Ignite Creation Date:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2026-02-23 @ 1:05 AM
Study NCT ID:
NCT02107703
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-21
First Post:
2014-04-04
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Abemaciclib (LY2835219) Combined With Fulvestrant in Women With Hormone Receptor Positive HER2 Negative Breast Cancer
Sponsor:
Organization:
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': 'D000077267', 'term': 'Fulvestrant'}], 'ancestors': [{'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 7 years 7.7 Months', 'description': 'Adverse Events: All randomized participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants. Analyses presented in this report are based on a database lock for the pre-planned final OS analysis of 22 April 2022.', 'eventGroups': [{'id': 'EG000', 'title': 'Abemaciclib + Fulvestrant', 'description': '150 mg Abemaciclib given orally once every 12 hours in 28 day cycles. 500 mg fulvestrant administered as two 250-mg injections intramuscularly (IM) on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants may continue to receive treatment until discontinuation criteria are met.', 'otherNumAtRisk': 441, 'deathsNumAtRisk': 446, 'otherNumAffected': 432, 'seriousNumAtRisk': 441, 'deathsNumAffected': 283, 'seriousNumAffected': 129}, {'id': 'EG001', 'title': 'Placebo + Fulvestrant', 'description': 'Placebo administered orally every 12 hours on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation were met.', 'otherNumAtRisk': 223, 'deathsNumAtRisk': 223, 'otherNumAffected': 194, 'seriousNumAtRisk': 223, 'deathsNumAffected': 157, 'seriousNumAffected': 33}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 313, 'numAffected': 155}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 15, 'numAffected': 11}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 500, 'numAffected': 148}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 10, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 113, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 9, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 760, 'numAffected': 219}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 15, 'numAffected': 8}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 135, 'numAffected': 79}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Lacrimation increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 44, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 28, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 320, 'numAffected': 166}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 65, 'numAffected': 36}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 96, 'numAffected': 73}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 47, 'numAffected': 36}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 1205, 'numAffected': 384}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 104, 'numAffected': 62}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 40, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 43, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 15, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 27, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 367, 'numAffected': 218}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 72, 'numAffected': 55}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 119, 'numAffected': 82}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 30, 'numAffected': 24}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 253, 'numAffected': 130}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 43, 'numAffected': 26}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 30, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 294, 'numAffected': 192}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 81, 'numAffected': 64}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 71, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 23, 'numAffected': 16}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 66, 'numAffected': 48}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 40, 'numAffected': 22}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 83, 'numAffected': 62}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 21, 'numAffected': 16}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 42, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 14, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 99, 'numAffected': 62}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 18, 'numAffected': 16}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 36, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 36, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 159, 'numAffected': 88}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 32, 'numAffected': 19}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 76, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 18, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 138, 'numAffected': 79}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 15, 'numAffected': 12}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 132, 'numAffected': 81}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 25, 'numAffected': 16}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 47, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 10, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 134, 'numAffected': 63}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 65, 'numAffected': 54}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 10, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 162, 'numAffected': 127}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 31, 'numAffected': 30}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 77, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 154, 'numAffected': 78}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 47, 'numAffected': 34}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 100, 'numAffected': 62}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 40, 'numAffected': 30}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 36, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 25, 'numAffected': 21}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 90, 'numAffected': 