Ignite Creation Date:
2025-12-24 @ 10:20 PM
Ignite Modification Date:
2025-12-25 @ 7:53 PM
Study NCT ID:
NCT01441635
Status:
COMPLETED
Last Update Posted:
2021-07-13
First Post:
2011-09-06
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of Elagolix in Pre-Menopausal Women With Heavy Uterine Bleeding and Uterine Fibroids
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Puerto Rico', 'United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D007889', 'term': 'Leiomyoma'}, {'id': 'D008595', 'term': 'Menorrhagia'}], 'ancestors': [{'id': 'D009379', 'term': 'Neoplasms, Muscle Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D014592', 'term': 'Uterine Hemorrhage'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D008599', 'term': 'Menstruation Disturbances'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C539351', 'term': 'elagolix'}, {'id': 'D004958', 'term': 'Estradiol'}, {'id': 'D000077563', 'term': 'Norethindrone Acetate'}, {'id': 'C418365', 'term': 'estradiol, norethindrone drug combination'}, {'id': 'D011374', 'term': 'Progesterone'}], 'ancestors': [{'id': 'D004963', 'term': 'Estrenes'}, {'id': 'D004962', 'term': 'Estranes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D045166', 'term': 'Estradiol Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009640', 'term': 'Norethindrone'}, {'id': 'D009652', 'term': 'Norpregnenes'}, {'id': 'D009650', 'term': 'Norpregnanes'}, {'id': 'D009654', 'term': 'Norsteroids'}, {'id': 'D011282', 'term': 'Pregnenediones'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D003339', 'term': 'Corpus Luteum Hormones'}, {'id': 'D045167', 'term': 'Progesterone Congeners'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '800-633-9110', 'title': 'Global Medical Services', 'organization': 'AbbVie (prior sponsor, Abbott)'}, 'certainAgreement': {'otherDetails': 'AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.', 'eventGroups': [{'id': 'EG000', 'title': 'Cohort 1 Placebo', 'description': 'Participants received placebo to elagolix twice a day for 3 months.', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 8, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Cohort 1 Elagolix 200 mg BID', 'description': 'Participants received elagolix 200 mg twice a day for 3 months.', 'otherNumAtRisk': 35, 'deathsNumAtRisk': 35, 'otherNumAffected': 26, 'seriousNumAtRisk': 35, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Cohort 2 Placebo', 'description': 'Participants received placebo to elagolix BID for 3 months.', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 10, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Cohort 2 Elagolix 300 mg BID', 'description': 'Participants received elagolix 300 mg twice a day for 3 months', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 20, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG004', 'title': 'Cohort 3 Elagolix 200 mg BID + LD E2/NETA', 'description': 'Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months.', 'otherNumAtRisk': 34, 'deathsNumAtRisk': 34, 'otherNumAffected': 20, 'seriousNumAtRisk': 34, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Cohort 4 Placebo', 'description': 'Participants received placebo to elagolix BID for 3 months.', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 9, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG006', 'title': 'Cohort 4 Elagolix 100 mg BID', 'description': 'Participants received elagolix 100 mg twice a day (BID) for 3 months.', 'otherNumAtRisk': 33, 'deathsNumAtRisk': 33, 'otherNumAffected': 20, 'seriousNumAtRisk': 33, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG007', 'title': 'Cohort 4 Golix 400 mg QD', 'description': 'Participants received elagolix 400 mg once a day (QD) for 3 months.', 'otherNumAtRisk': 32, 'deathsNumAtRisk': 32, 'otherNumAffected': 24, 'seriousNumAtRisk': 32, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG008', 'title': 'Cohort 5 Elagolix 600 mg QD', 'description': 'Participants received elagolix 600 mg once a day for 3 months.', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 22, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG009', 'title': 'Cohort 6 Elagolix 300 mg BID + CEP', 'description': 'Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months.', 'otherNumAtRisk': 27, 'deathsNumAtRisk': 27, 'otherNumAffected': 11, 'seriousNumAtRisk': 27, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'ABDOMINAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 27, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 32, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG008', 'numAtRisk': 30, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG009', 'numAtRisk': 27, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'FATIGUE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 34, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 32, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG008', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'OEDEMA PERIPHERAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'BRONCHITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'VAGINITIS BACTERIAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 32, 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'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'WEIGHT INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'DECREASED APPETITE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'DIABETES MELLITUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'BACK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 32, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG008', 'numAtRisk': 30, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG009', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'MUSCLE SPASMS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 34, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'DIZZINESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 34, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 32, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG008', 'numAtRisk': 30, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG009', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 34, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 33, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 32, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG008', 'numAtRisk': 30, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG009', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'MIGRAINE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'DEPRESSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'MOOD SWINGS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 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'EG006', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'OVARIAN CYST', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'CHLOASMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'URTICARIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'HYPERTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG009', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'LACERATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'HYPERSENSITIVITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}], 'seriousEvents': [{'term': 'ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'UTERINE LEIOMYOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'NECROSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'CHOLECYSTITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'HYPOVOLAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'UTERINE HAEMORRHAGE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'PANCREATITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'ABORTION INDUCED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Change From Baseline to the Last 28 Days of Treatment in Menstrual Blood Loss (MBL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}, {'value': '33', 'groupId': 'OG005'}, {'value': '28', 'groupId': 'OG006'}, {'value': '30', 'groupId': 'OG007'}, {'value': '15', 'groupId': 'OG008'}, {'value': '26', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 4 Elagolix 400 mg QD', 'description': 'Participants received elagolix 400 mg once a day (QD) for 3 months.'}, {'id': 'OG001', 'title': 'Cohort 4 Elagolix 100 mg BID', 'description': 'Participants received elagolix 100 mg twice a day (BID) for 3 months.'}, {'id': 'OG002', 'title': 'Cohort 4 Placebo', 'description': 'Participants received placebo to elagolix BID for 3 months.'}, {'id': 'OG003', 'title': 'Cohort 1 Elagolix 200 mg BID', 'description': 'Participants received elagolix 200 mg twice a day for 3 months.'}, {'id': 'OG004', 'title': 'Cohort 1 Placebo', 'description': 'Participants received placebo to elagolix twice a day for 3 months.'}, {'id': 'OG005', 'title': 'Cohort 3 Elagolix 200 mg BID + LD E2/NETA', 'description': 'Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months.'}, {'id': 'OG006', 'title': 'Cohort 5 Elagolix 600 mg QD', 'description': 'Participants received elagolix 600 mg once a day for 3 months.'}, {'id': 'OG007', 'title': 'Cohort 2 Elagolix 300 mg BID', 'description': 'Participants received elagolix 300 mg twice a day for 3 months.'}, {'id': 'OG008', 'title': 'Cohort 2 Placebo', 'description': 'Participants received placebo to elagolix BID for 3 months.'}, {'id': 'OG009', 'title': 'Cohort 6 Elagolix 300 mg BID + CEP', 'description': 'Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '213.70', 'spread': '108.08', 'groupId': 'OG000'}, {'value': '269.36', 'spread': '163.17', 'groupId': 'OG001'}, {'value': '321.73', 'spread': '327.57', 'groupId': 'OG002'}, {'value': '335.11', 'spread': '322.68', 'groupId': 'OG003'}, {'value': '251.72', 'spread': '160.29', 'groupId': 'OG004'}, {'value': '247.70', 'spread': '177.72', 'groupId': 'OG005'}, {'value': '215.62', 'spread': '122.84', 'groupId': 'OG006'}, {'value': '206.27', 'spread': '125.08', 'groupId': 'OG007'}, {'value': '349.17', 'spread': '424.12', 'groupId': 'OG008'}, {'value': '257.99', 'spread': '207.33', 'groupId': 'OG009'}]}]}, {'title': 'Change from Baseline', 'categories': [{'measurements': [{'value': '-183.97', 'spread': '132.19', 'groupId': 'OG000'}, {'value': '-184.69', 'spread': '187.05', 'groupId': 'OG001'}, {'value': '-10.46', 'spread': '85.04', 'groupId': 'OG002'}, {'value': '-272.97', 'spread': '271.39', 'groupId': 'OG003'}, {'value': '-79.00', 'spread': '161.33', 'groupId': 'OG004'}, {'value': '-192.33', 'spread': '191.51', 'groupId': 'OG005'}, {'value': '-189.05', 'spread': '151.15', 'groupId': 'OG006'}, {'value': '-202.57', 'spread': '127.93', 'groupId': 'OG007'}, {'value': '-175.31', 'spread': '342.14', 'groupId': 'OG008'}, {'value': '-216.15', 'spread': '157.08', 'groupId': 'OG009'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-205.9', 'ciLowerLimit': '-295.77', 'ciUpperLimit': '-116.01', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '45.10', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA model with treatment as a factor and baseline as a covariate.'}, {'pValue': '< 0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-189.9', 'ciLowerLimit': '-278.33', 'ciUpperLimit': '-101.53', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '44.36', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA model with treatment as a factor and baseline as a covariate.'}, {'pValue': '0.001', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-138.0', 'ciLowerLimit': '-220.18', 'ciUpperLimit': '-55.76', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '40.86', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA model with treatment as a factor and baseline as a covariate.'}, {'pValue': '0.001', 'groupIds': ['OG007', 'OG008'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-130.6', 'ciLowerLimit': '-206.70', 'ciUpperLimit': '-54.60', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '37.68', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA model with treatment as a factor and baseline as a covariate.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (last menstrual cycle during the screening period) and the last 28 days of treatment (approximately days 61 to 90)', 'description': 'The alkaline hematin method was used for the assessment of MBL. Sanitary products were collected at screening and for any spotting or bleeding episodes that occurred during treatment.\n\nParticipants with missing MBL volume for the last treatment period and no bleeding indicated in the electronic daily bleeding diary (eDiary) in the last treatment period, and participants with no post-baseline MBL data were assigned an MBL value of zero.', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized (Cohorts 1, 2, and 4) or treated (Cohorts 3, 5, and 6) participants, excluding participants with less than 28 days of treatment. Last observation carried forward (LOCF) imputation was used for participants with no MBL volume reported by alkaline hematin method but with light to heavy bleeding reported in the eDiary.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to the Last 28 Days of Treatment in Menstrual Blood Loss (MBL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}, {'value': '33', 'groupId': 'OG005'}, {'value': '28', 'groupId': 'OG006'}, {'value': '30', 'groupId': 'OG007'}, {'value': '15', 'groupId': 'OG008'}, {'value': '26', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 4 Elagolix 400 mg QD', 'description': 'Participants received elagolix 400 mg once a day (QD) for 3 months.'}, {'id': 'OG001', 'title': 'Cohort 4 Elagolix 100 mg BID', 'description': 'Participants received elagolix 100 mg twice a day (BID) for 3 months.'}, {'id': 'OG002', 'title': 'Cohort 4 Placebo', 'description': 'Participants received placebo to elagolix BID for 3 months.'}, {'id': 'OG003', 'title': 'Cohort 1 Elagolix 200 mg BID', 'description': 'Participants received elagolix 200 mg twice a day for 3 months.'}, {'id': 'OG004', 'title': 'Cohort 1 Placebo', 'description': 'Participants received placebo to elagolix twice a day for 3 months.'}, {'id': 'OG005', 'title': 'Cohort 3 Elagolix 200 mg BID + LD E2/NETA', 'description': 'Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months.'}, {'id': 'OG006', 'title': 'Cohort 5 Elagolix 600 mg QD', 'description': 'Participants received elagolix 600 mg once a day for 3 months.'}, {'id': 'OG007', 'title': 'Cohort 2 Elagolix 300 mg BID', 'description': 'Participants received elagolix 300 mg twice a day for 3 months.'