Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2026-04-19 @ 11:59 PM
Study NCT ID:
NCT03049735
Status:
COMPLETED
Last Update Posted:
2022-04-19
First Post:
2017-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
LIBERTY 1: Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D008595', 'term': 'Menorrhagia'}, {'id': 'D007889', 'term': 'Leiomyoma'}], 'ancestors': [{'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'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C561634', 'term': 'relugolix'}, {'id': 'C418365', 'term': 'estradiol, norethindrone drug combination'}, {'id': 'D004958', 'term': 'Estradiol'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@myovant.com', 'phone': '+1 650 238 0250', 'title': 'Clinical Trials at Myovant', 'organization': 'Myovant Sciences GmbH'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'None reported'}}, 'adverseEventsModule': {'timeFrame': 'From Baseline to Week 24', 'description': 'All participants who were randomized to treatment and who received at least 1 dose of study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'Relugolix Plus E2/NETA (Group A)', 'description': 'Relugolix 40 mg co-administered with estradiol (1.0 mg) and norethindrone acetate (0.5 mg) for 24 weeks.', 'otherNumAtRisk': 128, 'deathsNumAtRisk': 128, 'otherNumAffected': 32, 'seriousNumAtRisk': 128, 'deathsNumAffected': 0, 'seriousNumAffected': 7}, {'id': 'EG001', 'title': 'Relugolix Plus Delayed E2/NETA (Group B)', 'description': 'Relugolix 40 mg co-administered with placebo for E2/NETA for 12 weeks followed by relugolix co-administered with estradiol/norethindrone acetate (1.0/0.5 mg) for 12 weeks.', 'otherNumAtRisk': 132, 'deathsNumAtRisk': 132, 'otherNumAffected': 62, 'seriousNumAtRisk': 132, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'Placebo (Group C)', 'description': 'Placebo for relugolix co-administered with placebo for E2/NETA for 24 weeks.', 'otherNumAtRisk': 127, 'deathsNumAtRisk': 127, 'otherNumAffected': 33, 'seriousNumAtRisk': 127, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 48, 'numAffected': 47}, {'groupId': 'EG002', 'numAtRisk': 127, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 15, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 18, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 127, 'numEvents': 20, 'numAffected': 19}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 127, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 127, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 127, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}], 'seriousEvents': [{'term': 'Avulsion fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Uterine myoma expulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'uterine leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Vitreous detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Panic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Acute psychosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Haematemesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Menorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Pelvic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Rhabdomyolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage Of Participants Who Achieved A Menstrual Blood Loss (MBL) Volume Of < 80 mL And A ≥ 50% Reduction From Baseline MBL Volume With Relugolix Plus E2/NETA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Relugolix Plus E2/NETA (Group A)', 'description': 'Relugolix 40 mg co-administered with E2 (1.0 mg) and NETA (0.5 mg) for 24 weeks.'}, {'id': 'OG001', 'title': 'Placebo (Group C)', 'description': 'Placebo for relugolix co-administered with placebo for E2/NETA for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '73.4', 'groupId': 'OG000', 'lowerLimit': '64.91', 'upperLimit': '80.85'}, {'value': '18.9', 'groupId': 'OG001', 'lowerLimit': '12.50', 'upperLimit': '26.80'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '54.54', 'ciLowerLimit': '44.3', 'ciUpperLimit': '64.78', 'pValueComment': 'P-value was stratified by baseline MBL volume (\\< 225 mL or ≥ 225 mL) and geographic region (North America or Rest of World). Assessed at a 2-sided α = 0.05 significance level.', 'estimateComment': 'Treatment difference is relugolix + E2/NETA minus placebo.', 'groupDescription': 'The primary efficacy analysis was the comparison of the relugolix + E2/NETA group with the placebo group with respect to responder rate.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline up to last 35 days of treatment (up to Week 24)', 'description': 'A responder was a participant who had MBL volume of \\< 80 mL and at least a 50% reduction from baseline MBL volume over the last 35 days of treatment (up to Week 24). All returned feminine products collected at each clinical visit were analyzed by the alkaline hematin method to obtain the MBL volume. MBL volume was measured over the Week 24/early termination feminine product collection interval (up to 35 days prior to the last dose of treatment). The percentage of participants who were responders are presented.\n\nAs per the objective of the study, the pre-specified primary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intention-to-Treat Population: All participants who were randomized to treatment and who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage Of Participants With Amenorrhea Over The Last 35 Days Of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Relugolix Plus E2/NETA (Group A)', 'description': 'Relugolix 40 mg co-administered with E2 (1.0 mg) and NETA (0.5 mg) for 24 weeks.'}, {'id': 'OG001', 'title': 'Placebo (Group C)', 'description': 'Placebo for relugolix co-administered with placebo for E2/NETA for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '52.34', 'groupId': 'OG000', 'lowerLimit': '43.34', 'upperLimit': '61.24'}, {'value': '5.51', 'groupId': 'OG001', 'lowerLimit': '2.24', 'upperLimit': '11.03'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '46.83', 'ciLowerLimit': '37.31', 'ciUpperLimit': '56.35', 'pValueComment': 'P-value was based on Cochran-Mantel-Haenszel test stratified by Baseline MBL volume (\\< 225 mL, ≥ 225 mL) and geographic region (North America or Rest of World). Assessed at a 2-sided α = 0.05 significance level.', 'estimateComment': 'Treatment difference was relugolix plus E2/NETA minus placebo. 95% confidence interval (CI) for difference is based on the normal approximation.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline up to last 35 days of treatment (up to Week 24)', 'description': 'Amenorrhea was defined as meeting 1 of the following criteria for 2 consecutive visits:\n\n1. No feminine product returned due to reported amenorrhea;\n2. No feminine product returned due to reports of spotting/negligible bleeding coupled with electronic diary (eDiary) data indicating infrequent non-cyclic bleeding/spotting;\n3. Feminine product collection with a negligible observed MBL volume coupled with eDiary data indicating infrequent non-cyclic bleeding/spotting.\n\nAs per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized to treatment and who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline At Week 24 In MBL Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Relugolix Plus E2/NETA (Group A)', 'description': 'Relugolix 40 mg co-administered with E2 (1.0 mg) and NETA (0.5 mg) for 24 weeks.'}, {'id': 'OG001', 'title': 'Placebo (Group C)', 'description': 'Placebo for relugolix co-administered with placebo for E2/NETA for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-84.3', 'groupId': 'OG000', 'lowerLimit': '-93.5', 'upperLimit': '-75.0'}, {'value': '-23.2', 'groupId': 'OG001', 'lowerLimit': '-32.2', 'upperLimit': '-14.1'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-61.1', 'ciLowerLimit': '-73.5', 'ciUpperLimit': '-48.6', 'pValueComment': 'Treatment, visit, region, Baseline MBL and treatment by visit interaction included as fixed effects. The multiple visits for each participant were the repeated measures as random effect within each participant and an unstructured covariance.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.32', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Assessed at a 2-sided α = 0.05 significance. Treatment difference is relugolix plus E2/NETA minus placebo.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'MBL volume was measured using the alkaline hematin method. As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.', 'unitOfMeasure': 'percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized to treatment and who received at least 1 dose of study drug and had analyzable data for MBL volume at the specified timepoints.'}, {'type': 'SECONDARY', 'title': 'Percentage Of Participants With A Hemoglobin Level ≤ 10.5 g/dL At Baseline Who Achieved An Increase Of > 2 g/dL From Baseline At Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Relugolix Plus E2/NETA (Group A)', 'description': 'Relugolix 40 mg co-administered with E2 (1.0 mg) and NETA (0.5 mg) for 24 weeks.'}, {'id': 'OG001', 'title': 'Placebo (Group C)', 'description': 'Placebo for relugolix co-administered with placebo for E2/NETA for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000', 'lowerLimit': '31.30', 'upperLimit': '68.70'}, {'value': '21.74', 'groupId': 'OG001', 'lowerLimit': '7.46', 'upperLimit': '43.70'}]}]}], 'analyses': [{'pValue': '= 0.0377', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '28.26', 'ciLowerLimit': '3.68', 'ciUpperLimit': '52.84', 'pValueComment': 'P-value is based on Cochran-Mantel-Haenszel test stratified by Baseline MBL volume (\\< 225 mL, ≥ 225 mL). Assessed at a 2-sided α = 0.05 significance level.', 'estimateComment': 'Treatment difference is relugolix plus E2/NETA minus placebo. 95% CI for difference is based on the normal approximation.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline up to Week 24', 'description': 'Blood samples were collected from participants for hemoglobin measurements. Percentages are based on number of participants with hemoglobin ≤ 10.5 gram (g)/deciliter (dL) at Baseline and reported at Week 24.\n\nAs per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA with placebo arms are presented.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized to treatment and who received at least 1 dose of study drug and had analyzable data for hemoglobin levels at the specified timepoints.'}, {'type': 'SECONDARY', 'title': 'Percentage Of Participants With A Maximum NRS Score ≤ 1 For Uterine Fibroid-Associated Pain Over The Last 35 Days Of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Relugolix Plus E2/NETA (Group A)', 'description': 'Relugolix 40 mg co-administered with E2 (1.0 mg) and NETA (0.5 mg) for 24 weeks.'}, {'id': 'OG001', 'title': 'Placebo (Group C)', 'description': 'Placebo for relugolix co-administered with placebo for E2/NETA for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '43.10', 'groupId': 'OG000', 'lowerLimit': '30.16', 'upperLimit': '56.77'}, {'value': '10.14', 'groupId': 'OG001', 'lowerLimit': '4.18', 'upperLimit': '19.79'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '33.0', 'ciLowerLimit': '18.36', 'ciUpperLimit': '47.56', 'pValueComment': 'P-value is based on Cochran-Mantel-Haenszel test stratified by Baseline MBL volume (\\< 225 mL, ≥ 225 mL). Assessed at a 2-sided α = 0.05 significance level.', 'estimateComment': 'Treatment difference is relugolix plus E2/NETA minus placebo. 95% CI for difference is based on the normal approximation.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline up to Week 24', 'description': 'Uterine fibroid-associated pain was assessed by a pain numerical rating scale (NRS). The pain NRS is a validated, single-item, self-reported measure, which asks respondents to rank their pain on an 11-point scale as follows: 0 (no pain), 1 to 3 (mild pain), 4 to 6 (moderate pain), and 7 to 10 (severe pain).\n\nParticipants were asked to document, in an e-Diary, the worst pain associated with their uterine fibroids that they experienced during the last 24 hours, every day until the end of study drug administration. Pain evaluable participants, defined as those who had maximum NRS score ≥ 4 at Baseline and had at least 28 days (80% of the last 35 days of treatment) of pain scores recorded in the e-Diary, were analyzed.\n\nAs per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized to treatment and who received at least 1 dose of study drug and had analyzable data for uterine fibroid-associated pain at the specified timepoints.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline At Week 24 In Primary Uterine Fibroid Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Relugolix Plus E2/NETA (Group A)', 'description': 'Relugolix 40 mg co-administered with E2 (1.0 mg) and NETA (0.5 mg) for 24 weeks.'