53}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 19, 'numAffected': 15}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 57, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 17, 'numAffected': 14}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 119, 'numAffected': 52}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 13, 'numAffected': 11}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 111, 'numAffected': 67}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 18, 'numAffected': 16}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 106, 'numAffected': 82}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 203, 'numAffected': 108}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 67, 'numAffected': 36}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 51, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 26, 'numAffected': 21}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 26, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 28, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 12, 'numAffected': 10}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 53, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 24, 'numAffected': 21}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 114, 'numAffected': 78}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 35, 'numAffected': 30}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 58, 'numAffected': 51}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 28, 'numAffected': 23}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 32, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 15, 'numAffected': 14}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 88, 'numAffected': 76}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Dermatitis acneiform', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 29, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 61, 'numAffected': 48}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 82, 'numAffected': 64}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 18, 'numAffected': 16}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 75, 'numAffected': 54}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 13, 'numAffected': 11}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 31, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 71, 'numAffected': 51}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 28, 'numAffected': 25}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Lymphoedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 25, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Disseminated intravascular coagulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Atrioventricular block first degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 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'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Blood follicle stimulating hormone abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Electrocardiogram qt prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'General physical condition abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Hormone level abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Oestradiol abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Hypercalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Myositis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Osteonecrosis of jaw', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Adrenal adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Benign bone neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Colon cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Myelodysplastic syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Tumour pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Depressed level of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Psychotic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Chronic kidney disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Pelvic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Atelectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Fracture treatment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Internal fixation of fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Leg amputation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Medical device implantation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Lymphoedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Vasculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Progression-Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '446', 'groupId': 'OG000'}, {'value': '223', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abemaciclib + Fulvestrant', 'description': 'Abemaciclib 150 mg administered orally every 12 hours on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation were met.'}, {'id': 'OG001', 'title': 'Placebo + Fulvestrant', 'description': 'Placebo administered orally every 12 hours on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation were met.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.4', 'groupId': 'OG000', 'lowerLimit': '14.4', 'upperLimit': '19.3'}, {'value': '9.3', 'groupId': 'OG001', 'lowerLimit': '7.4', 'upperLimit': '11.4'}]}]}], 'analyses': [{'pValue': '<0.0000001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.553', 'ciLowerLimit': '0.449', 'ciUpperLimit': '0.681', 'pValueComment': 'This is two sided P value and it is statistically significant.', 'groupDescription': 'The final analysis was planned at 378 PFS events, which would provide approximately 90% power assuming a hazard ratio (HR) of 0.703 at a one-sided α of 0.025.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Log rank test is stratified by endocrine sensitivity and natural of disease by interactive web response system (IWRS).'}], 'paramType': 'MEDIAN', 'timeFrame': 'From Date of Randomization until Disease Progression or Death Due to Any Cause (Up To 31 Months)', 'description': 'PFS defined as the time from the date of randomization to the first evidence of disease progression as defined by response evaluation criteria in solid tumors (RECIST) v1.1 or death from any cause. Progressive Disease (PD) was 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. If a participant does not have a complete baseline disease assessment, then the PFS time was censored at the date of randomization, regardless of whether or not objectively determined disease progression or death has been observed for the participant. If a participant was not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time was censored at the last adequate tumor assessment date.