Ignite Creation Date:
2025-12-24 @ 6:44 PM
Ignite Modification Date:
2026-03-01 @ 12:50 PM
Study NCT ID:
NCT03213457
Status:
COMPLETED
Last Update Posted:
2024-12-20
First Post:
2017-07-07
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Clinical Study to Evaluate the Safety and Efficacy of Elagolix in Participants With Moderate to Severe Endometriosis-Associated Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['American Samoa']}, 'conditionBrowseModule': {'meshes': [{'id': 'D004715', 'term': 'Endometriosis'}, {'id': 'D004412', 'term': 'Dysmenorrhea'}], 'ancestors': [{'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': 'D008599', 'term': 'Menstruation Disturbances'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D017699', 'term': 'Pelvic Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C418365', 'term': 'estradiol, norethindrone drug combination'}, {'id': 'C539351', 'term': 'elagolix'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'abbvieclinicaltrials@abbvie.com', 'phone': '800-633-9110', 'title': 'Global Medical Services', 'organization': 'AbbVie'}, 'certainAgreement': {'otherDetails': 'AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).', 'description': 'Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment.\n\nArm counts include all randomized participants.', 'eventGroups': [{'id': 'EG000', 'title': 'SCR_Placebo', 'description': 'Screening (SCR) Period: Placebo for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.', 'otherNumAtRisk': 194, 'deathsNumAtRisk': 194, 'otherNumAffected': 1, 'seriousNumAtRisk': 194, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'SCR_Elagolix', 'description': 'Screening (SCR) Period: Elagolix 200 mg BID alone for the first 6 months of the 12-month placebo-controlled Treatment Period and elagolix 200 mg BID+E2/NETA 1 mg/0.5 mg QD for the second 6 months, followed by elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.', 'otherNumAtRisk': 98, 'deathsNumAtRisk': 98, 'otherNumAffected': 0, 'seriousNumAtRisk': 98, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'SCR_Elagolix_and_E2-NETA', 'description': 'Screening (SCR) Period: Elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.', 'otherNumAtRisk': 389, 'deathsNumAtRisk': 389, 'otherNumAffected': 1, 'seriousNumAtRisk': 389, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'DB_Placebo', 'description': 'Double-blinded (DB) Period: Placebo for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.', 'otherNumAtRisk': 194, 'deathsNumAtRisk': 194, 'otherNumAffected': 89, 'seriousNumAtRisk': 194, 'deathsNumAffected': 0, 'seriousNumAffected': 8}, {'id': 'EG004', 'title': 'DB_Elagolix', 'description': 'Double-blinded (DB) Period: Elagolix 200 mg BID alone for the first 6 months of the 12-month placebo-controlled Treatment Period and elagolix 200 mg BID+E2/NETA 1 mg/0.5 mg QD for the second 6 months, followed by elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.', 'otherNumAtRisk': 98, 'deathsNumAtRisk': 98, 'otherNumAffected': 74, 'seriousNumAtRisk': 98, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG005', 'title': 'DB_Elagolix_and_E2-NETA', 'description': 'Double-blinded (DB) Period: Elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.', 'otherNumAtRisk': 389, 'deathsNumAtRisk': 389, 'otherNumAffected': 236, 'seriousNumAtRisk': 389, 'deathsNumAffected': 0, 'seriousNumAffected': 14}, {'id': 'EG006', 'title': 'OL_Placebo_to_ELA_and_E2-NETA', 'description': 'Open-Label (OL) Period: Placebo for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.', 'otherNumAtRisk': 106, 'deathsNumAtRisk': 106, 'otherNumAffected': 60, 'seriousNumAtRisk': 106, 'deathsNumAffected': 0, 'seriousNumAffected': 7}, {'id': 'EG007', 'title': 'OL_ELA_to_ELA_and_E2-NETA', 'description': 'Open-Label (OL) Period: Elagolix 200 mg BID alone for the first 6 months of the 12-month placebo-controlled Treatment Period and elagolix 200 mg BID+E2/NETA 1 mg/0.5 mg QD for the second 6 months, followed by elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.', 'otherNumAtRisk': 59, 'deathsNumAtRisk': 59, 'otherNumAffected': 32, 'seriousNumAtRisk': 59, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG008', 'title': 'OL_ELA_and_E2-NETA_to_ELA_and_E2-NETA', 'description': 'Open-Label (OL) Period: Elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.', 'otherNumAtRisk': 215, 'deathsNumAtRisk': 215, 'otherNumAffected': 125, 'seriousNumAtRisk': 215, 'deathsNumAffected': 0, 'seriousNumAffected': 10}, {'id': 'EG009', 'title': 'FU_Placebo_to_ELA_and_E2-NETA', 'description': 'Follow-Up (FU) Period: Placebo for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.', 'otherNumAtRisk': 194, 'deathsNumAtRisk': 194, 'otherNumAffected': 2, 'seriousNumAtRisk': 194, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG010', 'title': 'FU_ELA_to_ELA_and_E2-NETA', 'description': 'Follow-Up (FU) Period: Elagolix 200 mg BID alone for the first 6 months of the 12-month placebo-controlled Treatment Period and elagolix 200 mg BID+E2/NETA 1 mg/0.5 mg QD for the second 6 months, followed by elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.', 'otherNumAtRisk': 98, 'deathsNumAtRisk': 98, 'otherNumAffected': 3, 'seriousNumAtRisk': 98, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG011', 'title': 'FU_ELA_and_E2-NETA_to_ELA_and_E2-NETA', 'description': 'Follow-Up (FU) Period: Elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.', 'otherNumAtRisk': 389, 'deathsNumAtRisk': 389, 'otherNumAffected': 6, 'seriousNumAtRisk': 389, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 389, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 194, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG004', 'numAtRisk': 98, 'numEvents': 19, 'numAffected': 16}, {'groupId': 'EG005', 'numAtRisk': 389, 'numEvents': 55, 'numAffected': 51}, {'groupId': 'EG006', 'numAtRisk': 106, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG007', 'numAtRisk': 59, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 215, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG009', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 389, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'FATIGUE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 389, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 194, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 98, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 389, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG006', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 59, 'numEvents': 7, 'numAffected': 4}, {'groupId': 'EG008', 'numAtRisk': 215, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG009', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 389, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'BRONCHITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 389, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 194, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 98, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 389, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG006', 'numAtRisk': 106, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG007', 'numAtRisk': 59, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG008', 'numAtRisk': 215, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG009', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 389, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 389, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 389, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 106, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG007', 'numAtRisk': 59, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG008', 'numAtRisk': 215, 'numEvents': 32, 'numAffected': 29}, {'groupId': 'EG009', 'numAtRisk': 194, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 389, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'EAR INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 389, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 194, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 389, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG006', 'numAtRisk': 106, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 59, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG008', 'numAtRisk': 215, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 389, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'GASTROENTERITIS VIRAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 389, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 194, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 98, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 389, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG006', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 59, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 215, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG009', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 389, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'INFLUENZA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 389, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 194, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 98, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 389, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG006', 'numAtRisk': 106, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 59, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG008', 'numAtRisk': 215, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG009', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 389, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'NASOPHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 389, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 194, 'numEvents': 10, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 98, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 389, 'numEvents': 24, 'numAffected': 21}, {'groupId': 'EG006', 'numAtRisk': 106, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 59, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG008', 'numAtRisk': 215, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG009', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 389, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'SINUSITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 389, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 194, 'numEvents': 14, 'numAffected': 13}, {'groupId': 'EG004', 'numAtRisk': 98, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG005', 'numAtRisk': 389, 'numEvents': 34, 'numAffected': 32}, {'groupId': 'EG006', 'numAtRisk': 106, 'numEvents': 13, 'numAffected': 9}, {'groupId': 'EG007', 'numAtRisk': 59, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG008', 'numAtRisk': 215, 'numEvents': 28, 'numAffected': 18}, {'groupId': 'EG009', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 389, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'UPPER RESPIRATORY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 389, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 194, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 98, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 389, 'numEvents': 18, 'numAffected': 17}, {'groupId': 'EG006', 'numAtRisk': 106, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG007', 'numAtRisk': 59, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 215, 'numEvents': 15, 'numAffected': 13}, {'groupId': 'EG009', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 389, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'URINARY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 389, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 194, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 98, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG005', 'numAtRisk': 389, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG006', 'numAtRisk': 106, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG007', 'numAtRisk': 59, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG008', 'numAtRisk': 215, 'numEvents': 19, 'numAffected': 16}, {'groupId': 'EG009', 'numAtRisk': 194, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 389, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'VULVOVAGINAL MYCOTIC INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 389, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 194, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 98, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 389, 'numEvents': 21, 'numAffected': 16}, {'groupId': 'EG006', 'numAtRisk': 106, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 59, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG008', 'numAtRisk': 215, 'numEvents': 18, 'numAffected': 14}, {'groupId': 'EG009', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 389, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'BONE DENSITY DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 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'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'THROMBOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 389, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 389, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 389, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Co-Primary Endpoint: Percentage of Participants With a Response for Dysmenorrhea (DYS) at Months 6 and 12 Based on Daily Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '384', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.'}, {'id': 'OG001', 'title': 'Elagolix + E2/NETA', 'description': 'Elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.'}], 'classes': [{'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '384', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23.7', 'groupId': 'OG000', 'lowerLimit': '17.64', 'upperLimit': '29.73'}, {'value': '62.8', 'groupId': 'OG001', 'lowerLimit': '57.93', 'upperLimit': '67.60'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '376', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29.1', 'groupId': 'OG000', 'lowerLimit': '22.62', 'upperLimit': '35.58'}, {'value': '63.8', 'groupId': 'OG001', 'lowerLimit': '58.97', 'upperLimit': '68.69'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.51', 'ciLowerLimit': '3.711', 'ciUpperLimit': '8.176', 'pValueComment': 'P-value for test of difference is from a logistic regression model including treatment as the main effect and baseline value as a covariate.', 'groupDescription': 'Month 6', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.33', 'ciLowerLimit': '2.968', 'ciUpperLimit': '6.331', 'pValueComment': 'P-value for test of difference is from a logistic regression model including treatment as the main effect and baseline value as a covariate.', 'groupDescription': 'Month 12', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Month 6, Month 12', 'description': 'Participants recorded rescue analgesic use for endometriosis-associated pain daily and DYS (pain during menstruation ) and its impact on daily activities each day of their period in an electronic diary (e-Diary). DYS was measured by the 4-point Endometriosis Daily Pain Impact Diary according to the following:\n\n* 0: No discomfort\n* 1: Mild discomfort but I was easily able to do the things I usually do\n* 2: Moderate discomfort or pain that made it difficult to do some of the things I usually do\n* 3: Severe pain that made it difficult to do the things I usually do.\n\nPain scores and analgesic use were averaged over 35 days prior to each visit.\n\nResponse was defined as a reduction of -0.92 or more from baseline in DYS as well as no increase in rescue analgesic use for endometriosis-associated pain (defined as a \\< 15% increase in average rescue analgesic pill count and no additional analgesic).