}, {'id': 'OG008', 'title': 'Cohort 2 Placebo', 'description': 'Participants received placebo to elagolix BID for 3 months.'}, {'id': 'OG009', 'title': 'Cohort 6 Elagolix 300 mg BID + CEP', 'description': 'Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '-83.83', 'spread': '35.23', 'groupId': 'OG000'}, {'value': '-71.85', 'spread': '49.20', 'groupId': 'OG001'}, {'value': '-6.98', 'spread': '40.78', 'groupId': 'OG002'}, {'value': '-81.03', 'spread': '55.77', 'groupId': 'OG003'}, {'value': '-11.12', 'spread': '103.11', 'groupId': 'OG004'}, {'value': '-79.60', 'spread': '43.63', 'groupId': 'OG005'}, {'value': '-88.58', 'spread': '39.58', 'groupId': 'OG006'}, {'value': '-97.31', 'spread': '12.57', 'groupId': 'OG007'}, {'value': '-42.64', 'spread': '39.68', 'groupId': 'OG008'}, {'value': '-85.39', 'spread': '28.08', 'groupId': 'OG009'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-75.60', 'ciLowerLimit': '-102.93', 'ciUpperLimit': '-48.28', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '13.71', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA model with treatment as a factor and baseline as a covariate.'}, {'pValue': '< 0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-64.27', 'ciLowerLimit': '-91.14', 'ciUpperLimit': '-37.39', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '13.48', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA model with treatment as a factor and baseline as a covariate.'}, {'pValue': '0.005', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-67.67', 'ciLowerLimit': '-113.39', 'ciUpperLimit': '-21.96', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '22.73', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA model with treatment as a factor and baseline as a covariate.'}, {'pValue': '< 0.001', 'groupIds': ['OG007', 'OG008'], 'paramType': 'LS mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-56.84', 'ciLowerLimit': '-73.24', 'ciUpperLimit': '-40.45', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA model with treatment as a factor and baseline as a covariate.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (last menstrual cycle during the screening period) and the last 28 days of treatment (approximately days 61 to 90)', 'description': 'The alkaline hematin method was used for the assessment of MBL. Sanitary products were collected at screening and for any spotting or bleeding episodes that occurred during treatment.\n\nParticipants with missing MBL volume for the last treatment period and no bleeding indicated in the electronic daily bleeding diary (eDiary) in the last treatment period, and participants with no post-baseline MBL data were assigned an MBL value of zero.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized (Cohorts 1, 2, and 4) or treated (Cohorts 3, 5, and 6) participants, excluding participants with less than 28 days of treatment. Last observation carried forward (LOCF) imputation was used for participants with no MBL volume reported by alkaline hematin method but with light to heavy bleeding reported in the electronic diary.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With MBL < 80 mL and With a ≥ 50% Reduction From Baseline in MBL During the Last 28 Days of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}, {'value': '33', 'groupId': 'OG005'}, {'value': '28', 'groupId': 'OG006'}, {'value': '30', 'groupId': 'OG007'}, {'value': '15', 'groupId': 'OG008'}, {'value': '26', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 4 Elagolix 400 mg QD', 'description': 'Participants received elagolix 400 mg once a day (QD) for 3 months.'}, {'id': 'OG001', 'title': 'Cohort 4 Elagolix 100 mg BID', 'description': 'Participants received elagolix 100 mg twice a day (BID) for 3 months.'}, {'id': 'OG002', 'title': 'Cohort 4 Placebo', 'description': 'Participants received placebo to elagolix BID for 3 months.'}, {'id': 'OG003', 'title': 'Cohort 1 Elagolix 200 mg BID', 'description': 'Participants received elagolix 200 mg twice a day for 3 months.'}, {'id': 'OG004', 'title': 'Cohort 1 Placebo', 'description': 'Participants received placebo to elagolix twice a day for 3 months.'}, {'id': 'OG005', 'title': 'Cohort 3 Elagolix 200 mg BID + LD E2/NETA', 'description': 'Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months.'}, {'id': 'OG006', 'title': 'Cohort 5 Elagolix 600 mg QD', 'description': 'Participants received elagolix 600 mg once a day for 3 months.'}, {'id': 'OG007', 'title': 'Cohort 2 Elagolix 300 mg BID', 'description': 'Participants received elagolix 300 mg twice a day for 3 months.'}, {'id': 'OG008', 'title': 'Cohort 2 Placebo', 'description': 'Participants received placebo to elagolix BID for 3 months.'}, {'id': 'OG009', 'title': 'Cohort 6 Elagolix 300 mg BID + CEP', 'description': 'Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '85', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}, {'value': '85', 'groupId': 'OG005'}, {'value': '93', 'groupId': 'OG006'}, {'value': '97', 'groupId': 'OG007'}, {'value': '33', 'groupId': 'OG008'}, {'value': '85', 'groupId': 'OG009'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.001', 'groupIds': ['OG001', 'OG002'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.001', 'groupIds': ['OG003', 'OG004'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.001', 'groupIds': ['OG007', 'OG008'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (last menstrual cycle during the screening period) and the last 28 days of treatment (approximately days 61 to 90)', 'description': 'The alkaline hematin method was used for the assessment of MBL. Sanitary products were collected at screening and for any spotting or bleeding episodes that occurred during treatment.\n\nParticipants with missing MBL volume for the last treatment period and no bleeding indicated in the electronic daily bleeding diary (eDiary) in the last treatment period, and participants with no post-baseline MBL data were assigned an MBL value of zero.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized (Cohorts 1, 2, and 4) or treated (Cohorts 3, 5, and 6) participants, excluding participants with less than 28 days of treatment. LOCF imputation was used for participants with no MBL volume reported by alkaline hematin method but with light to heavy bleeding reported in the eDiary.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With MBL < 80 mL During the Last 28 Days of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}, {'value': '33', 'groupId': 'OG005'}, {'value': '28', 'groupId': 'OG006'}, {'value': '30', 'groupId': 'OG007'}, {'value': '15', 'groupId': 'OG008'}, {'value': '26', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 4 Elagolix 400 mg QD', 'description': 'Participants received elagolix 400 mg once a day (QD) for 3 months.'}, {'id': 'OG001', 'title': 'Cohort 4 Elagolix 100 mg BID', 'description': 'Participants received elagolix 100 mg twice a day (BID) for 3 months.'}, {'id': 'OG002', 'title': 'Cohort 4 Placebo', 'description': 'Participants received placebo to elagolix BID for 3 months.'}, {'id': 'OG003', 'title': 'Cohort 1 Elagolix 200 mg BID', 'description': 'Participants received elagolix 200 mg twice a day for 3 months.'}, {'id': 'OG004', 'title': 'Cohort 1 Placebo', 'description': 'Participants received placebo to elagolix twice a day for 3 months.'}, {'id': 'OG005', 'title': 'Cohort 3 Elagolix 200 mg BID + LD E2/NETA', 'description': 'Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months.'}, {'id': 'OG006', 'title': 'Cohort 5 Elagolix 600 mg QD', 'description': 'Participants received elagolix 600 mg once a day for 3 months.'}, {'id': 'OG007', 'title': 'Cohort 2 Elagolix 300 mg BID', 'description': 'Participants received elagolix 300 mg twice a day for 3 months.'}, {'id': 'OG008', 'title': 'Cohort 2 Placebo', 'description': 'Participants received placebo to elagolix BID for 3 months.'}, {'id': 'OG009', 'title': 'Cohort 6 Elagolix 300 mg BID + CEP', 'description': 'Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '85', 'groupId': 'OG003'}, {'value': '22', 'groupId': 'OG004'}, {'value': '88', 'groupId': 'OG005'}, {'value': '93', 'groupId': 'OG006'}, {'value': '97', 'groupId': 'OG007'}, {'value': '47', 'groupId': 'OG008'}, {'value': '88', 'groupId': 'OG009'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.001', 'groupIds': ['OG003', 'OG004'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.001', 'groupIds': ['OG007', 'OG008'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'The last 28 days of treatment (approximately days 61 to 90)', 'description': 'The alkaline hematin method was used for the assessment of MBL. Sanitary products were collected at screening and for any spotting or bleeding episodes that occurred during treatment.\n\nParticipants with missing MBL volume for the last treatment period and no bleeding indicated in the electronic daily bleeding diary (eDiary) in the last treatment period, and participants with no post-baseline MBL data were assigned an MBL value of zero.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized (Cohorts 1, 2, and 4) or treated (Cohorts 3, 5, and 6) participants, excluding participants with less than 28 days of treatment. LOCF imputation was used for participants with no MBL volume reported by alkaline hematin method but with light to heavy bleeding reported in the eDiary.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a ≥ 50% Reduction From Baseline in MBL During the Last 28 Days of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}, {'value': '33', 'groupId': 'OG005'}, {'value': '28', 'groupId': 'OG006'}, {'value': '30', 'groupId': 'OG007'}, {'value': '15', 'groupId': 'OG008'}, {'value': '26', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 4 Elagolix 400 mg QD', 'description': 'Participants received elagolix 400 mg once a day (QD) for 3 months.'}, {'id': 'OG001', 'title': 'Cohort 4 Elagolix 100 mg BID', 'description': 'Participants received elagolix 100 mg twice a day (BID) for 3 months.'}, {'id': 'OG002', 'title': 'Cohort 4 Placebo', 'description': 'Participants received placebo to elagolix BID for 3 months.'}, {'id': 'OG003', 'title': 'Cohort 1 Elagolix 200 mg BID', 'description': 'Participants received elagolix 200 mg twice a day for 3 months.'}, {'id': 'OG004', 'title': 'Cohort 1 Placebo', 'description': 'Participants received placebo to elagolix twice a day for 3 months.'}, {'id': 'OG005', 'title': 'Cohort 3 Elagolix 200 mg BID + LD E2/NETA', 'description': 'Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months.'}, {'id': 'OG006', 'title': 'Cohort 5 Elagolix 600 mg QD', 'description': 'Participants received elagolix 600 mg once a day for 3 months.'}, {'id': 'OG007', 'title': 'Cohort 2 Elagolix 300 mg BID', 'description': 'Participants received elagolix 300 mg twice a day for 3 months.'}, {'id': 'OG008', 'title': 'Cohort 2 Placebo', 'description': 'Participants received placebo to elagolix BID for 3 months.'}, {'id': 'OG009', 'title': 'Cohort 6 Elagolix 300 mg BID + CEP', 'description': 'Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '91', 'groupId': 'OG003'}, {'value': '28', 'groupId': 'OG004'}, {'value': '85', 'groupId': 'OG005'}, {'value': '93', 'groupId': 'OG006'}, {'value': '97', 'groupId': 'OG007'}, {'value': '40', 'groupId': 'OG008'}, {'value': '88', 'groupId': 'OG009'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.001', 'groupIds': ['OG001', 'OG002'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.001', 'groupIds': ['OG003', 'OG004'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.001', 'groupIds': ['OG007', 'OG008'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (last menstrual cycle during the screening period) and the last 28 days of treatment (approximately days 61 to 90)', 'description': 'The alkaline hematin method was used for the assessment of MBL. Sanitary products were collected at screening and for any spotting or bleeding episodes that occurred during treatment.\n\nParticipants with missing MBL volume for the last treatment period and no bleeding indicated in the electronic daily bleeding diary (eDiary) in the last treatment period, and participants with no post-baseline MBL data were assigned an MBL value of zero.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized (Cohorts 1, 2, and 4) or treated (Cohorts 3, 5, and 6) participants, excluding participants with less than 28 days of treatment. LOCF imputation was used for participants with no MBL volume reported by alkaline hematin method but with light to heavy bleeding reported in the eDiary.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With No Change, Decrease From Baseline, or Increase From Baseline in Hemoglobin at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '28', 'groupId': 'OG005'}, {'value': '23', 'groupId': 'OG006'}, {'value': '25', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '21', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 4 Elagolix 400 mg QD', 'description': 'Participants received elagolix 400 mg once a day (QD) for 3 months.'}, {'id': 'OG001', 'title': 'Cohort 4 Elagolix 100 mg BID', 'description': 'Participants received elagolix 100 mg twice a day (BID) for 3 months.'}, {'id': 'OG002', 'title': 'Cohort 4 Placebo', 'description': 'Participants received placebo to elagolix BID for 3 months.'}, {'id': 'OG003', 'title': 'Cohort 1 Elagolix 200 mg BID', 'description': 'Participants received elagolix 200 mg twice a day for 3 months.'}, {'id': 'OG004', 'title': 'Cohort 1 Placebo', 'description': 'Participants received placebo to elagolix twice a day for 3 months.'}, {'id': 'OG005', 'title': 'Cohort 3 Elagolix 200 mg BID + LD E2/NETA', 'description': 'Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months.'}, {'id': 'OG006', 'title': 'Cohort 5 Elagolix 600 mg QD', 'description': 'Participants received elagolix 600 mg once a day for 3 months.'}, {'id': 'OG007', 'title': 'Cohort 2 Elagolix 300 mg BID', 'description': 'Participants received elagolix 300 mg twice a day for 3 months.'}, {'id': 'OG008', 'title': 'Cohort 2 Placebo', 'description': 'Participants received placebo to elagolix BID for 3 months.'}, {'id': 'OG009', 'title': 'Cohort 6 Elagolix 300 mg BID + CEP', 'description': 'Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months.'