Ignite Creation Date:
2025-12-24 @ 10:01 PM
Ignite Modification Date:
2026-02-09 @ 11:31 AM
Study NCT ID:
NCT00808132
Status:
COMPLETED
Last Update Posted:
2014-04-08
First Post:
2008-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study Evaluating The Effects Of Bazedoxifene/Conjugated Estrogens On Endometrial Safety And Postmenopausal Osteoporosis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010024', 'term': 'Osteoporosis'}], 'ancestors': [{'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C447119', 'term': 'bazedoxifene'}, {'id': 'D004966', 'term': 'Estrogens, Conjugated (USP)'}, {'id': 'D017258', 'term': 'Medroxyprogesterone Acetate'}, {'id': 'C466383', 'term': 'Prempro'}], 'ancestors': [{'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'}, {'id': 'D008525', 'term': 'Medroxyprogesterone'}, {'id': 'D006908', 'term': 'Hydroxyprogesterones'}, {'id': 'D011374', 'term': 'Progesterone'}, {'id': 'D011282', 'term': 'Pregnenediones'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg', 'description': 'Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.', 'otherNumAtRisk': 445, 'otherNumAffected': 407, 'seriousNumAtRisk': 445, 'seriousNumAffected': 16}, {'id': 'EG001', 'title': 'Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg', 'description': 'Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.', 'otherNumAtRisk': 474, 'otherNumAffected': 426, 'seriousNumAtRisk': 474, 'seriousNumAffected': 17}, {'id': 'EG002', 'title': 'Bazedoxifene 20 mg', 'description': 'Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year.', 'otherNumAtRisk': 230, 'otherNumAffected': 207, 'seriousNumAtRisk': 230, 'seriousNumAffected': 5}, {'id': 'EG003', 'title': 'Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg', 'description': 'Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.', 'otherNumAtRisk': 220, 'otherNumAffected': 197, 'seriousNumAtRisk': 220, 'seriousNumAffected': 13}, {'id': 'EG004', 'title': 'Placebo', 'description': 'Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.', 'otherNumAtRisk': 474, 'otherNumAffected': 423, 'seriousNumAtRisk': 474, 'seriousNumAffected': 18}], 'otherEvents': [{'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 474, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 220, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 474, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 474, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 220, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 474, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 474, 'numAffected': 34}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 220, 'numAffected': 13}, {'groupId': 'EG004', 'numAtRisk': 474, 'numAffected': 31}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 474, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 220, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 474, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 474, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 220, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 474, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 474, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 220, 'numAffected': 14}, {'groupId': 'EG004', 'numAtRisk': 474, 'numAffected': 20}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 474, 'numAffected': 36}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 220, 'numAffected': 13}, {'groupId': 'EG004', 'numAtRisk': 474, 'numAffected': 24}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 474, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 220, 'numAffected': 11}, {'groupId': 'EG004', 'numAtRisk': 474, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 474, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 220, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 474, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 474, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 220, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 474, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 474, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 474, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 474, 'numAffected': 29}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 220, 'numAffected': 11}, {'groupId': 'EG004', 'numAtRisk': 474, 'numAffected': 26}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 474, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 220, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 474, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 474, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 220, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 474, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 474, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 220, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 474, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 474, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 220, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 474, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 474, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 220, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 474, 'numAffected': 22}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 474, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 220, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 474, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Seasonal allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 474, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 220, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 474, 'numAffected': 9}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 474, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 220, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 474, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 474, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 220, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 474, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Ear infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 474, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 220, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 474, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 474, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 220, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 474, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 474, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 220, 'numAffected': 13}, {'groupId': 'EG004', 'numAtRisk': 474, 'numAffected': 23}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numAffected': 91}, {'groupId': 'EG001', 'numAtRisk': 474, 'numAffected': 72}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 44}, {'groupId': 'EG003', 'numAtRisk': 220, 'numAffected': 32}, {'groupId': 'EG004', 'numAtRisk': 474, 'numAffected': 65}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 474, 'numAffected': 37}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 19}, {'groupId': 'EG003', 'numAtRisk': 220, 'numAffected': 12}, {'groupId': 'EG004', 'numAtRisk': 474, 'numAffected': 33}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Tooth infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 474, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 220, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 474, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 474, 'numAffected': 38}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 220, 'numAffected': 13}, {'groupId': 'EG004', 'numAtRisk': 474, 'numAffected': 30}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 474, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 220, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 474, 'numAffected': 33}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 474, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 220, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 474, 'numAffected': 15}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Muscle strain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 474, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 220, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 474, 'numAffected': 16}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Post procedural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 474, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 220, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 474, 'numAffected': 13}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 474, 'numAffected': 36}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 220, 'numAffected': 14}, {'groupId': 'EG004', 'numAtRisk': 474, 'numAffected': 30}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Blood cholesterol increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 474, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 220, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 474, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 474, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 220, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 474, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Low density lipoprotein increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 474, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 220, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 474, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 474, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 220, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 474, 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1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Metastases to spine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 474, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 220, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 474, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Salivary gland adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 474, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 474, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 474, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 220, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 474, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Squamous cell carcinoma of skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 474, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 474, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 474, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 474, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Complex partial seizures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 474, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 474, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 474, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 220, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 474, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Migraine with aura', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 474, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 474, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 474, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 474, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Anxiety disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 474, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 474, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 474, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 474, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 474, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 474, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 474, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 474, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 474, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 474, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Circulatory collapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 474, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 474, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 474, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 220, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 474, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Hypertensive emergency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 474, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 220, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 474, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 474, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 230, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 474, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Endometrial Hyperplasia at Month 12: Main Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '335', 'groupId': 'OG000'}, {'value': '368', 'groupId': 'OG001'}, {'value': '169', 'groupId': 'OG002'}, {'value': '149', 'groupId': 'OG003'}, {'value': '354', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg', 'description': 'Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.'