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at given time point. Last observation carried forward. Per protocol, the primary comparison for the co-primary endpoints was between the elagolix plus E2/NETA and placebo arms only.'}, {'type': 'PRIMARY', 'title': 'Co-Primary Endpoint: Percentage of Participants With a Response for Non-menstrual Pelvic Pain (NMPP) at Months 6 and 12 Based on Daily Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '384', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.'}, {'id': 'OG001', 'title': 'Elagolix + E2/NETA', 'description': 'Elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.'}], 'classes': [{'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '384', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '36.8', 'groupId': 'OG000', 'lowerLimit': '29.98', 'upperLimit': '43.70'}, {'value': '51.3', 'groupId': 'OG001', 'lowerLimit': '46.30', 'upperLimit': '56.30'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '376', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '42.3', 'groupId': 'OG000', 'lowerLimit': '35.28', 'upperLimit': '49.37'}, {'value': '54.3', 'groupId': 'OG001', 'lowerLimit': '49.22', 'upperLimit': '59.29'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.82', 'ciLowerLimit': '1.275', 'ciUpperLimit': '2.605', 'pValueComment': 'P-value for test of difference is from a logistic regression model including treatment as the main effect and baseline value as a covariate.', 'groupDescription': 'Month 6', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.007', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.63', 'ciLowerLimit': '1.146', 'ciUpperLimit': '2.326', 'pValueComment': 'P-value for test of difference is from a logistic regression model including treatment as the main effect and baseline value as a covariate.', 'groupDescription': 'Month 12', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Month 6, Month 12', 'description': 'Participants recorded rescue analgesic medication for endometriosis-associated pain and assessed NMPP and its impact on their daily activities each day in an e-Diary was measured by the 4-point Endometriosis Daily Pain Impact Diary according to the following:\n\n* 0: No discomfort\n* 1: Mild discomfort but I was easily able to do the things I usually do\n* 2: Moderate discomfort or pain that made it difficult to do some of the things I usually do\n* 3: Severe pain that made it difficult to do the things I usually do.\n\nPain scores and analgesic use were averaged over the 35 days prior to each visit.\n\nResponse was defined as a reduction of -0.55 or greater from baseline for NMPP as well as no increase in rescue analgesic use for endometriosis-associated pain (defined as a \\< 15% increase in average pill count of rescue analgesics and no additional analgesics).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at given time point. Last observation carried forward. Per protocol, the primary comparison for the co-primary endpoints was between the elagolix plus E2/NETA and placebo arms only.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in DYS at Month 12 Based on Daily Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '216', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.'}, {'id': 'OG001', 'title': 'Elagolix + E2/NETA', 'description': 'Elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.73', 'spread': '0.077', 'groupId': 'OG000'}, {'value': '-1.73', 'spread': '0.055', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares (LS) Mean of Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.99', 'ciLowerLimit': '-1.180', 'ciUpperLimit': '-0.809', 'pValueComment': 'P value for the test of the difference is from an MMRM with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous fixed covariate of baseline pain score, and random effect for participant.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.094', 'groupDescription': 'Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix plus E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented.', 'statisticalMethod': 'mixed model repeated measures (MMRM)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Month 12', 'description': 'Participants assessed DYS (pain during menstruation) and its impact on their daily activities each day of their period in an e-Diary. DYS was measured by the 4-point Endometriosis Daily Pain Impact Diary according to the following:\n\n* 0: No discomfort\n* 1: Mild discomfort but I was easily able to do the things I usually do\n* 2: Moderate discomfort or pain that made it difficult to do some of the things I usually do\n* 3: Severe pain that made it difficult to do the things I usually do.\n\nPain scores were averaged over the 35 days prior to each visit.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment. Mixed-effects model repeated measures (MMRM) analysis. Per protocol, the primary comparison for the secondary endpoints was between the elagolix plus E2/NETA and placebo arms only.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in DYS at Month 6 Based on Daily Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '286', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.'}, {'id': 'OG001', 'title': 'Elagolix + E2/NETA', 'description': 'Elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.62', 'spread': '0.072', 'groupId': 'OG000'}, {'value': '-1.64', 'spread': '0.050', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean of Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.02', 'ciLowerLimit': '-1.190', 'ciUpperLimit': '-0.845', 'pValueComment': 'P value for the test of the difference is from an MMRM with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous fixed covariate of baseline pain score, and random effect for participant.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.088', 'groupDescription': 'Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix plus E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Month 6', 'description': 'Participants assessed DYS (pain during menstruation) and its impact on their daily activities each day of their period in an e-Diary. DYS was measured by the 4-point Endometriosis Daily Pain Impact Diary according to the following:\n\n0: No discomfort\n\n1. Mild discomfort but I was easily able to do the things I usually do\n2. Moderate discomfort or pain that made it difficult to do some of the things I usually do\n3. Severe pain that made it difficult to do the things I usually do.\n\nPain scores were averaged over the 35 days prior to each visit.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment. Mixed-effects model repeated measures (MMRM) analysis. Per protocol, the primary comparison for the secondary endpoints was between the elagolix plus E2/NETA and placebo arms only.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in DYS at Month 3 Based on Daily Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}, {'value': '335', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.'}, {'id': 'OG001', 'title': 'Elagolix + E2/NETA', 'description': 'Elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.56', 'spread': '0.069', 'groupId': 'OG000'}, {'value': '-1.54', 'spread': '0.049', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean of Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.99', 'ciLowerLimit': '-1.156', 'ciUpperLimit': '-0.823', 'pValueComment': 'P value for the test of the difference is from an MMRM with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous fixed covariate of baseline pain score, and random effect for participant.