}], 'classes': [{'title': 'No Change', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '5', 'groupId': 'OG009'}]}]}, {'title': 'Decreases from -0.5 to 0 g/dL', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '21', 'groupId': 'OG008'}, {'value': '5', 'groupId': 'OG009'}]}]}, {'title': 'Decreases from -1.0 to -0.5 g/dL', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '7', 'groupId': 'OG008'}, {'value': '10', 'groupId': 'OG009'}]}]}, {'title': 'Increase ≥ 0.5 g/dL', 'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '67', 'groupId': 'OG003'}, {'value': '29', 'groupId': 'OG004'}, {'value': '75', 'groupId': 'OG005'}, {'value': '83', 'groupId': 'OG006'}, {'value': '76', 'groupId': 'OG007'}, {'value': '29', 'groupId': 'OG008'}, {'value': '71', 'groupId': 'OG009'}]}]}, {'title': 'Increase ≥ 1.0 g/dL', 'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}, {'value': '29', 'groupId': 'OG004'}, {'value': '43', 'groupId': 'OG005'}, {'value': '57', 'groupId': 'OG006'}, {'value': '52', 'groupId': 'OG007'}, {'value': '29', 'groupId': 'OG008'}, {'value': '62', 'groupId': 'OG009'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Month 3', 'description': 'The percentage of subjects with changes in hemoglobin concentration from Baseline to Month 3 in each of the following categories:\n\n* No change from baseline in hemoglobin\n* Decrease from baseline in hemoglobin ≥ -0.5 g/dL\n* Decrease from baseline in hemoglobin ≥ -1.0 g/dL\n* Increase from baseline in hemoglobin ≥ 0.5 g/dL\n* Increase from baseline in hemoglobin ≥ 1.0 g/dL\n\nThe above categories are not all mutually exclusive or exhaustive.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized (Cohorts 1, 2, and 4) or treated (Cohorts 3, 5, and 6) participants with available hemoglobin data.'}, {'type': 'SECONDARY', 'title': 'Change in Hemoglobin Concentration From Baseline to Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '28', 'groupId': 'OG005'}, {'value': '23', 'groupId': 'OG006'}, {'value': '25', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '21', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 4 Elagolix 400 mg QD', 'description': 'Participants received elagolix 400 mg once a day (QD) for 3 months.'}, {'id': 'OG001', 'title': 'Cohort 4 Elagolix 100 mg BID', 'description': 'Participants received elagolix 100 mg twice a day (BID) for 3 months.'}, {'id': 'OG002', 'title': 'Cohort 4 Placebo', 'description': 'Participants received placebo to elagolix BID for 3 months.'}, {'id': 'OG003', 'title': 'Cohort 1 Elagolix 200 mg BID', 'description': 'Participants received elagolix 200 mg twice a day for 3 months.'}, {'id': 'OG004', 'title': 'Cohort 1 Placebo', 'description': 'Participants received placebo to elagolix twice a day for 3 months.'}, {'id': 'OG005', 'title': 'Cohort 3 Elagolix 200 mg BID + LD E2/NETA', 'description': 'Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months.'}, {'id': 'OG006', 'title': 'Cohort 5 Elagolix 600 mg QD', 'description': 'Participants received elagolix 600 mg once a day for 3 months.'}, {'id': 'OG007', 'title': 'Cohort 2 Elagolix 300 mg BID', 'description': 'Participants received elagolix 300 mg twice a day for 3 months.'}, {'id': 'OG008', 'title': 'Cohort 2 Placebo', 'description': 'Participants received placebo to elagolix BID for 3 months.'}, {'id': 'OG009', 'title': 'Cohort 6 Elagolix 300 mg BID + CEP', 'description': 'Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.18', 'spread': '0.99', 'groupId': 'OG000'}, {'value': '1.30', 'spread': '1.19', 'groupId': 'OG001'}, {'value': '-0.43', 'spread': '1.28', 'groupId': 'OG002'}, {'value': '1.13', 'spread': '1.29', 'groupId': 'OG003'}, {'value': '0.28', 'spread': '1.33', 'groupId': 'OG004'}, {'value': '0.92', 'spread': '0.81', 'groupId': 'OG005'}, {'value': '1.40', 'spread': '1.18', 'groupId': 'OG006'}, {'value': '1.19', 'spread': '0.85', 'groupId': 'OG007'}, {'value': '0.31', 'spread': '1.20', 'groupId': 'OG008'}, {'value': '1.54', 'spread': '1.81', 'groupId': 'OG009'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.8', 'ciLowerLimit': '0.97', 'ciUpperLimit': '2.56', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.40', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA model with treatment as a factor and baseline as a covariate.'}, {'pValue': '< 0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.8', 'ciLowerLimit': '1.00', 'ciUpperLimit': '2.56', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.39', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA model with treatment as a factor and baseline as a covariate.'}, {'pValue': '0.024', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.9', 'ciLowerLimit': '0.13', 'ciUpperLimit': '1.75', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.40', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA model with treatment as a factor and baseline as a covariate.'}, {'pValue': '0.005', 'groupIds': ['OG007', 'OG008'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.9', 'ciLowerLimit': '0.28', 'ciUpperLimit': '1.51', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.30', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA model with treatment as a factor and baseline as a covariate.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Month 3', 'unitOfMeasure': 'g/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized (Cohorts 1, 2, and 4) or treated (Cohorts 3, 5, and 6) participants with available hemoglobin data at baseline and month 3.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Month 3 in Uterine Bleeding Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}, {'value': '32', 'groupId': 'OG005'}, {'value': '26', 'groupId': 'OG006'}, {'value': '27', 'groupId': 'OG007'}, {'value': '15', 'groupId': 'OG008'}, {'value': '25', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 4 Elagolix 400 mg QD', 'description': 'Participants received elagolix 400 mg once a day (QD) for 3 months.'}, {'id': 'OG001', 'title': 'Cohort 4 Elagolix 100 mg BID', 'description': 'Participants received elagolix 100 mg twice a day (BID) for 3 months.'}, {'id': 'OG002', 'title': 'Cohort 4 Placebo', 'description': 'Participants received placebo to elagolix BID for 3 months.'}, {'id': 'OG003', 'title': 'Cohort 1 Elagolix 200 mg BID', 'description': 'Participants received elagolix 200 mg twice a day for 3 months.'}, {'id': 'OG004', 'title': 'Cohort 1 Placebo', 'description': 'Participants received placebo to elagolix twice a day for 3 months.'}, {'id': 'OG005', 'title': 'Cohort 3 Elagolix 200 mg BID + LD E2/NETA', 'description': 'Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months.'}, {'id': 'OG006', 'title': 'Cohort 5 Elagolix 600 mg QD', 'description': 'Participants received elagolix 600 mg once a day for 3 months.'}, {'id': 'OG007', 'title': 'Cohort 2 Elagolix 300 mg BID', 'description': 'Participants received elagolix 300 mg twice a day for 3 months.'}, {'id': 'OG008', 'title': 'Cohort 2 Placebo', 'description': 'Participants received placebo to elagolix BID for 3 months.'}, {'id': 'OG009', 'title': 'Cohort 6 Elagolix 300 mg BID + CEP', 'description': 'Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.50', 'spread': '0.56', 'groupId': 'OG000'}, {'value': '-0.37', 'spread': '0.46', 'groupId': 'OG001'}, {'value': '-0.19', 'spread': '0.33', 'groupId': 'OG002'}, {'value': '-0.52', 'spread': '0.65', 'groupId': 'OG003'}, {'value': '-0.22', 'spread': '0.32', 'groupId': 'OG004'}, {'value': '-0.24', 'spread': '0.47', 'groupId': 'OG005'}, {'value': '-0.44', 'spread': '0.71', 'groupId': 'OG006'}, {'value': '-0.53', 'spread': '0.33', 'groupId': 'OG007'}, {'value': '-0.38', 'spread': '0.77', 'groupId': 'OG008'}, {'value': '-0.25', 'spread': '0.64', 'groupId': 'OG009'}]}]}], 'analyses': [{'pValue': '0.011', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.36', 'ciLowerLimit': '-0.63', 'ciUpperLimit': '-0.08', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.14', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA model with treatment as a factor and baseline as a covariate.'}, {'pValue': '0.030', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.31', 'ciLowerLimit': '-0.59', 'ciUpperLimit': '-0.03', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.14', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA model with treatment as a factor and baseline as a covariate.'}, {'pValue': '0.109', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.26', 'ciLowerLimit': '-0.59', 'ciUpperLimit': '0.06', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.16', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA model with treatment as a factor and baseline as a covariate.'}, {'pValue': '0.002', 'groupIds': ['OG007', 'OG008'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.50', 'ciLowerLimit': '-0.80', 'ciUpperLimit': '-0.19', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.15', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA model with treatment as a factor and baseline as a covariate.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (average bleeding score over the 30 days prior to first dose) and month 3 (average bleeding score over days 61 to 90)', 'description': "Participants recorded the previous days' presence and severity of bleeding every morning in an electronic diary (eDiary) according to the Mansfield-Voda-Jorgenson Menstrual Bleeding Scale:\n\n* 1 (Spotting): A drop or 2 of blood, not even requiring sanitary protection.\n* 2 (Very light): Needing to change the least absorbent tampon or pad 1 to 2 times per day.\n* 3 (Light): Needing to change a low or regular absorbency tampon or pad 2 or 3 times per day.\n* 4 (Moderate): Needing to change a regular absorbency tampon or pad every 3 to 4 hours.\n* 5 (Heavy): Needing to change a high absorbency tampon or pad every 3 to 4 hours.\n* 6 (Very heavy/gushing): Very heavy bleeding, protection hardly works at all; needing to change the highest absorbency tampon or pad every hour or 2.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized (Cohorts 1, 2, and 4) or treated (Cohorts 3, 5, and 6) participants with available bleeding score data at baseline and month 3.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Month 3 in Percentage of Days With Any Uterine Bleeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}, {'value': '32', 'groupId': 'OG005'}, {'value': '26', 'groupId': 'OG006'}, {'value': '27', 'groupId': 'OG007'}, {'value': '15', 'groupId': 'OG008'}, {'value': '25', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 4 Elagolix 400 mg QD', 'description': 'Participants received elagolix 400 mg once a day (QD) for 3 months.'}, {'id': 'OG001', 'title': 'Cohort 4 Elagolix 100 mg BID', 'description': 'Participants received elagolix 100 mg twice a day (BID) for 3 months.'}, {'id': 'OG002', 'title': 'Cohort 4 Placebo', 'description': 'Participants received placebo to elagolix BID for 3 months.'}, {'id': 'OG003', 'title': 'Cohort 1 Elagolix 200 mg BID', 'description': 'Participants received elagolix 200 mg twice a day for 3 months.'}, {'id': 'OG004', 'title': 'Cohort 1 Placebo', 'description': 'Participants received placebo to elagolix twice a day for 3 months.'}, {'id': 'OG005', 'title': 'Cohort 3 Elagolix 200 mg BID + LD E2/NETA', 'description': 'Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months.'}, {'id': 'OG006', 'title': 'Cohort 5 Elagolix 600 mg QD', 'description': 'Participants received elagolix 600 mg once a day for 3 months.'}, {'id': 'OG007', 'title': 'Cohort 2 Elagolix 300 mg BID', 'description': 'Participants received elagolix 300 mg twice a day for 3 months.'}, {'id': 'OG008', 'title': 'Cohort 2 Placebo', 'description': 'Participants received placebo to elagolix BID for 3 months.'}, {'id': 'OG009', 'title': 'Cohort 6 Elagolix 300 mg BID + CEP', 'description': 'Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '-15.22', 'spread': '14.77', 'groupId': 'OG000'}, {'value': '-11.00', 'spread': '15.52', 'groupId': 'OG001'}, {'value': '-5.78', 'spread': '10.58', 'groupId': 'OG002'}, {'value': '-15.82', 'spread': '17.88', 'groupId': 'OG003'}, {'value': '-6.99', 'spread': '12.82', 'groupId': 'OG004'}, {'value': '3.63', 'spread': '24.74', 'groupId': 'OG005'}, {'value': '-15.38', 'spread': '23.21', 'groupId': 'OG006'}, {'value': '-16.91', 'spread': '11.13', 'groupId': 'OG007'}, {'value': '-13.95', 'spread': '23.83', 'groupId': 'OG008'}, {'value': '1.73', 'spread': '26.09', 'groupId': 'OG009'}]}]}], 'analyses': [{'pValue': '0.020', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-10.29', 'ciLowerLimit': '-18.90', 'ciUpperLimit': '-1.67', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.32', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA model with treatment as a factor and baseline as a covariate.'}, {'pValue': '0.087', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.62', 'ciLowerLimit': '-16.36', 'ciUpperLimit': '1.13', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.39', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA model with treatment as a factor and baseline as a covariate.'}, {'pValue': '0.045', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.81', 'ciLowerLimit': '-17.43', 'ciUpperLimit': '-0.19', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.28', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA model with treatment as a factor and baseline as a covariate.'}, {'pValue': '0.002', 'groupIds': ['OG007', 'OG008'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-13.69', 'ciLowerLimit': '-22.06', 'ciUpperLimit': '-5.32', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.14', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA model with treatment as a factor and baseline as a covariate.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (average bleeding score over the 30 days prior to first dose) and month 3 (average bleeding score over days 61 to 90)', 'description': "Participants recorded the previous days' presence and severity of bleeding every morning in an electronic diary (eDiary) according to the Mansfield-Voda-Jorgenson Menstrual Bleeding Scale:\n\n* 1 (Spotting): A drop or 2 of blood, not even requiring sanitary protection.\n* 2 (Very light): Needing to change the least absorbent tampon or pad 1 to 2 times per day.\n* 3 (Light): Needing to change a low or regular absorbency tampon or pad 2 or 3 times per day.\n* 4 (Moderate): Needing to change a regular absorbency tampon or pad every 3 to 4 hours.\n* 5 (Heavy): Needing to change a high absorbency tampon or pad every 3 to 4 hours.