}, {'id': 'OG001', 'title': 'Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg', 'description': 'Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.'}, {'id': 'OG002', 'title': 'Bazedoxifene 20 mg', 'description': 'Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year.'}, {'id': 'OG003', 'title': 'Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg', 'description': 'Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.'}], 'classes': [{'title': 'Definition 1', 'categories': [{'measurements': [{'value': '0.30', 'comment': 'Only upper limit of 95% confidence interval (1-sided) was calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': '1.41'}, {'value': '0.54', 'comment': 'Only upper limit of 95% confidence interval (1-sided) was calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': '1.70'}, {'value': '0.00', 'comment': 'Only upper limit of 95% confidence interval (1-sided) was calculated.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': '1.76'}, {'value': '0.00', 'comment': 'Only upper limit of 95% confidence interval (1-sided) was calculated.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': '1.99'}, {'value': '0.85', 'comment': 'Only upper limit of 95% confidence interval (1-sided) was calculated.', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': '2.18'}]}]}, {'title': 'Definition 2', 'categories': [{'measurements': [{'value': '0.30', 'comment': 'Only upper limit of 95% confidence interval (1-sided) was calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': '1.41'}, {'value': '0.27', 'comment': 'Only upper limit of 95% confidence interval (1-sided) was calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': '1.28'}, {'value': '0.00', 'comment': 'Only upper limit of 95% confidence interval (1-sided) was calculated.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': '1.76'}, {'value': '0.00', 'comment': 'Only upper limit of 95% confidence interval (1-sided) was calculated.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': '1.99'}, {'value': '0.28', 'comment': 'Only upper limit of 95% confidence interval (1-sided) was calculated.', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': '1.33'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 12', 'description': 'Endometrial hyperplasia was assessed by endometrial biopsies. All endometrial biopsies were read centrally by 2 primary pathologists. If both the pathologists disagreed on the presence of hyperplasia, a third pathologist was consulted. Results were summarized for two definitions of hyperplasia (simple hyperplasia with or without atypia or complex hyperplasia with or without atypia); definition 1: participants were considered to have a diagnosis of hyperplasia when the 3 pathologists disagreed but at least 1 pathologist determined hyperplasia; definition 2: participants were considered to have a diagnosis of hyperplasia if at least 2 of the 3 pathologists agreed on the diagnosis.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy evaluable (EE) population included all randomized participants who took at least 1 dose of study drug, who had a screening endometrial biopsy with readings by at least 2 blinded central pathologists, had a biopsy during Month 12, or had hyperplasia diagnosed before Month 12 and had no major protocol violations.'}, {'type': 'PRIMARY', 'title': 'Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at Month 12: Osteoporosis Sub-Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}, {'value': '139', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg', 'description': 'Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.'}, {'id': 'OG001', 'title': 'Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg', 'description': 'Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.'}, {'id': 'OG002', 'title': 'Bazedoxifene 20 mg', 'description': 'Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year.'}, {'id': 'OG003', 'title': 'Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg', 'description': 'Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.24', 'spread': '0.29', 'groupId': 'OG000'}, {'value': '0.60', 'spread': '0.27', 'groupId': 'OG001'}, {'value': '0.07', 'spread': '0.40', 'groupId': 'OG002'}, {'value': '1.30', 'spread': '0.39', 'groupId': 'OG003'}, {'value': '-1.28', 'spread': '0.28', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Least Squares (LS) Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.51', 'ciLowerLimit': '0.822', 'ciUpperLimit': '2.201', 'groupDescription': 'Analysis of covariance (ANCOVA) model was used with treatment and region as main effects and baseline BMD and years since menopause as covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.87', 'ciLowerLimit': '1.209', 'ciUpperLimit': '2.533', 'groupDescription': 'ANCOVA model was used with treatment and region as main effects and baseline BMD and years since menopause as covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Month 12', 'description': 'BMD measurements of the anteroposterior lumbar spine were acquired by using dual-energy x-ray absorptiometry (DXA) scans, twice at Month 12 for a subset of participants who entered the osteoporosis substudy. The second scan was to be performed on the same day as the first; however, the participant was to be removed completely from the table after the first scan and repositioned for the second scan. Mean percentage change from baseline of the 2 readings were reported.', 'unitOfMeasure': 'Percent Change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat (MITT) population included all randomized participants who met inclusion criteria for osteoporosis sub-study, who had taken at least 1 dose of the study drug, and had a baseline and at least 1 post baseline value. Last Observation Carried Forward (LOCF) method was used to impute missing values.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at Month 6: Osteoporosis Sub-Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '58', 'groupId': 'OG003'}, {'value': '135', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg', 'description': 'Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.'}, {'id': 'OG001', 'title': 'Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg', 'description': 'Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.'}, {'id': 'OG002', 'title': 'Bazedoxifene 20 mg', 'description': 'Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year.'}, {'id': 'OG003', 'title': 'Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg', 'description': 'Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.12', 'spread': '0.28', 'groupId': 'OG000'}, {'value': '0.51', 'spread': '0.26', 'groupId': 'OG001'}, {'value': '0.00', 'spread': '0.39', 'groupId': 'OG002'}, {'value': '0.64', 'spread': '0.37', 'groupId': 'OG003'}, {'value': '-0.68', 'spread': '0.27', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.017', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.80', 'ciLowerLimit': '0.139', 'ciUpperLimit': '1.470', 'groupDescription': 'ANCOVA model was used with treatment and region as main effects and baseline BMD and years since menopause as covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.19', 'ciLowerLimit': '0.556', 'ciUpperLimit': '1.830', 'groupDescription': 'ANCOVA model was used with treatment and region as main effects and baseline BMD and years since menopause as covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Month 6', 'description': 'BMD measurements of the anteroposterior lumbar spine were acquired by using DXA scans, twice at Month 6 for a subset of participants who entered the osteoporosis substudy. The second scan was to be performed on the same day as the first; however, the participant was to be removed completely from the table after the first scan and repositioned for the second scan. Mean percentage change from baseline of the 2 readings were reported.', 'unitOfMeasure': 'Percent Change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT population included all randomized participants who met inclusion criteria for osteoporosis sub-study, who had taken at least 1 dose of the study drug, and had baseline and at least 1 post baseline value. LOCF method was used to impute missing values. Here "N" signifies participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Bone Mineral Density (BMD) of Total Hip at Month 6, 12: Osteoporosis Sub-Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}, {'value': '139', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg', 'description': 'Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.'}, {'id': 'OG001', 'title': 'Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg', 'description': 'Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.'}, {'id': 'OG002', 'title': 'Bazedoxifene 20 mg', 'description': 'Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year.'}, {'id': 'OG003', 'title': 'Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg', 'description': 'Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.'}], 'classes': [{'title': 'Change at Month 6 (n=117, 136, 55, 57, 134)', 'categories': [{'measurements': [{'value': '0.43', 'spread': '0.18', 'groupId': 'OG000'}, {'value': '0.66', 'spread': '0.17', 'groupId': 'OG001'}, {'value': '0.32', 'spread': '0.25', 'groupId': 'OG002'}, {'value': '0.45', 'spread': '0.24', 'groupId': 'OG003'}, {'value': '-0.90', 'spread': '0.17', 'groupId': 'OG004'}]}]}, {'title': 'Change at Month 12 (n=119, 139, 56, 59, 139)', 'categories': [{'measurements': [{'value': '0.50', 'spread': '0.20', 'groupId': 'OG000'}, {'value': '0.89', 'spread': '0.18', 'groupId': 'OG001'}, {'value': '0.47', 'spread': '0.27', 'groupId': 'OG002'}, {'value': '0.71', 'spread': '0.26', 'groupId': 'OG003'}, {'value': '-0.72', 'spread': '0.18', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.32', 'ciLowerLimit': '0.901', 'ciUpperLimit': '1.742', 'groupDescription': 'Month 6: ANCOVA model was used with treatment and region as main effects and baseline BMD and years since menopause as covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.21', 'ciLowerLimit': '0.756', 'ciUpperLimit': '1.671', 'groupDescription': 'Month 12: ANCOVA model was used with treatment and region as main effects and baseline BMD and years since menopause as covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.56', 'ciLowerLimit': '1.152', 'ciUpperLimit': '1.962', 'groupDescription': 'Month 6: ANCOVA model was used with treatment and region as main effects and baseline BMD and years since menopause as covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.60', 'ciLowerLimit': '1.164', 'ciUpperLimit': '2.044', 'groupDescription': 'Month 12: ANCOVA model was used with treatment and region as main effects and baseline BMD and years since menopause as covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Month 6, Month 12', 'description': 'BMD measurements of the total hip were acquired by using DXA scans, twice at Month 6 and 12 for a subset of participants who entered the osteoporosis substudy. The second scan was to be performed on the same day as the first; however, the participant was to be removed completely from the table after the first scan and repositioned for the second scan. Mean percentage change from baseline of the 2 readings were reported.', 'unitOfMeasure': 'Percent Change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT for osteoporosis sub-study. LOCF method was used to impute missing values. Here "n" signifies participants who were evaluable at specified time points for each arm, respectively.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Cumulative Amenorrhea: Main Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '355', 'groupId': 'OG000'}, {'value': '390', 'groupId': 'OG001'}, {'value': '187', 'groupId': 'OG002'}, {'value': '158', 'groupId': 'OG003'}, {'value': '379', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg', 'description': 'Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.'}, {'id': 'OG001', 'title': 'Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg', 'description': 'Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.'}, {'id': 'OG002', 'title': 'Bazedoxifene 20 mg', 'description': 'Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year.'}, {'id': 'OG003', 'title': 'Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg', 'description': 'Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.'