': '110', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'C1D1 post dose, C2D1 post dose, C3D1 predose, C4D1 predose', 'description': 'Pharmacokinetics (PK): Area Under the Concentration Curve of Abemaciclib and its Metabolites LSN2839567 (M2) \\& LSN3106726 (M20) was reported.\n\nC=Cycle, D=day;', 'unitOfMeasure': 'Nanogram*hour per Millilitre (ng*h/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of Abemaciclib and had evaluable PK data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Abemaciclib + Nonsteroidal Aromatase Inhibitor (NSAI)', 'description': 'Participants received Abemaciclib orally every 12 hours (Q12H) plus anastrozole or letrozole given orally every 24 hours (Q24H) on days 1 to 28 of a 28 day cycle.'}, {'id': 'FG001', 'title': 'Placebo + NSAI', 'description': 'Participants received Placebo orally Q12H plus anastrozole or letrozole given orally Q24H on days 1 to 28 of a 28 day cycle.'}, {'id': 'FG002', 'title': 'Abemaciclib + Fulvestrant', 'description': 'Participants received Abemaciclib orally Q12H on days 1 to 28 of a 28 day cycle plus fulvestrant intramuscularly (IM) on days 1 and 15 of cycle 1, then on day 1 of cycle 2 and beyond.'}, {'id': 'FG003', 'title': 'Placebo + Fulvestrant', 'description': 'Participants received Placebo orally Q12H on days 1 to 28 of a 28 day cycle plus fulvestrant IM on days 1 and 15 of cycle 1, then on day 1 of cycle 2 and beyond.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '207'}, {'groupId': 'FG001', 'numSubjects': '99'}, {'groupId': 'FG002', 'numSubjects': '104'}, {'groupId': 'FG003', 'numSubjects': '53'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '89'}, {'groupId': 'FG001', 'numSubjects': '60'}, {'groupId': 'FG002', 'numSubjects': '50'}, {'groupId': 'FG003', 'numSubjects': '39'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '118'}, {'groupId': 'FG001', 'numSubjects': '39'}, {'groupId': 'FG002', 'numSubjects': '54'}, {'groupId': 'FG003', 'numSubjects': '14'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'On study treatment at study conclusion', 'reasons': [{'groupId': 'FG000', 'numSubjects': '114'}, {'groupId': 'FG001', 'numSubjects': '34'}, {'groupId': 'FG002', 'numSubjects': '54'}, {'groupId': 'FG003', 'numSubjects': '13'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Participants who died due to any cause or disease progression or alive and on study at conclusion but off treatment are considered as completed.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'BG000'}, {'value': '99', 'groupId': 'BG001'}, {'value': '104', 'groupId': 'BG002'}, {'value': '53', 'groupId': 'BG003'}, {'value': '463', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Abemaciclib + Nonsteroidal Aromatase Inhibitor (NSAI)', 'description': 'Participants received Abemaciclib orally every 12 hours (Q12H) plus anastrozole or letrozole given orally every 24 hours (Q24H) on days 1 to 28 of a 28 day cycle.'}, {'id': 'BG001', 'title': 'Placebo + NSAI', 'description': 'Participants received Placebo orally Q12H plus anastrozole or letrozole given orally Q24H on days 1 to 28 of a 28 day cycle.'}, {'id': 'BG002', 'title': 'Abemaciclib + Fulvestrant', 'description': 'Participants received Abemaciclib orally Q12H on days 1 to 28 of a 28 day cycle plus fulvestrant intramuscularly (IM) on days 1 and 15 of cycle 1, then on day 1 of cycle 2 and beyond.'}, {'id': 'BG003', 'title': 'Placebo + Fulvestrant', 'description': 'Participants received Placebo orally Q12H on days 1 to 28 of a 28 day cycle plus fulvestrant IM on days 1 and 15 of cycle 1, then on day 1 of cycle 2 and beyond.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.4', 'spread': '10.8', 'groupId': 'BG000'}, {'value': '55.5', 'spread': '9.8', 'groupId': 'BG001'}, {'value': '59.7', 'spread': '8.5', 'groupId': 'BG002'}, {'value': '58.2', 'spread': '10.3', 'groupId': 'BG003'}, {'value': '57.1', 'spread': '10.1', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '207', 'groupId': 'BG000'}, {'value': '99', 'groupId': 'BG001'}, {'value': '104', 'groupId': 'BG002'}, {'value': '53', 'groupId': 'BG003'}, {'value': '463', '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', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', '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': '207', 'groupId': 'BG000'}, {'value': '99', 'groupId': 'BG001'}, {'value': '104', 'groupId': 'BG002'}, {'value': '53', 'groupId': 'BG003'}, {'value': '463', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, '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': '182', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '94', 