\n* 6 (Very heavy/gushing): Very heavy bleeding, protection hardly works at all; needing to change the highest absorbency tampon or pad every hour or 2.\n\nA day with any uterine bleeding is defined as a days with a bleeding score ≥ 1.", 'unitOfMeasure': 'percentage of days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized (Cohorts 1, 2, and 4) or treated (Cohorts 3, 5, and 6) participants with available bleeding score data at baseline and month 3.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Month 3 in Percentage of Days With Moderate to Very Heavy Bleeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}, {'value': '32', 'groupId': 'OG005'}, {'value': '26', 'groupId': 'OG006'}, {'value': '27', 'groupId': 'OG007'}, {'value': '15', 'groupId': 'OG008'}, {'value': '25', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 4 Elagolix 400 mg QD', 'description': 'Participants received elagolix 400 mg once a day (QD) for 3 months.'}, {'id': 'OG001', 'title': 'Cohort 4 Elagolix 100 mg BID', 'description': 'Participants received elagolix 100 mg twice a day (BID) for 3 months.'}, {'id': 'OG002', 'title': 'Cohort 4 Placebo', 'description': 'Participants received placebo to elagolix BID for 3 months.'}, {'id': 'OG003', 'title': 'Cohort 1 Elagolix 200 mg BID', 'description': 'Participants received elagolix 200 mg twice a day for 3 months.'}, {'id': 'OG004', 'title': 'Cohort 1 Placebo', 'description': 'Participants received placebo to elagolix twice a day for 3 months.'}, {'id': 'OG005', 'title': 'Cohort 3 Elagolix 200 mg BID + LD E2/NETA', 'description': 'Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months.'}, {'id': 'OG006', 'title': 'Cohort 5 Elagolix 600 mg QD', 'description': 'Participants received elagolix 600 mg once a day for 3 months.'}, {'id': 'OG007', 'title': 'Cohort 2 Elagolix 300 mg BID', 'description': 'Participants received elagolix 300 mg twice a day for 3 months.'}, {'id': 'OG008', 'title': 'Cohort 2 Placebo', 'description': 'Participants received placebo to elagolix BID for 3 months.'}, {'id': 'OG009', 'title': 'Cohort 6 Elagolix 300 mg BID + CEP', 'description': 'Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.22', 'spread': '9.27', 'groupId': 'OG000'}, {'value': '-5.00', 'spread': '7.87', 'groupId': 'OG001'}, {'value': '-4.00', 'spread': '5.37', 'groupId': 'OG002'}, {'value': '-7.03', 'spread': '10.89', 'groupId': 'OG003'}, {'value': '-3.08', 'spread': '5.88', 'groupId': 'OG004'}, {'value': '-7.92', 'spread': '6.43', 'groupId': 'OG005'}, {'value': '-6.15', 'spread': '8.47', 'groupId': 'OG006'}, {'value': '-8.02', 'spread': '5.41', 'groupId': 'OG007'}, {'value': '-3.31', 'spread': '10.40', 'groupId': 'OG008'}, {'value': '-6.80', 'spread': '10.69', 'groupId': 'OG009'}]}]}], 'analyses': [{'pValue': '0.008', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.51', 'ciLowerLimit': '-9.56', 'ciUpperLimit': '-1.47', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.03', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA model with treatment as a factor and baseline as a covariate.'}, {'pValue': '0.020', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.95', 'ciLowerLimit': '-9.11', 'ciUpperLimit': '-0.80', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.08', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.194', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.63', 'ciLowerLimit': '-9.18', 'ciUpperLimit': '1.91', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.75', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA model with treatment as a factor and baseline as a covariate.'}, {'pValue': '0.001', 'groupIds': ['OG007', 'OG008'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.20', 'ciLowerLimit': '-11.33', 'ciUpperLimit': '-3.07', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.04', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA model with treatment as a factor and baseline as a covariate.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (average bleeding score over the 30 days prior to first dose) and month 3 (average bleeding score over days 61 to 90)', 'description': "Participants recorded the previous days' presence and severity of bleeding every morning in an electronic diary (eDiary) according to the Mansfield-Voda-Jorgenson Menstrual Bleeding Scale:\n\n* 1 (Spotting): A drop or 2 of blood, not even requiring sanitary protection.\n* 2 (Very light): Needing to change the least absorbent tampon or pad 1 to 2 times per day.\n* 3 (Light): Needing to change a low or regular absorbency tampon or pad 2 or 3 times per day.\n* 4 (Moderate): Needing to change a regular absorbency tampon or pad every 3 to 4 hours.\n* 5 (Heavy): Needing to change a high absorbency tampon or pad every 3 to 4 hours.\n* 6 (Very heavy/gushing): Very heavy bleeding, protection hardly works at all; needing to change the highest absorbency tampon or pad every hour or 2.\n\nA day with moderate to very heavy bleeding is defined as a days with a bleeding score ≥ 3.", 'unitOfMeasure': 'percentage of days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized (Cohorts 1, 2, and 4) or treated (Cohorts 3, 5, and 6) participants with available bleeding score data at baseline and month 3.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Any Uterine Bleeding or Moderate to Very Heavy Uterine Bleeding at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}, {'value': '32', 'groupId': 'OG005'}, {'value': '26', 'groupId': 'OG006'}, {'value': '27', 'groupId': 'OG007'}, {'value': '15', 'groupId': 'OG008'}, {'value': '26', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 4 Elagolix 400 mg QD', 'description': 'Participants received elagolix 400 mg once a day (QD) for 3 months.'}, {'id': 'OG001', 'title': 'Cohort 4 Elagolix 100 mg BID', 'description': 'Participants received elagolix 100 mg twice a day (BID) for 3 months.'}, {'id': 'OG002', 'title': 'Cohort 4 Placebo', 'description': 'Participants received placebo to elagolix BID for 3 months.'}, {'id': 'OG003', 'title': 'Cohort 1 Elagolix 200 mg BID', 'description': 'Participants received elagolix 200 mg twice a day for 3 months.'}, {'id': 'OG004', 'title': 'Cohort 1 Placebo', 'description': 'Participants received placebo to elagolix twice a day for 3 months.'}, {'id': 'OG005', 'title': 'Cohort 3 Elagolix 200 mg BID + LD E2/NETA', 'description': 'Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months.'}, {'id': 'OG006', 'title': 'Cohort 5 Elagolix 600 mg QD', 'description': 'Participants received elagolix 600 mg once a day for 3 months.'}, {'id': 'OG007', 'title': 'Cohort 2 Elagolix 300 mg BID', 'description': 'Participants received elagolix 300 mg twice a day for 3 months.'}, {'id': 'OG008', 'title': 'Cohort 2 Placebo', 'description': 'Participants received placebo to elagolix BID for 3 months.'}, {'id': 'OG009', 'title': 'Cohort 6 Elagolix 300 mg BID + CEP', 'description': 'Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months.'}], 'classes': [{'title': 'Any bleeding', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}, {'value': '94', 'groupId': 'OG004'}, {'value': '78', 'groupId': 'OG005'}, {'value': '27', 'groupId': 'OG006'}, {'value': '26', 'groupId': 'OG007'}, {'value': '80', 'groupId': 'OG008'}, {'value': '69', 'groupId': 'OG009'}]}]}, {'title': 'Moderate to Very Heavy Bleeding', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '82', 'groupId': 'OG004'}, {'value': '31', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}, {'value': '73', 'groupId': 'OG008'}, {'value': '35', 'groupId': 'OG009'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 3 (average bleeding score over days 61 to 90)', 'description': "Participants recorded the previous days' presence and severity of bleeding every morning in an eDiary according to the Mansfield-Voda-Jorgenson Menstrual Bleeding Scale:\n\n* 1 (Spotting): A drop or 2 of blood, not even requiring sanitary protection.\n* 2 (Very light): Needing to change the least absorbent tampon or pad 1 to 2 times per day.\n* 3 (Light): Needing to change a low or regular absorbency tampon or pad 2 or 3 times per day.\n* 4 (Moderate): Needing to change a regular absorbency tampon or pad every 3 to 4 hours.\n* 5 (Heavy): Needing to change a high absorbency tampon or pad every 3 to 4 hours.\n* 6 (Very heavy/gushing): Very heavy bleeding, protection hardly works at all; needing to change the highest absorbency tampon or pad every hour or 2.\n\nAny bleeding is defined as a score ≥ 1 and moderate to very heavy bleeding is defined as a score ≥ 3.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized (Cohorts 1, 2, and 4) or treated (Cohorts 3, 5, and 6) participants with available bleeding score data at month 3.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Suppression of Bleeding (Spotting Allowed) or Amenorrhea During the Last 56 Days of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}, {'value': '32', 'groupId': 'OG005'}, {'value': '26', 'groupId': 'OG006'}, {'value': '29', 'groupId': 'OG007'}, {'value': '16', 'groupId': 'OG008'}, {'value': '26', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 4 Elagolix 400 mg QD', 'description': 'Participants received elagolix 400 mg once a day (QD) for 3 months.'}, {'id': 'OG001', 'title': 'Cohort 4 Elagolix 100 mg BID', 'description': 'Participants received elagolix 100 mg twice a day (BID) for 3 months.'}, {'id': 'OG002', 'title': 'Cohort 4 Placebo', 'description': 'Participants received placebo to elagolix BID for 3 months.'}, {'id': 'OG003', 'title': 'Cohort 1 Elagolix 200 mg BID', 'description': 'Participants received elagolix 200 mg twice a day for 3 months.'}, {'id': 'OG004', 'title': 'Cohort 1 Placebo', 'description': 'Participants received placebo to elagolix twice a day for 3 months.'}, {'id': 'OG005', 'title': 'Cohort 3 Elagolix 200 mg BID + LD E2/NETA', 'description': 'Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months.'}, {'id': 'OG006', 'title': 'Cohort 5 Elagolix 600 mg QD', 'description': 'Participants received elagolix 600 mg once a day for 3 months.'}, {'id': 'OG007', 'title': 'Cohort 2 Elagolix 300 mg BID', 'description': 'Participants received elagolix 300 mg twice a day for 3 months.'}, {'id': 'OG008', 'title': 'Cohort 2 Placebo', 'description': 'Participants received placebo to elagolix BID for 3 months.'}, {'id': 'OG009', 'title': 'Cohort 6 Elagolix 300 mg BID + CEP', 'description': 'Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months.'}], 'classes': [{'title': 'Suppression of bleeding', 'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '66', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '31', 'groupId': 'OG005'}, {'value': '77', 'groupId': 'OG006'}, {'value': '79', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '32', 'groupId': 'OG009'}]}]}, {'title': 'Amenorrhea', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '19', 'groupId': 'OG005'}, {'value': '73', 'groupId': 'OG006'}, {'value': '66', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '19', 'groupId': 'OG009'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'The last 56 days of treatment (approximately days 33 to 90)', 'description': 'Suppression of bleeding is defined as no record of bleeding (spotting allowed) in the e-diary and no record of bleeding Indicated in the alkaline hematin data during the last 56 days of treatment.\n\nAmenorrhea is defined as no record of bleeding or spotting indicated in the e-diary and no record of bleeding or spotting Indicated in the alkaline hematin data during the last 56 days of treatment.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized (Cohorts 1, 2, and 4) or treated (Cohorts 3, 5, and 6) participants including participants with less than 56 days of treatment who bled but excluded those who did not bleed.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Month 3 in Uterine Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '22', 'groupId': 'OG005'}, {'value': '20', 'groupId': 'OG006'}, {'value': '20', 'groupId': 'OG007'}, {'value': '12', 'groupId': 'OG008'}, {'value': '11', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 4 Elagolix 400 mg QD', 'description': 'Participants received elagolix 400 mg once a day (QD) for 3 months.'}, {'id': 'OG001', 'title': 'Cohort 4 Elagolix 100 mg BID', 'description': 'Participants received elagolix 100 mg twice a day (BID) for 3 months.'}, {'id': 'OG002', 'title': 'Cohort 4 Placebo', 'description': 'Participants received placebo to elagolix BID for 3 months.'}, {'id': 'OG003', 'title': 'Cohort 1 Elagolix 200 mg BID', 'description': 'Participants received elagolix 200 mg twice a day for 3 months.'}, {'id': 'OG004', 'title': 'Cohort 1 Placebo', 'description': 'Participants received placebo to elagolix twice a day for 3 months.'}, {'id': 'OG005', 'title': 'Cohort 3 Elagolix 200 mg BID + LD E2/NETA', 'description': 'Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months.'}, {'id': 'OG006', 'title': 'Cohort 5 Elagolix 600 mg QD', 'description': 'Participants received elagolix 600 mg once a day for 3 months.'}, {'id': 'OG007', 'title': 'Cohort 2 Elagolix 300 mg BID', 'description': 'Participants received elagolix 300 mg twice a day for 3 months.'}, {'id': 'OG008', 'title': 'Cohort 2 Placebo', 'description': 'Participants received placebo to elagolix BID for 3 months.'}, {'id': 'OG009', 'title': 'Cohort 6 Elagolix 300 mg BID + CEP', 'description': 'Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '-21.01', 'spread': '26.79', 'groupId': 'OG000'}, {'value': '-21.37', 'spread': '24.84', 'groupId': 'OG001'}, {'value': '18.72', 'spread': '15.59', 'groupId': 'OG002'}, {'value': '-21.68', 'spread': '29.80', 'groupId': 'OG003'}, {'value': '-8.62', 'spread': '20.58', 'groupId': 'OG004'}, {'value': '-17.43', 'spread': '19.51', 'groupId': 'OG005'}, {'value': '-27.99', 'spread': '23.34', 'groupId': 'OG006'}, {'value': '-33.25', 'spread': '16.55', 'groupId': 'OG007'}, {'value': '-1.92', 'spread': '17.52', 'groupId': 'OG008'}, {'value': '-10.06', 'spread': '30.93', 'groupId': 'OG009'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'One-way Kruskal-Wallis test with treatment as a factor.'}, {'pValue': '< 0.001', 'groupIds': ['OG001', 'OG002'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'One-way Kruskal-Wallis test with treatment as a factor.'}, {'pValue': '0.052', 'groupIds': ['OG003', 'OG004'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'One-way Kruskal-Wallis test with treatment as a factor.'