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.085', 'groupDescription': 'Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix plus E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Month 3', 'description': 'Participants assessed DYS (pain during menstruation) and its impact on their daily activities each day of their period in an e-Diary. DYS was measured by the 4-point Endometriosis Daily Pain Impact Diary according to the following:\n\n0: No discomfort\n\n1. Mild discomfort but I was easily able to do the things I usually do\n2. Moderate discomfort or pain that made it difficult to do some of the things I usually do\n3. Severe pain that made it difficult to do the things I usually do.\n\nPain scores were averaged over the 35 days prior to each visit.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment. Mixed-effects model repeated measures (MMRM) analysis. Per protocol, the primary comparison for the secondary endpoints was between the elagolix plus E2/NETA and placebo arms only.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Non-menstrual Pelvic Pain (NMPP) at Month 12 Based on Daily Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '216', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.'}, {'id': 'OG001', 'title': 'Elagolix + E2/NETA', 'description': 'Elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.64', 'spread': '0.060', 'groupId': 'OG000'}, {'value': '-0.86', 'spread': '0.042', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean of Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.22', 'ciLowerLimit': '-0.367', 'ciUpperLimit': '-0.080', 'pValueComment': 'P value for the test of the difference is from an MMRM with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous fixed covariate of baseline pain score, and random effect for participant.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.073', 'groupDescription': 'Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix plus E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Month 12', 'description': 'Participants recorded rescue analgesic medication for endometriosis-associated pain and assessed NMPP and its impact on their daily activities each day in an e-Diary was measured by the 4-point Endometriosis Daily Pain Impact Diary according to the following:\n\n* 0: No discomfort\n* 1: Mild discomfort but I was easily able to do the things I usually do\n* 2: Moderate discomfort or pain that made it difficult to do some of the things I usually do\n* 3: Severe pain that made it difficult to do the things I usually do.\n\nPain scores and analgesic use were averaged over the 35 days prior to each visit.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment. Mixed-effects model repeated measures (MMRM) analysis. Per protocol, the primary comparison for the secondary endpoints was between the elagolix plus E2/NETA and placebo arms only.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in NMPP at Month 6 Based on Daily Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '286', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.'}, {'id': 'OG001', 'title': 'Elagolix + E2/NETA', 'description': 'Elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.57', 'spread': '0.051', 'groupId': 'OG000'}, {'value': '-0.78', 'spread': '0.036', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean of Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.21', 'ciLowerLimit': '-0.329', 'ciUpperLimit': '-0.085', 'pValueComment': 'P value for the test of the difference is from an MMRM with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous fixed covariate of baseline pain score, and random effect for participant.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.062', 'groupDescription': 'Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix plus E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Month 6', 'description': 'Participants recorded rescue analgesic medication for endometriosis-associated pain and assessed NMPP and its impact on their daily activities each day in an e-Diary was measured by the 4-point Endometriosis Daily Pain Impact Diary according to the following:\n\n* 0: No discomfort\n* 1: Mild discomfort but I was easily able to do the things I usually do\n* 2: Moderate discomfort or pain that made it difficult to do some of the things I usually do\n* 3: Severe pain that made it difficult to do the things I usually do.\n\nPain scores and analgesic use were averaged over the 35 days prior to each visit.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment. Mixed-effects model repeated measures (MMRM) analysis. Per protocol, the primary comparison for the secondary endpoints was between the elagolix plus E2/NETA and placebo arms only.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in NMPP at Month 3 Based on Daily Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}, {'value': '335', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.'}, {'id': 'OG001', 'title': 'Elagolix + E2/NETA', 'description': 'Elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.49', 'spread': '0.046', 'groupId': 'OG000'}, {'value': '-0.65', 'spread': '0.032', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.004', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean of Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.16', 'ciLowerLimit': '-0.270', 'ciUpperLimit': '-0.050', 'pValueComment': 'P value for the test of the difference is from an MMRM with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous fixed covariate of baseline pain score, and random effect for participant.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.056', 'groupDescription': 'Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix plus E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Month 3', 'description': 'Participants recorded rescue analgesic medication for endometriosis-associated pain and assessed NMPP and its impact on their daily activities each day in an e-Diary was measured by the 4-point Endometriosis Daily Pain Impact Diary according to the following:\n\n* 0: No discomfort\n* 1: Mild discomfort but I was easily able to do the things I usually do\n* 2: Moderate discomfort or pain that made it difficult to do some of the things I usually do\n* 3: Severe pain that made it difficult to do the things I usually do.\n\nPain scores and analgesic use were averaged over the 35 days prior to each visit.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment. Mixed-effects model repeated measures (MMRM) analysis. Per protocol, the primary comparison for the secondary endpoints was between the elagolix plus E2/NETA and placebo arms only.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Month 6 in Patient-Reported Outcome Measurement Information System (PROMIS) Fatigue Short Form 6a T-Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '302', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.'}, {'id': 'OG001', 'title': 'Elagolix + E2/NETA', 'description': 'Elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.71', 'spread': '0.739', 'groupId': 'OG000'}, {'value': '-7.22', 'spread': '0.514', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.005', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean of Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.51', 'ciLowerLimit': '-4.283', 'ciUpperLimit': '-0.746', 'pValueComment': 'P-value for test of difference at each post-baseline time point is from an ANCOVA model with treatment as the main effect and baseline as a covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.900', 'groupDescription': 'Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix plus E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Month 6', 'description': 'The PROMIS Fatigue Short Form 6a is self-administered and composed of 6 questions to evaluate fatigue over the past 7 days. All questions employ the following five response options: 1 = Never, 2 = Rarely, 3 = Sometimes, 4 = Often, and 5 = Always. The PROMIS Fatigue 6a score is calculated as a T-score, which is a standardized score with a mean of 50 (based on the average for the United States general population) and a standard deviation (SD) of 10. Higher scores indicate higher levels of fatigue. A decrease in score (negative change from baseline) indicates improvement in fatigue.', 'unitOfMeasure': 'T-score', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment. Observed cases. Per protocol, the primary comparison for the secondary endpoints was between the elagolix plus E2/NETA and placebo arms only.