}], 'classes': [{'categories': [{'measurements': [{'value': '87.89', 'groupId': 'OG000'}, {'value': '84.87', 'groupId': 'OG001'}, {'value': '82.35', 'groupId': 'OG002'}, {'value': '54.43', 'groupId': 'OG003'}, {'value': '83.91', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.138', 'groupIds': ['OG000', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '< 0.001', 'groupIds': ['OG000', 'OG003'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.765', 'groupIds': ['OG001', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '< 0.001', 'groupIds': ['OG001', 'OG003'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '< 0.001', 'groupIds': ['OG003', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 up to Day 364', 'description': 'Cumulative amenorrhea was defined as the absence of any bleeding or spotting for cumulative 4-week periods throughout 1-year study.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT population included all randomized participants who received at least 1 dose of the study drug, and had at least 1 day of on-therapy bleeding data. Here "N" signifies participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Breast Density at Month 12: Breast Density Sub-Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}, {'value': '97', 'groupId': 'OG002'}, {'value': '68', 'groupId': 'OG003'}, {'value': '181', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg', 'description': 'Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.'}, {'id': 'OG001', 'title': 'Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg', 'description': 'Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.'}, {'id': 'OG002', 'title': 'Bazedoxifene 20 mg', 'description': 'Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year.'}, {'id': 'OG003', 'title': 'Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg', 'description': 'Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.38', 'spread': '0.22', 'groupId': 'OG000'}, {'value': '-0.45', 'spread': '0.22', 'groupId': 'OG001'}, {'value': '-0.25', 'spread': '0.30', 'groupId': 'OG002'}, {'value': '1.60', 'spread': '0.35', 'groupId': 'OG003'}, {'value': '-0.32', 'spread': '0.23', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.832', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.06', 'ciLowerLimit': '-0.632', 'ciUpperLimit': '0.509', 'groupDescription': 'ANCOVA model was used with treatment and region as factors and baseline as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.651', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.13', 'ciLowerLimit': '-0.696', 'ciUpperLimit': '0.436', 'groupDescription': 'ANCOVA model was used with treatment and region as factors and baseline as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Month 12', 'description': 'Breast density was assessed by digitalized mammograms which were centrally read by a single radiologist using specifically-developed software. Breast density was assessed for subset of participants who entered the breast density sub-study', 'unitOfMeasure': 'Percent Change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-Protocol (PP) population included all randomized participants who met inclusion criteria for breast density sub-study, who had a baseline and at least 1 post-baseline breast density evaluation and did not have substantial protocol violations. Here "N" signifies participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Bone Turnover Markers (BTMs) at Month 6 and Month 12: Osteoporosis Sub-Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}, {'value': '134', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg', 'description': 'Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.'}, {'id': 'OG001', 'title': 'Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg', 'description': 'Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.'}, {'id': 'OG002', 'title': 'Bazedoxifene 20 mg', 'description': 'Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year.'}, {'id': 'OG003', 'title': 'Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg', 'description': 'Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.'}], 'classes': [{'title': 'Osteocalcin: Month 6 (n=115, 136, 56, 56, 134)', 'categories': [{'measurements': [{'value': '-25.21', 'groupId': 'OG000', 'lowerLimit': '-33.79', 'upperLimit': '-14.00'}, {'value': '-27.79', 'groupId': 'OG001', 'lowerLimit': '-38.12', 'upperLimit': '15.31'}, {'value': '-15.60', 'groupId': 'OG002', 'lowerLimit': '-22.48', 'upperLimit': '-6.75'}, {'value': '-25.34', 'groupId': 'OG003', 'lowerLimit': '-38.37', 'upperLimit': '-9.65'}, {'value': '-3.19', 'groupId': 'OG004', 'lowerLimit': '-15.32', 'upperLimit': '10.21'}]}]}, {'title': 'Osteocalcin: Month 12 (n=104, 127, 52, 50, 125)', 'categories': [{'measurements': [{'value': '-30.46', 'groupId': 'OG000', 'lowerLimit': '-40.77', 'upperLimit': '-18.79'}, {'value': '-37.02', 'groupId': 'OG001', 'lowerLimit': '-46.87', 'upperLimit': '-23.50'}, {'value': '-16.05', 'groupId': 'OG002', 'lowerLimit': '-33.67', 'upperLimit': '2.13'}, {'value': '-32.79', 'groupId': 'OG003', 'lowerLimit': '-48.90', 'upperLimit': '-13.03'}, {'value': '-5.28', 'groupId': 'OG004', 'lowerLimit': '-19.29', 'upperLimit': '11.16'}]}]}, {'title': 'C-Telopeptide: Month 6 (n=115, 136, 56, 56, 133)', 'categories': [{'measurements': [{'value': '-34.16', 'groupId': 'OG000', 'lowerLimit': '-48.76', 'upperLimit': '-17.35'}, {'value': '-41.41', 'groupId': 'OG001', 'lowerLimit': '-58.94', 'upperLimit': '-25.00'}, {'value': '-29.37', 'groupId': 'OG002', 'lowerLimit': '-40.81', 'upperLimit': '-8.23'}, {'value': '-54.05', 'groupId': 'OG003', 'lowerLimit': '-68.67', 'upperLimit': '-34.66'}, {'value': '-10.17', 'groupId': 'OG004', 'lowerLimit': '-26.57', 'upperLimit': '8.62'}]}]}, {'title': 'C-Telopeptide: Month 12 (n=104, 127, 52,50,124)', 'categories': [{'measurements': [{'value': '-40.86', 'groupId': 'OG000', 'lowerLimit': '-55.74', 'upperLimit': '-24.04'}, {'value': '-50.06', 'groupId': 'OG001', 'lowerLimit': '-63.47', 'upperLimit': '-29.90'}, {'value': '-27.39', 'groupId': 'OG002', 'lowerLimit': '-49.55', 'upperLimit': '0.74'}, {'value': '-52.56', 'groupId': 'OG003', 'lowerLimit': '-69.17', 'upperLimit': '-26.58'}, {'value': '-5.52', 'groupId': 'OG004', 'lowerLimit': '-30.37', 'upperLimit': '19.93'}]}]}, {'title': 'P1NP: Month 6 (n=114,135, 57, 56, 133)', 'categories': [{'measurements': [{'value': '-33.73', 'groupId': 'OG000', 'lowerLimit': '-43.68', 'upperLimit': '-18.26'}, {'value': '-30.26', 'groupId': 'OG001', 'lowerLimit': '-48.52', 'upperLimit': '-14.16'}, {'value': '-17.38', 'groupId': 'OG002', 'lowerLimit': '-33.86', 'upperLimit': '-2.53'}, {'value': '-39.99', 'groupId': 'OG003', 'lowerLimit': '-51.66', 'upperLimit': '-14.73'}, {'value': '5.99', 'groupId': 'OG004', 'lowerLimit': '-18.77', 'upperLimit': '12.77'}]}]}, {'title': 'P1NP: Month 12 (n=103, 127, 53, 50, 125)', 'categories': [{'measurements': [{'value': '-42.38', 'groupId': 'OG000', 'lowerLimit': '-49.71', 'upperLimit': '-24.16'}, {'value': '-43.58', 'groupId': 'OG001', 'lowerLimit': '-58.66', 'upperLimit': '-24.91'}, {'value': '-23.97', 'groupId': 'OG002', 'lowerLimit': '-40.42', 'upperLimit': '-7.33'}, {'value': '-50.19', 'groupId': 'OG003', 'lowerLimit': '-62.91', 'upperLimit': '-20.83'}, {'value': '-11.13', 'groupId': 'OG004', 'lowerLimit': '-26.66', 'upperLimit': '6.60'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Osteocalcin: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0074', 'groupIds': ['OG000', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Osteocalcin: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Osteocalcin: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Osteocalcin: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Osteocalcin: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Osteocalcin: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Osteocalcin: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Osteocalcin: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG002', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Osteocalcin: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0016', 'groupIds': ['OG002', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Osteocalcin: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG003', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Osteocalcin: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG003', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Osteocalcin: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'C-Telopeptide: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.1058', 'groupIds': ['OG000', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'C-Telopeptide: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'C-Telopeptide: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0024', 'groupIds': ['OG000', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'C-Telopeptide: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'C-Telopeptide: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'C-Telopeptide: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'C-Telopeptide: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'C-Telopeptide: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG002', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'C-Telopeptide: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0012', 'groupIds': ['OG002', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'C-Telopeptide: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG003', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'C-Telopeptide: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG003', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'C-Telopeptide: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'P1NP: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0029', 'groupIds': ['OG000', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'P1NP: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'P1NP: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0046', 'groupIds': ['OG000', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'P1NP: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'P1NP: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0043', 'groupIds': ['OG001', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'P1NP: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'P1NP: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'P1NP: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0016', 'groupIds': ['OG002', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'P1NP: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG002', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'P1NP: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG003', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'P1NP: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG003', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'P1NP: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Month 6, 12', 'description': 'Bone turnover is the removal of old bone from the body and its replacement by new bone. Bone turnover markers included serum osteocalcin, C-telopeptide, and procollagen type 1 N-propeptide (P1NP), were measured at Month 6 and Month 12 for a subset of participants who entered the osteoporosis substudy. Blood samples were collected to evaluate bone turnover markers levels.', 'unitOfMeasure': 'Percent Change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT for osteoporosis substudy. Here "N" signifies participants who were evaluable for this outcome measure and "n" signifies participants who were evaluable at specified time points for each arm respectively.'}, {'type': 'SECONDARY', 'title': 'Medical Outcomes Study (MOS) Sleep Scale at Baseline: Sleep Sub-Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}, {'value': '111', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg', 'description': 'Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.'}, {'id': 'OG001', 'title': 'Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg', 'description': 'Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.'}, {'id': 'OG002', 'title': 'Bazedoxifene 20 mg', 'description': 'Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year.'}, {'id': 'OG003', 'title': 'Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg', 'description': 'Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.'