}, {'id': 'OG001', 'title': 'Placebo (Group C)', 'description': 'Placebo for relugolix co-administered with placebo for E2/NETA for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-12.4', 'groupId': 'OG000', 'lowerLimit': '-23.5', 'upperLimit': '-1.4'}, {'value': '-0.3', 'groupId': 'OG001', 'lowerLimit': '-10.9', 'upperLimit': '10.4'}]}]}], 'analyses': [{'pValue': '0.0921', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-12.1', 'ciLowerLimit': '-26.3', 'ciUpperLimit': '2', 'pValueComment': 'Based on analysis of covariance model with treatment, randomization stratification factors, Baseline MBL volume, geographic region (North America, Rest of World), and Baseline values as covariate. Assessed at a 2-sided α = 0.05 significance level.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '7.19', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'The volume of the primary uterine fibroid was measured by transvaginal or transabdominal ultrasound.\n\nAs per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.', 'unitOfMeasure': 'Percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized to treatment and who received at least 1 dose of study drug and had analyzable data for primary uterine fibroid volume at the specified timepoints.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline At Week 24 In Uterine Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Relugolix Plus E2/NETA (Group A)', 'description': 'Relugolix 40 mg co-administered with E2 (1.0 mg) and NETA (0.5 mg) for 24 weeks.'}, {'id': 'OG001', 'title': 'Placebo (Group C)', 'description': 'Placebo for relugolix co-administered with placebo for E2/NETA for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-12.9', 'groupId': 'OG000', 'lowerLimit': '-19.0', 'upperLimit': '-6.9'}, {'value': '2.2', 'groupId': 'OG001', 'lowerLimit': '-3.7', 'upperLimit': '8.1'}]}]}], 'analyses': [{'pValue': '0.0002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-15.1', 'ciLowerLimit': '-23', 'ciUpperLimit': '-7.3', 'pValueComment': 'Based on analysis of covariance model with treatment, randomization stratification factors, Baseline MBL volume, geographic region (North America, Rest of World), and Baseline values as covariate. Assessed at a 2-sided α = 0.05 significance level.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.98', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'The volume of the uterus was measured by transvaginal or transabdominal ultrasound.\n\nAs per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.', 'unitOfMeasure': 'percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized to treatment and who received at least 1 dose of study drug and had analyzable data for uterine volume at the specified timepoints.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline At Week 24 In UFS-QoL Bleeding And Pelvic Discomfort Scale Score As Measured By The UFS-QoL (Q1, Q2, Q5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Relugolix Plus E2/NETA (Group A)', 'description': 'Relugolix 40 mg co-administered with E2 (1.0 mg) and NETA (0.5 mg) for 24 weeks.'}, {'id': 'OG001', 'title': 'Placebo (Group C)', 'description': 'Placebo for relugolix co-administered with placebo for E2/NETA for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-45.0', 'groupId': 'OG000', 'lowerLimit': '-50.7', 'upperLimit': '-39.3'}, {'value': '-16.1', 'groupId': 'OG001', 'lowerLimit': '-21.6', 'upperLimit': '-10.5'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-28.9', 'ciLowerLimit': '-36.3', 'ciUpperLimit': '-21.5', 'pValueComment': 'Treatment, visit, region, Baseline MBL and treatment by visit interaction included as fixed effects. The multiple visits for each participant were the repeated measures as random effect within each participant and an unstructured covariance.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.75', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Assessed at a 2-sided α = 0.05 significance level. LS means and p-value for test of difference is relugolix plus E2/NETA minus placebo.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'The Uterine Fibroid Symptom and Health-Related Quality of Life (UFS-QoL) Bleeding and Pelvic Discomfort (BPD) Scale has been derived from the UFS-QoL Symptoms Scale. The scale consists of the following 3 symptoms proximal to uterine fibroids: Heavy bleeding during your menstrual period (Question \\[Q\\] 1), passing blood clots during your menstrual period (Q2), and feeling tightness or pressure in your pelvic area (Q5). raw scores were transformed to a normalized score: Transformed Score = \\[(Actual raw score - lowest possible raw score)/(Possible raw score range)\\] \\* 100 Transformed score ranges from 0 to 100 based on Likert scale (None of time, a little of time, some of the time, most of the time and all of the time). Lower score indicates minimal symptom severity and higher score indicates maximum symptom severity.\n\nAs per the study objective, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only these two arms are presented.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized to treatment and who received at least 1 dose of study drug and had analyzable data for UFS-QoL BPD scores at the specified timepoints.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline At Week 12 In Bone Mineral Density At The Lumbar Spine (L1 To L4), As Assessed By DXA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Relugolix Plus E2/NETA (Group A)', 'description': 'Relugolix 40 mg co-administered with E2 (1.0 mg) and NETA (0.5 mg) for 24 weeks.'}, {'id': 'OG001', 'title': 'Relugolix Plus Delayed E2/NETA (Group B)', 'description': 'Relugolix 40 mg co-administered with placebo for E2/NETA for 12 weeks followed by relugolix co-administered with estradiol/norethindrone acetate (1.0/0.5 mg) for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.470', 'spread': '0.2915', 'groupId': 'OG000'}, {'value': '-1.995', 'spread': '0.2848', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'Bone mineral density (BMD) was assessed by dual-energy x-ray absorptiometry (DXA) at the lumbar spine (L1, L2, L3, and L4) at Baseline and at Week 12. The scans were read by the central radiology laboratory in accordance with the imaging charter. The same DXA machine was used at the local imaging center at each site and operated in the same scan mode for all images procured for an individual participant. All images were submitted for central reading. The central radiology laboratory collected and evaluated all DXA scans for acceptability and measured BMD.\n\nAs per the objective of the study, the pre-specified secondary analyses compared relugolix plus E2/NETA with relugolix plus delayed E2/NETA at Week 12 and are presented below.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized to treatment and who received at least 1 dose of study drug and had analyzable data for BMD at lumbar spine (L1 to L4) at the specified timepoints.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline At Week 24 In Bone Mineral Density At The Lumbar Spine (L1 To L4), Total Hip, And Femoral Neck', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Relugolix Plus E2/NETA (Group A)', 'description': 'Relugolix 40 mg co-administered with E2 (1.0 mg) and NETA (0.5 mg) for 24 weeks.'}, {'id': 'OG001', 'title': 'Placebo (Group C)', 'description': 'Placebo for relugolix co-administered with placebo for E2/NETA for 24 weeks.'}], 'classes': [{'title': 'Lumbar Spine (L1 to L4)', 'categories': [{'measurements': [{'value': '-0.356', 'spread': '0.2929', 'groupId': 'OG000'}, {'value': '0.052', 'spread': '0.2896', 'groupId': 'OG001'}]}]}, {'title': 'Total Hip', 'categories': [{'measurements': [{'value': '0.023', 'spread': '0.2461', 'groupId': 'OG000'}, {'value': '0.549', 'spread': '0.2407', 'groupId': 'OG001'}]}]}, {'title': 'Femoral Neck', 'categories': [{'measurements': [{'value': '-0.262', 'spread': '0.4466', 'groupId': 'OG000'}, {'value': '0.307', 'spread': '0.4395', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'BMD was assessed by DXA at the lumbar spine (L1, L2, L3, and L4), total hip, and femoral neck at Baseline and at Week 24. The scans were read by the central radiology laboratory in accordance with the imaging charter. The same DXA machine was used at the local imaging center at each site and operated in the same scan mode for all images procured for an individual participant. All images were submitted for central reading. The central radiology laboratory collected and evaluated all DXA scans for acceptability and measured BMD.\n\nAs per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized to treatment and who received at least 1 dose of study drug and had analyzable data for BMD at the lumbar spine (L1 to L4), total hip, and femoral neck at the specified timepoints.'}, {'type': 'SECONDARY', 'title': 'Percentage Of Participants Experiencing Vasomotor Symptoms Through Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Relugolix Plus E2/NETA (Group A)', 'description': 'Relugolix 40 mg co-administered with E2 (1.0 mg) and NETA (0.5 mg) for 24 weeks.'}, {'id': 'OG001', 'title': 'Relugolix Plus Delayed E2/NETA (Group B)', 'description': 'Relugolix 40 mg co-administered with placebo for E2/NETA for 12 weeks followed by relugolix co-administered with estradiol/norethindrone acetate (1.0/0.5 mg) for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.94', 'groupId': 'OG000', 'lowerLimit': '6.11', 'upperLimit': '17.67'}, {'value': '36.36', 'groupId': 'OG001', 'lowerLimit': '28.17', 'upperLimit': '45.18'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through Week 12', 'description': 'An adverse event was defined as an unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product, whether or not related to the medicinal product. The preferred terms of hyperhidrosis, feeling hot, hot flush, night sweats, and flushing were combined to describe vasomotor symptoms. Participants with multiple events for a given preferred term were counted only once for each preferred term.\n\nReported CI based on exact binomial 95% CI (Clopper-Pearson).\n\nAs per the objective of the study, this secondary analysis compared relugolix plus E2/NETA with relugolix plus delayed E2/NETA at Week 12 and are presented below.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized to treatment and who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage Of Participants Experiencing Vasomotor Symptoms Through Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Relugolix Plus E2/NETA (Group A)', 'description': 'Relugolix 40 mg co-administered with E2 (1.0 mg) and NETA (0.5 mg) for 24 weeks.'}, {'id': 'OG001', 'title': 'Placebo (Group C)', 'description': 'Placebo for relugolix co-administered with placebo for E2/NETA for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.8', 'groupId': 'OG000'}, {'value': '9.4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through Week 24', 'description': 'An adverse event was defined as an unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product, whether or not related to the medicinal product. The preferred terms of hyperhidrosis, feeling hot, hot flush, night sweats, and flushing were combined to describe vasomotor symptoms. Participants with multiple events for a given preferred term were counted only once for each preferred term.\n\nReported percentages based on the total number of participants in each treatment group.\n\nAs per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized to treatment and who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Predose Trough Concentrations Of Relugolix And Norethindrone (NET) In The Relugolix Plus E2/NETA Group At Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Relugolix Plus E2/NETA (Group A)', 'description': 'Relugolix 40 mg co-administered with E2 (1.0 mg) and NETA (0.5 mg) for 24 weeks.'}], 'classes': [{'title': 'Relugolix', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.13', 'spread': '2.144', 'groupId': 'OG000'}]}]}, {'title': 'NET', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.33', 'spread': '0.369', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 24', 'description': 'Blood samples for determination of relugolix and NET plasma concentrations were collected predose at Week 24. Relugolix and NET plasma concentrations were determined using validated bioanalytical methodology.\n\nConcentrations below the quantification limit (BQL) were set to 0 for analysis of summary statistics.\n\nAs per the objective of the study, only relugolix plus E2/NETA concentration is presented.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized to treatment and who received at least 1 dose of study drug and had analyzable PK data at the specified timepoint.'}, {'type': 'SECONDARY', 'title': 'Predose Trough Concentrations Of E2 In The Relugolix Plus E2/NETA Group At Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Relugolix Plus E2/NETA (Group A)', 'description': 'Relugolix 40 mg co-administered with E2 (1.0 mg) and NETA (0.5 mg) for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '48.34', 'spread': '59.660', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 24', 'description': 'Blood samples for determination of E2 serum concentrations were collected predose at Week 24. Relugolix and NET plasma concentrations were determined using validated bioanalytical methodology.