'groupId': 'BG002'}, {'value': '48', 'groupId': 'BG003'}, {'value': '413', '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': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '44', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', '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', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'China', 'categories': [{'measurements': [{'value': '164', 'groupId': 'BG000'}, {'value': '82', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}, {'value': '380', 'groupId': 'BG004'}]}]}, {'title': 'Brazil', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '44', 'groupId': 'BG004'}]}]}, {'title': 'South Africa', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}]}]}, {'title': 'India', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '32', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All randomized participants.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-05-14', 'size': 1127163, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-03-11T06:21', 'hasProtocol': True}, {'date': '2019-04-25', 'size': 4689298, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-03-11T06:27', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 463}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-12-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-29', 'studyFirstSubmitDate': '2016-05-04', 'resultsFirstSubmitDate': '2020-03-16', 'studyFirstSubmitQcDate': '2016-05-04', 'lastUpdatePostDateStruct': {'date': '2025-09-11', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2020-03-16', 'studyFirstPostDateStruct': {'date': '2016-05-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-03-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression Free Survival (PFS) (Abemaciclib + NSAI & Placebo NSAI)', 'timeFrame': 'Randomization to Measured Progressive Disease or Death (up to 26 Months)', 'description': 'Progression-free survival time was measured from randomization until the date of objective progression as defined by Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1), or death from any cause. 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. Patients 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': 'Progression Free Survival (PFS) (Abemaciclib + Fulvestrant and Placebo + Fulvestrant Arms)', 'timeFrame': 'Randomization to Measured Progressive Disease or Death (up to 26 Months)', 'description': 'Progression-free survival time was measured from randomization until the date of objective progression as defined by Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1), or death from any cause. 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. Patients 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.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'Randomization to Date of Death from Any Cause (Estimated up to 38 Months)'}, {'measure': 'Percentage of Participants With Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]', 'timeFrame': 'Randomization to Measured Progressive Disease (up to 26 Months)', 'description': 'Objective response rate is the percentage of participants with a BOR of CR or PR as defined by RECIST v1.1. CR is defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR is 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': 'Duration of Response (DoR)', 'timeFrame': 'Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Estimated up to 38 Months)'}, {'measure': 'Percentage of Participants Who Exhibit Stable Disease (SD) or CR or PR [Disease Control Rate (DCR)]', 'timeFrame': 'Randomization to Measured Progressive Disease (up to 26 Months)', 'description': 'Disease control rate (DCR) is the percentage of participants with a best overall response of CR, PR or SD as defined by RECIST v1.1. CR is defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) for target lesions, no progression of non-target lesions, and no appearance of new lesions. 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.'}, {'measure': 'Percentage of Participants With Best Overall Response of CR, PR, or SD With Duration of SD for at Least 6 Months [Clinical Benefit Rate (CBR)]', 'timeFrame': 'Randomization to Measured Progressive Disease (up to 26 Months)', 'description': 'Clinical benefit rate (CBR) is the percentage of participants with a BOR of CR or PR, or SD for at least 6 months. CR is defined as the disappearance of all target and non-target lesions \\& no appearance of new lesions. PR is 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. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, no progression of non-target lesions, and no appearance of new lesions. 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.'}, {'measure': 'Change From Randomization in Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)', 'timeFrame': 'Baseline through 19 Months', 'description': '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': 'Pharmacokinetics (PK): Area Under the Concentration Curve of Abemaciclib, Its Metabolites (M2 & M20)', 'timeFrame': 'C1D1 post dose, C2D1 post dose, C3D1 predose, C4D1 predose', 'description': 'Pharmacokinetics (PK): Area Under the Concentration Curve of Abemaciclib and its Metabolites LSN2839567 (M2) \\& LSN3106726 (M20) was reported.\n\nC=Cycle, D=day;'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Hormone Receptor-Positive', 'HER2-Negative', 'CDK4', 'CDK6'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '39385327', 'type': 'DERIVED', 'citation': 'Hu X, Zhang Q, Sun T, Yin Y, Li H, Yan M, Tong Z, Li M, Teng Y, Oppermann CP, Kanakasetty GB, Portugal MC, Yang L, Zhang W, Jiang Z. Abemaciclib plus non-steroidal aromatase inhibitor or fulvestrant in women with HR+/HER2- advanced breast cancer: Final results of the randomized phase III MONARCH plus trial. Chin Med J (Engl). 2025 Jun 20;138(12):1477-1486. doi: 10.1097/CM9.0000000000003151. Epub 2024 Oct 10.'}, {'pmid': '33149768', 'type': 'DERIVED', 'citation': 'Zhang QY, Sun T, Yin YM, Li HP, Yan M, Tong ZS, Oppermann CP, Liu YP, Costa R, Li M, Cheng Y, Ouyang QC, Chen X, Liao N, Wu XH, Wang XJ, Feng JF, Hegg R, Kanakasetty GB, Coccia-Portugal MA, Han RB, Lu Y, Chi HD, Jiang ZF, Hu XC. MONARCH plus: abemaciclib plus endocrine therapy in women with HR+/HER2- advanced breast cancer: the multinational randomized phase III study. Ther Adv Med Oncol. 2020 Oct 22;12:1758835920963925. doi: 10.1177/1758835920963925. eCollection 2020.'}], 'seeAlsoLinks': [{'url': 'https://trials.lillytrialguide.com/en-US/trial/5gZx1MGGogIqeyI6uuKOO', 'label': 'A Study of Abemaciclib (LY2835219) in Participants With Breast Cancer'}]}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to evaluate the efficacy of the study drug abemaciclib in postmenopausal women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) locoregionally recurrent or 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. Although not required as a protocol procedure, metastatic disease should be considered for biopsy whenever possible to reassess hormone receptor (HR) and human epidermal growth factor receptor 2 (HER2) status if clinically indicated.\n\n * To fulfill the requirement for HR+ disease, a breast cancer must express, by immunohistochemistry (IHC), at least 1 of the HRs (estrogen receptor \\[ER\\], progesterone receptor \\[PgR\\]) as defined in the relevant American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines.\n * To fulfill the requirement of HER2- disease, a breast cancer must not demonstrate, at initial diagnosis or upon subsequent biopsy, overexpression of HER2 by either IHC or in-situ hybridization as defined in the relevant ASCO/CAP guidelines.\n* Meet either Inclusion Criterion (2a) or Inclusion Criterion (2b). Participants meeting Inclusion Criterion 2a will be enrolled in Cohort A and participants meeting Inclusion Criterion 2b will be enrolled in Cohort B.\n* (2a) Have locoregionally recurrent disease not amenable to resection or radiation therapy with curative intent or metastatic disease.\n\n * Relapsed with radiologic evidence of progression more than 1 year from completion of adjuvant endocrine therapy and have received no prior endocrine therapy for locoregionally recurrent or metastatic disease (Note: prior adjuvant endocrine therapy for localized disease may have included, but is not limited to, anti-estrogens or aromatase inhibitors. In addition, a participant may be enrolled if she has received ≤2 weeks of NSAI in this disease setting immediately preceding screening and agrees to discontinue NSAI until study treatment initiation.) OR\n * Presented with de novo metastatic breast cancer (mBC) and not received any prior endocrine therapy. OR\n* Relapsed with radiologic evidence of progression less than 1 year from completion of or while receiving adjuvant endocrine therapy (except for letrozole or anastrozole) and have received no prior endocrine therapy for locoregionally recurrent or metastatic disease.