}], 'classes': [{'title': 'SD (n=112, 121, 47, 52, 111)', 'categories': [{'measurements': [{'value': '48.9', 'spread': '22.9', 'groupId': 'OG000'}, {'value': '48.2', 'spread': '21.7', 'groupId': 'OG001'}, {'value': '50.5', 'spread': '24.4', 'groupId': 'OG002'}, {'value': '50.4', 'spread': '21.1', 'groupId': 'OG003'}, {'value': '47.8', 'spread': '24.6', 'groupId': 'OG004'}]}]}, {'title': 'Snoring (n=110, 121, 47, 51, 108)', 'categories': [{'measurements': [{'value': '32.1', 'spread': '30.1', 'groupId': 'OG000'}, {'value': '27.6', 'spread': '26.9', 'groupId': 'OG001'}, {'value': '37.9', 'spread': '30.7', 'groupId': 'OG002'}, {'value': '33.1', 'spread': '29.6', 'groupId': 'OG003'}, {'value': '34.4', 'spread': '30.5', 'groupId': 'OG004'}]}]}, {'title': 'ASoB or H (n=112, 121, 47,52,111)', 'categories': [{'measurements': [{'value': '12.5', 'spread': '19.2', 'groupId': 'OG000'}, {'value': '11.9', 'spread': '19.4', 'groupId': 'OG001'}, {'value': '13.2', 'spread': '20.1', 'groupId': 'OG002'}, {'value': '13.1', 'spread': '20.2', 'groupId': 'OG003'}, {'value': '12.1', 'spread': '20.4', 'groupId': 'OG004'}]}]}, {'title': 'Somnolence (n=112, 121, 47, 52, 111)', 'categories': [{'measurements': [{'value': '36.3', 'spread': '21.6', 'groupId': 'OG000'}, {'value': '30.0', 'spread': '20.1', 'groupId': 'OG001'}, {'value': '34.6', 'spread': '23.5', 'groupId': 'OG002'}, {'value': '28.7', 'spread': '19.4', 'groupId': 'OG003'}, {'value': '31.2', 'spread': '19.2', 'groupId': 'OG004'}]}]}, {'title': 'SA (n=112, 121, 47, 52, 111)', 'categories': [{'measurements': [{'value': '39.3', 'spread': '24.3', 'groupId': 'OG000'}, {'value': '41.7', 'spread': '23.9', 'groupId': 'OG001'}, {'value': '37.4', 'spread': '23.2', 'groupId': 'OG002'}, {'value': '36.5', 'spread': '20.6', 'groupId': 'OG003'}, {'value': '40.3', 'spread': '23.6', 'groupId': 'OG004'}]}]}, {'title': 'SPI I (n=112, 121, 47, 52, 111)', 'categories': [{'measurements': [{'value': '44.5', 'spread': '17.3', 'groupId': 'OG000'}, {'value': '42.0', 'spread': '16.7', 'groupId': 'OG001'}, {'value': '44.7', 'spread': '18.2', 'groupId': 'OG002'}, {'value': '44.9', 'spread': '16.0', 'groupId': 'OG003'}, {'value': '43.4', 'spread': '18.1', 'groupId': 'OG004'}]}]}, {'title': 'SPI II (n=112, 121, 47, 52, 111)', 'categories': [{'measurements': [{'value': '45.5', 'spread': '17.2', 'groupId': 'OG000'}, {'value': '43.2', 'spread': '16.8', 'groupId': 'OG001'}, {'value': '46.4', 'spread': '18.0', 'groupId': 'OG002'}, {'value': '45.2', 'spread': '16.1', 'groupId': 'OG003'}, {'value': '43.7', 'spread': '18.3', 'groupId': 'OG004'}]}]}, {'title': 'SQ (n=111, 121, 47, 52, 111)', 'categories': [{'measurements': [{'value': '6.2', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '6.1', 'spread': '1.1', 'groupId': 'OG001'}, {'value': '5.9', 'spread': '1.1', 'groupId': 'OG002'}, {'value': '6.2', 'spread': '1.3', 'groupId': 'OG003'}, {'value': '6.2', 'spread': '1.1', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Participant-rated questionnaire to assess sleep quality and quantity. Consists of 12-item questionnaires answered on a range of 1 to 6 for questions (Q) 3 to 12, 1 to 5 for Q1 (some questions are reversed so that a high score reflects more of the attributes); and Q2 answered on 0 to 24. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range\\* 100); total score range: 0 to 100; higher score = greater intensity of attribute. The items contribute to each scale and are averaged to create the 7 scale scores and a sleep quantity scale. Scales with at least one item answered was used to generate a scale score. Scales include; sleep disturbance (SD), snoring, awaken short of breath (ASoB) or with a headache (H), somnolence, sleep adequacy (SA), sleep problem index (SPI) I and II (range: 0-100) and sleep quantity (SQ \\[range 0 to 24\\]). Except for sleep quantity, higher scores=greater impairment.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT population included all randomized participants who met inclusion criteria for sleep sub-study and had baseline and at least 1 post-baseline evaluation for the respective endpoint. Here N = maximum number of participants who were evaluable for this outcome and n = participants who were evaluable at specified time points for each arm.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants With Breast Tenderness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '429', 'groupId': 'OG000'}, {'value': '449', 'groupId': 'OG001'}, {'value': '220', 'groupId': 'OG002'}, {'value': '206', 'groupId': 'OG003'}, {'value': '457', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg', 'description': 'Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.'}, {'id': 'OG001', 'title': 'Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg', 'description': 'Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.'}, {'id': 'OG002', 'title': 'Bazedoxifene 20 mg', 'description': 'Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year.'}, {'id': 'OG003', 'title': 'Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg', 'description': 'Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.'}], 'classes': [{'title': 'Screening (n=429, 449, 220, 206, 457)', 'categories': [{'measurements': [{'value': '6.29', 'groupId': 'OG000'}, {'value': '6.46', 'groupId': 'OG001'}, {'value': '4.55', 'groupId': 'OG002'}, {'value': '7.28', 'groupId': 'OG003'}, {'value': '6.56', 'groupId': 'OG004'}]}]}, {'title': 'Week 1-4 (n=426, 449, 220, 205, 457)', 'categories': [{'measurements': [{'value': '9.39', 'groupId': 'OG000'}, {'value': '9.13', 'groupId': 'OG001'}, {'value': '5.91', 'groupId': 'OG002'}, {'value': '20.49', 'groupId': 'OG003'}, {'value': '8.32', 'groupId': 'OG004'}]}]}, {'title': 'Week 5-8 (n=423, 447, 216, 202, 456)', 'categories': [{'measurements': [{'value': '8.04', 'groupId': 'OG000'}, {'value': '6.94', 'groupId': 'OG001'}, {'value': '7.87', 'groupId': 'OG002'}, {'value': '24.26', 'groupId': 'OG003'}, {'value': '8.55', 'groupId': 'OG004'}]}]}, {'title': 'Week 9-12 (n=412, 439, 212, 196, 447)', 'categories': [{'measurements': [{'value': '5.83', 'groupId': 'OG000'}, {'value': '7.97', 'groupId': 'OG001'}, {'value': '6.60', 'groupId': 'OG002'}, {'value': '23.98', 'groupId': 'OG003'}, {'value': '5.37', 'groupId': 'OG004'}]}]}, {'title': 'Week 13-16 (n=411, 433, 208, 193, 440)', 'categories': [{'measurements': [{'value': '7.06', 'groupId': 'OG000'}, {'value': '8.31', 'groupId': 'OG001'}, {'value': '8.65', 'groupId': 'OG002'}, {'value': '21.24', 'groupId': 'OG003'}, {'value': '5.91', 'groupId': 'OG004'}]}]}, {'title': 'Week 17-20 (n=395, 412, 197, 181, 420)', 'categories': [{'measurements': [{'value': '4.05', 'groupId': 'OG000'}, {'value': '4.37', 'groupId': 'OG001'}, {'value': '6.09', 'groupId': 'OG002'}, {'value': '17.13', 'groupId': 'OG003'}, {'value': '4.29', 'groupId': 'OG004'}]}]}, {'title': 'Week 21-24 (n=391, 410, 195, 180, 416)', 'categories': [{'measurements': [{'value': '4.60', 'groupId': 'OG000'}, {'value': '3.90', 'groupId': 'OG001'}, {'value': '5.64', 'groupId': 'OG002'}, {'value': '15.00', 'groupId': 'OG003'}, {'value': '4.33', 'groupId': 'OG004'}]}]}, {'title': 'Week 25-28 (n=389, 409, 193, 179, 416)', 'categories': [{'measurements': [{'value': '3.08', 'groupId': 'OG000'}, {'value': '5.62', 'groupId': 'OG001'}, {'value': '4.15', 'groupId': 'OG002'}, {'value': '15.64', 'groupId': 'OG003'}, {'value': '4.09', 'groupId': 'OG004'}]}]}, {'title': 'Week 29-32 (n=372, 403, 190, 171, 401)', 'categories': [{'measurements': [{'value': '4.57', 'groupId': 'OG000'}, {'value': '3.97', 'groupId': 'OG001'}, {'value': '1.58', 'groupId': 'OG002'}, {'value': '15.20', 'groupId': 'OG003'}, {'value': '2.00', 'groupId': 'OG004'}]}]}, {'title': 'Week 33-36 (n=369, 401, 188, 168, 395)', 'categories': [{'measurements': [{'value': '2.98', 'groupId': 'OG000'}, {'value': '3.49', 'groupId': 'OG001'}, {'value': '3.19', 'groupId': 'OG002'}, {'value': '12.50', 'groupId': 'OG003'}, {'value': '2.28', 'groupId': 'OG004'}]}]}, {'title': 'Week 37-40 (n=369, 399, 187, 166, 390)', 'categories': [{'measurements': [{'value': '4.07', 'groupId': 'OG000'}, {'value': '4.01', 'groupId': 'OG001'}, {'value': '2.67', 'groupId': 'OG002'}, {'value': '12.05', 'groupId': 'OG003'}, {'value': '3.08', 'groupId': 'OG004'}]}]}, {'title': 'Week 41-44 (n=359, 384, 184, 159, 382)', 'categories': [{'measurements': [{'value': '3.62', 'groupId': 'OG000'}, {'value': '2.60', 'groupId': 'OG001'}, {'value': '1.63', 'groupId': 'OG002'}, {'value': '9.43', 'groupId': 'OG003'}, {'value': '2.62', 'groupId': 'OG004'}]}]}, {'title': 'Week 45-48 (n=354, 382, 184, 157, 379)', 'categories': [{'measurements': [{'value': '3.67', 'groupId': 'OG000'}, {'value': '3.14', 'groupId': 'OG001'}, {'value': '2.17', 'groupId': 'OG002'}, {'value': '10.83', 'groupId': 'OG003'}, {'value': '3.17', 'groupId': 'OG004'}]}]}, {'title': 'Week 49-52 (n=353, 380, 183, 156, 376)', 'categories': [{'measurements': [{'value': '3.12', 'groupId': 'OG000'}, {'value': '2.89', 'groupId': 'OG001'}, {'value': '1.64', 'groupId': 'OG002'}, {'value': '9.62', 'groupId': 'OG003'}, {'value': '2.66', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.546', 'groupIds': ['OG000', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 1-4: Cochran-Mantel-Haenszel test was stratified by baseline value.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.821', 'groupIds': ['OG000', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 5-8: Cochran-Mantel-Haenszel test was stratified by baseline value.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.698', 'groupIds': ['OG000', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 9-12: Cochran-Mantel-Haenszel test was stratified by baseline value.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.446', 'groupIds': ['OG000', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 13-16: Cochran-Mantel-Haenszel test was stratified by baseline value.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.892', 'groupIds': ['OG000', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 17-20: Cochran-Mantel-Haenszel test was stratified by baseline value.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.810', 'groupIds': ['OG000', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 21-24: Cochran-Mantel-Haenszel test was stratified by baseline value.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.473', 'groupIds': ['OG000', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 25-28: Cochran-Mantel-Haenszel test was stratified by baseline value.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.030', 'groupIds': ['OG000', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 29-32: Cochran-Mantel-Haenszel test was stratified by baseline value.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.453', 'groupIds': ['OG000', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 33-36: Cochran-Mantel-Haenszel test was stratified by baseline value.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.391', 'groupIds': ['OG000', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 37-40: Cochran-Mantel-Haenszel test was stratified by baseline value.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.407', 'groupIds': ['OG000', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 41-44: Cochran-Mantel-Haenszel test was stratified by baseline value.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.644', 'groupIds': ['OG000', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 45-48: Cochran-Mantel-Haenszel test was stratified by baseline value.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.666', 'groupIds': ['OG000', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 49-52: Cochran-Mantel-Haenszel test was stratified by baseline value.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.641', 'groupIds': ['OG001', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 1-4: Cochran-Mantel-Haenszel test was stratified by baseline value.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.361', 'groupIds': ['OG001', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 5-8: Cochran-Mantel-Haenszel test was stratified by baseline value.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.100', 'groupIds': ['OG001', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 9-12: Cochran-Mantel-Haenszel test was stratified by baseline value.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.142', 'groupIds': ['OG001', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 13-16: Cochran-Mantel-Haenszel test was stratified by baseline value.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.906', 'groupIds': ['OG001', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 17-20: Cochran-Mantel-Haenszel test was stratified by baseline value.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.798', 'groupIds': ['OG001', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 21-24: Cochran-Mantel-Haenszel test was stratified by baseline value.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.258', 'groupIds': ['OG001', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 25-28: Cochran-Mantel-Haenszel test was stratified by baseline value.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.058', 'groupIds': ['OG001', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 29-32: Cochran-Mantel-Haenszel test was stratified by baseline value.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.230', 'groupIds': ['OG001', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 33-36: Cochran-Mantel-Haenszel test was stratified by baseline value.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.360', 'groupIds': ['OG001', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 37-40: Cochran-Mantel-Haenszel test was stratified by baseline value.