\n\nConcentrations below the quantification limit (BQL) were set to 0 for analysis of summary statistics. As per the objective of the study, only relugolix plus E2/NETA concentration is presented.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized to treatment and who received at least 1 dose of study drug and had analyzable PK data at the specified timepoint.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline At Week 24 In Predose Concentrations Of Estradiol In The Relugolix Plus E2/NETA Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Relugolix Plus E2/NETA (Group A)', 'description': 'Relugolix 40 mg co-administered with E2 (1.0 mg) and NETA (0.5 mg) for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-22.95', 'spread': '84.005', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'Blood samples for determination of serum concentrations were collected predose at Week 24. Relugolix and NET plasma concentrations were determined using validated bioanalytical methodology.\n\nConcentrations below the quantification limit (BQL) were set to 0 for analysis of summary statistics. As per the objective of the study, only relugolix plus E2/NETA concentration is presented.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized to treatment and who received at least 1 dose of study drug and had analyzable PK data at the specified timepoint.'}, {'type': 'SECONDARY', 'title': 'Time To MBL Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Relugolix Plus E2/NETA (Group A)', 'description': 'Relugolix 40 mg co-administered with E2 (1.0 mg) and NETA (0.5 mg) for 24 weeks.'}, {'id': 'OG001', 'title': 'Placebo (Group C)', 'description': 'Placebo for relugolix co-administered with placebo for E2/NETA for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.3', 'groupId': 'OG000', 'lowerLimit': '8.1', 'upperLimit': '8.7'}, {'value': '25.1', 'groupId': 'OG001', 'lowerLimit': '24.1', 'upperLimit': '28.1'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value is based on Log-rank test stratified by Baseline MBL volume (\\< 225 mL, ≥ 225 mL) and geographic region (North America, Rest of World) from the proportional hazard regression model comparing relugolix + E2/NETA with placebo.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From Baseline through Week 24', 'description': 'Defined as the time to achieve an MBL volume of \\< 80 mL and a ≥ 50% reduction from Baseline MBL volume as measured by the alkaline hematin method. MBL volume was measured using the alkaline hematin method.\n\nAs per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.', 'unitOfMeasure': 'weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized to treatment and who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Sustained Amenorrhea Rate (No Or Negligible Bleeding)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Relugolix Plus E2/NETA (Group A)', 'description': 'Relugolix 40 mg co-administered with E2 (1.0 mg) and NETA (0.5 mg) for 24 weeks.'}, {'id': 'OG001', 'title': 'Placebo (Group C)', 'description': 'Placebo for relugolix co-administered with placebo for E2/NETA for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value for testing difference between relugolix plus E2/NETA and placebo is based on Cochran-Mantel-Haenszel test stratified by Baseline MBL volume (\\< 225 mL, ≥ 225 mL) and geographic region (North America, Rest of World).', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 24', 'description': 'Sustained amenorrhea is defined as participants time to achieve and maintain amenorrhea until the date of last study drug.\n\nAs per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized to treatment and who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Time To Achieving Sustained Amenorrhea (No Or Negligible Bleeding)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Relugolix Plus E2/NETA (Group A)', 'description': 'Relugolix 40 mg co-administered with E2 (1.0 mg) and NETA (0.5 mg) for 24 weeks.'}, {'id': 'OG001', 'title': 'Placebo (Group C)', 'description': 'Placebo for relugolix co-administered with placebo for E2/NETA for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.3', 'groupId': 'OG000', 'lowerLimit': '5.1', 'upperLimit': '18.6'}, {'value': 'NA', 'comment': 'Sustained amenorrhea was not reached.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value is based on Log-rank test stratified by Baseline MBL volume (\\< 225 mL, ≥ 225 mL) and geographic region (North America, Rest of World) from the proportional hazard regression model comparing relugolix plus E2/NETA with placebo.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From Baseline through Week 24', 'description': 'Sustained amenorrhea status as determined based on time to achieve and maintain amenorrhea status.\n\nAs per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.', 'unitOfMeasure': 'weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized to treatment and who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Time To Achieving Amenorrhea (No Or Negligible Bleeding)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Relugolix Plus E2/NETA (Group A)', 'description': 'Relugolix 40 mg co-administered with E2 (1.0 mg) and NETA (0.5 mg) for 24 weeks.'}, {'id': 'OG001', 'title': 'Placebo (Group C)', 'description': 'Placebo for relugolix co-administered with placebo for E2/NETA for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.3', 'groupId': 'OG000', 'lowerLimit': '5.0', 'upperLimit': '9.1'}, {'value': 'NA', 'comment': 'Amenorrhea was not reached.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value was based on Log-rank test stratified by Baseline MBL volume (\\< 225 mL, ≥ 225 mL) and geographic region (North America, Rest of World) from the proportional hazard regression model comparing relugolix + E2/NETA with placebo.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From Baseline through Week 24', 'description': 'Time to amenorrhea was defined as the weeks from date of first dose of study drug to the start of amenorrhea.\n\nAs per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.', 'unitOfMeasure': 'weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized to treatment and who received at least 1 dose of study drug and had analyzable data at the specified timepoint.'}, {'type': 'SECONDARY', 'title': 'Number Of Participants With Hemoglobin ≤ 10.5 g/dL At Baseline And Achieved An Increase Of > 2 g/dL At Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Relugolix Plus E2/NETA (Group A)', 'description': 'Relugolix 40 mg co-administered with E2 (1.0 mg) and NETA (0.5 mg) for 24 weeks.'}, {'id': 'OG001', 'title': 'Placebo (Group C)', 'description': 'Placebo for relugolix co-administered with placebo for E2/NETA for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0377', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value was based on Cochran-Mantel-Haenszel test stratified by Baseline MBL volume (\\< 225 mL, ≥ 225 mL).', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Baseline through Week 24', 'description': 'As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized to treatment, received at least 1 dose of study drug, and had hemoglobin ≤ 10.5 g/dL at Baseline and an assessment at Week 24.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline In Hemoglobin For Women With a Hemoglobin ≤ 10.5 g/dL At Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Relugolix Plus E2/NETA (Group A)', 'description': 'Relugolix 40 mg co-administered with E2 (1.0 mg) and NETA (0.5 mg) for 24 weeks.'}, {'id': 'OG001', 'title': 'Placebo (Group C)', 'description': 'Placebo for relugolix co-administered with placebo for E2/NETA for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '20.8', 'spread': '3.05', 'groupId': 'OG000'}, {'value': '10.0', 'spread': '3.53', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0117', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Treatment, visit, region, Baseline MBL and treatment by visit interaction included as fixed effects. The multiple visits for each participant were the repeated measures as random effect within each participant and an unstructured covariance.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'LS means and p-value for test of difference is relugolix plus E2/NETA minus placebo.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 24', 'description': 'LS means and p-value for test of difference is relugolix plus E2/NETA minus Placebo based on mixed-effect model with treatment, visit, region, Baseline MBL and treatment by visit interaction included as fixed effects.\n\nAs per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized to treatment and who received at least 1 dose of study drug and had evaluable data at the specified timeframe.'}, {'type': 'SECONDARY', 'title': 'Number Of Participants With Hemoglobin Increase Of ≥ 1 g/dL From Baseline To Week 24 Among Those With Below Lower Limit Of Normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Relugolix Plus E2/NETA (Group A)', 'description': 'Relugolix 40 mg co-administered with E2 (1.0 mg) and NETA (0.5 mg) for 24 weeks.'}, {'id': 'OG001', 'title': 'Placebo (Group C)', 'description': 'Placebo for relugolix co-administered with placebo for E2/NETA for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0084', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value was based on Cochran-Mantel-Haenszel test stratified by Baseline MBL volume (\\< 225 mL, ≥ 225 mL) and geographic region (North America, Rest of World). Lower limit of normal is Hgb \\< 11.6 g/dL.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 24', 'description': 'As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized to treatment and who received at least 1 dose of study drug and had hemoglobin below lower normal limit of normal at baseline.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline At Week 24 In The UFS-QoL Symptom Severity Scale Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Relugolix Plus E2/NETA (Group A)', 'description': 'Relugolix 40 mg co-administered with E2 (1.0 mg) and NETA (0.5 mg) for 24 weeks.'}, {'id': 'OG001', 'title': 'Placebo (Group C)', 'description': 'Placebo for relugolix co-administered with placebo for E2/NETA for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-30.9', 'spread': '2.61', 'groupId': 'OG000'}, {'value': '-10.5', 'spread': '2.55', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Treatment, visit, region, Baseline MBL and treatment by visit interaction included as fixed effects. The multiple visits for each participant were the repeated measures as random effect within each participant and an unstructured covariance.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'LS means and p-value for test of difference is relugolix plus E2/NETA minus placebo.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'Transformed score ranges from 0 to 100 based on Likert scale (None of time, a little of time, some of the time, most of the time and all of the time). Lower score indicates minimal symptom severity and higher score indicates maximum symptom severity. A negative change from baseline indicates improvement.\n\nAs per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized to treatment and who received at least 1 dose of study drug and had evaluable data at the specified timepoint.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline At Week 24 In The UFS-QoL Activities Scale Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Relugolix Plus E2/NETA (Group A)', 'description': 'Relugolix 40 mg co-administered with E2 (1.0 mg) and NETA (0.5 mg) for 24 weeks.'}, {'id': 'OG001', 'title': 'Placebo (Group C)', 'description': 'Placebo for relugolix co-administered with placebo for E2/NETA for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '44.4', 'spread': '3.06', 'groupId': 'OG000'}, {'value': '14.6', 'spread': '2.99', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Treatment, visit, region, Baseline MBL and treatment by visit interaction included as fixed effects. The multiple visits for each participant were the repeated measures as random effect within each participant and an unstructured covariance.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'LS means and p-value for test of difference is relugolix plus E2/NETA minus placebo.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'Transformed score ranges from 0 to 100 based on Likert scale (None of time, a little of time, some of the time, most of the time and all of the time). Lower score indicates minimal symptom severity and higher score indicates maximum symptom severity.\n\nAs per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized to treatment and who received at least 1 dose of study drug and had evaluable data at the specified timepoint.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline At Week 24 In The UFS-QoL Revised Activities Scale Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Relugolix Plus E2/NETA (Group A)', 'description': 'Relugolix 40 mg co-administered with E2 (1.0 mg) and NETA (0.5 mg) for 24 weeks.'