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Dyspareunia (DYSP) at Month 12 Based on Daily Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.'}, {'id': 'OG001', 'title': 'Elagolix + E2/NETA', 'description': 'Elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.60', 'spread': '0.079', 'groupId': 'OG000'}, {'value': '-0.70', 'spread': '0.058', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.284', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean of Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.11', 'ciLowerLimit': '-0.298', 'ciUpperLimit': '0.088', 'pValueComment': 'P value for the test of the difference is from an MMRM with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous fixed covariate of baseline pain score, and random effect for participant.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.098', 'groupDescription': 'Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix plus E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Month 12', 'description': 'Participants assessed DYSP each day in an e-Diary according to the following response options:\n\n* 0: None; No discomfort during sexual intercourse\n* 1: Mild; Able to tolerate the discomfort during sexual intercourse\n* 2: Moderate; Intercourse was interrupted due to pain\n* 3: Severe; Avoided intercourse because of pain\n* Not applicable; I was not sexually active for reasons other than endometriosis or did not have sexual intercourse.\n\nPain scores were averaged over the 35 days prior to each visit. Responses of "Not Applicable" were excluded.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment. Mixed-effects model repeated measures (MMRM) analysis. Per protocol, the primary comparison for the secondary endpoints was between the elagolix plus E2/NETA and placebo arms only.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in DYSP at Month 6 Based on Daily Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.'}, {'id': 'OG001', 'title': 'Elagolix + E2/NETA', 'description': 'Elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.54', 'spread': '0.076', 'groupId': 'OG000'}, {'value': '-0.63', 'spread': '0.053', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.286', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean of Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.10', 'ciLowerLimit': '-0.279', 'ciUpperLimit': '0.083', 'pValueComment': 'P value for the test of the difference is from an MMRM with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous fixed covariate of baseline pain score, and random effect for participant.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.092', 'groupDescription': 'Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix plus E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Month 6', 'description': 'Participants assessed DYSP each day in an e-Diary according to the following response options:\n\n* 0: None; No discomfort during sexual intercourse\n* 1: Mild; Able to tolerate the discomfort during sexual intercourse\n* 2: Moderate; Intercourse was interrupted due to pain\n* 3: Severe; Avoided intercourse because of pain\n* Not applicable; I was not sexually active for reasons other than endometriosis or did not have sexual intercourse.\n\nPain scores were averaged over the 35 days prior to each visit. Responses of "Not Applicable" were excluded.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment. Mixed-effects model repeated measures (MMRM) analysis. Per protocol, the primary comparison for the secondary endpoints was between the elagolix plus E2/NETA and placebo arms only.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in DYSP at Month 3 Based on Daily Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '257', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.'}, {'id': 'OG001', 'title': 'Elagolix + E2/NETA', 'description': 'Elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.40', 'spread': '0.064', 'groupId': 'OG000'}, {'value': '-0.62', 'spread': '0.045', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.005', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean of Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.22', 'ciLowerLimit': '-0.375', 'ciUpperLimit': '-0.066', 'pValueComment': 'P value for the test of the difference is from an MMRM with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous fixed covariate of baseline pain score, and random effect for participant.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.079', 'groupDescription': 'Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Month 3', 'description': 'Participants assessed DYSP each day in an e-Diary according to the following response options:\n\n* 0: None; No discomfort during sexual intercourse\n* 1: Mild; Able to tolerate the discomfort during sexual intercourse\n* 2: Moderate; Intercourse was interrupted due to pain\n* 3: Severe; Avoided intercourse because of pain\n* Not applicable; I was not sexually active for reasons other than endometriosis or did not have sexual intercourse.\n\nPain scores were averaged over the 35 days prior to each visit. Responses of "Not Applicable" were excluded.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment. Mixed-effects model repeated measures (MMRM) analysis. Per protocol, the primary comparison for the secondary endpoints was between the elagolix plus E2/NETA and placebo arms only.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Month 12 in Patient-Reported Outcome Measurement Information System (PROMIS) Fatigue Short Form 6a T-Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.'}, {'id': 'OG001', 'title': 'Elagolix + E2/NETA', 'description': 'Elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.43', 'spread': '0.949', 'groupId': 'OG000'}, {'value': '-8.92', 'spread': '0.665', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.032', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean of Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.49', 'ciLowerLimit': '-4.773', 'ciUpperLimit': '-0.216', 'pValueComment': 'P-value for test of difference at each post-baseline time point is from an ANCOVA model with treatment as the main effect and baseline as a covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.158', 'groupDescription': 'Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix plus E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Month 12', 'description': 'The PROMIS Fatigue Short Form 6a is self-administered and composed of 6 questions to evaluate fatigue over the past 7 days. All questions employ the following five response options: 1 = Never, 2 = Rarely, 3 = Sometimes, 4 = Often, and 5 = Always. The PROMIS Fatigue 6a score is calculated as a T-score, which is a standardized score with a mean of 50 (based on the average for the United States general population) and a standard deviation (SD) of 10. Higher scores indicate higher levels of fatigue. A decrease in score (negative change from baseline) indicates improvement in fatigue.', 'unitOfMeasure': 'T-score', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment. Observed cases. Per protocol, the primary comparison for the secondary endpoints was between the elagolix plus E2/NETA and placebo arms only.