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.892', 'groupIds': ['OG001', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 41-44: Cochran-Mantel-Haenszel test was stratified by baseline value.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.912', 'groupIds': ['OG001', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 45-48: Cochran-Mantel-Haenszel test was stratified by baseline value.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.791', 'groupIds': ['OG001', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 49-52: Cochran-Mantel-Haenszel test was stratified by baseline value.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Screening, Week 1-4, 5-8, 9-12, 13-16, 17-20, 21-24, 25-28, 29-32, 33-36, 37-40, 41-44, 45-48, 49-52', 'description': 'Percentage of participants who reported at least 1 day of breast tenderness during each 4-week period for 1-year on therapy was calculated.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT population included all randomized participants who took 1 dose of study drug and had at least 20 days of data available at screening and at least 20 continuous days of data in at least one 4-week interval after baseline.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Month 3: Sleep Sub-Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}, {'value': '111', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg', 'description': 'Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.'}, {'id': 'OG001', 'title': 'Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg', 'description': 'Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.'}, {'id': 'OG002', 'title': 'Bazedoxifene 20 mg', 'description': 'Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year.'}, {'id': 'OG003', 'title': 'Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg', 'description': 'Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.'}], 'classes': [{'title': 'SD (n=112, 121, 47, 52, 111)', 'categories': [{'measurements': [{'value': '-17.27', 'spread': '2.01', 'groupId': 'OG000'}, {'value': '-18.18', 'spread': '1.94', 'groupId': 'OG001'}, {'value': '-11.64', 'spread': '2.94', 'groupId': 'OG002'}, {'value': '-18.01', 'spread': '2.79', 'groupId': 'OG003'}, {'value': '-14.34', 'spread': '2.01', 'groupId': 'OG004'}]}]}, {'title': 'Snoring (n=110, 121, 47, 51, 108)', 'categories': [{'measurements': [{'value': '-5.86', 'spread': '1.83', 'groupId': 'OG000'}, {'value': '-5.38', 'spread': '1.76', 'groupId': 'OG001'}, {'value': '-2.54', 'spread': '2.67', 'groupId': 'OG002'}, {'value': '-2.90', 'spread': '2.55', 'groupId': 'OG003'}, {'value': '-2.71', 'spread': '1.84', 'groupId': 'OG004'}]}]}, {'title': 'ASoB or H (n=112,121,47,52,111)', 'categories': [{'measurements': [{'value': '-4.26', 'spread': '1.41', 'groupId': 'OG000'}, {'value': '-5.81', 'spread': '1.35', 'groupId': 'OG001'}, {'value': '-3.12', 'spread': '2.06', 'groupId': 'OG002'}, {'value': '-3.62', 'spread': '1.95', 'groupId': 'OG003'}, {'value': '-3.63', 'spread': '1.40', 'groupId': 'OG004'}]}]}, {'title': 'Somnolence (n=112,121,47,52,111)', 'categories': [{'measurements': [{'value': '-10.54', 'spread': '1.53', 'groupId': 'OG000'}, {'value': '-9.72', 'spread': '1.48', 'groupId': 'OG001'}, {'value': '-6.12', 'spread': '2.25', 'groupId': 'OG002'}, {'value': '-7.36', 'spread': '2.14', 'groupId': 'OG003'}, {'value': '-10.55', 'spread': '1.53', 'groupId': 'OG004'}]}]}, {'title': 'SA (n=112, 121, 47, 52, 111)', 'categories': [{'measurements': [{'value': '14.22', 'spread': '2.40', 'groupId': 'OG000'}, {'value': '14.30', 'spread': '2.32', 'groupId': 'OG001'}, {'value': '9.10', 'spread': '3.52', 'groupId': 'OG002'}, {'value': '15.10', 'spread': '3.34', 'groupId': 'OG003'}, {'value': '11.46', 'spread': '2.40', 'groupId': 'OG004'}]}]}, {'title': 'SPI I (n=112, 121, 47, 52, 111)', 'categories': [{'measurements': [{'value': '-13.19', 'spread': '1.51', 'groupId': 'OG000'}, {'value': '-13.99', 'spread': '1.46', 'groupId': 'OG001'}, {'value': '-8.92', 'spread': '2.21', 'groupId': 'OG002'}, {'value': '-13.71', 'spread': '2.09', 'groupId': 'OG003'}, {'value': '-11.84', 'spread': '1.50', 'groupId': 'OG004'}]}]}, {'title': 'SPI II (n=112, 121, 47, 52,111)', 'categories': [{'measurements': [{'value': '-14.01', 'spread': '1.51', 'groupId': 'OG000'}, {'value': '-14.53', 'spread': '1.46', 'groupId': 'OG001'}, {'value': '-9.64', 'spread': '2.21', 'groupId': 'OG002'}, {'value': '-14.12', 'spread': '2.10', 'groupId': 'OG003'}, {'value': '-12.04', 'spread': '1.51', 'groupId': 'OG004'}]}]}, {'title': 'SQ (n=111, 121, 47, 52, 111)', 'categories': [{'measurements': [{'value': '0.28', 'spread': '0.10', 'groupId': 'OG000'}, {'value': '0.44', 'spread': '0.09', 'groupId': 'OG001'}, {'value': '0.32', 'spread': '0.14', 'groupId': 'OG002'}, {'value': '0.41', 'spread': '0.13', 'groupId': 'OG003'}, {'value': '0.36', 'spread': '0.10', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.253', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.93', 'ciLowerLimit': '-7.96', 'ciUpperLimit': '2.10', 'groupDescription': 'Sleep disturbance: ANCOVA model was used with treatment and region as factors and baseline as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.127', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.84', 'ciLowerLimit': '-8.78', 'ciUpperLimit': '1.10', 'groupDescription': 'Sleep disturbance: ANCOVA model was used with treatment and region as factors and baseline as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.180', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.15', 'ciLowerLimit': '-7.76', 'ciUpperLimit': '1.46', 'groupDescription': 'Snoring: ANCOVA model was used with treatment and region as factors and baseline as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.247', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.67', 'ciLowerLimit': '-7.19', 'ciUpperLimit': '1.85', 'groupDescription': 'Snoring: ANCOVA model was used with treatment and region as factors and baseline as a covariate.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.726', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.63', 'ciLowerLimit': '-4.15', 'ciUpperLimit': '2.90', 'groupDescription': 'ASoB: ANCOVA model was used with treatment and region as factors and baseline as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.218', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.17', 'ciLowerLimit': '-5.63', 'ciUpperLimit': '1.29', 'groupDescription': 'ASoB: ANCOVA model was used with treatment and region as factors and baseline as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.996', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.01', 'ciLowerLimit': '-3.85', 'ciUpperLimit': '3.87', 'groupDescription': 'Somnolence: ANCOVA model was used with treatment and region as factors and baseline as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.665', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean DIfference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.83', 'ciLowerLimit': '-2.94', 'ciUpperLimit': '4.60', 'groupDescription': 'Somnolence: ANCOVA model was used with treatment and region as factors and baseline as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.368', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.76', 'ciLowerLimit': '-3.26', 'ciUpperLimit': '8.78', 'groupDescription': 'Sleep adequacy: Month 3, ANCOVA model was used with treatment and region as factors and baseline as a covariate.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.345', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.84', 'ciLowerLimit': '-3.07', 'ciUpperLimit': '8.75', 'groupDescription': 'Sleep adequacy: ANCOVA model was used with treatment and region as factors and baseline as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.482', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.35', 'ciLowerLimit': '-5.12', 'ciUpperLimit': '2.42', 'groupDescription': 'Sleep problem index I: ANCOVA model was used with treatment and region as factors and baseline as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.254', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean DIfference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.15', 'ciLowerLimit': '-5.86', 'ciUpperLimit': '1.55', 'groupDescription': 'Sleep problem index I: ANCOVA model was used with treatment and region as factors and baseline as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.308', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.97', 'ciLowerLimit': '-5.76', 'ciUpperLimit': '1.82', 'groupDescription': 'Sleep problem index II: ANCOVA model was used with treatment and region as factors and baseline as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.190', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.48', 'ciLowerLimit': '-6.20', 'ciUpperLimit': '1.23', 'groupDescription': 'Sleep problem index II: ANCOVA model was used with treatment and region as factors and baseline as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.550', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.07', 'ciLowerLimit': '-0.32', 'ciUpperLimit': '0.17', 'groupDescription': 'Sleep quantity: ANCOVA model was used with treatment and region as factors and baseline as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.477', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.09', 'ciLowerLimit': '-0.15', 'ciUpperLimit': '0.32', 'groupDescription': 'Sleep quantity: ANCOVA model was used with treatment and region as factors and baseline as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Month 3', 'description': 'Participant-rated questionnaire to assess sleep quality and quantity. Consists of 12-item questionnaires answered on a range of 1 to 6 for questions (Q) 3 to 12, 1 to 5 for Q1 (some questions are reversed so that a high score reflects more of the attributes); and Q2 answered on 0 to 24. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range\\* 100); total score range: 0 to 100; higher score = greater intensity of attribute. The items contribute to each scale and are averaged to create the 7 scale scores and a sleep quantity scale. Scales with at least one item answered was used to generate a scale score. Scales include; sleep disturbance (SD), snoring, awaken short of breath (ASoB) or with a headache (H), somnolence, sleep adequacy (SA), sleep problem index (SPI) I and II (range: 0-100) and sleep quantity (SQ \\[range 0 to 24\\]). Except for sleep quantity, higher scores=greater impairment.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT population included all randomized participants who met inclusion criteria for sleep sub-study and had baseline and at least 1 post-baseline evaluation for the respective endpoint. Here N = maximum number of participants who were evaluable for this outcome and n = participants who were evaluable at specified time points for each arm.'}, {'type': 'SECONDARY', 'title': 'Menopause-Specific Quality of Life (MENQOL) Score at Baseline: Sleep Sub-Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}, {'value': '112', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg', 'description': 'Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.'}, {'id': 'OG001', 'title': 'Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg', 'description': 'Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.'}, {'id': 'OG002', 'title': 'Bazedoxifene 20 mg', 'description': 'Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year.'}, {'id': 'OG003', 'title': 'Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg', 'description': 'Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.'