}, {'id': 'OG001', 'title': 'Placebo (Group C)', 'description': 'Placebo for relugolix co-administered with placebo for E2/NETA for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '45.8', 'spread': '3.19', 'groupId': 'OG000'}, {'value': '15.1', 'spread': '3.12', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Treatment, visit, region, Baseline MBL and treatment by visit interaction included as fixed effects. The multiple visits for each participant were the repeated measures as random effect within each participant and an unstructured covariance.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'LS means and p-value for test of difference is relugolix plus E2/NETA minus placebo.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'Transformed score ranges from 0 to 100 based on Likert scale (none of time, a little of time, some of the time, most of the time and all of the time). Lower score indicates minimal symptom severity and higher score indicates maximum symptom severity.\n\nAs per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized to treatment and who received at least 1 dose of study drug and had evaluable data at the specified timepoint.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline In UFS-QoL Score By Health-Related Quality Of Life Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Relugolix Plus E2/NETA (Group A)', 'description': 'Relugolix 40 mg co-administered with E2 (1.0 mg) and NETA (0.5 mg) for 24 weeks.'}, {'id': 'OG001', 'title': 'Placebo (Group C)', 'description': 'Placebo for relugolix co-administered with placebo for E2/NETA for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '38.0', 'spread': '2.80', 'groupId': 'OG000'}, {'value': '12.8', 'spread': '2.73', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Treatment, visit, region, Baseline MBL and treatment by visit interaction included as fixed effects. The multiple visits for each participant were the repeated measures as random effect within each participant and an unstructured covariance.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'LS means and p-value for test of difference is relugolix plus E2/NETA minus placebo.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'The UFS-QoL total score was the sum of 6 subscales (concern, activities, energy/mood, control, self-conscious, and sexual function). The raw scores were transformed to normalized scores. Transformed score ranges from 0 to 100. Higher scores are indicative of better health-related quality of life (high = good).\n\nAs per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized to treatment and who received at least 1 dose of study drug and had evaluable data at the specified timepoint.'}, {'type': 'SECONDARY', 'title': 'Number Of Responders With At Least 20 Points Increase From Baseline At Week 24 In UFS-QoL Revised Activities Scale Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Relugolix Plus E2/NETA (Group A)', 'description': 'Relugolix 40 mg co-administered with E2 (1.0 mg) and NETA (0.5 mg) for 24 weeks.'}, {'id': 'OG001', 'title': 'Placebo (Group C)', 'description': 'Placebo for relugolix co-administered with placebo for E2/NETA for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value for testing difference between Relugolix plus E2/NETA and placebo is based on Cochran-Mantel-Haenszel test stratified by Baseline MBL volume (\\< 225 mL, ≥ 225 mL) and geographic region (North America, Rest of World).', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Baseline through Week 24', 'description': 'As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized to treatment and who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline In UFS-QoL Bleeding And Pelvic Discomfort Scale Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Relugolix Plus E2/NETA (Group A)', 'description': 'Relugolix 40 mg co-administered with E2 (1.0 mg) and NETA (0.5 mg) for 24 weeks.'}, {'id': 'OG001', 'title': 'Placebo (Group C)', 'description': 'Placebo for relugolix co-administered with placebo for E2/NETA for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-45.0', 'spread': '2.88', 'groupId': 'OG000'}, {'value': '-16.1', 'spread': '2.81', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Treatment, visit, region, Baseline MBL and treatment by visit interaction included as fixed effects. The multiple visits for each participant were the repeated measures as random effect within each participant and an unstructured covariance.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'LS means and p-value for test of difference is relugolix plus E2/NETA minus placebo.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'The Bleeding and Pelvic Discomfort Scale consists of 3 items proximal to uterine fibroids that are experienced by most patients (heavy bleeding during the menstrual period \\[Question 1\\], passing blood clots during the menstrual period \\[Question 2\\], and feeling tightness or pressure in the pelvic area \\[Question 5\\]).Transformed score ranges from 0 to 100 based on Likert scale (None of time, a little of time, some of the time, most of the time and all of the time). Lower score indicates minimal symptom severity and higher score indicates maximum symptom severity. A negative change from baseline indicates improvement.\n\nAs per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized to treatment and who received at least 1 dose of study drug and had evaluable data at the specified timepoint.'}, {'type': 'SECONDARY', 'title': 'Number Of Responders With At Least 20 Points Decrease In UFS-QoL Bleeding And Pelvic Discomfort Scale Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Relugolix Plus E2/NETA (Group A)', 'description': 'Relugolix 40 mg co-administered with E2 (1.0 mg) and NETA (0.5 mg) for 24 weeks.'}, {'id': 'OG001', 'title': 'Placebo (Group C)', 'description': 'Placebo for relugolix co-administered with placebo for E2/NETA for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '79', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value was based on Cochran-Mantel-Haenszel test stratified by Baseline MBL volume (\\< 225 mL, ≥ 225 mL) and geographic region (North America, Rest of World).', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, Week 24', 'description': 'A Responder was defined as meeting a meaningful change threshold, set as a 20-point change from Baseline, in the Bleeding And Pelvic Discomfort Scale at Week 24 on the transformed score.\n\nAs per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized to treatment and who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline At Week 24 In The Interference Of Uterine Fibroids With Physical Activities Based On UFS-QoL Question 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Relugolix Plus E2/NETA (Group A)', 'description': 'Relugolix 40 mg co-administered with E2 (1.0 mg) and NETA (0.5 mg) for 24 weeks.'}, {'id': 'OG001', 'title': 'Placebo (Group C)', 'description': 'Placebo for relugolix co-administered with placebo for E2/NETA for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.1', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '0.13', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Treatment, visit, region, Baseline MBL and treatment by visit interaction included as fixed effects. The multiple visits for each participant were the repeated measures as random effect within each participant and an unstructured covariance.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'LS means and p-value for test of difference is relugolix plus E2/NETA minus placebo.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'Transformed score ranges from 0 to 100 based on Likert scale (None of time, a little of time, some of the time, most of the time and all of the time). Lower score indicates minimal symptom severity and higher score indicates maximum symptom severity. A negative change from baseline indicates improvement.\n\nAs per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized to treatment and who received at least 1 dose of study drug and had analyzable data at the specified timepoint.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline At Week 24 In The Interference Of Uterine Fibroids With Social Activities Based On UFS-QoL Question 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Relugolix Plus E2/NETA (Group A)', 'description': 'Relugolix 40 mg co-administered with E2 (1.0 mg) and NETA (0.5 mg) for 24 weeks.'}, {'id': 'OG001', 'title': 'Placebo (Group C)', 'description': 'Placebo for relugolix co-administered with placebo for E2/NETA for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.7', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '0.14', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Treatment, visit, region, Baseline MBL and treatment by visit interaction included as fixed effects. The multiple visits for each participant were the repeated measures as random effect within each participant and an unstructured covariance.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'LS means and p-value for test of difference is relugolix plus E2/NETA minus placebo.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'Transformed score ranges from 0 to 100 based on Likert scale (None of time, a little of time, some of the time, most of the time and all of the time). Lower score indicates minimal symptom severity and higher score indicates maximum symptom severity. A negative change from baseline indicates improvement.\n\nAs per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized to treatment and who received at least 1 dose of study drug and had analyzable data at the specified timepoint.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline At Week 24 In Embarrassment Caused By Uterine Fibroids Based On UFS-QoL Question 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Relugolix Plus E2/NETA (Group A)', 'description': 'Relugolix 40 mg co-administered with E2 (1.0 mg) and NETA (0.5 mg) for 24 weeks.'}, {'id': 'OG001', 'title': 'Placebo (Group C)', 'description': 'Placebo for relugolix co-administered with placebo for E2/NETA for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.5', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '0.14', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'Transformed score ranges from 0 to 100 based on Likert scale (None of time, a little of time, some of the time, most of the time and all of the time). Lower score indicates minimal symptom severity and higher score indicates maximum symptom severity. A negative change from baseline indicates improvement.\n\nAs per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized to treatment and who received at least 1 dose of study drug and had analyzable data at the specified timepoint.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline At Week 24 In Symptoms Assessed Using The Patient Global Assessment (PGA) Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Relugolix Plus E2/NETA (Group A)', 'description': 'Relugolix 40 mg co-administered with E2 (1.0 mg) and NETA (0.5 mg) for 24 weeks.'}, {'id': 'OG001', 'title': 'Placebo (Group C)', 'description': 'Placebo for relugolix co-administered with placebo for E2/NETA for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.1', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '0.13', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Treatment, visit, region, Baseline MBL and treatment by visit interaction included as fixed effects. The multiple visits for each participant were the repeated measures as random effect within each participant and an unstructured covariance.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'LS means and p-value for test of difference is relugolix plus E2/NETA minus placebo.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 24', 'description': "The PGAs assessed participants' limitation in activities and the severity of symptoms due to uterine fibroids over the previous 4 weeks, as perceived by the participant. The PGA for symptoms is a 1-item questionnaire designed to assess participant's impression of the severity of their symptoms related to uterine fibroids. The PGA for function and symptoms was evaluated using a 5-point response scale (no limitation at all \\[1\\], mild limitation \\[2\\], moderate limitation \\[3\\], quite a bit of limitation \\[4\\], and extreme limitation \\[5\\]).\n\nAs per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized to treatment and who received at least 1 dose of study drug and had analyzable data at the specified timepoint.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline At Week 24 In Function Assessed Using The PGA Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Relugolix Plus E2/NETA (Group A)', 'description': 'Relugolix 40 mg co-administered with E2 (1.0 mg) and NETA (0.5 mg) for 24 weeks.'