}, {'pValue': '< 0.001', 'groupIds': ['OG007', 'OG008'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'One-way Kruskal-Wallis test with treatment as a factor.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and month 3', 'description': 'Uterine volume was determined using transabdominal ultrasound. The images were analyzed by a central imaging center.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized (Cohorts 1, 2, and 4) or treated (Cohorts 3, 5, and 6) participants with available uterine volume data at baseline and month 3.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With ≥ 25% Reduction in Uterine Volume at Month 3 / Final Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}, {'value': '33', 'groupId': 'OG005'}, {'value': '27', 'groupId': 'OG006'}, {'value': '29', 'groupId': 'OG007'}, {'value': '15', 'groupId': 'OG008'}, {'value': '24', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 4 Elagolix 400 mg QD', 'description': 'Participants received elagolix 400 mg once a day (QD) for 3 months.'}, {'id': 'OG001', 'title': 'Cohort 4 Elagolix 100 mg BID', 'description': 'Participants received elagolix 100 mg twice a day (BID) for 3 months.'}, {'id': 'OG002', 'title': 'Cohort 4 Placebo', 'description': 'Participants received placebo to elagolix BID for 3 months.'}, {'id': 'OG003', 'title': 'Cohort 1 Elagolix 200 mg BID', 'description': 'Participants received elagolix 200 mg twice a day for 3 months.'}, {'id': 'OG004', 'title': 'Cohort 1 Placebo', 'description': 'Participants received placebo to elagolix twice a day for 3 months.'}, {'id': 'OG005', 'title': 'Cohort 3 Elagolix 200 mg BID + LD E2/NETA', 'description': 'Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months.'}, {'id': 'OG006', 'title': 'Cohort 5 Elagolix 600 mg QD', 'description': 'Participants received elagolix 600 mg once a day for 3 months.'}, {'id': 'OG007', 'title': 'Cohort 2 Elagolix 300 mg BID', 'description': 'Participants received elagolix 300 mg twice a day for 3 months.'}, {'id': 'OG008', 'title': 'Cohort 2 Placebo', 'description': 'Participants received placebo to elagolix BID for 3 months.'}, {'id': 'OG009', 'title': 'Cohort 6 Elagolix 300 mg BID + CEP', 'description': 'Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '42', 'groupId': 'OG005'}, {'value': '56', 'groupId': 'OG006'}, {'value': '69', 'groupId': 'OG007'}, {'value': '7', 'groupId': 'OG008'}, {'value': '25', 'groupId': 'OG009'}]}]}], 'analyses': [{'pValue': '0.003', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.016', 'groupIds': ['OG001', 'OG002'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.012', 'groupIds': ['OG003', 'OG004'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.001', 'groupIds': ['OG007', 'OG008'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and month 3 or the final visit during the treatment period for participants who prematurely discontinued.', 'description': 'Uterine volume was determined using transabdominal ultrasound. The images were analyzed by a central imaging center.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized (Cohorts 1, 2, and 4) or treated (Cohorts 3, 5, and 6) participants with available uterine volume data at baseline and month 3.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Month 3 in Volume of the Largest Fibroid', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '22', 'groupId': 'OG005'}, {'value': '18', 'groupId': 'OG006'}, {'value': '20', 'groupId': 'OG007'}, {'value': '12', 'groupId': 'OG008'}, {'value': '10', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 4 Elagolix 400 mg QD', 'description': 'Participants received elagolix 400 mg once a day (QD) for 3 months.'}, {'id': 'OG001', 'title': 'Cohort 4 Elagolix 100 mg BID', 'description': 'Participants received elagolix 100 mg twice a day (BID) for 3 months.'}, {'id': 'OG002', 'title': 'Cohort 4 Placebo', 'description': 'Participants received placebo to elagolix BID for 3 months.'}, {'id': 'OG003', 'title': 'Cohort 1 Elagolix 200 mg BID', 'description': 'Participants received elagolix 200 mg twice a day for 3 months.'}, {'id': 'OG004', 'title': 'Cohort 1 Placebo', 'description': 'Participants received placebo to elagolix twice a day for 3 months.'}, {'id': 'OG005', 'title': 'Cohort 3 Elagolix 200 mg BID + LD E2/NETA', 'description': 'Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months.'}, {'id': 'OG006', 'title': 'Cohort 5 Elagolix 600 mg QD', 'description': 'Participants received elagolix 600 mg once a day for 3 months.'}, {'id': 'OG007', 'title': 'Cohort 2 Elagolix 300 mg BID', 'description': 'Participants received elagolix 300 mg twice a day for 3 months.'}, {'id': 'OG008', 'title': 'Cohort 2 Placebo', 'description': 'Participants received placebo to elagolix BID for 3 months.'}, {'id': 'OG009', 'title': 'Cohort 6 Elagolix 300 mg BID + CEP', 'description': 'Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.23', 'spread': '187.83', 'groupId': 'OG000'}, {'value': '-22.19', 'spread': '51.14', 'groupId': 'OG001'}, {'value': '-7.26', 'spread': '36.35', 'groupId': 'OG002'}, {'value': '-38.52', 'spread': '41.72', 'groupId': 'OG003'}, {'value': '-2.05', 'spread': '71.83', 'groupId': 'OG004'}, {'value': '-25.77', 'spread': '46.64', 'groupId': 'OG005'}, {'value': '-16.60', 'spread': '39.61', 'groupId': 'OG006'}, {'value': '-35.79', 'spread': '24.49', 'groupId': 'OG007'}, {'value': '6.70', 'spread': '45.42', 'groupId': 'OG008'}, {'value': '-4.94', 'spread': '100.68', 'groupId': 'OG009'}]}]}], 'analyses': [{'pValue': '0.161', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'One-way Kruskal-Wallis test with treatment as a factor'}, {'pValue': '0.173', 'groupIds': ['OG001', 'OG002'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'One-way Kruskal-Wallis test with treatment as a factor.'}, {'pValue': '0.072', 'groupIds': ['OG003', 'OG004'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'One-way Kruskal-Wallis test with treatment as a factor.'}, {'pValue': '0.003', 'groupIds': ['OG007', 'OG008'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'One-way Kruskal-Wallis test with treatment as a factor.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and month 3', 'description': 'The volume of the largest fibroid was determined using transabdominal ultrasound. The images were analyzed by a central imaging center.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized (Cohorts 1, 2, and 4) or treated (Cohorts 3, 5, and 6) participants with available fibroid volume data at baseline and month 3.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With ≥ 25% Reduction in Volume of Largest Fibroid at Month 3 / Final Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}, {'value': '33', 'groupId': 'OG005'}, {'value': '25', 'groupId': 'OG006'}, {'value': '29', 'groupId': 'OG007'}, {'value': '15', 'groupId': 'OG008'}, {'value': '21', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 4 Elagolix 400 mg QD', 'description': 'Participants received elagolix 400 mg once a day (QD) for 3 months.'}, {'id': 'OG001', 'title': 'Cohort 4 Elagolix 100 mg BID', 'description': 'Participants received elagolix 100 mg twice a day (BID) for 3 months.'}, {'id': 'OG002', 'title': 'Cohort 4 Placebo', 'description': 'Participants received placebo to elagolix BID for 3 months.'}, {'id': 'OG003', 'title': 'Cohort 1 Elagolix 200 mg BID', 'description': 'Participants received elagolix 200 mg twice a day for 3 months.'}, {'id': 'OG004', 'title': 'Cohort 1 Placebo', 'description': 'Participants received placebo to elagolix twice a day for 3 months.'}, {'id': 'OG005', 'title': 'Cohort 3 Elagolix 200 mg BID + LD E2/NETA', 'description': 'Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months.'}, {'id': 'OG006', 'title': 'Cohort 5 Elagolix 600 mg QD', 'description': 'Participants received elagolix 600 mg once a day for 3 months.'}, {'id': 'OG007', 'title': 'Cohort 2 Elagolix 300 mg BID', 'description': 'Participants received elagolix 300 mg twice a day for 3 months.'}, {'id': 'OG008', 'title': 'Cohort 2 Placebo', 'description': 'Participants received placebo to elagolix BID for 3 months.'}, {'id': 'OG009', 'title': 'Cohort 6 Elagolix 300 mg BID + CEP', 'description': 'Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '68', 'groupId': 'OG003'}, {'value': '35', 'groupId': 'OG004'}, {'value': '58', 'groupId': 'OG005'}, {'value': '60', 'groupId': 'OG006'}, {'value': '55', 'groupId': 'OG007'}, {'value': '27', 'groupId': 'OG008'}, {'value': '48', 'groupId': 'OG009'}]}]}], 'analyses': [{'pValue': '0.203', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.342', 'groupIds': ['OG001', 'OG002'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.038', 'groupIds': ['OG003', 'OG004'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.111', 'groupIds': ['OG007', 'OG008'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and month 3 or the final visit during the treatment period for participants who prematurely discontinued.', 'description': 'The volume of the largest fibroid was determined using transabdominal ultrasound. The images were analyzed by a central imaging center.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized (Cohorts 1, 2, and 4) or treated (Cohorts 3, 5, and 6) participants with available uterine volume data at baseline and month 3.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Month 3 in the Uterine Fibroid Symptom Quality of Life Questionnaire (UFS-QoL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '22', 'groupId': 'OG005'}, {'value': '20', 'groupId': 'OG006'}, {'value': '25', 'groupId': 'OG007'}, {'value': '13', 'groupId': 'OG008'}, {'value': '14', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 4 Elagolix 400 mg QD', 'description': 'Participants received elagolix 400 mg once a day (QD) for 3 months.'}, {'id': 'OG001', 'title': 'Cohort 4 Elagolix 100 mg BID', 'description': 'Participants received elagolix 100 mg twice a day (BID) for 3 months.'}, {'id': 'OG002', 'title': 'Cohort 4 Placebo', 'description': 'Participants received placebo to elagolix BID for 3 months.'}, {'id': 'OG003', 'title': 'Cohort 1 Elagolix 200 mg BID', 'description': 'Participants received elagolix 200 mg twice a day for 3 months.'}, {'id': 'OG004', 'title': 'Cohort 1 Placebo', 'description': 'Participants received placebo to elagolix twice a day for 3 months.'}, {'id': 'OG005', 'title': 'Cohort 3 Elagolix 200 mg BID + LD E2/NETA', 'description': 'Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months.'}, {'id': 'OG006', 'title': 'Cohort 5 Elagolix 600 mg QD', 'description': 'Participants received elagolix 600 mg once a day for 3 months.'}, {'id': 'OG007', 'title': 'Cohort 2 Elagolix 300 mg BID', 'description': 'Participants received elagolix 300 mg twice a day for 3 months.'}, {'id': 'OG008', 'title': 'Cohort 2 Placebo', 'description': 'Participants received placebo to elagolix BID for 3 months.'}, {'id': 'OG009', 'title': 'Cohort 6 Elagolix 300 mg BID + CEP', 'description': 'Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months.'}], 'classes': [{'title': 'Symptom severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '22', 'groupId': 'OG005'}, {'value': '20', 'groupId': 'OG006'}, {'value': '25', 'groupId': 'OG007'}, {'value': '13', 'groupId': 'OG008'}, {'value': '14', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-39.0', 'spread': '24.70', 'groupId': 'OG000'}, {'value': '-33.2', 'spread': '28.17', 'groupId': 'OG001'}, {'value': '-19.6', 'spread': '32.80', 'groupId': 'OG002'}, {'value': '-31.6', 'spread': '28.87', 'groupId': 'OG003'}, {'value': '-21.4', 'spread': '20.63', 'groupId': 'OG004'}, {'value': '-20.3', 'spread': '25.35', 'groupId': 'OG005'}, {'value': '-36.4', 'spread': '24.74', 'groupId': 'OG006'}, {'value': '-44.1', 'spread': '22.12', 'groupId': 'OG007'}, {'value': '-12.0', 'spread': '22.49', 'groupId': 'OG008'}, {'value': '-39.1', 'spread': '24.09', 'groupId': 'OG009'}]}]}, {'title': 'HRQL total', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '22', 'groupId': 'OG005'}, {'value': '20', 'groupId': 'OG006'}, {'value': '25', 'groupId': 'OG007'}, {'value': '13', 'groupId': 'OG008'}, {'value': '14', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '35.3', 'spread': '21.87', 'groupId': 'OG000'}, {'value': '29.1', 'spread': '30.96', 'groupId': 'OG001'}, {'value': '16.3', 'spread': '30.43', 'groupId': 'OG002'}, {'value': '36.0', 'spread': '27.91', 'groupId': 'OG003'}, {'value': '18.3', 'spread': '36.66', 'groupId': 'OG004'}, {'value': '28.6', 'spread': '24.12', 'groupId': 'OG005'}, {'value': '29.9', 'spread': '30.72', 'groupId': 'OG006'}, {'value': '33.5', 'spread': '29.42', 'groupId': 'OG007'}, {'value': '11.0', 'spread': '20.90', 'groupId': 'OG008'}, {'value': '33.1', 'spread': '30.34', 'groupId': 'OG009'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and month 3', 'description': 'The UFS-QoL is a disease-specific, self-administered, validated questionnaire developed to evaluate the symptoms associated with uterine fibroids and their impact on health-related quality of life (HRQL) in women with symptomatic uterine fibroids. The questionnaire consists of 37 questions, divided into 2 parts: 1) an 8-item symptom severity scale and 2) a 29-item HRQL subscale comprising 6 domains (concern, activities, energy/mood, control, self-consiousness, and sexual function), with a 4-week recall. All items are scored on a 5-point scale, ranging from "not at all" to "a very great deal" for symptom severity items and "none of the time" to "all of the time" for the HRQL items. Symptom severity and HRQL subscale scores were summed and transformed into a 0 to 100 point scale to provide a total score for each of the 2 components.\n\nLower symptom severity scores indicate better quality of life and higher total HRQL scores indicate better quality of life.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized (Cohorts 1, 2, and 4) or treated (Cohorts 3, 5, and 6) participants with available UFS-QoL data at baseline and month 3.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Month 3 in the Uterine Fibroids Daily Symptom Scale Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '22', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}, {'value': '20', 'groupId': 'OG007'}, {'value': '9', 'groupId': 'OG008'}, {'value': '11', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 4 Elagolix 400 mg QD', 'description': 'Participants received elagolix 400 mg once a day (QD) for 3 months.'