}], 'classes': [{'title': 'Vasomotor function (n=111, 121, 47, 52, 112)', 'categories': [{'measurements': [{'value': '5.40', 'spread': '1.564', 'groupId': 'OG000'}, {'value': '5.60', 'spread': '1.468', 'groupId': 'OG001'}, {'value': '5.87', 'spread': '1.246', 'groupId': 'OG002'}, {'value': '5.65', 'spread': '1.620', 'groupId': 'OG003'}, {'value': '5.62', 'spread': '1.596', 'groupId': 'OG004'}]}]}, {'title': 'Psychosocial function (n=111, 121, 47, 52, 112)', 'categories': [{'measurements': [{'value': '3.46', 'spread': '1.716', 'groupId': 'OG000'}, {'value': '3.41', 'spread': '1.628', 'groupId': 'OG001'}, {'value': '3.49', 'spread': '1.663', 'groupId': 'OG002'}, {'value': '3.48', 'spread': '1.793', 'groupId': 'OG003'}, {'value': '3.22', 'spread': '1.522', 'groupId': 'OG004'}]}]}, {'title': 'Physical function (n=111, 121, 47, 52, 112)', 'categories': [{'measurements': [{'value': '3.74', 'spread': '1.377', 'groupId': 'OG000'}, {'value': '3.58', 'spread': '1.385', 'groupId': 'OG001'}, {'value': '3.96', 'spread': '1.475', 'groupId': 'OG002'}, {'value': '3.74', 'spread': '1.409', 'groupId': 'OG003'}, {'value': '3.58', 'spread': '1.445', 'groupId': 'OG004'}]}]}, {'title': 'Sexual function (n=110, 121, 47, 52, 112)', 'categories': [{'measurements': [{'value': '3.74', 'spread': '2.200', 'groupId': 'OG000'}, {'value': '3.63', 'spread': '2.182', 'groupId': 'OG001'}, {'value': '4.05', 'spread': '2.265', 'groupId': 'OG002'}, {'value': '3.73', 'spread': '2.238', 'groupId': 'OG003'}, {'value': '3.83', 'spread': '2.243', 'groupId': 'OG004'}]}]}, {'title': 'MENQOL Total Score (n=110, 121, 47, 52, 112)', 'categories': [{'measurements': [{'value': '4.07', 'spread': '1.227', 'groupId': 'OG000'}, {'value': '4.05', 'spread': '1.246', 'groupId': 'OG001'}, {'value': '4.34', 'spread': '1.156', 'groupId': 'OG002'}, {'value': '4.15', 'spread': '1.314', 'groupId': 'OG003'}, {'value': '4.06', 'spread': '1.155', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'MENQOL questionnaire assessed how bothered participants were due to menopause. It consists of 29 items divided into 4 domains: vasomotor function (3 items), psychosocial function (7 items), physical function (16 items), and sexual function (3 items). Each item scores a range from 1 to 8, with 1 indicating that the participant did not experience the symptom or problem, 8 indicating that the participant was extremely bothered by the symptom or problem. The total score for each domain is the average of item scores and ranged from 1 to 8 with higher score indicating worsening of symptoms. The MENQOL total score is the mean of these 4 domain scores and ranged from 1 to 8 with higher score indicating worsening of symptoms.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT population included all randomized participants who met inclusion criteria for sleep sub-study and had baseline and at least 1 post-baseline evaluation for the respective endpoint. Here N = maximum number of participants who were evaluable for this outcome and n = participants who were evaluable at specified time points for each arm.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Menopause-Specific Quality of Life (MENQOL) Score at Month 3: Sleep Sub-Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}, {'value': '112', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg', 'description': 'Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.'}, {'id': 'OG001', 'title': 'Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg', 'description': 'Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.'}, {'id': 'OG002', 'title': 'Bazedoxifene 20 mg', 'description': 'Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year.'}, {'id': 'OG003', 'title': 'Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg', 'description': 'Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.'}], 'classes': [{'title': 'Vasomotor function (n=111, 121, 47, 52, 112)', 'categories': [{'measurements': [{'value': '-2.37', 'spread': '0.17', 'groupId': 'OG000'}, {'value': '-2.75', 'spread': '0.17', 'groupId': 'OG001'}, {'value': '-1.25', 'spread': '0.25', 'groupId': 'OG002'}, {'value': '-3.19', 'spread': '0.24', 'groupId': 'OG003'}, {'value': '-1.45', 'spread': '0.17', 'groupId': 'OG004'}]}]}, {'title': 'Psychosocial function (n=111, 121, 47, 52, 112)', 'categories': [{'measurements': [{'value': '-0.67', 'spread': '0.12', 'groupId': 'OG000'}, {'value': '-0.84', 'spread': '0.12', 'groupId': 'OG001'}, {'value': '-0.47', 'spread': '0.18', 'groupId': 'OG002'}, {'value': '-0.83', 'spread': '0.17', 'groupId': 'OG003'}, {'value': '-0.74', 'spread': '0.12', 'groupId': 'OG004'}]}]}, {'title': 'Physical function (n=111, 121, 47, 52, 112)', 'categories': [{'measurements': [{'value': '-0.92', 'spread': '0.10', 'groupId': 'OG000'}, {'value': '-1.11', 'spread': '0.10', 'groupId': 'OG001'}, {'value': '-0.67', 'spread': '0.15', 'groupId': 'OG002'}, {'value': '-0.76', 'spread': '0.14', 'groupId': 'OG003'}, {'value': '-0.87', 'spread': '0.10', 'groupId': 'OG004'}]}]}, {'title': 'Sexual function (n=110, 121, 47, 52, 112)', 'categories': [{'measurements': [{'value': '-1.20', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '-1.40', 'spread': '0.15', 'groupId': 'OG001'}, {'value': '-0.09', 'spread': '0.23', 'groupId': 'OG002'}, {'value': '-0.76', 'spread': '0.22', 'groupId': 'OG003'}, {'value': '-1.04', 'spread': '0.16', 'groupId': 'OG004'}]}]}, {'title': 'MENQOL Total Score (n=110, 121, 47, 52, 112)', 'categories': [{'measurements': [{'value': '-1.27', 'spread': '0.10', 'groupId': 'OG000'}, {'value': '-1.53', 'spread': '0.10', 'groupId': 'OG001'}, {'value': '-0.63', 'spread': '0.15', 'groupId': 'OG002'}, {'value': '-1.39', 'spread': '0.14', 'groupId': 'OG003'}, {'value': '-1.03', 'spread': '0.10', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'groupDescription': 'Vasomotor function: ANCOVA model was used with treatment and region as factors and baseline as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG004'], 'groupDescription': 'Vasomotor function: ANCOVA model was used with treatment and region as factors and baseline as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.680', 'groupIds': ['OG000', 'OG004'], 'groupDescription': 'Psychosocial function: ANCOVA model was used with treatment and region as factors and baseline as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.493', 'groupIds': ['OG001', 'OG004'], 'groupDescription': 'Psychosocial function: ANCOVA model was used with treatment and region as factors and baseline as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.698', 'groupIds': ['OG000', 'OG004'], 'groupDescription': 'Physical function: ANCOVA model was used with treatment and region as factors and baseline as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.055', 'groupIds': ['OG001', 'OG004'], 'groupDescription': 'Physical function: ANCOVA model was used with treatment and region as factors and baseline as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.428', 'groupIds': ['OG000', 'OG004'], 'groupDescription': 'Sexual function: ANCOVA model was used with treatment and region as factors and baseline as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.071', 'groupIds': ['OG001', 'OG004'], 'groupDescription': 'Sexual function: ANCOVA model was used with treatment and region as factors and baseline as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Month 3', 'description': 'MENQOL questionnaire assessed how bothered participants were due to menopause. It consists of 29 items divided into 4 domains: vasomotor function (3 items), psychosocial function (7 items), physical function (16 items), and sexual function (3 items). Each item scores a range from 1 to 8, with 1 indicating that the participant did not experience the symptom or problem, 8 indicating that the participant was extremely bothered by the symptom or problem. The total score for each domain is the average of item scores and ranged from 1 to 8 with higher score indicating worsening of symptoms. The MENQOL total score is the mean of these 4 domain scores and ranged from 1 to 8 with higher score indicating worsening of symptoms.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT population included all randomized participants who met inclusion criteria for sleep sub-study and had baseline and at least 1 post-baseline evaluation for the respective endpoint. Here "N": maximum number of participants who were evaluable for this outcome and "n": participants who were evaluable at specified time points for each arm.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Uterine Bleeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '440', 'groupId': 'OG000'}, {'value': '468', 'groupId': 'OG001'}, {'value': '229', 'groupId': 'OG002'}, {'value': '216', 'groupId': 'OG003'}, {'value': '470', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg', 'description': 'Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.'}, {'id': 'OG001', 'title': 'Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg', 'description': 'Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.'}, {'id': 'OG002', 'title': 'Bazedoxifene 20 mg', 'description': 'Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year.'}, {'id': 'OG003', 'title': 'Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg', 'description': 'Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.'}], 'classes': [{'title': 'Week 1-4 (n=440, 468, 229, 216, 470)', 'categories': [{'measurements': [{'value': '3.86', 'groupId': 'OG000'}, {'value': '6.20', 'groupId': 'OG001'}, {'value': '5.68', 'groupId': 'OG002'}, {'value': '20.83', 'groupId': 'OG003'}, {'value': '4.68', 'groupId': 'OG004'}]}]}, {'title': 'Week 5-8 (n=428, 458, 221, 205, 462)', 'categories': [{'measurements': [{'value': '4.44', 'groupId': 'OG000'}, {'value': '5.02', 'groupId': 'OG001'}, {'value': '3.62', 'groupId': 'OG002'}, {'value': '24.39', 'groupId': 'OG003'}, {'value': '4.11', 'groupId': 'OG004'}]}]}, {'title': 'Week 9-12 (n=417, 451, 217, 199, 452)', 'categories': [{'measurements': [{'value': '2.16', 'groupId': 'OG000'}, {'value': '3.55', 'groupId': 'OG001'}, {'value': '2.76', 'groupId': 'OG002'}, {'value': '25.63', 'groupId': 'OG003'}, {'value': '4.42', 'groupId': 'OG004'}]}]}, {'title': 'Week 13-16 (n=415, 446, 213, 196, 446)', 'categories': [{'measurements': [{'value': '2.41', 'groupId': 'OG000'}, {'value': '2.91', 'groupId': 'OG001'}, {'value': '3.29', 'groupId': 'OG002'}, {'value': '24.49', 'groupId': 'OG003'}, {'value': '3.36', 'groupId': 'OG004'}]}]}, {'title': 'Week 17-20 (n=399,426,201,184,427)', 'categories': [{'measurements': [{'value': '2.26', 'groupId': 'OG000'}, {'value': '2.58', 'groupId': 'OG001'}, {'value': '2.49', 'groupId': 'OG002'}, {'value': '18.48', 'groupId': 'OG003'}, {'value': '3.51', 'groupId': 'OG004'}]}]}, {'title': 'Week 21-24 (n=395, 424, 199, 183, 423)', 'categories': [{'measurements': [{'value': '2.78', 'groupId': 'OG000'}, {'value': '2.12', 'groupId': 'OG001'}, {'value': '2.01', 'groupId': 'OG002'}, {'value': '18.58', 'groupId': 'OG003'}, {'value': '3.31', 'groupId': 'OG004'}]}]}, {'title': 'Week 25-28 (n=393, 422, 197, 182, 420)', 'categories': [{'measurements': [{'value': '2.04', 'groupId': 'OG000'}, {'value': '2.13', 'groupId': 'OG001'}, {'value': '1.02', 'groupId': 'OG002'}, {'value': '14.84', 'groupId': 'OG003'}, {'value': '3.33', 'groupId': 'OG004'}]}]}, {'title': 'Week 29-32 (n=376, 416, 194, 173, 405)', 'categories': [{'measurements': [{'value': '1.60', 'groupId': 'OG000'}, {'value': '1.68', 'groupId': 'OG001'}, {'value': '1.55', 'groupId': 'OG002'}, {'value': '12.14', 'groupId': 'OG003'}, {'value': '1.73', 'groupId': 'OG004'}]}]}, {'title': 'Week 33-36 (n=373, 413, 192, 170, 399)', 'categories': [{'measurements': [{'value': '0.54', 'groupId': 'OG000'}, {'value': '2.91', 'groupId': 'OG001'}, {'value': '2.08', 'groupId': 'OG002'}, {'value': '12.94', 'groupId': 'OG003'}, {'value': '2.26', 'groupId': 'OG004'}]}]}, {'title': 'Week 37-40 (n=373, 411, 191, 168, 394)', 'categories': [{'measurements': [{'value': '1.61', 'groupId': 'OG000'}, {'value': '2.92', 'groupId': 'OG001'}, {'value': '1.57', 'groupId': 'OG002'}, {'value': '14.29', 'groupId': 'OG003'}, {'value': '4.82', 'groupId': 'OG004'}]}]}, {'title': 'Week 41-44 (n=363, 396, 188, 162, 386)', 'categories': [{'measurements': [{'value': '1.38', 'groupId': 'OG000'}, {'value': '1.26', 'groupId': 'OG001'}, {'value': '0.00', 'groupId': 'OG002'}, {'value': '13.58', 'groupId': 'OG003'}, {'value': '1.55', 'groupId': 'OG004'}]}]}, {'title': 'Week 45-48 (n=358, 394, 188, 160, 383)', 'categories': [{'measurements': [{'value': '0.84', 'groupId': 'OG000'}, {'value': '2.28', 'groupId': 'OG001'}, {'value': '0.53', 'groupId': 'OG002'}, {'value': '14.38', 'groupId': 'OG003'}, {'value': '2.09', 'groupId': 'OG004'}]}]}, {'title': 'Week 49-52 (n=357, 392, 187, 159, 380)', 'categories': [{'measurements': [{'value': '1.68', 'groupId': 'OG000'}, {'value': '1.28', 'groupId': 'OG001'}, {'value': '1.07', 'groupId': 'OG002'}, {'value': '8.81', 'groupId': 'OG003'}, {'value': '1.58', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.624', 'groupIds': ['OG000', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 1-4: The Fisher exact test was used for comparisons between groups.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.868', 'groupIds': ['OG000', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 5-8: The Fisher exact test was used for comparisons between groups.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.087', 'groupIds': ['OG000', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 9-12: The Fisher exact test was used for comparisons between groups.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.425', 'groupIds': ['OG000', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 13-16: The Fisher exact test was used for comparisons between groups.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.307', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 17-20: The Fisher exact test was used for comparisons between groups.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.689', 'groupIds': ['OG000', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 21-24: The Fisher exact test was used for comparisons between groups.