\n* (2b) Have locoregionally recurrent disease not amenable to resection or radiation therapy with curative intent or metastatic disease.\n\n * Relapsed with radiologic evidence of progression while receiving neoadjuvant or adjuvant endocrine therapy, with no subsequent endocrine therapy received following progression OR\n * Relapsed with radiologic evidence of progression within 1 year from completion of adjuvant endocrine therapy, with no subsequent endocrine therapy received following progression OR\n * Relapsed with radiologic evidence of progression more than 1 year from completion of adjuvant endocrine therapy and then subsequently relapsed with radiologic evidence of progression after receiving treatment with either an antiestrogen or an aromatase inhibitor as firstline endocrine therapy for metastatic disease. Participants may not have received more than 1 line of endocrine therapy or any prior chemotherapy for metastatic disease OR\n * Presented with de novo metastatic disease and then relapsed with radiologic evidence of progression after receiving treatment with either an antiestrogen or an aromatase inhibitor as first-line endocrine therapy for metastatic disease. Participants may not have received more than 1 line of endocrine therapy or any prior chemotherapy for metastatic disease.\n* Have postmenopausal status defined as meeting at least 1 of the following:\n\n * Prior bilateral oophorectomy\n * Age ≥60 years\n * Age \\<60 years and amenorrheic for at least 12 months (in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression) and follicle-stimulating hormone (FSH) and estradiol levels in the postmenopausal range.\n* Have 1 of the following, as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1:\n\n * Measurable disease\n * Nonmeasurable bone-only disease. Nonmeasurable bone-only disease may include any of the following: blastic bone lesions, lytic bone lesions without a measurable soft tissue component, or mixed lytic-blastic bone lesions without a measurable soft tissue component.\n* Have a performance status (PS) of ≤1 on the Eastern Cooperative Oncology (ECOG) scale.\n* Have adequate organ function, including:\n\n * Hematologic: absolute neutrophil count (ANC) ≥1.5 × 109/Liter (L), platelets\n\n ≥100 × 109/L, and hemoglobin ≥8 g/deciliter (dL). Participants may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator; however, initial study drug treatment must not begin earlier than the day after the erythrocyte transfusion.\n * Hepatic: Total bilirubin ≤1.5 times the upper limit of normal (ULN) and alanine aminotransferase (ALT) and aspartate aminotransferase (AST)\n\n ≤3.0 times ULN (or ALT and AST ≤5 times ULN if liver metastases are present).\n * Renal: serum creatinine ≤1.5 times ULN.\n* Have discontinued previous localized radiotherapy for palliative purposes or for lytic lesions at risk of fracture at least 2 weeks prior to randomization 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* Are able to swallow capsules.\n* Are reliable, willing to be available for the duration of the study, and willing to follow study procedures.\n\nExclusion Criteria:\n\n* Have visceral crisis, lymphangitic spread, or leptomeningeal carcinomatosis. Visceral crisis is not the mere presence of visceral metastases, but implies severe organ dysfunction as assessed by symptoms and signs, laboratory studies, and rapid progression of the disease.\n* Have inflammatory breast cancer.\n* Have clinical evidence or a history of central nervous system (CNS) metastasis. Screening test is not required for enrollment.\n* Are currently receiving or have previously received chemotherapy for locoregionally recurrent or metastatic breast cancer. (Note: Participants may be enrolled if they received prior \\[neo\\]adjuvant chemotherapy for localized disease.)\n* Have received prior treatment with everolimus or fulvestrant (for Cohort B only).\n* Have received prior treatment with any cyclin-dependent kinases 4 and 6 (CDK4 and CDK6) inhibitor (or participated in any CDK4 and CDK6 inhibitor clinical trial for which treatment assignment is still blinded).\n* Have initiated bisphosphonates or approved Receptor activator of nuclear factor kappa-B ligand (RANK-L) targeted agents \\<7 days prior to randomization.\n* Are currently enrolled in a clinical trial involving an investigational product (IP) or non-approved use of a drug or device (other than the IP/device used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study. If a participant is currently enrolled in a clinical trial involving non-approved use of a device, then agreement with the investigator and Eli Lilly and Company (Lilly) clinical research physician (CRP) is required to establish eligibility.