}, {'id': 'OG001', 'title': 'Cohort 4 Elagolix 100 mg BID', 'description': 'Participants received elagolix 100 mg twice a day (BID) for 3 months.'}, {'id': 'OG002', 'title': 'Cohort 4 Placebo', 'description': 'Participants received placebo to elagolix BID for 3 months.'}, {'id': 'OG003', 'title': 'Cohort 1 Elagolix 200 mg BID', 'description': 'Participants received elagolix 200 mg twice a day for 3 months.'}, {'id': 'OG004', 'title': 'Cohort 1 Placebo', 'description': 'Participants received placebo to elagolix twice a day for 3 months.'}, {'id': 'OG005', 'title': 'Cohort 3 Elagolix 200 mg BID + LD E2/NETA', 'description': 'Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months.'}, {'id': 'OG006', 'title': 'Cohort 5 Elagolix 600 mg QD', 'description': 'Participants received elagolix 600 mg once a day for 3 months.'}, {'id': 'OG007', 'title': 'Cohort 2 Elagolix 300 mg BID', 'description': 'Participants received elagolix 300 mg twice a day for 3 months.'}, {'id': 'OG008', 'title': 'Cohort 2 Placebo', 'description': 'Participants received placebo to elagolix BID for 3 months.'}, {'id': 'OG009', 'title': 'Cohort 6 Elagolix 300 mg BID + CEP', 'description': 'Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months.'}], 'classes': [{'title': 'Pelvic pain', 'categories': [{'measurements': [{'value': '-1.0', 'spread': '2.27', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '2.39', 'groupId': 'OG001'}, {'value': '-0.3', 'spread': '1.45', 'groupId': 'OG002'}, {'value': '-0.6', 'spread': '1.75', 'groupId': 'OG003'}, {'value': '-1.4', 'spread': '1.62', 'groupId': 'OG004'}, {'value': '-1.1', 'spread': '1.35', 'groupId': 'OG005'}, {'value': '-0.9', 'spread': '2.15', 'groupId': 'OG006'}, {'value': '-1.0', 'spread': '1.75', 'groupId': 'OG007'}, {'value': '-1.2', 'spread': '1.73', 'groupId': 'OG008'}, {'value': '-2.4', 'spread': '3.00', 'groupId': 'OG009'}]}]}, {'title': 'Fatigue', 'categories': [{'measurements': [{'value': '-0.5', 'spread': '1.26', 'groupId': 'OG000'}, {'value': '-0.0', 'spread': '2.23', 'groupId': 'OG001'}, {'value': '-0.6', 'spread': '1.45', 'groupId': 'OG002'}, {'value': '-0.6', 'spread': '1.29', 'groupId': 'OG003'}, {'value': '-0.5', 'spread': '1.69', 'groupId': 'OG004'}, {'value': '-1.2', 'spread': '1.92', 'groupId': 'OG005'}, {'value': '-1.0', 'spread': '2.57', 'groupId': 'OG006'}, {'value': '-1.5', 'spread': '1.16', 'groupId': 'OG007'}, {'value': '-0.5', 'spread': '2.88', 'groupId': 'OG008'}, {'value': '-2.1', 'spread': '3.11', 'groupId': 'OG009'}]}]}, {'title': 'Menstrual cramping', 'categories': [{'measurements': [{'value': '-1.2', 'spread': '1.31', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '2.51', 'groupId': 'OG001'}, {'value': '-0.5', 'spread': '1.55', 'groupId': 'OG002'}, {'value': '-0.9', 'spread': '1.16', 'groupId': 'OG003'}, {'value': '-1.2', 'spread': '0.80', 'groupId': 'OG004'}, {'value': '-0.9', 'spread': '1.25', 'groupId': 'OG005'}, {'value': '-1.1', 'spread': '1.35', 'groupId': 'OG006'}, {'value': '-1.2', 'spread': '1.09', 'groupId': 'OG007'}, {'value': '-1.0', 'spread': '2.33', 'groupId': 'OG008'}, {'value': '-1.3', 'spread': '2.15', 'groupId': 'OG009'}]}]}, {'title': 'Impact of uterine fibroids', 'categories': [{'measurements': [{'value': '-1.1', 'spread': '1.18', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '1.86', 'groupId': 'OG001'}, {'value': '-0.8', 'spread': '1.40', 'groupId': 'OG002'}, {'value': '-1.0', 'spread': '1.37', 'groupId': 'OG003'}, {'value': '-1.0', 'spread': '1.81', 'groupId': 'OG004'}, {'value': '-0.9', 'spread': '1.62', 'groupId': 'OG005'}, {'value': '-1.7', 'spread': '2.41', 'groupId': 'OG006'}, {'value': '-1.3', 'spread': '1.11', 'groupId': 'OG007'}, {'value': '-1.0', 'spread': '2.18', 'groupId': 'OG008'}, {'value': '-3.1', 'spread': '2.78', 'groupId': 'OG009'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (average score over the 30 days prior to first dose) and month 3 (average score over days 61 to 90)', 'description': "The uterine fibroid daily symptom scale is self-administered questionnaire, with a scale that ranges from 0 to 10 for the symptoms of pelvic pain, fatigue, and cramping and the impact of uterine fibroids on the subject's daily life, with 0 being the absence of the symptom and 10 being the worst severity of the symptoms or completely preventing the subjects from performing daily activities. Participants self-reported values daily in the e-Diary.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized (Cohorts 1, 2, and 4) or treated (Cohorts 3, 5, and 6) participants with available data at baseline and month 3.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Month 3 in the Subject Surgery Intention Questionnaire (SSIQ) Version 2.0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '22', 'groupId': 'OG005'}, {'value': '20', 'groupId': 'OG006'}, {'value': '25', 'groupId': 'OG007'}, {'value': '13', 'groupId': 'OG008'}, {'value': '14', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 4 Elagolix 400 mg QD', 'description': 'Participants received elagolix 400 mg once a day (QD) for 3 months.'}, {'id': 'OG001', 'title': 'Cohort 4 Elagolix 100 mg BID', 'description': 'Participants received elagolix 100 mg twice a day (BID) for 3 months.'}, {'id': 'OG002', 'title': 'Cohort 4 Placebo', 'description': 'Participants received placebo to elagolix BID for 3 months.'}, {'id': 'OG003', 'title': 'Cohort 1 Elagolix 200 mg BID', 'description': 'Participants received elagolix 200 mg twice a day for 3 months.'}, {'id': 'OG004', 'title': 'Cohort 1 Placebo', 'description': 'Participants received placebo to elagolix twice a day for 3 months.'}, {'id': 'OG005', 'title': 'Cohort 3 Elagolix 200 mg BID + LD E2/NETA', 'description': 'Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months.'}, {'id': 'OG006', 'title': 'Cohort 5 Elagolix 600 mg QD', 'description': 'Participants received elagolix 600 mg once a day for 3 months.'}, {'id': 'OG007', 'title': 'Cohort 2 Elagolix 300 mg BID', 'description': 'Participants received elagolix 300 mg twice a day for 3 months.'}, {'id': 'OG008', 'title': 'Cohort 2 Placebo', 'description': 'Participants received placebo to elagolix BID for 3 months.'}, {'id': 'OG009', 'title': 'Cohort 6 Elagolix 300 mg BID + CEP', 'description': 'Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months.'}], 'classes': [{'title': 'Likelihood of having myomectomy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '22', 'groupId': 'OG005'}, {'value': '20', 'groupId': 'OG006'}, {'value': '25', 'groupId': 'OG007'}, {'value': '13', 'groupId': 'OG008'}, {'value': '14', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-1.2', 'spread': '3.68', 'groupId': 'OG000'}, {'value': '-3.1', 'spread': '4.52', 'groupId': 'OG001'}, {'value': '1.0', 'spread': '2.12', 'groupId': 'OG002'}, {'value': '-1.8', 'spread': '4.70', 'groupId': 'OG003'}, {'value': '2.3', 'spread': '5.35', 'groupId': 'OG004'}, {'value': '-1.4', 'spread': '4.34', 'groupId': 'OG005'}, {'value': '-1.7', 'spread': '4.18', 'groupId': 'OG006'}, {'value': '-0.6', 'spread': '5.10', 'groupId': 'OG007'}, {'value': '0.4', 'spread': '4.16', 'groupId': 'OG008'}, {'value': '0.1', 'spread': '2.63', 'groupId': 'OG009'}]}]}, {'title': 'Likelihood of having hysterectomy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '22', 'groupId': 'OG005'}, {'value': '20', 'groupId': 'OG006'}, {'value': '25', 'groupId': 'OG007'}, {'value': '13', 'groupId': 'OG008'}, {'value': '14', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '4.04', 'groupId': 'OG000'}, {'value': '-1.9', 'spread': '4.19', 'groupId': 'OG001'}, {'value': '2.0', 'spread': '3.64', 'groupId': 'OG002'}, {'value': '-0.8', 'spread': '4.91', 'groupId': 'OG003'}, {'value': '-0.3', 'spread': '0.52', 'groupId': 'OG004'}, {'value': '-0.7', 'spread': '3.10', 'groupId': 'OG005'}, {'value': '-0.8', 'spread': '4.42', 'groupId': 'OG006'}, {'value': '0.2', 'spread': '3.65', 'groupId': 'OG007'}, {'value': '0.0', 'spread': '1.96', 'groupId': 'OG008'}, {'value': '-1.5', 'spread': '3.92', 'groupId': 'OG009'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and month 3', 'description': "The Subject Intention Questionnaire (SSIQ) is a non-validated, exploratory questionnaires intended to evaluate the subject's intent to undergo surgical procedures if current endometriosis-associated symptoms continued. The scoring scale ranged from 0 (not at all likely to consider surgery) to 10 (very likely to consider surgery).\n\nSSIQ included the 2 following questions:\n\n1. How likely are you to consider having myomectomy surgery to treat your uterine fibroid if your symptoms continue as they are now?\n2. How likely are you to consider hysterectomy surgery if your uterine fibroid symptoms continue as they are now?", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized (Cohorts 1, 2, and 4) or treated (Cohorts 3, 5, and 6) participants with available data at baseline and month 3.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Month 3 in the Physician Surgery Intention Questionnaire (PSIQ) Version 2.0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '22', 'groupId': 'OG005'}, {'value': '20', 'groupId': 'OG006'}, {'value': '24', 'groupId': 'OG007'}, {'value': '13', 'groupId': 'OG008'}, {'value': '14', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 4 Elagolix 400 mg QD', 'description': 'Participants received elagolix 400 mg once a day (QD) for 3 months.'}, {'id': 'OG001', 'title': 'Cohort 4 Elagolix 100 mg BID', 'description': 'Participants received elagolix 100 mg twice a day (BID) for 3 months.'}, {'id': 'OG002', 'title': 'Cohort 4 Placebo', 'description': 'Participants received placebo to elagolix BID for 3 months.'}, {'id': 'OG003', 'title': 'Cohort 1 Elagolix 200 mg BID', 'description': 'Participants received elagolix 200 mg twice a day for 3 months.'}, {'id': 'OG004', 'title': 'Cohort 1 Placebo', 'description': 'Participants received placebo to elagolix twice a day for 3 months.'}, {'id': 'OG005', 'title': 'Cohort 3 Elagolix 200 mg BID + LD E2/NETA', 'description': 'Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months.'}, {'id': 'OG006', 'title': 'Cohort 5 Elagolix 600 mg QD', 'description': 'Participants received elagolix 600 mg once a day for 3 months.'}, {'id': 'OG007', 'title': 'Cohort 2 Elagolix 300 mg BID', 'description': 'Participants received elagolix 300 mg twice a day for 3 months.'}, {'id': 'OG008', 'title': 'Cohort 2 Placebo', 'description': 'Participants received placebo to elagolix BID for 3 months.'}, {'id': 'OG009', 'title': 'Cohort 6 Elagolix 300 mg BID + CEP', 'description': 'Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months.'}], 'classes': [{'title': 'Likelihood to recommend myomectomy', 'categories': [{'measurements': [{'value': '-0.9', 'spread': '2.86', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '3.31', 'groupId': 'OG001'}, {'value': '-2.7', 'spread': '3.53', 'groupId': 'OG002'}, {'value': '-0.8', 'spread': '1.76', 'groupId': 'OG003'}, {'value': '0.7', 'spread': '1.11', 'groupId': 'OG004'}, {'value': '-0.6', 'spread': '2.97', 'groupId': 'OG005'}, {'value': '-1.3', 'spread': '3.62', 'groupId': 'OG006'}, {'value': '-1.2', 'spread': '3.59', 'groupId': 'OG007'}, {'value': '0.0', 'spread': '3.25', 'groupId': 'OG008'}, {'value': '0.0', 'spread': '3.94', 'groupId': 'OG009'}]}]}, {'title': 'Likelihood to recommend hysterectomy', 'categories': [{'measurements': [{'value': '-0.8', 'spread': '3.34', 'groupId': 'OG000'}, {'value': '-1.8', 'spread': '4.37', 'groupId': 'OG001'}, {'value': '-0.2', 'spread': '3.15', 'groupId': 'OG002'}, {'value': '-2.2', 'spread': '2.82', 'groupId': 'OG003'}, {'value': '0.4', 'spread': '1.62', 'groupId': 'OG004'}, {'value': '-1.4', 'spread': '3.08', 'groupId': 'OG005'}, {'value': '-2.3', 'spread': '3.99', 'groupId': 'OG006'}, {'value': '-1.5', 'spread': '3.96', 'groupId': 'OG007'}, {'value': '-0.6', 'spread': '2.81', 'groupId': 'OG008'}, {'value': '-2.8', 'spread': '2.98', 'groupId': 'OG009'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and month 3', 'description': "The Physician Intention Questionnaire (PSIQ) is a non-validated, exploratory questionnaire intended to evaluate the investigator's intent to recommend surgical procedures if current endometriosis-associated symptoms continued. The scoring scale ranged from 0 (not at all likely to recommend surgery) to 10 (very likely to recommend surgery).\n\nThe PSIQ included the 2 following questions:\n\n1. How likely are you to recommend myomectomy to treat this patient's uterine fibroid if her symptoms continue as they are now?\n2. How likely are you to recommend definitive surgery hysterectomy for this patient if her uterine fibroid symptoms continue as they are now?", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized (Cohorts 1, 2, and 4) or treated (Cohorts 3, 5, and 6) participants with available data at baseline and month 3.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cohort 4 Elagolix 400 mg QD', 'description': 'Participants received elagolix 400 mg once a day (QD) for 3 months.'}, {'id': 'FG001', 'title': 'Cohort 4 Elagolix 100 mg BID', 'description': 'Participants received elagolix 100 mg twice a day (BID) for 3 months.'}, {'id': 'FG002', 'title': 'Cohort 4 Placebo', 'description': 'Participants received placebo to elagolix BID for 3 months.'}, {'id': 'FG003', 'title': 'Cohort 1 Elagolix 200 mg BID', 'description': 'Participants received elagolix 200 mg twice a day for 3 months.'}, {'id': 'FG004', 'title': 'Cohort 1 Placebo', 'description': 'Participants received placebo to elagolix twice a day for 3 months.'}, {'id': 'FG005', 'title': 'Cohort 3 Elagolix 200 mg BID + LD E2/NETA', 'description': 'Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months.'}, {'id': 'FG006', 'title': 'Cohort 5 Elagolix 600 mg QD', 'description': 'Participants received elagolix 600 mg once a day for 3 months.'}, {'id': 'FG007', 'title': 'Cohort 2 Elagolix 300 mg BID', 'description': 'Participants received elagolix 300 mg twice a day for 3 months.'}, {'id': 'FG008', 'title': 'Cohort 2 Placebo', 'description': 'Participants received placebo to elagolix BID for 3 months.'