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.285', 'groupIds': ['OG000', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 25-28: The Fisher exact test was used for comparisons between groups.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '1.000', 'groupIds': ['OG000', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 29-32: The Fisher exact test was used for comparisons between groups.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.065', 'groupIds': ['OG000', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 33-36: The Fisher exact test was used for comparisons between groups.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.014', 'groupIds': ['OG000', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 37-40: The Fisher exact test was used for comparisons between groups.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '1.000', 'groupIds': ['OG000', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 41-44: The Fisher exact test was used for comparisons between groups.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.226', 'groupIds': ['OG000', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 45-48: The Fisher exact test was used for comparisons between groups.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '1.000', 'groupIds': ['OG000', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 49-52: The Fisher exact test was used for comparisons between groups.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '< 0.001', 'groupIds': ['OG000', 'OG003'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 1-4: The Fisher exact test was used for comparisons between groups.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '< 0.001', 'groupIds': ['OG000', 'OG003'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 5-8: The Fisher exact test was used for comparisons between groups.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '< 0.001', 'groupIds': ['OG000', 'OG003'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 9-12: The Fisher exact test was used for comparisons between groups.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '< 0.001', 'groupIds': ['OG000', 'OG003'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 13-16: The Fisher exact test was used for comparisons between groups.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '< 0.001', 'groupIds': ['OG000', 'OG003'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 17-20: The Fisher exact test was used for comparisons between groups.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '< 0.001', 'groupIds': ['OG000', 'OG003'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 21-24: The Fisher exact test was used for comparisons between groups.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '< 0.001', 'groupIds': ['OG000', 'OG003'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 25-28: The Fisher exact test was used for comparisons between groups.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '< 0.001', 'groupIds': ['OG000', 'OG003'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 29-32: The Fisher exact test was used for comparisons between groups.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '< 0.001', 'groupIds': ['OG000', 'OG003'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 33-36: The Fisher exact test was used for comparisons between groups.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '< 0.001', 'groupIds': ['OG000', 'OG003'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 37-40: The Fisher exact test was used for comparisons between groups.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '< 0.001', 'groupIds': ['OG000', 'OG003'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 41-44: The Fisher exact test was used for comparisons between groups.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '< 0.001', 'groupIds': ['OG000', 'OG003'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 45-48: The Fisher exact test was used for comparisons between groups.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '< 0.001', 'groupIds': ['OG000', 'OG003'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 49-52: The Fisher exact test was used for comparisons between groups.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.317', 'groupIds': ['OG001', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 1-4: The Fisher exact test was used for comparisons between groups.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.531', 'groupIds': ['OG001', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 5-8: The Fisher exact test was used for comparisons between groups.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.610', 'groupIds': ['OG001', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 9-12: The Fisher exact test was used for comparisons between groups.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.848', 'groupIds': ['OG001', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 13-16: The Fisher exact test was used for comparisons between groups.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.551', 'groupIds': ['OG001', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 17-20: The Fisher exact test was used for comparisons between groups.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.300', 'groupIds': ['OG001', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 21-24: The Fisher exact test was used for comparisons between groups.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.299', 'groupIds': ['OG001', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 25-28: The Fisher exact test was used for comparisons between groups.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '1.000', 'groupIds': ['OG001', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 29-32: The Fisher exact test was used for comparisons between groups.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.660', 'groupIds': ['OG001', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 33-36: The Fisher exact test was used for comparisons between groups.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.199', 'groupIds': ['OG001', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 37-40: The Fisher exact test was used for comparisons between groups.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.770', 'groupIds': ['OG001', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 41-44: The Fisher exact test was used for comparisons between groups.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '1.000', 'groupIds': ['OG001', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 45-48: The Fisher exact test was used for comparisons between groups.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.769', 'groupIds': ['OG001', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 49-52: The Fisher exact test was used for comparisons between groups.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '< 0.001', 'groupIds': ['OG001', 'OG003'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 1-4: The Fisher exact test was used for comparisons between groups.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '< 0.001', 'groupIds': ['OG001', 'OG003'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 5-8: The Fisher exact test was used for comparisons between groups.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '< 0.001', 'groupIds': ['OG001', 'OG003'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 9-12: The Fisher exact test was used for comparisons between groups.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '< 0.001', 'groupIds': ['OG001', 'OG003'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 13-16: The Fisher exact test was used for comparisons between groups.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '< 0.001', 'groupIds': ['OG001', 'OG003'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 17-20: The Fisher exact test was used for comparisons between groups.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '< 0.001', 'groupIds': ['OG001', 'OG003'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 21-24: The Fisher exact test was used for comparisons between groups.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '< 0.001', 'groupIds': ['OG001', 'OG003'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 25-28: The Fisher exact test was used for comparisons between groups.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '< 0.001', 'groupIds': ['OG001', 'OG003'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 29-32: The Fisher exact test was used for comparisons between groups.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '< 0.001', 'groupIds': ['OG001', 'OG003'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 33-36: The Fisher exact test was used for comparisons between groups.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '< 0.001', 'groupIds': ['OG001', 'OG003'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 37-40: The Fisher exact test was used for comparisons between groups.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '< 0.001', 'groupIds': ['OG001', 'OG003'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 41-44: The Fisher exact test was used for comparisons between groups.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '< 0.001', 'groupIds': ['OG001', 'OG003'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 45-48: The Fisher exact test was used for comparisons between groups.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '< 0.001', 'groupIds': ['OG001', 'OG003'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 49-52: The Fisher exact test was used for comparisons between groups.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 1-4, 5-8, 9-12, 13-16, 17-20, 21-24, 25-28, 29-32, 33-36, 37-40, 41-44, 45-48, 49-52', 'description': 'Percentage of participants with uterine bleeding were calculated for each 4-week period for 1-year on therapy.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT population included all randomized participants who took at least 1 dose of the study drug, and had at least 1 day of on-therapy bleeding data. Here "N" signifies participants who were evaluable for this outcome measure and "n" signifies participants who were evaluable at specified time points for each arm respectively.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg', 'description': 'Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.'}, {'id': 'FG001', 'title': 'Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg', 'description': 'Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.'}, {'id': 'FG002', 'title': 'Bazedoxifene 20 mg', 'description': 'Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year.'}, {'id': 'FG003', 'title': 'Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg', 'description': 'Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.'}, {'id': 'FG004', 'title': 'Placebo', 'description': 'Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '455'}, {'groupId': 'FG001', 'numSubjects': '481'}, {'groupId': 'FG002', 'numSubjects': '239'}, {'groupId': 'FG003', 'numSubjects': '228'}, {'groupId': 'FG004', 'numSubjects': '483'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '445'}, {'groupId': 'FG001', 'numSubjects': '474'}, {'groupId': 'FG002', 'numSubjects': '230'}, {'groupId': 'FG003', 'numSubjects': '220'}, {'groupId': 'FG004', 'numSubjects': '474'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '357'}, {'groupId': 'FG001', 'numSubjects': '393'}, {'groupId': 'FG002', 'numSubjects': '185'}, {'groupId': 'FG003', 'numSubjects': '159'}, {'groupId': 'FG004', 'numSubjects': '383'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '98'}, {'groupId': 'FG001', 'numSubjects': '88'}, {'groupId': 'FG002', 'numSubjects': '54'}, {'groupId': 'FG003', 'numSubjects': '69'}, {'groupId': 'FG004', 'numSubjects': '100'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '33'}, {'groupId': 'FG002', 'numSubjects': '16'}, {'groupId': 'FG003', 'numSubjects': '31'}, {'groupId': 'FG004', 'numSubjects': '33'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '9'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'groupId': 'FG004', 'numSubjects': '5'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '16'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '15'}]}, {'type': 'Randomized, but not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '9'}]}, {'type': 'Unsatisfactory response', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '12'}]}]}], 'preAssignmentDetails': 'This main study also included 3 sub-studies only for the purpose of the assessment of relevant parameters: breast density sub-study, osteoporosis sub-study (OSS), and sleep sub-study. A participant could participate in more than 1 sub-study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '445', 'groupId': 'BG000'}, {'value': '474', 'groupId': 'BG001'}, {'value': '230', 'groupId': 'BG002'}, {'value': '220', 'groupId': 'BG003'}, {'value': '474', 'groupId': 'BG004'}, {'value': '1843', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg', 'description': 'Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.'