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Endometriosis-Associated Pain Score at Month 12 Assessed With Numeric Rating Scale (NRS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.'}, {'id': 'OG001', 'title': 'Elagolix + E2/NETA', 'description': 'Elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.25', 'spread': '0.263', 'groupId': 'OG000'}, {'value': '-4.39', 'spread': '0.186', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean of Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.14', 'ciLowerLimit': '-1.774', 'ciUpperLimit': '-0.508', 'pValueComment': 'P value for the test of the difference is from an MMRM with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous fixed covariate of baseline pain score, and random effect for participant.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.322', 'groupDescription': 'Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix plus E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Month 12', 'description': "The NRS measured endometriosis-associated pain with and without menstruation on an 11-point scale from 0 = no pain to 10 = worst pain ever. Site staff administered the Overall Endometriosis-Associated Pain questionnaire assessing pain over a 7-day recall period, and recorded the participant's response electronically via a tablet at the time of visit. Pain scores were averaged over the 35 days prior to each visit.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment. Mixed-effects model repeated measures (MMRM) analysis. Per protocol, the primary comparison for the secondary endpoints was between the elagolix plus E2/NETA and placebo arms only.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Endometriosis-Associated Pain Score at Month 6 Assessed With NRS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '269', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.'}, {'id': 'OG001', 'title': 'Elagolix + E2/NETA', 'description': 'Elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.74', 'spread': '0.248', 'groupId': 'OG000'}, {'value': '-4.12', 'spread': '0.174', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean of Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.38', 'ciLowerLimit': '-1.978', 'ciUpperLimit': '-0.788', 'pValueComment': 'P value for the test of the difference is from an MMRM with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous fixed covariate of baseline pain score, and random effect for participant.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.303', 'groupDescription': 'Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix plus E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Month 6', 'description': "The NRS measured endometriosis-associated pain with and without menstruation on an 11-point scale from 0 = no pain to 10 = worst pain ever. Site staff administered the Overall Endometriosis-Associated Pain questionnaire assessing pain over a 7-day recall period, and recorded the participant's response electronically via a tablet at the time of visit. Pain scores were averaged over the 35 days prior to each visit.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment. Mixed-effects model repeated measures (MMRM) analysis. Per protocol, the primary comparison for the secondary endpoints was between the elagolix plus E2/NETA and placebo arms only.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Endometriosis-Associated Pain Score at Month 3 Assessed With NRS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '304', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.'}, {'id': 'OG001', 'title': 'Elagolix + E2/NETA', 'description': 'Elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA \\[1 mg/0.5 mg\\] QD for the remaining 36 months of the Treatment Period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.33', 'spread': '0.225', 'groupId': 'OG000'}, {'value': '-3.79', 'spread': '0.161', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean of Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.46', 'ciLowerLimit': '-2.002', 'ciUpperLimit': '-0.915', 'pValueComment': 'P value for the test of the difference is from an MMRM with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous fixed covariate of baseline pain score, and random effect for participant.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.276', 'groupDescription': 'Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix plus E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Month 3', 'description': "The NRS measured endometriosis-associated pain with and without menstruation on an 11-point scale from 0 = no pain to 10 = worst pain ever. Site staff administered the Overall Endometriosis-Associated Pain questionnaire assessing pain over a 7-day recall period, and recorded the participant's response electronically via a tablet at the time of visit. Pain scores were averaged over the 35 days prior to each visit.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment. Mixed-effects model repeated measures (MMRM) analysis. Per protocol, the primary comparison for the secondary endpoints was between the elagolix plus E2/NETA and placebo arms only.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Placebo for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.'}, {'id': 'FG001', 'title': 'Elagolix / Elagolix + E2/NETA', 'description': 'Elagolix 200 mg BID alone for the first 6 months of the 12-month placebo-controlled Treatment Period and elagolix 200 mg BID+E2/NETA 1 mg/0.5 mg QD for the second 6 months, followed by elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.'}, {'id': 'FG002', 'title': 'Elagolix + E2/NETA', 'description': 'Elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.'}], 'periods': [{'title': 'Screening Period', 'milestones': [{'type': 'STARTED', 'comment': 'Includes all randomized participants.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '194'}, {'groupId': 'FG001', 'numSubjects': '98'}, {'groupId': 'FG002', 'numSubjects': '389'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '193'}, {'groupId': 'FG001', 'numSubjects': '97'}, {'groupId': 'FG002', 'numSubjects': '389'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Double-Blind Period', 'milestones': [{'type': 'STARTED', 'comment': 'Includes all treated participants who received at least one dose of study drug.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '193'}, {'groupId': 'FG001', 'numSubjects': '97'}, {'groupId': 'FG002', 'numSubjects': '389'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '157'}, {'groupId': 'FG001', 'numSubjects': '85'}, {'groupId': 'FG002', 'numSubjects': '337'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '52'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '14'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '9'}]}, {'type': 'Requires surgery or invasive intervention for treatment of endometriosis', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Non-compliance with study procedures', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '17'}]}]}, {'title': 'Open-Label Period', 'milestones': [{'type': 'STARTED', 'comment': 'Includes participants who completed the Placebo-Controlled Treatment Period and entered the Open-Label Treatment Period.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '106'}, {'groupId': 'FG001', 'numSubjects': '59'}, {'groupId': 'FG002', 'numSubjects': '215'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '90'}, {'groupId': 'FG001', 'numSubjects': '48'}, {'groupId': 'FG002', 'numSubjects': '170'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '45'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '24'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'Requires surgery or invasive intervention for treatment of endometriosis', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Non-compliance with study procedures', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Exclusionary medications', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '6'}]}]}, {'title': 'Follow-Up Period', 'milestones': [{'type': 'STARTED', 'comment': 'Includes all randomized participants. Participants were expected to enter the Follow-Up Period after Treatment Month 48, or if a participant prematurely discontinued from the Treatment Period at the time of or after Treatment Month 6.