}, {'id': 'OG001', 'title': 'Placebo (Group C)', 'description': 'Placebo for relugolix co-administered with placebo for E2/NETA for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.6', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '0.15', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 24', 'description': "The PGAs assessed participants' limitation in activities and the severity of symptoms due to uterine fibroids over the previous 4 weeks, as perceived by the participant. The PGA for symptoms is a 1-item questionnaire designed to assess participant's impression of the severity of their symptoms related to uterine fibroids. The PGA for function and symptoms was evaluated using a 5-point response scale (no limitation at all \\[1\\], mild limitation \\[2\\], moderate limitation \\[3\\], quite a bit of limitation \\[4\\], and extreme limitation \\[5\\]).\n\nAs per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized to treatment and who received at least 1 dose of study drug and had analyzable data at the specified timepoint.'}, {'type': 'SECONDARY', 'title': 'Participants Achieving Improvement From Baseline In The PGA Questionnaire For Symptoms From Baseline At Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Relugolix Plus E2/NETA (Group A)', 'description': 'Relugolix 40 mg co-administered with E2 (1.0 mg) and NETA (0.5 mg) for 24 weeks.'}, {'id': 'OG001', 'title': 'Placebo (Group C)', 'description': 'Placebo for relugolix co-administered with placebo for E2/NETA for 24 weeks.'}], 'classes': [{'title': '1 Category improvement (-1)', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}, {'title': '2 Category improvement (-2)', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': '3 Category improvement (-3)', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': '4 Category improvement (-4)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Baseline through Week 24', 'description': "The PGAs assessed participants' limitation in activities and the severity of symptoms due to uterine fibroids over the previous 4 weeks, as perceived by the participant. The PGA for function and symptoms was evaluated using a 5-point response scale (no limitation at all \\[1\\], mild limitation \\[2\\], moderate limitation \\[3\\], quite a bit of limitation \\[4\\], and extreme limitation \\[5\\]). Category improvements for symptoms are presented. A 1-category improvement would be severe at baseline to moderate.\n\nAs per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized to treatment and who received at least 1 dose of study drug and had analyzable data at the specified timepoint.'}, {'type': 'SECONDARY', 'title': 'Participants Achieving Improvement From Baseline In The PGA Questionnaire For Uterine Fibroid-related Function From Baseline At Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Relugolix Plus E2/NETA (Group A)', 'description': 'Relugolix 40 mg co-administered with E2 (1.0 mg) and NETA (0.5 mg) for 24 weeks.'}, {'id': 'OG001', 'title': 'Placebo (Group C)', 'description': 'Placebo for relugolix co-administered with placebo for E2/NETA for 24 weeks.'}], 'classes': [{'title': '1 Category improvement (-1)', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': '2 Category improvement (-2)', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': '3 Category improvement (-3)', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': '4 Category improvement (-4)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Baseline through Week 24', 'description': "The PGAs assessed participants' limitation in activities and the severity of symptoms due to uterine fibroids over the previous 4 weeks, as perceived by the participant. The PGA for function and symptoms was evaluated using a 5-point response scale (no limitation at all \\[1\\], mild limitation \\[2\\], moderate limitation \\[3\\], quite a bit of limitation \\[4\\], and extreme limitation \\[5\\]). Category improvements for symptoms are presented. A 1-category improvement would be severe at baseline to moderate.\n\nAs per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized to treatment and who received at least 1 dose of study drug and had analyzable data at the specified timepoint.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline At Week 24 In The Menorrhagia Impact Questionnaire Score For Physical Activities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Relugolix Plus E2/NETA (Group A)', 'description': 'Relugolix 40 mg co-administered with E2 (1.0 mg) and NETA (0.5 mg) for 24 weeks.'}, {'id': 'OG001', 'title': 'Placebo (Group C)', 'description': 'Placebo for relugolix co-administered with placebo for E2/NETA for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.0', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '0.14', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'The Menorrhagia Impact was evaluated using a 5-point response scale to assess level of improvement from Baseline to Week 24. Response scale: Not at all, 2. Slightly, 3.Moderately, 4. Quite a bit and 5. Extremely.\n\nAs per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized to treatment and who received at least 1 dose of study drug and had analyzable data at the specified timepoint.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline At Week 24 In The Menorrhagia Impact Questionnaire Score For Social Activities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Relugolix Plus E2/NETA (Group A)', 'description': 'Relugolix 40 mg co-administered with E2 (1.0 mg) and NETA (0.5 mg) for 24 weeks.'}, {'id': 'OG001', 'title': 'Placebo (Group C)', 'description': 'Placebo for relugolix co-administered with placebo for E2/NETA for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.9', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '0.14', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'The Menorrhagia Impact was evaluated using a 5-point response scale to assess level of improvement from Baseline to Week 24. Response scale: Not at all, 2. Slightly, 3.Moderately, 4. Quite a bit and 5. Extremely.\n\nAs per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized to treatment and who received at least 1 dose of study drug and had analyzable data at the specified timepoint.'}, {'type': 'SECONDARY', 'title': 'Number Of Participants Who Achieved A Maximum NRS Score ≤ 1 For Uterine Fibroid-associated Pain Over The Last 35 Days Of Treatment Who Had Maximum Pain Scores ≥ 4 During The 35 Days Prior To Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Relugolix Plus E2/NETA (Group A)', 'description': 'Relugolix 40 mg co-administered with E2 (1.0 mg) and NETA (0.5 mg) for 24 weeks.'}, {'id': 'OG001', 'title': 'Placebo (Group C)', 'description': 'Placebo for relugolix co-administered with placebo for E2/NETA for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Baseline up to the last 35 days of treatment (up to 24 weeks)', 'description': 'Uterine fibroid-associated pain was assessed by a pain NRS. The pain NRS is a validated, single-item, self-reported measure, which asks respondents to rank their pain on an 11-point scale as follows: 0 (no pain), 1 to 3 (mild pain), 4 to 6 (moderate pain), and 7 to 10 (severe pain).\n\nAs per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized to treatment and who received at least 1 dose of study drug who had a maximum NRS score ≥ 4 at baseline.'}, {'type': 'SECONDARY', 'title': 'Number Of Participants With A ≥ 30% Reduction in NRS Score From Baseline to Last 35 Days of Treatment Who Had Maximum Pain Scores ≥ 4 At Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Relugolix Plus E2/NETA (Group A)', 'description': 'Relugolix 40 mg co-administered with E2 (1.0 mg) and NETA (0.5 mg) for 24 weeks.'}, {'id': 'OG001', 'title': 'Placebo (Group C)', 'description': 'Placebo for relugolix co-administered with placebo for E2/NETA for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0002', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value was based on Cochran-Mantel-Haenszel test stratified by Baseline MBL volume (\\< 225 mL, ≥ 225 mL).', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, Week 24', 'description': 'Uterine fibroid-associated pain was assessed by a pain NRS. The pain NRS is a validated, single-item, self-reported measure, which asks respondents to rank their pain on an 11-point scale as follows: 0 (no pain), 1 to 3 (mild pain), 4 to 6 (moderate pain), and 7 to 10 (severe pain).\n\nAs per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized to treatment and who received at least 1 dose of study drug who had a maximum NRS score ≥ 4 at baseline and had at least 28 days (80% of the last 35 days of treatment) of pain scores recorded in the e-Diary.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline In Luteinizing Serum Concentration At Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Relugolix Plus E2/NETA (Group A)', 'description': 'Relugolix 40 mg co-administered with E2 (1.0 mg) and NETA (0.5 mg) for 24 weeks.'}, {'id': 'OG001', 'title': 'Placebo (Group C)', 'description': 'Placebo for relugolix co-administered with placebo for E2/NETA for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.90', 'spread': '20.496', 'groupId': 'OG000'}, {'value': '3.62', 'spread': '12.524', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.', 'unitOfMeasure': 'IU/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized to treatment and who received at least 1 dose of study drug and had analyzable data at the specified timepoint.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline In Follicle Stimulating Serum Concentration At Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Relugolix Plus E2/NETA (Group A)', 'description': 'Relugolix 40 mg co-administered with E2 (1.0 mg) and NETA (0.5 mg) for 24 weeks.'}, {'id': 'OG001', 'title': 'Placebo (Group C)', 'description': 'Placebo for relugolix co-administered with placebo for E2/NETA for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.25', 'spread': '14.779', 'groupId': 'OG000'}, {'value': '0.10', 'spread': '11.024', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.', 'unitOfMeasure': 'IU/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized to treatment and who received at least 1 dose of study drug and had analyzable data at the specified timepoint.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline In E2 Serum Concentration At Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Relugolix Plus E2/NETA (Group A)', 'description': 'Relugolix 40 mg co-administered with E2 (1.0 mg) and NETA (0.5 mg) for 24 weeks.'}, {'id': 'OG001', 'title': 'Placebo (Group C)', 'description': 'Placebo for relugolix co-administered with placebo for E2/NETA for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-22.95', 'spread': '84.005', 'groupId': 'OG000'}, {'value': '51.72', 'spread': '145.346', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized to treatment and who received at least 1 dose of study drug and had analyzable data at the specified timepoint.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline In Progesterone Serum Concentration At Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Relugolix Plus E2/NETA (Group A)', 'description': 'Relugolix 40 mg co-administered with E2 (1.0 mg) and NETA (0.5 mg) for 24 weeks.'}, {'id': 'OG001', 'title': 'Placebo (Group C)', 'description': 'Placebo for relugolix co-administered with placebo for E2/NETA for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.05', 'spread': '2.262', 'groupId': 'OG000'}, {'value': '3.00', 'spread': '4.802', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized to treatment and who received at least 1 dose of study drug and had analyzable data at the specified timepoint.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Relugolix Plus Estradiol (E2)/ Norethindrone Acetate (NETA) (Group A)', 'description': 'Relugolix 40 milligrams (mg) co-administered with E2 (1.0 mg) and NETA (0.5 mg) for 24 weeks.'}, {'id': 'FG001', 'title': 'Relugolix Plus Delayed E2/NETA (Group B)', 'description': 'Relugolix 40 mg co-administered with placebo for E2/NETA for 12 weeks followed by relugolix co-administered with E2/NETA (1.0/0.5 mg) for 12 weeks.'}, {'id': 'FG002', 'title': 'Placebo (Group C)', 'description': 'Placebo for relugolix co-administered with placebo for E2/NETA for 24 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '128'}, {'groupId': 'FG001', 'numSubjects': '132'}, {'groupId': 'FG002', 'numSubjects': '128'}]}, {'type': 'Received at Least 1 Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '128'}, {'groupId': 'FG001', 'numSubjects': '132'}, {'groupId': 'FG002', 'numSubjects': '127'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '100'}, {'groupId': 'FG001', 'numSubjects': '103'}, {'groupId': 'FG002', 'numSubjects': '105'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '29'}, {'groupId': 'FG002', 'numSubjects': '23'}]}], 'dropWithdraws': [{'type': 'Discontinued due to AE (not dosed)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Protocol deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}]}]}], 'recruitmentDetails': 'A total of 80 study centers globally were initiated in this study, including centers in the United States, Brazil, Italy, Poland, South Africa, and the United Kingdom.', 'preAssignmentDetails': 'A total of 388 premenopausal women aged 18 to 50 years with heavy menstrual bleeding (≥ 80 milliliters \\[mL\\] per cycle for 2 cycles or ≥ 160 mL during 1 cycle documented by the alkaline hematin method) associated with uterine fibroids were randomized. One placebo participant was randomized and not treated due to a serious adverse event.