}, {'id': 'FG009', 'title': 'Cohort 6 Elagolix 300 mg BID + CEP', 'description': 'Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '33'}, {'groupId': 'FG002', 'numSubjects': '16'}, {'groupId': 'FG003', 'numSubjects': '35'}, {'groupId': 'FG004', 'numSubjects': '18'}, {'groupId': 'FG005', 'numSubjects': '34'}, {'groupId': 'FG006', 'numSubjects': '30'}, {'groupId': 'FG007', 'numSubjects': '30'}, {'groupId': 'FG008', 'numSubjects': '16'}, {'groupId': 'FG009', 'numSubjects': '27'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '27'}, {'groupId': 'FG002', 'numSubjects': '13'}, {'groupId': 'FG003', 'numSubjects': '28'}, {'groupId': 'FG004', 'numSubjects': '16'}, {'groupId': 'FG005', 'numSubjects': '29'}, {'groupId': 'FG006', 'numSubjects': '24'}, {'groupId': 'FG007', 'numSubjects': '26'}, {'groupId': 'FG008', 'numSubjects': '14'}, {'groupId': 'FG009', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '5'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '4'}, {'groupId': 'FG008', 'numSubjects': '2'}, {'groupId': 'FG009', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '2'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '1'}]}, {'type': 'Noncompliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'Surgery or Invasive Intervention', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'Received Exclusionary Medication', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Overall, 271 female participants were enrolled into the study across 45 sites in the United States.', 'preAssignmentDetails': 'Six cohorts of participants were enrolled, with 3 double-blind cohorts comparing elagolix with placebo, 2 open-label cohorts assessing add-back therapies, and 1 open-label cohort assessing the elagolix 600 mg QD dosing regimen.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}, {'value': '34', 'groupId': 'BG005'}, {'value': '30', 'groupId': 'BG006'}, {'value': '30', 'groupId': 'BG007'}, {'value': '16', 'groupId': 'BG008'}, {'value': '27', 'groupId': 'BG009'}, {'value': '271', 'groupId': 'BG010'}]}], 'groups': [{'id': 'BG000', 'title': 'Cohort 4 Elagolix 400 mg QD', 'description': 'Participants received elagolix 400 mg once a day (QD) for 3 months.'}, {'id': 'BG001', 'title': 'Cohort 4 Elagolix 100 mg BID', 'description': 'Participants received elagolix 100 mg twice a day (BID) for 3 months.'}, {'id': 'BG002', 'title': 'Cohort 4 Placebo', 'description': 'Participants received placebo to elagolix BID for 3 months.'}, {'id': 'BG003', 'title': 'Cohort 1 Elagolix 200 mg BID', 'description': 'Participants received elagolix 200 mg twice a day for 3 months.'}, {'id': 'BG004', 'title': 'Cohort 1 Placebo', 'description': 'Participants received placebo to elagolix twice a day for 3 months.'}, {'id': 'BG005', 'title': 'Cohort 3 Elagolix 200 mg BID + LD E2/NETA', 'description': 'Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months.'}, {'id': 'BG006', 'title': 'Cohort 5 Elagolix 600 mg QD', 'description': 'Participants received elagolix 600 mg once a day for 3 months.'}, {'id': 'BG007', 'title': 'Cohort 2 Elagolix 300 mg BID', 'description': 'Participants received elagolix 300 mg twice a day for 3 months.'}, {'id': 'BG008', 'title': 'Cohort 2 Placebo', 'description': 'Participants received placebo to elagolix BID for 3 months.'}, {'id': 'BG009', 'title': 'Cohort 6 Elagolix 300 mg BID + CEP', 'description': 'Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months.'}, {'id': 'BG010', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '40.8', 'spread': '5.50', 'groupId': 'BG000'}, {'value': '42.1', 'spread': '5.09', 'groupId': 'BG001'}, {'value': '41.1', 'spread': '5.88', 'groupId': 'BG002'}, {'value': '43.1', 'spread': '4.29', 'groupId': 'BG003'}, {'value': '44.0', 'spread': '4.24', 'groupId': 'BG004'}, {'value': '40.9', 'spread': '6.02', 'groupId': 'BG005'}, {'value': '40.8', 'spread': '5.78', 'groupId': 'BG006'}, {'value': '42.6', 'spread': '5.55', 'groupId': 'BG007'}, {'value': '41.6', 'spread': '7.10', 'groupId': 'BG008'}, {'value': '41.6', 'spread': '5.26', 'groupId': 'BG009'}, {'value': '41.8', 'spread': '5.4', 'groupId': 'BG010'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'categories': [{'title': '< 35 years', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '3', 'groupId': 'BG008'}, {'value': '3', 'groupId': 'BG009'}, {'value': '32', 'groupId': 'BG010'}]}, {'title': '35 to < 40 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '5', 'groupId': 'BG007'}, {'value': '3', 'groupId': 'BG008'}, {'value': '6', 'groupId': 'BG009'}, {'value': '51', 'groupId': 'BG010'}]}, {'title': '40 to < 45 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '11', 'groupId': 'BG006'}, {'value': '9', 'groupId': 'BG007'}, {'value': '3', 'groupId': 'BG008'}, {'value': '10', 'groupId': 'BG009'}, {'value': '86', 'groupId': 'BG010'}]}, {'title': '≥ 45 years', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '11', 'groupId': 'BG005'}, {'value': '9', 'groupId': 'BG006'}, {'value': '13', 'groupId': 'BG007'}, {'value': '7', 'groupId': 'BG008'}, {'value': '8', 'groupId': 'BG009'}, {'value': '102', 'groupId': 'BG010'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}, {'value': '34', 'groupId': 'BG005'}, {'value': '30', 'groupId': 'BG006'}, {'value': '30', 'groupId': 'BG007'}, {'value': '16', 'groupId': 'BG008'}, {'value': '27', 'groupId': 'BG009'}, {'value': '271', 'groupId': 'BG010'}]}, {'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'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}, {'value': '12', 'groupId': 'BG009'}, {'value': '33', 'groupId': 'BG010'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}, {'value': '33', 'groupId': 'BG005'}, {'value': '24', 'groupId': 'BG006'}, {'value': '30', 'groupId': 'BG007'}, {'value': '14', 'groupId': 'BG008'}, {'value': '15', 'groupId': 'BG009'}, {'value': '238', 'groupId': 'BG010'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'White', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '7', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}, {'value': '6', 'groupId': 'BG007'}, {'value': '6', 'groupId': 'BG008'}, {'value': '11', 'groupId': 'BG009'}, {'value': '63', 'groupId': 'BG010'}]}, {'title': 'Black', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}, {'value': '26', 'groupId': 'BG005'}, {'value': '24', 'groupId': 'BG006'}, {'value': '23', 'groupId': 'BG007'}, {'value': '9', 'groupId': 'BG008'}, {'value': '15', 'groupId': 'BG009'}, {'value': '200', 'groupId': 'BG010'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '4', 'groupId': 'BG010'}]}, {'title': 'Other', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '3', 'groupId': 'BG010'}]}, {'title': 'Multirace', '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'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '1', 'groupId': 'BG010'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 271}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'dispFirstSubmitDate': '2014-11-25', 'completionDateStruct': {'date': '2014-05-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-09', 'studyFirstSubmitDate': '2011-09-06', 'dispFirstSubmitQcDate': '2014-11-25', 'resultsFirstSubmitDate': '2020-06-09', 'studyFirstSubmitQcDate': '2011-09-26', 'dispFirstPostDateStruct': {'date': '2014-12-11', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2021-07-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-07-01', 'studyFirstPostDateStruct': {'date': '2011-09-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-07-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Change From Baseline to the Last 28 Days of Treatment in Menstrual Blood Loss (MBL)', 'timeFrame': 'Baseline (last menstrual cycle during the screening period) and the last 28 days of treatment (approximately days 61 to 90)', 'description': 'The alkaline hematin method was used for the assessment of MBL. Sanitary products were collected at screening and for any spotting or bleeding episodes that occurred during treatment.\n\nParticipants with missing MBL volume for the last treatment period and no bleeding indicated in the electronic daily bleeding diary (eDiary) in the last treatment period, and participants with no post-baseline MBL data were assigned an MBL value of zero.'}], 'secondaryOutcomes': [{'measure': 'Percent Change From Baseline to the Last 28 Days of Treatment in Menstrual Blood Loss (MBL)', 'timeFrame': 'Baseline (last menstrual cycle during the screening period) and the last 28 days of treatment (approximately days 61 to 90)', 'description': 'The alkaline hematin method was used for the assessment of MBL. Sanitary products were collected at screening and for any spotting or bleeding episodes that occurred during treatment.\n\nParticipants with missing MBL volume for the last treatment period and no bleeding indicated in the electronic daily bleeding diary (eDiary) in the last treatment period, and participants with no post-baseline MBL data were assigned an MBL value of zero.'}, {'measure': 'Percentage of Participants With MBL < 80 mL and With a ≥ 50% Reduction From Baseline in MBL During the Last 28 Days of Treatment', 'timeFrame': 'Baseline (last menstrual cycle during the screening period) and the last 28 days of treatment (approximately days 61 to 90)', 'description': 'The alkaline hematin method was used for the assessment of MBL. Sanitary products were collected at screening and for any spotting or bleeding episodes that occurred during treatment.\n\nParticipants with missing MBL volume for the last treatment period and no bleeding indicated in the electronic daily bleeding diary (eDiary) in the last treatment period, and participants with no post-baseline MBL data were assigned an MBL value of zero.'}, {'measure': 'Percentage of Participants With MBL < 80 mL During the Last 28 Days of Treatment', 'timeFrame': 'The last 28 days of treatment (approximately days 61 to 90)', 'description': 'The alkaline hematin method was used for the assessment of MBL. Sanitary products were collected at screening and for any spotting or bleeding episodes that occurred during treatment.\n\nParticipants with missing MBL volume for the last treatment period and no bleeding indicated in the electronic daily bleeding diary (eDiary) in the last treatment period, and participants with no post-baseline MBL data were assigned an MBL value of zero.'}, {'measure': 'Percentage of Participants With a ≥ 50% Reduction From Baseline in MBL During the Last 28 Days of Treatment', 'timeFrame': 'Baseline (last menstrual cycle during the screening period) and the last 28 days of treatment (approximately days 61 to 90)', 'description': 'The alkaline hematin method was used for the assessment of MBL. Sanitary products were collected at screening and for any spotting or bleeding episodes that occurred during treatment.\n\nParticipants with missing MBL volume for the last treatment period and no bleeding indicated in the electronic daily bleeding diary (eDiary) in the last treatment period, and participants with no post-baseline MBL data were assigned an MBL value of zero.'}, {'measure': 'Percentage of Participants With No Change, Decrease From Baseline, or Increase From Baseline in Hemoglobin at Month 3', 'timeFrame': 'Baseline and Month 3', 'description': 'The percentage of subjects with changes in hemoglobin concentration from Baseline to Month 3 in each of the following categories:\n\n* No change from baseline in hemoglobin\n* Decrease from baseline in hemoglobin ≥ -0.5 g/dL\n* Decrease from baseline in hemoglobin ≥ -1.0 g/dL\n* Increase from baseline in hemoglobin ≥ 0.5 g/dL\n* Increase from baseline in hemoglobin ≥ 1.0 g/dL\n\nThe above categories are not all mutually exclusive or exhaustive.'}, {'measure': 'Change in Hemoglobin Concentration From Baseline to Month 3', 'timeFrame': 'Baseline and Month 3'}, {'measure': 'Change From Baseline to Month 3 in Uterine Bleeding Score', 'timeFrame': 'Baseline (average bleeding score over the 30 days prior to first dose) and month 3 (average bleeding score over days 61 to 90)', 'description': "Participants recorded the previous days' presence and severity of bleeding every morning in an electronic diary (eDiary) according to the Mansfield-Voda-Jorgenson Menstrual Bleeding Scale:\n\n* 1 (Spotting): A drop or 2 of blood, not even requiring sanitary protection.\n* 2 (Very light): Needing to change the least absorbent tampon or pad 1 to 2 times per day.\n* 3 (Light): Needing to change a low or regular absorbency tampon or pad 2 or 3 times per day.\n* 4 (Moderate): Needing to change a regular absorbency tampon or pad every 3 to 4 hours.\n* 5 (Heavy): Needing to change a high absorbency tampon or pad every 3 to 4 hours.\n* 6 (Very heavy/gushing): Very heavy bleeding, protection hardly works at all; needing to change the highest absorbency tampon or pad every hour or 2."}, {'measure': 'Change From Baseline to Month 3 in Percentage of Days With Any Uterine Bleeding', 'timeFrame': 'Baseline (average bleeding score over the 30 days prior to first dose) and month 3 (average bleeding score over days 61 to 90)', 'description': "Participants recorded the previous days' presence and severity of bleeding every morning in an electronic diary (eDiary) according to the Mansfield-Voda-Jorgenson Menstrual Bleeding Scale:\n\n* 1 (Spotting): A drop or 2 of blood, not even requiring sanitary protection.\n* 2 (Very light): Needing to change the least absorbent tampon or pad 1 to 2 times per day.\n* 3 (Light): Needing to change a low or regular absorbency tampon or pad 2 or 3 times per day.\n* 4 (Moderate): Needing to change a regular absorbency tampon or pad every 3 to 4 hours.\n* 5 (Heavy): Needing to change a high absorbency tampon or pad every 3 to 4 hours.\n* 6 (Very heavy/gushing): Very heavy bleeding, protection hardly works at all; needing to change the highest absorbency tampon or pad every hour or 2.\n\nA day with any uterine bleeding is defined as a days with a bleeding score ≥ 1."}, {'measure': 'Change From Baseline to Month 3 in Percentage of Days With Moderate to Very Heavy Bleeding', 'timeFrame': 'Baseline (average bleeding score over the 30 days prior to first dose) and month 3 (average bleeding score over days 61 to 90)', 'description': "Participants recorded the previous days' presence and severity of bleeding every morning in an electronic diary (eDiary) according to the Mansfield-Voda-Jorgenson Menstrual Bleeding Scale:\n\n* 1 (Spotting): A drop or 2 of blood, not even requiring sanitary protection.\n* 2 (Very light): Needing to change the least absorbent tampon or pad 1 to 2 times per day.