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '194'}, {'groupId': 'FG001', 'numSubjects': '98'}, {'groupId': 'FG002', 'numSubjects': '389'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '102'}, {'groupId': 'FG001', 'numSubjects': '51'}, {'groupId': 'FG002', 'numSubjects': '185'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '92'}, {'groupId': 'FG001', 'numSubjects': '47'}, {'groupId': 'FG002', 'numSubjects': '204'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '37'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '55'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '50'}]}, {'type': 'Requires surgery or invasive intervention for treatment of endometriosis', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Non-compliance with study procedures', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '18'}]}, {'type': 'Exclusionary medications', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'COVID-19 logistical restrictions', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '31'}]}]}], 'recruitmentDetails': 'A total of 679 subjects were treated at 137 sites in 2 countries (US \\[including Puerto Rico\\] and Canada). Of the 679 subjects who were treated on study, 299 subjects discontinued study drug prematurely during the Placebo-Controlled Treatment Period and 240 discontinued study drug prematurely during the Open-Label Treatment Period.', 'preAssignmentDetails': 'Participants were randomly assigned on Study Day 1 in a 4:1:2 ratio as follows:\n\n* elagolix 200 mg twice daily (BID) plus estradiol/norethindrone acetate (E2/NETA) 1 mg/0.5 mg once daily (QD)\n* elagolix 200 mg BID\n* placebo\n\nData are presented for the 12-month Placebo-Controlled Treatment Period.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'BG000'}, {'value': '97', 'groupId': 'BG001'}, {'value': '389', 'groupId': 'BG002'}, {'value': '679', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Placebo for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.'}, {'id': 'BG001', 'title': 'Elagolix / Elagolix + E2/NETA', 'description': 'Elagolix 200 mg BID alone for the first 6 months of the 12-month placebo-controlled Treatment Period and elagolix 200 mg BID+E2/NETA 1 mg/0.5 mg QD for the second 6 months, followed by elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.'}, {'id': 'BG002', 'title': 'Elagolix + E2/NETA', 'description': 'Elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '33.1', 'spread': '6.72', 'groupId': 'BG000'}, {'value': '32.5', 'spread': '6.44', 'groupId': 'BG001'}, {'value': '32.3', 'spread': '6.74', 'groupId': 'BG002'}, {'value': '32.5', 'spread': '6.69', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '193', 'groupId': 'BG000'}, {'value': '97', 'groupId': 'BG001'}, {'value': '389', 'groupId': 'BG002'}, {'value': '679', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '106', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '156', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '331', 'groupId': 'BG002'}, {'value': '573', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', '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 (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}, {'value': '99', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '159', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '328', 'groupId': 'BG002'}, {'value': '561', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Full Analysis Set: all randomized participants who received at least 1 dose of study drug.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-04-07', 'size': 1351172, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-11-25T10:26', 'hasProtocol': True}, {'date': '2020-05-08', 'size': 772977, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-03-24T18:29', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 681}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2023-12-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-25', 'studyFirstSubmitDate': '2017-07-07', 'resultsFirstSubmitDate': '2021-03-24', 'studyFirstSubmitQcDate': '2017-07-07', 'lastUpdatePostDateStruct': {'date': '2024-12-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-03-24', 'studyFirstPostDateStruct': {'date': '2017-07-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-04-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Co-Primary Endpoint: Percentage of Participants With a Response for Dysmenorrhea (DYS) at Months 6 and 12 Based on Daily Assessment', 'timeFrame': 'Month 6, Month 12', 'description': 'Participants recorded rescue analgesic use for endometriosis-associated pain daily and DYS (pain during menstruation ) and its impact on daily activities each day of their period in an electronic diary (e-Diary). DYS was measured by the 4-point Endometriosis Daily Pain Impact Diary according to the following:\n\n* 0: No discomfort\n* 1: Mild discomfort but I was easily able to do the things I usually do\n* 2: Moderate discomfort or pain that made it difficult to do some of the things I usually do\n* 3: Severe pain that made it difficult to do the things I usually do.\n\nPain scores and analgesic use were averaged over 35 days prior to each visit.\n\nResponse was defined as a reduction of -0.92 or more from baseline in DYS as well as no increase in rescue analgesic use for endometriosis-associated pain (defined as a \\< 15% increase in average rescue analgesic pill count and no additional analgesic).'}, {'measure': 'Co-Primary Endpoint: Percentage of Participants With a Response for Non-menstrual Pelvic Pain (NMPP) at Months 6 and 12 Based on Daily Assessment', 'timeFrame': 'Month 6, Month 12', 'description': 'Participants recorded rescue analgesic medication for endometriosis-associated pain and assessed NMPP and its impact on their daily activities each day in an e-Diary was measured by the 4-point Endometriosis Daily Pain Impact Diary according to the following:\n\n* 0: No discomfort\n* 1: Mild discomfort but I was easily able to do the things I usually do\n* 2: Moderate discomfort or pain that made it difficult to do some of the things I usually do\n* 3: Severe pain that made it difficult to do the things I usually do.\n\nPain scores and analgesic use were averaged over the 35 days prior to each visit.\n\nResponse was defined as a reduction of -0.55 or greater from baseline for NMPP as well as no increase in rescue analgesic use for endometriosis-associated pain (defined as a \\< 15% increase in average pill count of rescue analgesics and no additional analgesics).'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in DYS at Month 12 Based on Daily Assessment', 'timeFrame': 'Baseline, Month 12', 'description': 'Participants assessed DYS (pain during menstruation) and its impact on their daily activities each day of their period in an e-Diary. DYS was measured by the 4-point Endometriosis Daily Pain Impact Diary according to the following:\n\n* 0: No discomfort\n* 1: Mild discomfort but I was easily able to do the things I usually do\n* 2: Moderate discomfort or pain that made it difficult to do some of the things I usually do\n* 3: Severe pain that made it difficult to do the things I usually do.\n\nPain scores were averaged over the 35 days prior to each visit.'