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants. Censored participants: Abemaciclib=224.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '446', 'groupId': 'OG000'}, {'value': '223', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abemaciclib + Fulvestrant', 'description': 'Abemaciclib 150 mg administered orally every 12 hours on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation were met.'}, {'id': 'OG001', 'title': 'Placebo + Fulvestrant', 'description': 'Placebo administered orally every 12 hours on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation were met.'}], 'classes': [{'categories': [{'measurements': [{'value': '45.80', 'groupId': 'OG000', 'lowerLimit': '38.96', 'upperLimit': '52.64'}, {'value': '37.25', 'groupId': 'OG001', 'lowerLimit': '34.36', 'upperLimit': '43.20'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From Date of Randomization until Death Due to Any Cause (Up To 72 Months)', 'description': 'OS defined as the time from the date of randomization to the date of death due to any cause. For each participant who is not known to have died as of the data-inclusion cutoff date for overall survival analysis, OS time was censored on the last date the participant is known to be alive. The final analysis of the OS outcome was conducted after 440 OS events had been observed.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants. Censored participants: Abemaciclib=163 (36.5%), Placebo = 66 (29.6).'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '446', 'groupId': 'OG000'}, {'value': '223', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abemaciclib + Fulvestrant', 'description': 'Abemaciclib 150 mg administered orally every 12 hours on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation were met.'}, {'id': 'OG001', 'title': 'Placebo + Fulvestrant', 'description': 'Placebo administered orally every 12 hours on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation were met.'}], 'classes': [{'categories': [{'measurements': [{'value': '35.2', 'groupId': 'OG000', 'lowerLimit': '30.8', 'upperLimit': '39.6'}, {'value': '16.1', 'groupId': 'OG001', 'lowerLimit': '11.3', 'upperLimit': '21.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 31 Months)', 'description': 'ORR was the percentage of participants achieving a best overall response (BOR) of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. PD was 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': 'Duration of Response (DOR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abemaciclib + Fulvestrant', 'description': 'Abemaciclib 150 mg administered orally every 12 hours on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation were met.'}, {'id': 'OG001', 'title': 'Placebo + Fulvestrant', 'description': 'Placebo administered orally every 12 hours on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation were met.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'The median DoR for participants has not been reached.', 'groupId': 'OG000', 'lowerLimit': '18.05', 'upperLimit': 'NA'}, {'value': '25.6', 'groupId': 'OG001', 'lowerLimit': '11.9', 'upperLimit': '25.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From Date of CR, PR until Disease Progression or Death Due to Any Cause (Up To 31 Months)', 'description': 'DOR was the time from the date of first evidence of complete response or partial response to the date of objective progression or the date of death due to any cause, whichever is earlier. CR and PR were defined using the RECIST v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR 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. If a responder was not known to have died or have objective progression as of the data inclusion cutoff date, duration of response was censored at the last adequate tumor assessment date. PD was 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': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with response.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving CR, PR or Stable Disease (SD) (Disease Control Rate [DCR])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '446', 'groupId': 'OG000'}, {'value': '223', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abemaciclib + Fulvestrant', 'description': 'Abemaciclib 150 mg administered orally every 12 hours on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation were met.'}, {'id': 'OG001', 'title': 'Placebo + Fulvestrant', 'description': 'Placebo administered orally every 12 hours on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation were met.'}], 'classes': [{'categories': [{'measurements': [{'value': '83.0', 'groupId': 'OG000', 'lowerLimit': '79.5', 'upperLimit': '86.4'}, {'value': '75.8', 'groupId': 'OG001', 'lowerLimit': '70.2', 'upperLimit': '81.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 31 Months)', 'description': 'Disease Control Rate (DCR) was the percentage of participants with a best overall response of CR, PR, or Stable Disease (SD) as per Response using RECIST v1.1 criteria. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR 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 was 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 was 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 CR, PR or SD With a Duration of At Least 6 Months (Clinical Benefit Rate [CBR])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '446', 'groupId': 'OG000'}, {'value': '223', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abemaciclib + Fulvestrant', 'description': 'Abemaciclib 150 mg administered orally every 12 hours on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation were met.'}, {'id': 'OG001', 'title': 'Placebo + Fulvestrant', 'description': 'Placebo administered orally every 12 hours on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation were met.'