\n* 3 (Light): Needing to change a low or regular absorbency tampon or pad 2 or 3 times per day.\n* 4 (Moderate): Needing to change a regular absorbency tampon or pad every 3 to 4 hours.\n* 5 (Heavy): Needing to change a high absorbency tampon or pad every 3 to 4 hours.\n* 6 (Very heavy/gushing): Very heavy bleeding, protection hardly works at all; needing to change the highest absorbency tampon or pad every hour or 2.\n\nA day with moderate to very heavy bleeding is defined as a days with a bleeding score ≥ 3."}, {'measure': 'Percentage of Participants With Any Uterine Bleeding or Moderate to Very Heavy Uterine Bleeding at Month 3', 'timeFrame': 'Month 3 (average bleeding score over days 61 to 90)', 'description': "Participants recorded the previous days' presence and severity of bleeding every morning in an eDiary according to the Mansfield-Voda-Jorgenson Menstrual Bleeding Scale:\n\n* 1 (Spotting): A drop or 2 of blood, not even requiring sanitary protection.\n* 2 (Very light): Needing to change the least absorbent tampon or pad 1 to 2 times per day.\n* 3 (Light): Needing to change a low or regular absorbency tampon or pad 2 or 3 times per day.\n* 4 (Moderate): Needing to change a regular absorbency tampon or pad every 3 to 4 hours.\n* 5 (Heavy): Needing to change a high absorbency tampon or pad every 3 to 4 hours.\n* 6 (Very heavy/gushing): Very heavy bleeding, protection hardly works at all; needing to change the highest absorbency tampon or pad every hour or 2.\n\nAny bleeding is defined as a score ≥ 1 and moderate to very heavy bleeding is defined as a score ≥ 3."}, {'measure': 'Percentage of Participants With Suppression of Bleeding (Spotting Allowed) or Amenorrhea During the Last 56 Days of Treatment', 'timeFrame': 'The last 56 days of treatment (approximately days 33 to 90)', 'description': 'Suppression of bleeding is defined as no record of bleeding (spotting allowed) in the e-diary and no record of bleeding Indicated in the alkaline hematin data during the last 56 days of treatment.\n\nAmenorrhea is defined as no record of bleeding or spotting indicated in the e-diary and no record of bleeding or spotting Indicated in the alkaline hematin data during the last 56 days of treatment.'}, {'measure': 'Percent Change From Baseline to Month 3 in Uterine Volume', 'timeFrame': 'Baseline and month 3', 'description': 'Uterine volume was determined using transabdominal ultrasound. The images were analyzed by a central imaging center.'}, {'measure': 'Percentage of Participants With ≥ 25% Reduction in Uterine Volume at Month 3 / Final Visit', 'timeFrame': 'Baseline and month 3 or the final visit during the treatment period for participants who prematurely discontinued.', 'description': 'Uterine volume was determined using transabdominal ultrasound. The images were analyzed by a central imaging center.'}, {'measure': 'Percent Change From Baseline to Month 3 in Volume of the Largest Fibroid', 'timeFrame': 'Baseline and month 3', 'description': 'The volume of the largest fibroid was determined using transabdominal ultrasound. The images were analyzed by a central imaging center.'}, {'measure': 'Percentage of Participants With ≥ 25% Reduction in Volume of Largest Fibroid at Month 3 / Final Visit', 'timeFrame': 'Baseline and month 3 or the final visit during the treatment period for participants who prematurely discontinued.', 'description': 'The volume of the largest fibroid was determined using transabdominal ultrasound. The images were analyzed by a central imaging center.'}, {'measure': 'Change From Baseline to Month 3 in the Uterine Fibroid Symptom Quality of Life Questionnaire (UFS-QoL)', 'timeFrame': 'Baseline and month 3', 'description': 'The UFS-QoL is a disease-specific, self-administered, validated questionnaire developed to evaluate the symptoms associated with uterine fibroids and their impact on health-related quality of life (HRQL) in women with symptomatic uterine fibroids. The questionnaire consists of 37 questions, divided into 2 parts: 1) an 8-item symptom severity scale and 2) a 29-item HRQL subscale comprising 6 domains (concern, activities, energy/mood, control, self-consiousness, and sexual function), with a 4-week recall. All items are scored on a 5-point scale, ranging from "not at all" to "a very great deal" for symptom severity items and "none of the time" to "all of the time" for the HRQL items. Symptom severity and HRQL subscale scores were summed and transformed into a 0 to 100 point scale to provide a total score for each of the 2 components.\n\nLower symptom severity scores indicate better quality of life and higher total HRQL scores indicate better quality of life.'}, {'measure': 'Change From Baseline to Month 3 in the Uterine Fibroids Daily Symptom Scale Scores', 'timeFrame': 'Baseline (average score over the 30 days prior to first dose) and month 3 (average score over days 61 to 90)', 'description': "The uterine fibroid daily symptom scale is self-administered questionnaire, with a scale that ranges from 0 to 10 for the symptoms of pelvic pain, fatigue, and cramping and the impact of uterine fibroids on the subject's daily life, with 0 being the absence of the symptom and 10 being the worst severity of the symptoms or completely preventing the subjects from performing daily activities. Participants self-reported values daily in the e-Diary."}, {'measure': 'Change From Baseline to Month 3 in the Subject Surgery Intention Questionnaire (SSIQ) Version 2.0', 'timeFrame': 'Baseline and month 3', 'description': "The Subject Intention Questionnaire (SSIQ) is a non-validated, exploratory questionnaires intended to evaluate the subject's intent to undergo surgical procedures if current endometriosis-associated symptoms continued. The scoring scale ranged from 0 (not at all likely to consider surgery) to 10 (very likely to consider surgery).\n\nSSIQ included the 2 following questions:\n\n1. How likely are you to consider having myomectomy surgery to treat your uterine fibroid if your symptoms continue as they are now?\n2. How likely are you to consider hysterectomy surgery if your uterine fibroid symptoms continue as they are now?"}, {'measure': 'Change From Baseline to Month 3 in the Physician Surgery Intention Questionnaire (PSIQ) Version 2.0', 'timeFrame': 'Baseline and month 3', 'description': "The Physician Intention Questionnaire (PSIQ) is a non-validated, exploratory questionnaire intended to evaluate the investigator's intent to recommend surgical procedures if current endometriosis-associated symptoms continued. The scoring scale ranged from 0 (not at all likely to recommend surgery) to 10 (very likely to recommend surgery).\n\nThe PSIQ included the 2 following questions:\n\n1. How likely are you to recommend myomectomy to treat this patient's uterine fibroid if her symptoms continue as they are now?\n2. How likely are you to recommend definitive surgery hysterectomy for this patient if her uterine fibroid symptoms continue as they are now?"}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Uterine Fibroids', 'Heavy Uterine Bleeding', 'Elagolix', 'Menorrhagia', 'ABT-620', 'Leiomyomata', 'Elagolix sodium'], 'conditions': ['Heavy Uterine Bleeding', 'Uterine Fibroids']}, 'referencesModule': {'references': [{'pmid': '28579415', 'type': 'BACKGROUND', 'citation': 'Archer DF, Stewart EA, Jain RI, Feldman RA, Lukes AS, North JD, Soliman AM, Gao J, Ng JW, Chwalisz K. Elagolix for the management of heavy menstrual bleeding associated with uterine fibroids: results from a phase 2a proof-of-concept study. Fertil Steril. 2017 Jul;108(1):152-160.e4. doi: 10.1016/j.fertnstert.2017.05.006. Epub 2017 Jun 1.'}, {'pmid': '27733082', 'type': 'DERIVED', 'citation': 'Coyne KS, Soliman AM, Margolis MK, Thompson CL, Chwalisz K. Validation of the 4 week recall version of the Uterine Fibroid Symptom and Health-related Quality of Life (UFS-QOL) Questionnaire. Curr Med Res Opin. 2017 Feb;33(2):193-200. doi: 10.1080/03007995.2016.1248382. Epub 2016 Nov 18.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this proof-of-concept study is to assess the safety and effectiveness of elagolix versus placebo to reduce uterine bleeding associated with uterine fibroids, and to reduce fibroid volume and uterine volume in premenopausal women 20 to 49 years of age with heavy uterine bleeding.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject is a pre-menopausal female 20 to 49 years of age.\n* Subject has a diagnosis of uterine fibroids documented by a pelvic ultrasound assessed by a central reader and verification that a fibroid present met the following criteria:\n\n * At least 1 fibroid with diameter ≥ 2 cm (longest diameter), or multiple small fibroids with a total uterine volume of ≥ 200 cm³ to ≤ 2,500 cm³ (approximately 22 weeks' gestation) as documented by a centrally read ultrasound.\n * Only intramural, submucosal non-pedunculated, and subserosal fibroids qualified subjects for enrollment (intracavitary pedunculated fibroids were exclusionary).\n * Ultrasound procedures were performed during the Screening Period, and subjects were not randomized until the investigator reviewed the central reader results verifying the inclusion requirements.\n* Subject has a history of regular menstrual cycles between 24 to 35 days.\n* Subject has heavy uterine bleeding associated with uterine fibroids as evidenced by blood loss \\> 80 mL during 2 screening menstrual cycles, measured by the alkaline hematin method.\n\nExclusion Criteria:\n\n* Subject has had a myomectomy, uterine artery embolization, or high intensity focused ultrasound for fibroid destruction within 1 year prior to randomization or any history of endometrial ablation.\n* Subject has a history of osteoporosis or other metabolic bone disease.\n* Subject shows evidence of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric (including depression), or neurologic diseases or any uncontrolled medical illness such as uncontrolled type 2 diabetes.\n* Subject has a history of clinically significant condition(s) including but not limited to:\n\n * Endometriosis\n * Epilepsy or seizures\n * Type 1 diabetes\n * Any cancer (except basal cell carcinoma of the skin), including breast or ovarian cancer or subject has taken any systemic cancer chemotherapy"}, 'identificationModule': {'nctId': 'NCT01441635', 'briefTitle': 'Safety and Efficacy of Elagolix in Pre-Menopausal Women With Heavy Uterine Bleeding and Uterine Fibroids', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'Phase 2a Proof Of Concept Study to Evaluate the Safety and Efficacy of Elagolix in Pre-Menopausal Women With Heavy Uterine Bleeding and Uterine Fibroids', 'orgStudyIdInfo': {'id': 'M12-663'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 4 Elagolix 400 mg QD', 'description': 'Participants received elagolix 400 mg once a day (QD) for 3 months.', 'interventionNames': ['Drug: Elagolix']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 4 Elagolix 100 mg BID', 'description': 'Participants received elagolix 100 mg twice a day (BID) for 3 months.', 'interventionNames': ['Drug: Elagolix']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Cohort 4 Placebo', 'description': 'Participants received placebo to elagolix BID for 3 months.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 1 Elagolix 200 mg BID', 'description': 'Participants received elagolix 200 mg twice a day for 3 months.', 'interventionNames': ['Drug: Elagolix']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Cohort 1 Placebo', 'description': 'Participants received placebo to elagolix twice a day for 3 months.', 'interventionNames': ['Drug: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Cohort 3 Elagolix 200 mg BID + LD E2/NETA', 'description': 'Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months.', 'interventionNames': ['Drug: Elagolix', 'Drug: Estradiol/Norethindrone acetate (E2/NETA)']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 5 Elagolix 600 mg QD', 'description': 'Participants received elagolix 600 mg once a day for 3 months.', 'interventionNames': ['Drug: Elagolix']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2 Elagolix 300 mg BID', 'description': 'Participants received elagolix 300 mg twice a day for 3 months.', 'interventionNames': ['Drug: Elagolix']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2 Placebo', 'description': 'Participants received placebo to elagolix BID for 3 months.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 6 Elagolix 300 mg BID + CEP', 'description': 'Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months.', 'interventionNames': ['Drug: Elagolix', 'Drug: Estradiol', 'Drug: Progesterone']}], 'interventions': [{'name': 'Elagolix', 'type': 'DRUG', 'otherNames': ['ABT-620'], 'description': 'Elagolix tablets', 'armGroupLabels': ['Cohort 1 Elagolix 200 mg BID', 'Cohort 2 Elagolix 300 mg BID', 'Cohort 3 Elagolix 200 mg BID + LD E2/NETA', 'Cohort 4 Elagolix 100 mg BID', 'Cohort 4 Elagolix 400 mg QD', 'Cohort 5 Elagolix 600 mg QD', 'Cohort 6 Elagolix 300 mg BID + CEP']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Matching placebo tablets', 'armGroupLabels': ['Cohort 1 Placebo', 'Cohort 2 Placebo', 'Cohort 4 Placebo']}, {'name': 'Estradiol/Norethindrone acetate (E2/NETA)', 'type': 'DRUG', 'otherNames': ['Activella®'], 'description': 'A continuous once-daily oral tablet containing estrogen and progestin; the low-dose strength contains estradiol 0.5 mg and norethindrone acetate 0.1 mg.', 'armGroupLabels': ['Cohort 3 Elagolix 200 mg BID + LD E2/NETA']}, {'name': 'Estradiol', 'type': 'DRUG', 'otherNames': ['Estrace®'], 'description': '1.0 mg micronized estradiol tablets administered once a day', 'armGroupLabels': ['Cohort 6 Elagolix 300 mg BID + CEP']}, {'name': 'Progesterone', 'type': 'DRUG', 'otherNames': ['Prometrium®'], 'description': 'Progesterone 200 mg administered during the last 12 days of the 28-day menstrual cycle', 'armGroupLabels': ['Cohort 6 Elagolix 300 mg BID + CEP']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'AbbVie Inc.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'ipdSharingStatementModule': {'url': 'https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.', 'ipdSharing': 'YES', 'description': 'AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.', 'accessCriteria': 'Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie (prior sponsor, Abbott)', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}