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'BG000'}, {'value': '132', 'groupId': 'BG001'}, {'value': '128', 'groupId': 'BG002'}, {'value': '388', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Relugolix Plus E2/NETA (Group A)', 'description': 'Relugolix 40 mg co-administered with E2 (1.0 mg) and NETA (0.5 mg) for 24 weeks.'}, {'id': 'BG001', 'title': 'Relugolix Plus Delayed E2/NETA (Group B)', 'description': 'Relugolix 40 mg co-administered with placebo for E2/NETA for 12 weeks followed by relugolix co-administered with E2/NETA (1.0/0.5 mg) for 12 weeks.'}, {'id': 'BG002', 'title': 'Placebo (Group C)', 'description': 'Placebo for relugolix co-administered with placebo for E2/NETA for 24 weeks.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '128', 'groupId': 'BG000'}, {'value': '132', 'groupId': 'BG001'}, {'value': '128', 'groupId': 'BG002'}, {'value': '388', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '42.5', 'spread': '4.99', 'groupId': 'BG000'}, {'value': '41.3', 'spread': '5.39', 'groupId': 'BG001'}, {'value': '42.2', 'spread': '5.70', 'groupId': 'BG002'}, {'value': '42.0', 'spread': '5.38', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '128', 'groupId': 'BG000'}, {'value': '132', 'groupId': 'BG001'}, {'value': '128', 'groupId': 'BG002'}, {'value': '388', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}, {'value': '192', 'groupId': 'BG003'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}, {'value': '173', 'groupId': 'BG003'}]}]}, {'title': 'Other Race', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}, {'title': 'Multiple Race', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}]}, {'title': 'Race Not reported', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}, {'title': 'Not Hispanic or Latino', 'categories': [{'measurements': [{'value': '92', 'groupId': 'BG000'}, {'value': '99', 'groupId': 'BG001'}, {'value': '104', 'groupId': 'BG002'}, {'value': '295', 'groupId': 'BG003'}]}]}, {'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '90', 'groupId': 'BG003'}]}]}, {'title': 'Ethnicity Not reported', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '98', 'groupId': 'BG000'}, {'value': '101', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}, {'value': '298', 'groupId': 'BG003'}]}]}, {'title': 'Brazil', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '50', 'groupId': 'BG003'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}]}]}, {'title': 'South Africa', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'All participants who were enrolled and randomized in the study.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-09-18', 'size': 9630066, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-01-03T14:07', 'hasProtocol': True}, {'date': '2019-06-14', 'size': 6051130, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-01-03T14:08', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 388}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'dispFirstSubmitDate': '2020-04-02', 'completionDateStruct': {'date': '2020-08-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-23', 'studyFirstSubmitDate': '2017-02-08', 'dispFirstSubmitQcDate': '2022-03-23', 'resultsFirstSubmitDate': '2022-01-03', 'studyFirstSubmitQcDate': '2017-02-08', 'dispFirstPostDateStruct': {'date': '2022-04-19', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2022-04-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-03-23', 'studyFirstPostDateStruct': {'date': '2017-02-10', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-04-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage Of Participants Who Achieved A Menstrual Blood Loss (MBL) Volume Of < 80 mL And A ≥ 50% Reduction From Baseline MBL Volume With Relugolix Plus E2/NETA', 'timeFrame': 'From Baseline up to last 35 days of treatment (up to Week 24)', 'description': 'A responder was a participant who had MBL volume of \\< 80 mL and at least a 50% reduction from baseline MBL volume over the last 35 days of treatment (up to Week 24). All returned feminine products collected at each clinical visit were analyzed by the alkaline hematin method to obtain the MBL volume. MBL volume was measured over the Week 24/early termination feminine product collection interval (up to 35 days prior to the last dose of treatment). The percentage of participants who were responders are presented.\n\nAs per the objective of the study, the pre-specified primary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.'}], 'secondaryOutcomes': [{'measure': 'Percentage Of Participants With Amenorrhea Over The Last 35 Days Of Treatment', 'timeFrame': 'From Baseline up to last 35 days of treatment (up to Week 24)', 'description': 'Amenorrhea was defined as meeting 1 of the following criteria for 2 consecutive visits:\n\n1. No feminine product returned due to reported amenorrhea;\n2. No feminine product returned due to reports of spotting/negligible bleeding coupled with electronic diary (eDiary) data indicating infrequent non-cyclic bleeding/spotting;\n3. Feminine product collection with a negligible observed MBL volume coupled with eDiary data indicating infrequent non-cyclic bleeding/spotting.\n\nAs per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.'}, {'measure': 'Percent Change From Baseline At Week 24 In MBL Volume', 'timeFrame': 'Baseline, Week 24', 'description': 'MBL volume was measured using the alkaline hematin method. As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.'}, {'measure': 'Percentage Of Participants With A Hemoglobin Level ≤ 10.5 g/dL At Baseline Who Achieved An Increase Of > 2 g/dL From Baseline At Week 24', 'timeFrame': 'From Baseline up to Week 24', 'description': 'Blood samples were collected from participants for hemoglobin measurements. Percentages are based on number of participants with hemoglobin ≤ 10.5 gram (g)/deciliter (dL) at Baseline and reported at Week 24.\n\nAs per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA with placebo arms are presented.'}, {'measure': 'Percentage Of Participants With A Maximum NRS Score ≤ 1 For Uterine Fibroid-Associated Pain Over The Last 35 Days Of Treatment', 'timeFrame': 'From Baseline up to Week 24', 'description': 'Uterine fibroid-associated pain was assessed by a pain numerical rating scale (NRS). The pain NRS is a validated, single-item, self-reported measure, which asks respondents to rank their pain on an 11-point scale as follows: 0 (no pain), 1 to 3 (mild pain), 4 to 6 (moderate pain), and 7 to 10 (severe pain).\n\nParticipants were asked to document, in an e-Diary, the worst pain associated with their uterine fibroids that they experienced during the last 24 hours, every day until the end of study drug administration. Pain evaluable participants, defined as those who had maximum NRS score ≥ 4 at Baseline and had at least 28 days (80% of the last 35 days of treatment) of pain scores recorded in the e-Diary, were analyzed.\n\nAs per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.'}, {'measure': 'Percent Change From Baseline At Week 24 In Primary Uterine Fibroid Volume', 'timeFrame': 'Baseline, Week 24', 'description': 'The volume of the primary uterine fibroid was measured by transvaginal or transabdominal ultrasound.\n\nAs per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.'}, {'measure': 'Percent Change From Baseline At Week 24 In Uterine Volume', 'timeFrame': 'Baseline, Week 24', 'description': 'The volume of the uterus was measured by transvaginal or transabdominal ultrasound.\n\nAs per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.'}, {'measure': 'Change From Baseline At Week 24 In UFS-QoL Bleeding And Pelvic Discomfort Scale Score As Measured By The UFS-QoL (Q1, Q2, Q5)', 'timeFrame': 'Baseline, Week 24', 'description': 'The Uterine Fibroid Symptom and Health-Related Quality of Life (UFS-QoL) Bleeding and Pelvic Discomfort (BPD) Scale has been derived from the UFS-QoL Symptoms Scale. The scale consists of the following 3 symptoms proximal to uterine fibroids: Heavy bleeding during your menstrual period (Question \\[Q\\] 1), passing blood clots during your menstrual period (Q2), and feeling tightness or pressure in your pelvic area (Q5). raw scores were transformed to a normalized score: Transformed Score = \\[(Actual raw score - lowest possible raw score)/(Possible raw score range)\\] \\* 100 Transformed score ranges from 0 to 100 based on Likert scale (None of time, a little of time, some of the time, most of the time and all of the time). Lower score indicates minimal symptom severity and higher score indicates maximum symptom severity.\n\nAs per the study objective, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only these two arms are presented.'}, {'measure': 'Percent Change From Baseline At Week 12 In Bone Mineral Density At The Lumbar Spine (L1 To L4), As Assessed By DXA', 'timeFrame': 'Baseline, Week 12', 'description': 'Bone mineral density (BMD) was assessed by dual-energy x-ray absorptiometry (DXA) at the lumbar spine (L1, L2, L3, and L4) at Baseline and at Week 12. The scans were read by the central radiology laboratory in accordance with the imaging charter. The same DXA machine was used at the local imaging center at each site and operated in the same scan mode for all images procured for an individual participant. All images were submitted for central reading. The central radiology laboratory collected and evaluated all DXA scans for acceptability and measured BMD.\n\nAs per the objective of the study, the pre-specified secondary analyses compared relugolix plus E2/NETA with relugolix plus delayed E2/NETA at Week 12 and are presented below.'}, {'measure': 'Percent Change From Baseline At Week 24 In Bone Mineral Density At The Lumbar Spine (L1 To L4), Total Hip, And Femoral Neck', 'timeFrame': 'Baseline, Week 24', 'description': 'BMD was assessed by DXA at the lumbar spine (L1, L2, L3, and L4), total hip, and femoral neck at Baseline and at Week 24. The scans were read by the central radiology laboratory in accordance with the imaging charter. The same DXA machine was used at the local imaging center at each site and operated in the same scan mode for all images procured for an individual participant. All images were submitted for central reading. The central radiology laboratory collected and evaluated all DXA scans for acceptability and measured BMD.\n\nAs per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.'}, {'measure': 'Percentage Of Participants Experiencing Vasomotor Symptoms Through Week 12', 'timeFrame': 'Baseline through Week 12', 'description': 'An adverse event was defined as an unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product, whether or not related to the medicinal product. The preferred terms of hyperhidrosis, feeling hot, hot flush, night sweats, and flushing were combined to describe vasomotor symptoms. Participants with multiple events for a given preferred term were counted only once for each preferred term.\n\nReported CI based on exact binomial 95% CI (Clopper-Pearson).\n\nAs per the objective of the study, this secondary analysis compared relugolix plus E2/NETA with relugolix plus delayed E2/NETA at Week 12 and are presented below.'}, {'measure': 'Percentage Of Participants Experiencing Vasomotor Symptoms Through Week 24', 'timeFrame': 'Baseline through Week 24', 'description': 'An adverse event was defined as an unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product, whether or not related to the medicinal product. The preferred terms of hyperhidrosis, feeling hot, hot flush, night sweats, and flushing were combined to describe vasomotor symptoms. Participants with multiple events for a given preferred term were counted only once for each preferred term.\n\nReported percentages based on the total number of participants in each treatment group.\n\nAs per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.'}, {'measure': 'Predose Trough Concentrations Of Relugolix And Norethindrone (NET) In The Relugolix Plus E2/NETA Group At Week 24', 'timeFrame': 'Week 24', 'description': 'Blood samples for determination of relugolix and NET plasma concentrations were collected predose at Week 24. Relugolix and NET plasma concentrations were determined using validated bioanalytical methodology.\n\nConcentrations below the quantification limit (BQL) were set to 0 for analysis of summary statistics.\n\nAs per the objective of the study, only relugolix plus E2/NETA concentration is presented.'}, {'measure': 'Predose Trough Concentrations Of E2 In The Relugolix Plus E2/NETA Group At Week 24', 'timeFrame': 'Week 24', 'description': 'Blood samples for determination of E2 serum concentrations were collected predose at Week 24. Relugolix and NET plasma concentrations were determined using validated bioanalytical methodology.