}], 'classes': [{'categories': [{'measurements': [{'value': '72.2', 'groupId': 'OG000', 'lowerLimit': '68.0', 'upperLimit': '76.4'}, {'value': '56.1', 'groupId': 'OG001', 'lowerLimit': '49.5', 'upperLimit': '62.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 31 Months)', 'description': 'Clinical benefit rate defined as percentage of participants with best overall response of CR, PR, or SD with a duration of at least 6 months.CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions.PR 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 was 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. Percentage of participants=(participants with CR+PR+SD with a duration of at least 6 months /number of participants enrolled) \\*100.PD was at least a 20% increase in 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 Baseline in Pain and Symptom Burden Assessment Using the Modified Brief Pain Inventory-Short Form (mBPI-sf)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '441', 'groupId': 'OG000'}, {'value': '223', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abemaciclib + Fulvestrant', 'description': 'Abemaciclib 150 mg administered orally every 12 hours on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation were met.'}, {'id': 'OG001', 'title': 'Placebo + Fulvestrant', 'description': 'Placebo administered orally every 12 hours on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation were met.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.06', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.10', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, End of Study (Up To 31 Months)', 'description': 'A self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). The overall change is based on the estimated main treatment effect. Least square (LS) Mean value was controlled for Treatment, visit, Treatment\\*Visit and baseline.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug with a baseline and at least 1 post-baseline result.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of Abemaciclib, Its Metabolites M2 and M20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '326', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Abemaciclib + Fulvestrant', 'description': 'Abemaciclib 150 mg administered orally every 12 hours on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation were met.'}], 'classes': [{'title': 'Abemaciclib', 'categories': [{'measurements': [{'value': '2960', 'spread': '32.2', 'groupId': 'OG000'}]}]}, {'title': 'M2', 'categories': [{'measurements': [{'value': '1640', 'spread': '70.2', 'groupId': 'OG000'}]}]}, {'title': 'M20', 'categories': [{'measurements': [{'value': '2870', 'spread': '69.6', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 1 2-4 hours (h) post dose, Cycle 1 Day 15 4 and 7h post dose, Cycle 2 Day 1 pre dose and 3h post dose, Cycle 3 Day1 pre dose', 'description': 'Area Under the Plasma Concentration versus Time Curve from Time Zero to Infinity (AUC\\[0-∞\\]) was evaluated for Abemaciclib and Metabolites M2 and M20.', 'unitOfMeasure': 'Nanograms*hour/milliliters (ng*h/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of 150 mg study drug (Abemaciclib) with evaluable Abemaciclib, M2 and M20 PK data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Health Status Using the EuroQol 5-Dimension 5 Level (EQ-5D 5L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '441', 'groupId': 'OG000'}, {'value': '223', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abemaciclib + Fulvestrant', 'description': 'Abemaciclib 150 mg administered orally every 12 hours on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation were met.'}, {'id': 'OG001', 'title': 'Placebo + Fulvestrant', 'description': 'Placebo administered orally every 12 hours on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation were met.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.12', 'spread': '0.65', 'groupId': 'OG000'}, {'value': '1.16', 'spread': '0.92', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, End of Study (Up To 31 Months)', 'description': 'European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a standardized measure of health status of the participant. The EQ-5D-5L is assessed using a visual analog scale (VAS) that ranged from 0 to 100mm, where 0 is the worst health you can imagine and 100 is the best health you can imagine. A higher score indicates better health state. LS Mean value was controlled for Treatment, visit, Treatment\\*Visit and baseline.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug with baseline and post-baseline EQ-5D 5L data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Short Term Follow up in Quality of Life Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abemaciclib + Fulvestrant', 'description': 'Abemaciclib 150 mg administered orally every 12 hours on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation were met.'}, {'id': 'OG001', 'title': 'Placebo + Fulvestrant', 'description': 'Placebo administered orally every 12 hours on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation were met.'}], 'classes': [{'title': 'Global health status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.57', 'spread': '1.55', 'groupId': 'OG000'}, {'value': '-8.15', 'spread': '1.87', 'groupId': 'OG001'}]}]}, {'title': 'Functional scale: Physical functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.76', 'spread': '1.29', 'groupId': 'OG000'}, {'value': '-7.59', 'spread': '1.59', 'groupId': 'OG001'}]}]}, {'title': 'Functional scale: Role functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.87', 'spread': '1.73', 'groupId': 'OG000'}, {'value': '-9.58', 'spread': '2.12', 'groupId': 'OG001'}]}]}, {'title': 'Functional scale: Emotional functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.38', 'spread': '1.38', 'groupId': 'OG000'}, {'value': '-2.44', 'spread': '1.70', 'groupId': 'OG001'}]}]}, {'title': 'Functional scale: Cognitive functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.16', 'spread': '1.29', 'groupId': 'OG000'}, {'value': '-2.96', 'spread': '1.58', 'groupId': 'OG001'}]}]}, {'title': 'Functional scale: Social functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.62', 'spread': '1.61', 'groupId': 'OG000'}, {'value': '-4.78', 'spread': '1.97', 'groupId': 'OG001'}]}]}, {'title': 'Symptom scale: Fatigue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.01', 