\n* Have received treatment with a drug that has not received regulatory approval for any indication within 14 or 21 days of randomization for a nonmyelosuppressive or myelosuppressive agent, respectively.\n* Have had major surgery within 14 days prior to randomization to allow for post-operative healing of the surgical wound and site(s).\n* Have received recent (within 28 days prior to randomization) live attenuated vaccines such as yellow fever vaccine.\n* Have serious preexisting medical conditions that, in the judgment of the investigator, would preclude participation in this study (eg, history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis).\n* Have a personal history within the last 12 months of any of the following conditions: syncope of cardiovascular etiology, ventricular tachycardia, ventricular fibrillation, or sudden cardiac arrest.\n* Have a history of any other cancer (except nonmelanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission with no therapy for a minimum of 3 years.\n* Have received an autologous or allogeneic stem-cell transplant.\n* Have clinical evidence of active bacterial or fungal infection or active viral infection that, in the judgment of the investigator, would preclude participation in this study (eg, human immunodeficiency virus \\[HIV\\] or viral hepatitis). Screening test is not required for enrollment."}, 'identificationModule': {'nctId': 'NCT02763566', 'acronym': 'MONARCH plus', 'briefTitle': 'A Study of Abemaciclib (LY2835219) in Participants With Breast Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Compare NSAI (Anastrozole or Letrozole) Plus Abemaciclib, a CDK4 and CDK6 Inhibitor, or Plus Placebo, and to Compare Fulvestrant Plus Abemaciclib or Plus Placebo in Postmenopausal Women With Hormone Receptor-Positive, HER2-Negative Locoregionally Recurrent or Metastatic Breast Cancer', 'orgStudyIdInfo': {'id': '15530'}, 'secondaryIdInfos': [{'id': 'I3Y-CR-JPBQ', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Abemaciclib + Nonsteroidal Aromatase Inhibitor (NSAI)', 'description': 'Abemaciclib given orally every 12 hours (Q12H) plus anastrozole or letrozole given orally every 24 hours (Q24H) on days 1 to 28 of a 28 day cycle. Participants receiving benefit may continue until disease progression.', 'interventionNames': ['Drug: Abemaciclib', 'Drug: Anastrozole', 'Drug: Letrozole']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo + NSAI', 'description': 'Placebo given orally Q12H plus anastrozole or letrozole given orally Q24H on days 1 to 28 of a 28 day cycle. Participants receiving benefit may continue until disease progression.', 'interventionNames': ['Drug: Anastrozole', 'Drug: Letrozole', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Abemaciclib + Fulvestrant', 'description': 'Abemaciclib given orally Q12H on days 1 to 28 of a 28 day cycle plus fulvestrant intramuscularly (IM) on days 1 and 15 of cycle 1, then on day 1 of cycle 2 and beyond. Participants receiving benefit may continue until disease progression.', 'interventionNames': ['Drug: Abemaciclib', 'Drug: Fulvestrant']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo + Fulvestrant', 'description': 'Placebo given orally Q12H on days 1 to 28 of a 28 day cycle plus fulvestrant IM on days 1 and 15 of cycle 1, then on day 1 of cycle 2 and beyond. Participants receiving benefit may continue until disease progression.', 'interventionNames': ['Drug: Placebo', 'Drug: Fulvestrant']}], 'interventions': [{'name': 'Abemaciclib', 'type': 'DRUG', 'otherNames': ['LY2835219'], 'description': 'Administered orally', 'armGroupLabels': ['Abemaciclib + Fulvestrant', 'Abemaciclib + Nonsteroidal Aromatase Inhibitor (NSAI)']}, {'name': 'Anastrozole', 'type': 'DRUG', 'description': 'Administered orally', 'armGroupLabels': ['Abemaciclib + Nonsteroidal Aromatase Inhibitor (NSAI)', 'Placebo + NSAI']}, {'name': 'Letrozole', 'type': 'DRUG', 'description': 'Administered orally', 'armGroupLabels': ['Abemaciclib + Nonsteroidal Aromatase Inhibitor (NSAI)', 'Placebo + NSAI']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered orally', 'armGroupLabels': ['Placebo + Fulvestrant', 'Placebo + NSAI']}, {'name': 'Fulvestrant', 'type': 'DRUG', 'description': 'Administered intramuscularly', 'armGroupLabels': ['Abemaciclib + Fulvestrant', 'Placebo + 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