\n\nConcentrations below the quantification limit (BQL) were set to 0 for analysis of summary statistics. As per the objective of the study, only relugolix plus E2/NETA concentration is presented.'}, {'measure': 'Change From Baseline At Week 24 In Predose Concentrations Of Estradiol In The Relugolix Plus E2/NETA Group', 'timeFrame': 'Baseline, Week 24', 'description': 'Blood samples for determination of serum concentrations were collected predose at Week 24. Relugolix and NET plasma concentrations were determined using validated bioanalytical methodology.\n\nConcentrations below the quantification limit (BQL) were set to 0 for analysis of summary statistics. As per the objective of the study, only relugolix plus E2/NETA concentration is presented.'}, {'measure': 'Time To MBL Response', 'timeFrame': 'From Baseline through Week 24', 'description': 'Defined as the time to achieve an MBL volume of \\< 80 mL and a ≥ 50% reduction from Baseline MBL volume as measured by the alkaline hematin method. MBL volume was measured using the alkaline hematin method.\n\nAs per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.'}, {'measure': 'Sustained Amenorrhea Rate (No Or Negligible Bleeding)', 'timeFrame': 'Week 24', 'description': 'Sustained amenorrhea is defined as participants time to achieve and maintain amenorrhea until the date of last study drug.\n\nAs per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.'}, {'measure': 'Time To Achieving Sustained Amenorrhea (No Or Negligible Bleeding)', 'timeFrame': 'From Baseline through Week 24', 'description': 'Sustained amenorrhea status as determined based on time to achieve and maintain amenorrhea status.\n\nAs per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.'}, {'measure': 'Time To Achieving Amenorrhea (No Or Negligible Bleeding)', 'timeFrame': 'From Baseline through Week 24', 'description': 'Time to amenorrhea was defined as the weeks from date of first dose of study drug to the start of amenorrhea.\n\nAs per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.'}, {'measure': 'Number Of Participants With Hemoglobin ≤ 10.5 g/dL At Baseline And Achieved An Increase Of > 2 g/dL At Week 24', 'timeFrame': 'From Baseline through Week 24', 'description': 'As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.'}, {'measure': 'Percent Change From Baseline In Hemoglobin For Women With a Hemoglobin ≤ 10.5 g/dL At Baseline', 'timeFrame': 'Week 24', 'description': 'LS means and p-value for test of difference is relugolix plus E2/NETA minus Placebo based on mixed-effect model with treatment, visit, region, Baseline MBL and treatment by visit interaction included as fixed effects.\n\nAs per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.'}, {'measure': 'Number Of Participants With Hemoglobin Increase Of ≥ 1 g/dL From Baseline To Week 24 Among Those With Below Lower Limit Of Normal', 'timeFrame': 'Week 24', 'description': 'As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.'}, {'measure': 'Change From Baseline At Week 24 In The UFS-QoL Symptom Severity Scale Score', 'timeFrame': 'Baseline, Week 24', 'description': 'Transformed score ranges from 0 to 100 based on Likert scale (None of time, a little of time, some of the time, most of the time and all of the time). Lower score indicates minimal symptom severity and higher score indicates maximum symptom severity. A negative change from baseline indicates improvement.\n\nAs per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.'}, {'measure': 'Change From Baseline At Week 24 In The UFS-QoL Activities Scale Score', 'timeFrame': 'Baseline, Week 24', 'description': 'Transformed score ranges from 0 to 100 based on Likert scale (None of time, a little of time, some of the time, most of the time and all of the time). Lower score indicates minimal symptom severity and higher score indicates maximum symptom severity.\n\nAs per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.'}, {'measure': 'Change From Baseline At Week 24 In The UFS-QoL Revised Activities Scale Score', 'timeFrame': 'Baseline, Week 24', 'description': 'Transformed score ranges from 0 to 100 based on Likert scale (none of time, a little of time, some of the time, most of the time and all of the time). Lower score indicates minimal symptom severity and higher score indicates maximum symptom severity.\n\nAs per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.'}, {'measure': 'Change From Baseline In UFS-QoL Score By Health-Related Quality Of Life Total Score', 'timeFrame': 'Baseline, Week 24', 'description': 'The UFS-QoL total score was the sum of 6 subscales (concern, activities, energy/mood, control, self-conscious, and sexual function). The raw scores were transformed to normalized scores. Transformed score ranges from 0 to 100. Higher scores are indicative of better health-related quality of life (high = good).\n\nAs per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.'}, {'measure': 'Number Of Responders With At Least 20 Points Increase From Baseline At Week 24 In UFS-QoL Revised Activities Scale Score', 'timeFrame': 'From Baseline through Week 24', 'description': 'As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.'}, {'measure': 'Change From Baseline In UFS-QoL Bleeding And Pelvic Discomfort Scale Score', 'timeFrame': 'Baseline, Week 24', 'description': 'The Bleeding and Pelvic Discomfort Scale consists of 3 items proximal to uterine fibroids that are experienced by most patients (heavy bleeding during the menstrual period \\[Question 1\\], passing blood clots during the menstrual period \\[Question 2\\], and feeling tightness or pressure in the pelvic area \\[Question 5\\]).Transformed score ranges from 0 to 100 based on Likert scale (None of time, a little of time, some of the time, most of the time and all of the time). Lower score indicates minimal symptom severity and higher score indicates maximum symptom severity. A negative change from baseline indicates improvement.\n\nAs per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.'}, {'measure': 'Number Of Responders With At Least 20 Points Decrease In UFS-QoL Bleeding And Pelvic Discomfort Scale Score', 'timeFrame': 'Baseline, Week 24', 'description': 'A Responder was defined as meeting a meaningful change threshold, set as a 20-point change from Baseline, in the Bleeding And Pelvic Discomfort Scale at Week 24 on the transformed score.\n\nAs per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.'}, {'measure': 'Change From Baseline At Week 24 In The Interference Of Uterine Fibroids With Physical Activities Based On UFS-QoL Question 11', 'timeFrame': 'Baseline, Week 24', 'description': 'Transformed score ranges from 0 to 100 based on Likert scale (None of time, a little of time, some of the time, most of the time and all of the time). Lower score indicates minimal symptom severity and higher score indicates maximum symptom severity. A negative change from baseline indicates improvement.\n\nAs per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.'}, {'measure': 'Change From Baseline At Week 24 In The Interference Of Uterine Fibroids With Social Activities Based On UFS-QoL Question 20', 'timeFrame': 'Baseline, Week 24', 'description': 'Transformed score ranges from 0 to 100 based on Likert scale (None of time, a little of time, some of the time, most of the time and all of the time). Lower score indicates minimal symptom severity and higher score indicates maximum symptom severity. A negative change from baseline indicates improvement.\n\nAs per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.'}, {'measure': 'Change From Baseline At Week 24 In Embarrassment Caused By Uterine Fibroids Based On UFS-QoL Question 29', 'timeFrame': 'Baseline, Week 24', 'description': 'Transformed score ranges from 0 to 100 based on Likert scale (None of time, a little of time, some of the time, most of the time and all of the time). Lower score indicates minimal symptom severity and higher score indicates maximum symptom severity. A negative change from baseline indicates improvement.\n\nAs per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.'}, {'measure': 'Change From Baseline At Week 24 In Symptoms Assessed Using The Patient Global Assessment (PGA) Questionnaire', 'timeFrame': 'Baseline, Week 24', 'description': "The PGAs assessed participants' limitation in activities and the severity of symptoms due to uterine fibroids over the previous 4 weeks, as perceived by the participant. The PGA for symptoms is a 1-item questionnaire designed to assess participant's impression of the severity of their symptoms related to uterine fibroids. The PGA for function and symptoms was evaluated using a 5-point response scale (no limitation at all \\[1\\], mild limitation \\[2\\], moderate limitation \\[3\\], quite a bit of limitation \\[4\\], and extreme limitation \\[5\\]).\n\nAs per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented."}, {'measure': 'Change From Baseline At Week 24 In Function Assessed Using The PGA Questionnaire', 'timeFrame': 'Baseline, Week 24', 'description': "The PGAs assessed participants' limitation in activities and the severity of symptoms due to uterine fibroids over the previous 4 weeks, as perceived by the participant. The PGA for symptoms is a 1-item questionnaire designed to assess participant's impression of the severity of their symptoms related to uterine fibroids. The PGA for function and symptoms was evaluated using a 5-point response scale (no limitation at all \\[1\\], mild limitation \\[2\\], moderate limitation \\[3\\], quite a bit of limitation \\[4\\], and extreme limitation \\[5\\]).\n\nAs per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented."}, {'measure': 'Participants Achieving Improvement From Baseline In The PGA Questionnaire For Symptoms From Baseline At Week 24', 'timeFrame': 'From Baseline through Week 24', 'description': "The PGAs assessed participants' limitation in activities and the severity of symptoms due to uterine fibroids over the previous 4 weeks, as perceived by the participant. The PGA for function and symptoms was evaluated using a 5-point response scale (no limitation at all \\[1\\], mild limitation \\[2\\], moderate limitation \\[3\\], quite a bit of limitation \\[4\\], and extreme limitation \\[5\\]). Category improvements for symptoms are presented. A 1-category improvement would be severe at baseline to moderate.\n\nAs per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented."}, {'measure': 'Participants Achieving Improvement From Baseline In The PGA Questionnaire For Uterine Fibroid-related Function From Baseline At Week 24', 'timeFrame': 'From Baseline through Week 24', 'description': "The PGAs assessed participants' limitation in activities and the severity of symptoms due to uterine fibroids over the previous 4 weeks, as perceived by the participant. The PGA for function and symptoms was evaluated using a 5-point response scale (no limitation at all \\[1\\], mild limitation \\[2\\], moderate limitation \\[3\\], quite a bit of limitation \\[4\\], and extreme limitation \\[5\\]). Category improvements for symptoms are presented. A 1-category improvement would be severe at baseline to moderate.\n\nAs per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented."}, {'measure': 'Change From Baseline At Week 24 In The Menorrhagia Impact Questionnaire Score For Physical Activities', 'timeFrame': 'Baseline, Week 24', 'description': 'The Menorrhagia Impact was evaluated using a 5-point response scale to assess level of improvement from Baseline to Week 24. Response scale: Not at all, 2. Slightly, 3.Moderately, 4. Quite a bit and 5. Extremely.\n\nAs per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.'}, {'measure': 'Change From Baseline At Week 24 In The Menorrhagia Impact Questionnaire Score For Social Activities', 'timeFrame': 'Baseline, Week 24', 'description': 'The Menorrhagia Impact was evaluated using a 5-point response scale to assess level of improvement from Baseline to Week 24. Response scale: Not at all, 2. Slightly, 3.Moderately, 4. Quite a bit and 5. Extremely.\n\nAs per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.'}, {'measure': 'Number Of Participants Who Achieved A Maximum NRS Score ≤ 1 For Uterine Fibroid-associated Pain Over The Last 35 Days Of Treatment Who Had Maximum Pain Scores ≥ 4 During The 35 Days Prior To Randomization', 'timeFrame': 'From Baseline up to the last 35 days of treatment (up to 24 weeks)', 'description': 'Uterine fibroid-associated pain was assessed by a pain NRS. The pain NRS is a validated, single-item, self-reported measure, which asks respondents to rank their pain on an 11-point scale as follows: 0 (no pain), 1 to 3 (mild pain), 4 to 6 (moderate pain), and 7 to 10 (severe pain).\n\nAs per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.'