'spread': '1.45', 'groupId': 'OG000'}, {'value': '7.83', 'spread': '1.78', 'groupId': 'OG001'}]}]}, {'title': 'Symptom scale: Nausea and vomiting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.81', 'spread': '1.35', 'groupId': 'OG000'}, {'value': '6.49', 'spread': '1.64', 'groupId': 'OG001'}]}]}, {'title': 'Symptom scale: Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.47', 'spread': '1.82', 'groupId': 'OG000'}, {'value': '4.38', 'spread': '2.21', 'groupId': 'OG001'}]}]}, {'title': 'Symptom scale: Dyspnoea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.21', 'spread': '1.70', 'groupId': 'OG000'}, {'value': '5.39', 'spread': '2.10', 'groupId': 'OG001'}]}]}, {'title': 'Symptom scale: Insomnia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.04', 'spread': '1.86', 'groupId': 'OG000'}, {'value': '3.76', 'spread': '2.27', 'groupId': 'OG001'}]}]}, {'title': 'Symptom scale: Appetite loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.06', 'spread': '1.85', 'groupId': 'OG000'}, {'value': '6.40', 'spread': '2.23', 'groupId': 'OG001'}]}]}, {'title': 'Symptom scale: Constipation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.15', 'spread': '1.59', 'groupId': 'OG000'}, {'value': '3.79', 'spread': '1.92', 'groupId': 'OG001'}]}]}, {'title': 'Symptom scale: Diarrhoea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.14', 'spread': '1.66', 'groupId': 'OG000'}, {'value': '2.67', 'spread': '1.99', 'groupId': 'OG001'}]}]}, {'title': 'Symptom scale: Financial difficulties', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.34', 'spread': '1.60', 'groupId': 'OG000'}, {'value': '2.85', 'spread': '1.96', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Short Term Follow Up (Up To 31 Months)', 'description': 'EORTC QLQ-C30 v3.0 was a self-administered questionnaire with multidimensional scales that measures 5 functional domains (physical, role, cognitive, emotional, and social), global health status, and symptom scales of fatigue, pain, nausea and vomiting, dyspnea, loss of appetite, insomnia, constipation and diarrhea, and financial difficulties. A linear transformation is applied to standardize the raw scores to range between 0 and 100 per developer guidelines. For functional domains and global health status, scores range from 0 to 110 with higher scores representing a better level of functioning. For symptoms scales, scores range from 0 to 100 with higher scores representing a greater degree of symptoms. LS Mean value of changing from baseline to short follow up was estimated from the mixed model that was controlled for Treatment, visit, Treatment\\*Visit and baseline.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug with baseline and post-baseline EORTC QLQ-C30 data at short term follow up for each EORTC QLQ-C30 items.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Short Term Follow up in Quality of Life Using the EORTC QLQ-BR23 (Breast) Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '182', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abemaciclib + Fulvestrant', 'description': 'Abemaciclib 150 mg administered orally every 12 hours on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation were met.'}, {'id': 'OG001', 'title': 'Placebo + Fulvestrant', 'description': 'Placebo administered orally every 12 hours on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation were met.'}], 'classes': [{'title': 'Functional scale: Body image', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.20', 'spread': '1.46', 'groupId': 'OG000'}, {'value': '-3.27', 'spread': '1.83', 'groupId': 'OG001'}]}]}, {'title': 'Functional scale:Sexual functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.41', 'spread': '1.00', 'groupId': 'OG000'}, {'value': '-1.60', 'spread': '1.25', 'groupId': 'OG001'}]}]}, {'title': 'Functional scale: Future perspective', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.06', 'spread': '2.06', 'groupId': 'OG000'}, {'value': '10.05', 'spread': '2.51', 'groupId': 'OG001'}]}]}, {'title': 'Symptom scale: Systemic therapy side effects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '182', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.23', 'spread': '1.00', 'groupId': 'OG000'}, {'value': '6.98', 'spread': '1.22', 'groupId': 'OG001'}]}]}, {'title': 'Symptom scale: Breast symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.10', 'spread': '0.89', 'groupId': 'OG000'}, {'value': '-0.96', 'spread': '1.09', 'groupId': 'OG001'}]}]}, {'title': 'Symptom scale: Arm symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '182', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.45', 'spread': '1.29', 'groupId': 'OG000'}, {'value': '0.10', 'spread': '1.59', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Short Term Follow Up (Up To 31 Months)', 'description': 'EORTC-QLQ-BR23 measured multi-item functional scales for body image, sexual functioning and future perspective and measured single item symptoms scales which assessed systemic therapy side effects, breast symptoms and arm symptoms. For functional scales, scores ranged from 0 to 100 where higher scores represented a better level of functioning. For symptoms scales, scores ranged from 0 to 100 where higher scores represented a greater degree of symptoms. LS Mean value of changing from baseline to short follow up was estimated from the mixed model that was controlled for Treatment, visit, Treatment\\*Visit and baseline.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug with baseline and post-baseline EORTC QLQ-BR23 data at short term follow up for each BR23 items.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Abemaciclib + Fulvestrant', 'description': 'Abemaciclib 150 milligram (mg) administered orally every 12 hours on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500mg administered intramuscularly (IM) on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation were met.'}, {'id': 'FG001', 'title': 'Placebo + Fulvestrant', 'description': 'Placebo administered orally every 12 hours on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. 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Participants received treatment until discontinuation were met.'