}, {'id': 'BG001', 'title': 'Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg', 'description': 'Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.'}, {'id': 'BG002', 'title': 'Bazedoxifene 20 mg', 'description': 'Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year.'}, {'id': 'BG003', 'title': 'Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg', 'description': 'Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.'}, {'id': 'BG004', 'title': 'Placebo', 'description': 'Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.43', 'spread': '4.02', 'groupId': 'BG000'}, {'value': '53.89', 'spread': '4.00', 'groupId': 'BG001'}, {'value': '54.07', 'spread': '4.01', 'groupId': 'BG002'}, {'value': '54.15', 'spread': '4.50', 'groupId': 'BG003'}, {'value': '54.19', 'spread': '4.07', 'groupId': 'BG004'}, {'value': '54.15', 'spread': '4.09', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '445', 'groupId': 'BG000'}, {'value': '474', 'groupId': 'BG001'}, {'value': '230', 'groupId': 'BG002'}, {'value': '220', 'groupId': 'BG003'}, {'value': '474', 'groupId': 'BG004'}, {'value': '1843', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety population included all randomized participants who received at least one dose of study drug.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1886}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'dispFirstSubmitDate': '2013-01-07', 'completionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-03-10', 'studyFirstSubmitDate': '2008-12-12', 'dispFirstSubmitQcDate': '2013-01-07', 'resultsFirstSubmitDate': '2013-10-30', 'studyFirstSubmitQcDate': '2008-12-12', 'dispFirstPostDateStruct': {'date': '2013-01-14', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2014-04-08', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-10-30', 'studyFirstPostDateStruct': {'date': '2008-12-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-12-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Percentage of Participants With Breast Tenderness', 'timeFrame': 'Screening, Week 1-4, 5-8, 9-12, 13-16, 17-20, 21-24, 25-28, 29-32, 33-36, 37-40, 41-44, 45-48, 49-52', 'description': 'Percentage of participants who reported at least 1 day of breast tenderness during each 4-week period for 1-year on therapy was calculated.'}], 'primaryOutcomes': [{'measure': 'Percentage of Participants With Endometrial Hyperplasia at Month 12: Main Study', 'timeFrame': 'Month 12', 'description': 'Endometrial hyperplasia was assessed by endometrial biopsies. All endometrial biopsies were read centrally by 2 primary pathologists. If both the pathologists disagreed on the presence of hyperplasia, a third pathologist was consulted. Results were summarized for two definitions of hyperplasia (simple hyperplasia with or without atypia or complex hyperplasia with or without atypia); definition 1: participants were considered to have a diagnosis of hyperplasia when the 3 pathologists disagreed but at least 1 pathologist determined hyperplasia; definition 2: participants were considered to have a diagnosis of hyperplasia if at least 2 of the 3 pathologists agreed on the diagnosis.'}, {'measure': 'Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at Month 12: Osteoporosis Sub-Study', 'timeFrame': 'Baseline, Month 12', 'description': 'BMD measurements of the anteroposterior lumbar spine were acquired by using dual-energy x-ray absorptiometry (DXA) scans, twice at Month 12 for a subset of participants who entered the osteoporosis substudy. The second scan was to be performed on the same day as the first; however, the participant was to be removed completely from the table after the first scan and repositioned for the second scan. Mean percentage change from baseline of the 2 readings were reported.'}], 'secondaryOutcomes': [{'measure': 'Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at Month 6: Osteoporosis Sub-Study', 'timeFrame': 'Baseline, Month 6', 'description': 'BMD measurements of the anteroposterior lumbar spine were acquired by using DXA scans, twice at Month 6 for a subset of participants who entered the osteoporosis substudy. The second scan was to be performed on the same day as the first; however, the participant was to be removed completely from the table after the first scan and repositioned for the second scan. Mean percentage change from baseline of the 2 readings were reported.'}, {'measure': 'Percent Change From Baseline in Bone Mineral Density (BMD) of Total Hip at Month 6, 12: Osteoporosis Sub-Study', 'timeFrame': 'Baseline, Month 6, Month 12', 'description': 'BMD measurements of the total hip were acquired by using DXA scans, twice at Month 6 and 12 for a subset of participants who entered the osteoporosis substudy. The second scan was to be performed on the same day as the first; however, the participant was to be removed completely from the table after the first scan and repositioned for the second scan. Mean percentage change from baseline of the 2 readings were reported.'}, {'measure': 'Percentage of Participants With Cumulative Amenorrhea: Main Study', 'timeFrame': 'Day 1 up to Day 364', 'description': 'Cumulative amenorrhea was defined as the absence of any bleeding or spotting for cumulative 4-week periods throughout 1-year study.'}, {'measure': 'Percent Change From Baseline in Breast Density at Month 12: Breast Density Sub-Study', 'timeFrame': 'Baseline, Month 12', 'description': 'Breast density was assessed by digitalized mammograms which were centrally read by a single radiologist using specifically-developed software. Breast density was assessed for subset of participants who entered the breast density sub-study'}, {'measure': 'Percent Change From Baseline in Bone Turnover Markers (BTMs) at Month 6 and Month 12: Osteoporosis Sub-Study', 'timeFrame': 'Baseline, Month 6, 12', 'description': 'Bone turnover is the removal of old bone from the body and its replacement by new bone. Bone turnover markers included serum osteocalcin, C-telopeptide, and procollagen type 1 N-propeptide (P1NP), were measured at Month 6 and Month 12 for a subset of participants who entered the osteoporosis substudy. Blood samples were collected to evaluate bone turnover markers levels.'}, {'measure': 'Medical Outcomes Study (MOS) Sleep Scale at Baseline: Sleep Sub-Study', 'timeFrame': 'Baseline', 'description': 'Participant-rated questionnaire to assess sleep quality and quantity. Consists of 12-item questionnaires answered on a range of 1 to 6 for questions (Q) 3 to 12, 1 to 5 for Q1 (some questions are reversed so that a high score reflects more of the attributes); and Q2 answered on 0 to 24. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range\\* 100); total score range: 0 to 100; higher score = greater intensity of attribute. The items contribute to each scale and are averaged to create the 7 scale scores and a sleep quantity scale. Scales with at least one item answered was used to generate a scale score. Scales include; sleep disturbance (SD), snoring, awaken short of breath (ASoB) or with a headache (H), somnolence, sleep adequacy (SA), sleep problem index (SPI) I and II (range: 0-100) and sleep quantity (SQ \\[range 0 to 24\\]). Except for sleep quantity, higher scores=greater impairment.'}, {'measure': 'Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Month 3: Sleep Sub-Study', 'timeFrame': 'Baseline, Month 3', 'description': 'Participant-rated questionnaire to assess sleep quality and quantity. Consists of 12-item questionnaires answered on a range of 1 to 6 for questions (Q) 3 to 12, 1 to 5 for Q1 (some questions are reversed so that a high score reflects more of the attributes); and Q2 answered on 0 to 24. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range\\* 100); total score range: 0 to 100; higher score = greater intensity of attribute. The items contribute to each scale and are averaged to create the 7 scale scores and a sleep quantity scale. Scales with at least one item answered was used to generate a scale score. Scales include; sleep disturbance (SD), snoring, awaken short of breath (ASoB) or with a headache (H), somnolence, sleep adequacy (SA), sleep problem index (SPI) I and II (range: 0-100) and sleep quantity (SQ \\[range 0 to 24\\]). Except for sleep quantity, higher scores=greater impairment.'}, {'measure': 'Menopause-Specific Quality of Life (MENQOL) Score at Baseline: Sleep Sub-Study', 'timeFrame': 'Baseline', 'description': 'MENQOL questionnaire assessed how bothered participants were due to menopause. It consists of 29 items divided into 4 domains: vasomotor function (3 items), psychosocial function (7 items), physical function (16 items), and sexual function (3 items). Each item scores a range from 1 to 8, with 1 indicating that the participant did not experience the symptom or problem, 8 indicating that the participant was extremely bothered by the symptom or problem. The total score for each domain is the average of item scores and ranged from 1 to 8 with higher score indicating worsening of symptoms. The MENQOL total score is the mean of these 4 domain scores and ranged from 1 to 8 with higher score indicating worsening of symptoms.'}, {'measure': 'Change From Baseline in Menopause-Specific Quality of Life (MENQOL) Score at Month 3: Sleep Sub-Study', 'timeFrame': 'Baseline, Month 3', 'description': 'MENQOL questionnaire assessed how bothered participants were due to menopause. It consists of 29 items divided into 4 domains: vasomotor function (3 items), psychosocial function (7 items), physical function (16 items), and sexual function (3 items). Each item scores a range from 1 to 8, with 1 indicating that the participant did not experience the symptom or problem, 8 indicating that the participant was extremely bothered by the symptom or problem. The total score for each domain is the average of item scores and ranged from 1 to 8 with higher score indicating worsening of symptoms. The MENQOL total score is the mean of these 4 domain scores and ranged from 1 to 8 with higher score indicating worsening of symptoms.'}, {'measure': 'Percentage of Participants With Uterine Bleeding', 'timeFrame': 'Week 1-4, 5-8, 9-12, 13-16, 17-20, 21-24, 25-28, 29-32, 33-36, 37-40, 41-44, 45-48, 49-52', 'description': 'Percentage of participants with uterine bleeding were calculated for each 4-week period for 1-year on therapy.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Postmenopausal Women', 'Bazedoxifene/Conjugated Estrogens'], 'conditions': ['Menopause', 'Osteoporosis']}, 'referencesModule': {'references': [{'pmid': '24438370', 'type': 'DERIVED', 'citation': 'Pinkerton JV, Harvey JA, Lindsay R, Pan K, Chines AA, Mirkin S, Archer DF; SMART-5 Investigators. Effects of bazedoxifene/conjugated estrogens on the endometrium and bone: a randomized trial. J Clin Endocrinol Metab. 2014 Feb;99(2):E189-98. doi: 10.1210/jc.2013-1707. Epub 2014 Jan 17.'}, {'pmid': '23635731', 'type': 'DERIVED', 'citation': 'Pinkerton JV, Harvey JA, Pan K, Thompson JR, Ryan KA, Chines AA, Mirkin S. Breast effects of bazedoxifene-conjugated estrogens: a randomized controlled trial. Obstet Gynecol. 2013 May;121(5):959-968. doi: 10.1097/AOG.0b013e31828c5974.'}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=3115A1-3307&StudyName=Study%20Evaluating%20The%20Effects%20Of%20Bazedoxifene/Conjugated%20Estrogens%20On%20Endometrial%20Safety%20And%20Postmenopausal%20Osteoporosis', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to evaluate the safety and effectiveness of this investigational drug for the treatment of menopausal symptoms while protecting the endometrium (uterine lining) and preventing postmenopausal osteoporosis. Subject participation will last approximately 14.5 months.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Generally healthy, postmenopausal women, aged 40 to 64 seeking treatment for menopausal symptoms\n* At least 12 months of spontaneous amenorrhea, OR 6 months spontaneous amenorrhea with follicle-stimulating hormone (FSH) levels \\> 40 mIU/mL\n* Intact Uterus\n\nExclusion Criteria:\n\n* Use of oral estrogen, progestin, androgen, or selective estrogen receptor modulator (SERM) containing drug products within 8 weeks before screening\n* A history or active presence of clinically important medical disease: eg. cardiovascular disease (stroke, heart attack), chronic renal or liver disease, breast cancer, etc.'}, 'identificationModule': {'nctId': 'NCT00808132', 'briefTitle': 'Study Evaluating The Effects Of Bazedoxifene/Conjugated Estrogens On 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