}, {'measure': 'Number Of Participants With A ≥ 30% Reduction in NRS Score From Baseline to Last 35 Days of Treatment Who Had Maximum Pain Scores ≥ 4 At Baseline', 'timeFrame': 'Baseline, Week 24', 'description': 'Uterine fibroid-associated pain was assessed by a pain NRS. The pain NRS is a validated, single-item, self-reported measure, which asks respondents to rank their pain on an 11-point scale as follows: 0 (no pain), 1 to 3 (mild pain), 4 to 6 (moderate pain), and 7 to 10 (severe pain).\n\nAs per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.'}, {'measure': 'Change From Baseline In Luteinizing Serum Concentration At Week 24', 'timeFrame': 'Baseline, Week 24', 'description': 'As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.'}, {'measure': 'Change From Baseline In Follicle Stimulating Serum Concentration At Week 24', 'timeFrame': 'Baseline, Week 24', 'description': 'As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.'}, {'measure': 'Change From Baseline In E2 Serum Concentration At Week 24', 'timeFrame': 'Baseline, Week 24', 'description': 'As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.'}, {'measure': 'Change From Baseline In Progesterone Serum Concentration At Week 24', 'timeFrame': 'Baseline, Week 24', 'description': 'As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Uterine Fibroid', 'Heavy Menstrual Bleeding', 'Menstrual Blood Volume'], 'conditions': ['Heavy Menstrual Bleeding', 'Uterine Fibroid']}, 'referencesModule': {'references': [{'pmid': '39466126', 'type': 'DERIVED', 'citation': 'Stewart EA, Lukes AS, Venturella R, Ferreira JA, Li Y, Hunsche E, Wagman RB, Al-Hendy A. A plain language summary describing changes in pain associated with uterine fibroids among women receiving relugolix combination therapy. Pain Manag. 2024 Sep;14(9):469-476. doi: 10.1080/17581869.2024.2408114. Epub 2024 Oct 28.'}, {'pmid': '37863160', 'type': 'DERIVED', 'citation': 'Stewart EA, Al-Hendy A, Lukes AS, Madueke-Laveaux OS, Zhu E, Proehl S, Schulmann T, Marsh EE. Relugolix combination therapy in Black/African American women with symptomatic uterine fibroids: LIBERTY Long-Term Extension study. Am J Obstet Gynecol. 2024 Feb;230(2):237.e1-237.e11. doi: 10.1016/j.ajog.2023.10.030. Epub 2023 Oct 18.'}, {'pmid': '37477173', 'type': 'DERIVED', 'citation': 'Al-Hendy A, Lukes AS, Venturella R, Villarroel C, McKain L, Li Y, Wagman RB, Stewart EA. A plain language summary of the long-term relugolix combination therapy study for uterine fibroids. J Comp Eff Res. 2023 Aug;12(8):e230069. doi: 10.57264/cer-2023-0069. Epub 2023 Jul 21.'}, {'pmid': '37183454', 'type': 'DERIVED', 'citation': 'Al-Hendy A, Lukes AS, Poindexter AN 3rd, Venturella R, Villarroel C, Critchley HO, Li Y, McKain L, Arjona Ferreira JC, Langenberg AG, Wagman RB, Stewart EA. A plain language summary of the safety of relugolix combination therapy and improvement in symptoms in women with uterine fibroids from the LIBERTY 1 and LIBERTY 2 studies. Pain Manag. 2023 Apr;13(4):205-211. doi: 10.2217/pmt-2022-0085. Epub 2023 May 15.'}, {'pmid': '36357960', 'type': 'DERIVED', 'citation': 'Al-Hendy A, Lukes AS, Poindexter AN 3rd, Venturella R, Villarroel C, McKain L, Li Y, Wagman RB, Stewart EA. Long-term Relugolix Combination Therapy for Symptomatic Uterine Leiomyomas. Obstet Gynecol. 2022 Dec 1;140(6):920-930. doi: 10.1097/AOG.0000000000004988. Epub 2022 Nov 2.'}, {'pmid': '35675604', 'type': 'DERIVED', 'citation': 'Stewart EA, Lukes AS, Venturella R, Arjona Ferreira JC, Li Y, Hunsche E, Wagman RB, Al-Hendy A. Relugolix Combination Therapy for Uterine Leiomyoma-Associated Pain in the LIBERTY Randomized Trials. Obstet Gynecol. 2022 Jun 1;139(6):1070-1081. doi: 10.1097/AOG.0000000000004787. Epub 2022 May 2.'}, {'pmid': '35415708', 'type': 'DERIVED', 'citation': 'Hunsche E, Rakov V, Scippa K, Witherspoon B, McKain L. The Burden of Uterine Fibroids from the Perspective of US Women Participating in Open-Ended Interviews. Womens Health Rep (New Rochelle). 2022 Mar 4;3(1):286-296. doi: 10.1089/whr.2021.0086. eCollection 2022.'}, {'pmid': '33596357', 'type': 'DERIVED', 'citation': 'Al-Hendy A, Lukes AS, Poindexter AN 3rd, Venturella R, Villarroel C, Critchley HOD, Li Y, McKain L, Arjona Ferreira JC, Langenberg AGM, Wagman RB, Stewart EA. Treatment of Uterine Fibroid Symptoms with Relugolix Combination Therapy. N Engl J Med. 2021 Feb 18;384(7):630-642. doi: 10.1056/NEJMoa2008283.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the benefit of relugolix 40 milligrams (mg) once a day co-administered with estradiol (E2) 1 mg and norethindrone acetate (NETA) 0.5 mg compared with placebo for 24 weeks on heavy menstrual bleeding associated with uterine fibroids.', 'detailedDescription': "This study is an international phase 3 randomized, double-blind, placebo-controlled efficacy and safety study to evaluate 24 weeks of oral daily relugolix 40 mg co-administered with low-dose E2 and NETA (Group A) and 12 weeks of daily oral relugolix 40 mg alone followed by 12 weeks of daily oral relugolix 40 mg co-administered with low-dose E2 and NETA (Group B) compared with 24 weeks of placebo (Group C).\n\nAll participants completing the Week 24 visit, including women randomized to placebo, were offered the opportunity to enroll in an open-label extension study in which all eligible participants will receive relugolix co-administered with low-dose E2 and NETA. Participants who did not enroll into the extension study had a follow-up visit approximately 30 days after the end of treatment (that is, after the participant's last dose of study medication).\n\nSafety will be assessed throughout the study by monitoring adverse events, vital signs, physical examinations, clinical laboratory tests, 12-lead electrocardiograms, and assessments of bone mineral density."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n1. Premenopausal female aged 18 to 50 years old (inclusive) on the day of signing and dating the informed consent form.\n2. Has regularly occurring menstrual periods of ≤ 14 days duration with a cycle of 21 to 38 days from the start of 1 menstrual period until the start of the next, by participant history for at least 3 months prior to the first screening visit.\n3. Has a diagnosis of uterine fibroids that is confirmed by a transvaginal and/or transabdominal ultrasound performed during the screening period.\n4. Has heavy menstrual bleeding associated with uterine fibroids as evidenced by an MBL of ≥ 160 milliliter (mL) during 1 cycle or ≥ 80 mL per cycle for 2 menstrual cycles as measured by the alkaline hematin method during the screening period.\n\nKey Exclusion Criteria:\n\n1. Has transvaginal and/or transabdominal ultrasound during the screening period demonstrating pathology other than uterine fibroids that could be responsible for or contributing to the patient's heavy menstrual bleeding.\n2. Has known rapidly enlarging uterine fibroids in the opinion of the investigator.\n3. Has a weight that exceeds the weight limit of the DXA scanner or has a condition that precludes an adequate DXA measurement at the lumbar spine and proximal femur.\n4. Has a history of or currently has osteoporosis, or other metabolic bone disease, hyperparathyroidism, hyperprolactinemia, hyperthyroidism, anorexia nervosa, or low traumatic (from the standing position) or atraumatic fracture (toe, finger, skull, face and ankle fractures are allowed). A history of successfully treated hyperparathyroidism, hyperprolactinemia, or hyperthyroidism is allowed if the participant's bone mineral density is within normal limits.\n5. Has a history of the use of bisphosphonates, calcitonin, calcitriol, ipriflavone, teriparatide, denosumab, or any medication other than calcium and vitamin D preparations to treat bone mineral density loss.\n6. Has been a participant in an investigational drug or device study within the 1 month prior to the first screening visit."}, 'identificationModule': {'nctId': 'NCT03049735', 'briefTitle': 'LIBERTY 1: Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids', 'organization': {'class': 'INDUSTRY', 'fullName': 'Myovant Sciences GmbH'}, 'officialTitle': 'LIBERTY 1: An International Phase 3 Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study to Evaluate Relugolix Co-Administered With and Without Low-Dose Estradiol and Norethindrone Acetate in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids', 'orgStudyIdInfo': {'id': 'MVT-601-3001'}, 'secondaryIdInfos': [{'id': '2016-003727-27', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Relugolix plus E2/NETA (Group A)', 'description': 'Relugolix co-administered with E2/NETA for 24 weeks.', 'interventionNames': ['Drug: Relugolix', 'Drug: Estradiol/norethindrone acetate']}, {'type': 'EXPERIMENTAL', 'label': 'Relugolix plus Delayed E2/NETA (Group B)', 'description': 'Relugolix co-administered with E2/NETA placebo for 12 weeks, followed by relugolix co-administered with E2/NETA for 12 weeks.', 'interventionNames': ['Drug: Relugolix', 'Drug: Estradiol/norethindrone acetate', 'Drug: Estradiol/norethindrone acetate placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (Group C)', 'description': 'Relugolix placebo co-administered with E2/NETA placebo for 24 weeks.', 'interventionNames': ['Drug: Estradiol/norethindrone acetate placebo', 'Drug: Relugolix placebo']}], 'interventions': [{'name': 'Relugolix', 'type': 'DRUG', 'otherNames': ['TAK-385', 'MVT-601'], 'description': 'Relugolix (40 mg) tablet administered orally once daily.', 'armGroupLabels': ['Relugolix plus Delayed E2/NETA (Group B)', 'Relugolix plus E2/NETA (Group A)']}, {'name': 'Estradiol/norethindrone acetate', 'type': 'DRUG', 'otherNames': ['E2/NETA', 'low-dose hormonal add-back'], 'description': 'E2 (1.0 mg)/NETA (0.5 mg) co-formulated capsule administered orally once daily.', 'armGroupLabels': ['Relugolix plus Delayed E2/NETA (Group B)', 'Relugolix plus E2/NETA (Group A)']}, {'name': 'Estradiol/norethindrone acetate placebo', 'type': 'DRUG', 'description': 'E2 (0 mg)/NETA (0 mg) placebo capsule administered orally once daily and designed to match the capsule containing E2/NETA in size, shape, color, and odor.', 'armGroupLabels': ['Placebo (Group C)', 'Relugolix plus Delayed E2/NETA (Group B)']}, {'name': 'Relugolix placebo', 'type': 'DRUG', 'description': 'Relugolix (0 mg) placebo tablet administered orally once daily and manufactured to match the relugolix tablet in size, shape, color, and odor.', 'armGroupLabels': ['Placebo (Group C)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36420', 'city': 'Andalusia', 'state': 'Alabama', 'country': 'United States', 'facility': 'Andalusia', 'geoPoint': {'lat': 31.30808, 'lon': -86.48243}}, {'zip': '36608', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'Mobile', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Little Rock', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '91942', 'city': 'La Mesa', 'state': 'California', 'country': 'United States', 'facility': 'La Mesa', 'geoPoint': {'lat': 32.76783, 'lon': -117.02308}}, {'zip': '90717', 'city': 'Lomita', 'state': 'California', 'country': 'United States', 'facility': 'Lomita', 'geoPoint': {'lat': 33.79224, 'lon': -118.31507}}, {'zip': '90650', 'city': 'Norwalk', 'state': 'California', 'country': 'United States', 'facility': 'Norwalk', 'geoPoint': {'lat': 33.90224, 'lon': -118.08173}}, {'zip': '92056', 'city': 'Oceanside', 'state': 'California', 'country': 'United States', 'facility': 'Oceanside', 'geoPoint': {'lat': 33.19587, 'lon': -117.37948}}, {'zip': '92108', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'San Diego', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '92111', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'San Diego', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '80209', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Denver', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '33180', 'city': 'Aventura', 'state': 'Florida', 'country': 'United States', 'facility': 'Aventura', 'geoPoint': {'lat': 25.95648, 'lon': -80.13921}}, {'zip': '33510', 'city': 'Brandon', 'state': 'Florida', 'country': 'United States', 'facility': 'Brandon', 'geoPoint': {'lat': 27.9378, 'lon': -82.28592}}, {'zip': '33759', 'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'facility': 'Clearwater', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '34711', 'city': 'Clermont', 'state': 'Florida', 'country': 'United States', 'facility': 'Clermont', 'geoPoint': {'lat': 28.54944, 'lon': -81.77285}}, {'zip': '33912', 'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'facility': 'Fort Myers', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'zip': '33012', 'city': 'Hialeah', 'state': 'Florida', 'country': 'United States', 'facility': 'Hialeah', 'geoPoint': {'lat': 25.8576, 'lon': -80.27811}}, {'zip': '33016', 'city': 'Hialeah', 'state': 'Florida', 'country': 'United States', 'facility': 'Hialeah', 'geoPoint': {'lat': 25.8576, 'lon': -80.27811}}, {'zip': '32207', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Jacksonville', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33319', 'city': 'Lauderdale Lakes', 'state': 'Florida', 'country': 'United States', 'facility': 'Lauderdale Lakes', 'geoPoint': {'lat': 26.16647, 'lon': -80.20838}}, {'zip': '33063', 'city': 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