}, {'id': 'BG001', 'title': 'Placebo + Fulvestrant', 'description': 'Placebo administered orally every 12 hours on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation were met.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '446', 'groupId': 'BG000'}, {'value': '223', 'groupId': 'BG001'}, {'value': '669', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '59.3', 'spread': '11.2', 'groupId': 'BG000'}, {'value': '61.1', 'spread': '11.7', 'groupId': 'BG001'}, {'value': '59.9', 'spread': '11.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '446', 'groupId': 'BG000'}, {'value': '223', 'groupId': 'BG001'}, {'value': '669', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '446', 'groupId': 'BG000'}, {'value': '223', 'groupId': 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'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'populationDescription': 'All randomized participants who had baseline Ethnicity data.'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '446', 'groupId': 'BG000'}, {'value': '223', 'groupId': 'BG001'}, {'value': '669', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '149', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '214', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': 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{'value': '58', 'groupId': 'BG001'}, {'value': '178', 'groupId': 'BG002'}]}]}, {'title': 'Europe', 'denoms': [{'units': 'Participants', 'counts': [{'value': '446', 'groupId': 'BG000'}, {'value': '223', 'groupId': 'BG001'}, {'value': '669', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '179', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '279', 'groupId': 'BG002'}]}]}, {'title': 'Taiwan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '446', 'groupId': 'BG000'}, {'value': '223', 'groupId': 'BG001'}, {'value': '669', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}]}, {'title': 'Japan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '446', 'groupId': 'BG000'}, {'value': '223', 'groupId': 'BG001'}, {'value': '669', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}]}]}, {'title': 'South Korea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '446', 'groupId': 'BG000'}, {'value': '223', 'groupId': 'BG001'}, {'value': '669', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All randomized participants.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2014-04-01', 'size': 3774475, 'label': 'Study Protocol: JPBL 05 Protocol_Redacted', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-01-29T13:18', 'hasProtocol': True}, {'date': '2015-01-12', 'size': 19523281, 'label': 'Study Protocol: JPBL 05 Protocol (a)_Redacted', 'hasIcf': False, 'hasSap': 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'Prot', 'uploadDate': '2023-08-17T12:42', 'hasProtocol': True}, {'date': '2016-07-08', 'size': 653030, 'label': 'Statistical Analysis Plan: version 4', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_005.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-01-29T15:25', 'hasProtocol': False}, {'date': '2017-08-25', 'size': 335867, 'label': 'Statistical Analysis Plan: Addendum for Overall Survival Analyses', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_006.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-01-31T09:46', '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': 669}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2014-07-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'nctId': 'NCT03763604', 'statusForNctId': 'APPROVED_FOR_MARKETING', 'hasExpandedAccess': True}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-17', 'studyFirstSubmitDate': '2014-04-04', 'resultsFirstSubmitDate': '2018-02-12', 'studyFirstSubmitQcDate': '2014-04-04', 'lastUpdatePostDateStruct': {'date': '2025-10-21', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2018-02-12', 'studyFirstPostDateStruct': {'date': '2014-04-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-02-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-Free Survival (PFS)', 'timeFrame': 'From Date of Randomization until Disease Progression or Death Due to Any Cause (Up To 31 Months)', 'description': 'PFS defined as the time from the date of randomization to the first evidence of disease progression as defined by response evaluation criteria in solid tumors (RECIST) v1.1 or death from any cause. Progressive Disease (PD) was 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. If a participant does not have a complete baseline disease assessment, then the PFS time was censored at the date of randomization, regardless of whether or not objectively determined disease progression or death has been observed for the participant. If a participant was not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time was censored at the last adequate tumor assessment date.'}], 'secondaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': 'From Date of Randomization until Death Due to Any Cause (Up To 72 Months)', 'description': 'OS defined as the time from the date of randomization to the date of death due to any cause. For each participant who is not known to have died as of the data-inclusion cutoff date for overall survival analysis, OS time was censored on the last date the participant is known to be alive. The final analysis of the OS outcome was conducted after 440 OS events had been observed.'}, {'measure': 'Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])', 'timeFrame': 'From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 31 Months)', 'description': 'ORR was the percentage of participants achieving a best overall response (BOR) of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. PD was 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': 'Duration of Response (DOR)', 'timeFrame': 'From Date of CR, PR until Disease Progression or Death Due to Any Cause (Up To 31 Months)', 'description': 'DOR was the time from the date of first evidence of complete response or partial response to the date of objective progression or the date of death due to any cause, whichever is earlier. CR and PR were defined using the RECIST v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR 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. If a responder was not known to have died or have objective progression as of the data inclusion cutoff date, duration of response was censored at the last adequate tumor assessment date. PD was 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 Achieving CR, PR or Stable Disease (SD) (Disease Control Rate [DCR])', 'timeFrame': 'From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 31 Months)', 'description': 'Disease Control Rate (DCR) was the percentage of participants with a best overall response of CR, PR, or Stable Disease (SD) as per Response using RECIST v1.1 criteria. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR 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 was 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 was 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 CR, PR or SD With a Duration of At Least 6 Months (Clinical Benefit Rate [CBR])', 'timeFrame': 'From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 31 Months)', 'description': 'Clinical benefit rate defined as percentage of participants with best overall response of CR, PR, or SD with a duration of at least 6 months.CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions.PR 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 was 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. Percentage of participants=(participants with CR+PR+SD with a duration of at least 6 months /number of participants enrolled) \\*100.PD was at least a 20% increase in 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 Baseline in Pain and Symptom Burden Assessment Using the Modified Brief Pain Inventory-Short Form (mBPI-sf)', 'timeFrame': 'Baseline, End of Study (Up To 31 Months)', 'description': 'A self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). The overall change is based on the estimated main treatment effect. Least square (LS) Mean value was controlled for Treatment, visit, Treatment\\*Visit and baseline.'}, {'measure': 'Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of Abemaciclib, Its Metabolites M2 and M20', 'timeFrame': 'Cycle 1 Day 1 2-4 hours (h) post dose, Cycle 1 Day 15 4 and 7h post dose, Cycle 2 Day 1 pre dose and 3h post dose, Cycle 3 Day1 pre dose', 'description': 'Area Under the Plasma Concentration versus Time Curve from Time Zero to Infinity (AUC\\[0-∞\\]) was evaluated for Abemaciclib and Metabolites M2 and M20.'}, {'measure': 'Change From Baseline in Health Status Using the EuroQol 5-Dimension 5 Level (EQ-5D 5L)', 'timeFrame': 'Baseline, End of Study (Up To 31 Months)', 'description': 'European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a standardized measure of health status of the participant. The EQ-5D-5L is assessed using a visual analog scale (VAS) that ranged from 0 to 100mm, where 0 is the worst health you can imagine and 100 is the best health you can imagine. A higher score indicates better health state. LS Mean value was controlled for Treatment, visit, Treatment\\*Visit and baseline.'}, {'measure': 'Change From Baseline to Short Term Follow up in Quality of Life Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)', 'timeFrame': 'Baseline, Short Term Follow Up (Up To 31 Months)', 'description': 'EORTC QLQ-C30 v3.0 was a self-administered questionnaire with multidimensional scales that measures 5 functional domains (physical, role, cognitive, emotional, and social), global health status, and symptom scales of fatigue, pain, nausea and vomiting, dyspnea, loss of appetite, insomnia, constipation and diarrhea, and financial difficulties. A linear transformation is applied to standardize the raw scores to range between 0 and 100 per developer guidelines. For functional domains and global health status, scores range from 0 to 110 with higher scores representing a better level of functioning. For symptoms scales, scores range from 0 to 100 with higher scores representing a greater degree of symptoms. LS Mean value of changing from baseline to short follow up was estimated from the mixed model that was controlled for Treatment, visit, Treatment\\*Visit and baseline.'}, {'measure': 'Change From Baseline to Short Term Follow up in Quality of Life Using the EORTC QLQ-BR23 (Breast) Questionnaire', 'timeFrame': 'Baseline, Short Term Follow Up (Up To 31 Months)', 'description': 'EORTC-QLQ-BR23 measured multi-item functional scales for body image, sexual functioning and future perspective and measured single item symptoms scales which assessed systemic therapy side effects, breast symptoms and arm symptoms. For functional scales, scores ranged from 0 to 100 where higher scores represented a better level of functioning. For symptoms scales, scores ranged from 0 to 100 where higher scores represented a greater degree of symptoms. LS Mean value of changing from baseline to short follow up was estimated from the mixed model that was controlled for Treatment, visit, Treatment\\*Visit and baseline.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['MONARCH 2'], 'conditions': ['Breast Neoplasms']}, 'referencesModule': {'references': [{'pmid': '34425869', 'type': 'DERIVED', 'citation': 'Neven P, Rugo HS, Tolaney SM, Iwata H, Toi M, Goetz MP, Kaufman PA, Lu Y, Haddad N, Hurt KC, Sledge GW Jr. Abemaciclib plus fulvestrant in hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer in premenopausal women: subgroup analysis from the MONARCH 2 trial. Breast Cancer Res. 2021 Aug 23;23(1):87. doi: 10.1186/s13058-021-01463-2.'}, {'pmid': '33797023', 'type': 'DERIVED', 'citation': 'Inoue K, Masuda N, Iwata H, Takahashi M, Ito Y, Miyoshi Y, Nakayama T, Mukai H, van der Walt JS, Mori J, Sakaguchi S, Kawaguchi T, Tanizawa Y, Llombart-Cussac A, Sledge GW Jr, Toi M. Japanese subpopulation analysis of MONARCH 2: phase 3 study of abemaciclib plus fulvestrant for treatment of hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer that progressed on endocrine therapy. Breast Cancer. 2021 Sep;28(5):1038-1050. doi: 10.1007/s12282-021-01239-8. Epub 2021 Apr 1.'}, {'pmid': '33392835', 'type': 'DERIVED', 'citation': 'Goetz MP, Okera M, Wildiers H, Campone M, Grischke EM, Manso L, Andre VAM, Chouaki N, San Antonio B, Toi M, Sledge GW Jr. Safety and efficacy of abemaciclib plus endocrine therapy in older patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer: an age-specific subgroup analysis of MONARCH 2 and 3 trials. Breast Cancer Res Treat. 2021 Apr;186(2):417-428. doi: 10.1007/s10549-020-06029-y. Epub 2021 Jan 3.'}, {'pmid': '31563959', 'type': 'DERIVED', 'citation': 'Sledge GW Jr, Toi M, Neven P, Sohn J, Inoue K, Pivot X, Burdaeva O, Okera M, Masuda N, Kaufman PA, Koh H, Grischke EM, Conte P, Lu Y, Barriga S, Hurt K, Frenzel M, Johnston S, Llombart-Cussac A. The Effect of Abemaciclib Plus Fulvestrant on Overall Survival in Hormone Receptor-Positive, ERBB2-Negative Breast Cancer That Progressed on Endocrine Therapy-MONARCH 2: A Randomized Clinical Trial. JAMA Oncol. 2020 Jan 1;6(1):116-124. doi: 10.1001/jamaoncol.2019.4782.'}, {'pmid': '28580882', 'type': 'DERIVED', 'citation': 'Sledge GW Jr, Toi M, Neven P, Sohn J, Inoue K, Pivot X, Burdaeva O, Okera M, Masuda N, Kaufman PA, Koh H, Grischke EM, Frenzel M, Lin Y, Barriga S, Smith IC, Bourayou N, Llombart-Cussac A. MONARCH 2: Abemaciclib in Combination With Fulvestrant in Women With HR+/HER2- Advanced Breast Cancer Who Had Progressed While Receiving Endocrine Therapy. J Clin Oncol. 2017 Sep 1;35(25):2875-2884. doi: 10.1200/JCO.2017.73.7585. Epub 2017 Jun 3.'}]}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to compare progression-free survival for women with hormone receptor positive (HR+), human epidermal growth factor receptor (HER2) negative advanced breast cancer receiving either abemaciclib + fulvestrant or fulvestrant alone. Participants will be randomized to abemaciclib or placebo in a 2:1 ratio. The study will last about 9 months for each participant.\n\nFor the endocrine naïve cohort, all participants will received abemaciclib + fulvestrant.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Have a diagnosis of HR+, HER2- breast cancer\n* Have locally advanced disease not amenable to curative treatment by surgery or metastatic disease. In addition, participants must fulfill 1 of the following criteria:\n\n * relapsed with radiologic evidence of progression while receiving neoadjuvant or adjuvant endocrine therapy, with no subsequent endocrine therapy received following progression\n * relapsed with radiologic evidence of progression within 1 year from completion of adjuvant endocrine therapy, with no subsequent endocrine therapy received following progression\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 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 * presented de novo with 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 * for the endocrine naïve cohort: Must not have received prior endocrine therapy in current or prior disease setting\n* Have postmenopausal status due to either surgical/natural menopause or ovarian suppression (initiated at least 28 days prior to Day 1 of Cycle 1) with a gonadotropin-releasing hormone (GnRH) agonist such as goserelin\n* Have a negative serum pregnancy test at baseline (within 14 days prior to randomization) and agree to use medically approved precautions to prevent pregnancy during the study and for 12 weeks following the last dose of abemaciclib if postmenopausal status is due to ovarian suppression with a GnRH agonist\n* Have either measurable disease or nonmeasurable bone only disease\n* Have a performance status ≤1 on the Eastern Cooperative Oncology Group (ECOG) scale\n* Have discontinued previous therapies for cancer (including specifically, aromatase inhibitors, anti-estrogens, chemotherapy, radiotherapy, and immunotherapy) for at least 21 days for myelosuppressive agents or 14 days for nonmyelosuppressive agents prior to receiving study drug, and recovered from the acute effects of therapy (until the toxicity resolves to either baseline or at least Grade 1) except for residual alopecia or peripheral neuropathy\n\nExclusion Criteria\n\n* Are currently receiving an investigational drug in a clinical trial or participating in any other type of medical research judged not to be scientifically or medically compatible with this study\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 clinical evidence or history of central nervous system metastasis\n* Have received prior treatment with chemotherapy (except for neoadjuvant/ adjuvant chemotherapy), fulvestrant, everolimus, or any CDK4/6 inhibitor. For the endocrine naïve cohort: In addition, have received treatment with any prior endocrine therapy\n* Have received treatment with a drug that has not received regulatory approval for any indication within 14 or 21 days prior to randomization of study drug for a nonmyelosuppressive or myelosuppressive agent, respectively\n* Have received recent (within 28 days prior to randomization) yellow fever vaccination\n* Have had major surgery within 14 days prior to randomization of study drug to allow for post-operative healing of the surgical wound and site(s)\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 inflammatory breast cancer or 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 active bacterial or fungal infection, or detectable viral infection\n* Have initiated bisphosphonates or approved Receptor activator of nuclear factor kappa-B (RANK) ligand targeted agents \\<7 days prior to randomization'}, 'identificationModule': {'nctId': 'NCT02107703', 'acronym': 'MONARCH 2', 'briefTitle': 'A Study of Abemaciclib (LY2835219) Combined With Fulvestrant in Women With Hormone Receptor Positive HER2 Negative Breast Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'MONARCH 2: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Fulvestrant With or Without Abemaciclib, a CDK4/6 Inhibitor, for Women With Hormone Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer', 'orgStudyIdInfo': {'id': '15362'}, 'secondaryIdInfos': [{'id': 'I3Y-MC-JPBL', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}, {'id': '2013-004728-13', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Abemaciclib + Fulvestrant', 'description': 'Abemaciclib 150 milligram (mg) administered orally every 12 hours on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500mg administered intramuscularly (IM) on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation were met.', 'interventionNames': ['Drug: Abemaciclib', 'Drug: Fulvestrant']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo + Fulvestrant', 'description': 'Placebo administered orally every 12 hours on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. 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