}, {'measure': 'Change From Baseline in DYS at Month 6 Based on Daily Assessment', 'timeFrame': 'Baseline, Month 6', 'description': 'Participants assessed DYS (pain during menstruation) and its impact on their daily activities each day of their period in an e-Diary. DYS was measured by the 4-point Endometriosis Daily Pain Impact Diary according to the following:\n\n0: No discomfort\n\n1. Mild discomfort but I was easily able to do the things I usually do\n2. Moderate discomfort or pain that made it difficult to do some of the things I usually do\n3. Severe pain that made it difficult to do the things I usually do.\n\nPain scores were averaged over the 35 days prior to each visit.'}, {'measure': 'Change From Baseline in DYS at Month 3 Based on Daily Assessment', 'timeFrame': 'Baseline, Month 3', 'description': 'Participants assessed DYS (pain during menstruation) and its impact on their daily activities each day of their period in an e-Diary. DYS was measured by the 4-point Endometriosis Daily Pain Impact Diary according to the following:\n\n0: No discomfort\n\n1. Mild discomfort but I was easily able to do the things I usually do\n2. Moderate discomfort or pain that made it difficult to do some of the things I usually do\n3. Severe pain that made it difficult to do the things I usually do.\n\nPain scores were averaged over the 35 days prior to each visit.'}, {'measure': 'Change From Baseline in Non-menstrual Pelvic Pain (NMPP) at Month 12 Based on Daily Assessment', 'timeFrame': 'Baseline, Month 12', 'description': 'Participants recorded rescue analgesic medication for endometriosis-associated pain and assessed NMPP and its impact on their daily activities each day in an e-Diary was measured by the 4-point Endometriosis Daily Pain Impact Diary according to the following:\n\n* 0: No discomfort\n* 1: Mild discomfort but I was easily able to do the things I usually do\n* 2: Moderate discomfort or pain that made it difficult to do some of the things I usually do\n* 3: Severe pain that made it difficult to do the things I usually do.\n\nPain scores and analgesic use were averaged over the 35 days prior to each visit.'}, {'measure': 'Change From Baseline in NMPP at Month 6 Based on Daily Assessment', 'timeFrame': 'Baseline, Month 6', 'description': 'Participants recorded rescue analgesic medication for endometriosis-associated pain and assessed NMPP and its impact on their daily activities each day in an e-Diary was measured by the 4-point Endometriosis Daily Pain Impact Diary according to the following:\n\n* 0: No discomfort\n* 1: Mild discomfort but I was easily able to do the things I usually do\n* 2: Moderate discomfort or pain that made it difficult to do some of the things I usually do\n* 3: Severe pain that made it difficult to do the things I usually do.\n\nPain scores and analgesic use were averaged over the 35 days prior to each visit.'}, {'measure': 'Change From Baseline in NMPP at Month 3 Based on Daily Assessment', 'timeFrame': 'Baseline, Month 3', 'description': 'Participants recorded rescue analgesic medication for endometriosis-associated pain and assessed NMPP and its impact on their daily activities each day in an e-Diary was measured by the 4-point Endometriosis Daily Pain Impact Diary according to the following:\n\n* 0: No discomfort\n* 1: Mild discomfort but I was easily able to do the things I usually do\n* 2: Moderate discomfort or pain that made it difficult to do some of the things I usually do\n* 3: Severe pain that made it difficult to do the things I usually do.\n\nPain scores and analgesic use were averaged over the 35 days prior to each visit.'}, {'measure': 'Change From Baseline to Month 6 in Patient-Reported Outcome Measurement Information System (PROMIS) Fatigue Short Form 6a T-Score', 'timeFrame': 'Baseline, Month 6', 'description': 'The PROMIS Fatigue Short Form 6a is self-administered and composed of 6 questions to evaluate fatigue over the past 7 days. All questions employ the following five response options: 1 = Never, 2 = Rarely, 3 = Sometimes, 4 = Often, and 5 = Always. The PROMIS Fatigue 6a score is calculated as a T-score, which is a standardized score with a mean of 50 (based on the average for the United States general population) and a standard deviation (SD) of 10. Higher scores indicate higher levels of fatigue. A decrease in score (negative change from baseline) indicates improvement in fatigue.'}, {'measure': 'Change From Baseline in Dyspareunia (DYSP) at Month 12 Based on Daily Assessment', 'timeFrame': 'Baseline, Month 12', 'description': 'Participants assessed DYSP each day in an e-Diary according to the following response options:\n\n* 0: None; No discomfort during sexual intercourse\n* 1: Mild; Able to tolerate the discomfort during sexual intercourse\n* 2: Moderate; Intercourse was interrupted due to pain\n* 3: Severe; Avoided intercourse because of pain\n* Not applicable; I was not sexually active for reasons other than endometriosis or did not have sexual intercourse.\n\nPain scores were averaged over the 35 days prior to each visit. Responses of "Not Applicable" were excluded.'}, {'measure': 'Change From Baseline in DYSP at Month 6 Based on Daily Assessment', 'timeFrame': 'Baseline, Month 6', 'description': 'Participants assessed DYSP each day in an e-Diary according to the following response options:\n\n* 0: None; No discomfort during sexual intercourse\n* 1: Mild; Able to tolerate the discomfort during sexual intercourse\n* 2: Moderate; Intercourse was interrupted due to pain\n* 3: Severe; Avoided intercourse because of pain\n* Not applicable; I was not sexually active for reasons other than endometriosis or did not have sexual intercourse.\n\nPain scores were averaged over the 35 days prior to each visit. Responses of "Not Applicable" were excluded.'}, {'measure': 'Change From Baseline in DYSP at Month 3 Based on Daily Assessment', 'timeFrame': 'Baseline, Month 3', 'description': 'Participants assessed DYSP each day in an e-Diary according to the following response options:\n\n* 0: None; No discomfort during sexual intercourse\n* 1: Mild; Able to tolerate the discomfort during sexual intercourse\n* 2: Moderate; Intercourse was interrupted due to pain\n* 3: Severe; Avoided intercourse because of pain\n* Not applicable; I was not sexually active for reasons other than endometriosis or did not have sexual intercourse.\n\nPain scores were averaged over the 35 days prior to each visit. Responses of "Not Applicable" were excluded.'}, {'measure': 'Change From Baseline to Month 12 in Patient-Reported Outcome Measurement Information System (PROMIS) Fatigue Short Form 6a T-Score', 'timeFrame': 'Baseline, Month 12', 'description': 'The PROMIS Fatigue Short Form 6a is self-administered and composed of 6 questions to evaluate fatigue over the past 7 days. All questions employ the following five response options: 1 = Never, 2 = Rarely, 3 = Sometimes, 4 = Often, and 5 = Always. The PROMIS Fatigue 6a score is calculated as a T-score, which is a standardized score with a mean of 50 (based on the average for the United States general population) and a standard deviation (SD) of 10. Higher scores indicate higher levels of fatigue. A decrease in score (negative change from baseline) indicates improvement in fatigue.'}, {'measure': 'Change From Baseline in Endometriosis-Associated Pain Score at Month 12 Assessed With Numeric Rating Scale (NRS)', 'timeFrame': 'Baseline, Month 12', 'description': "The NRS measured endometriosis-associated pain with and without menstruation on an 11-point scale from 0 = no pain to 10 = worst pain ever. Site staff administered the Overall Endometriosis-Associated Pain questionnaire assessing pain over a 7-day recall period, and recorded the participant's response electronically via a tablet at the time of visit. Pain scores were averaged over the 35 days prior to each visit."}, {'measure': 'Change From Baseline in Endometriosis-Associated Pain Score at Month 6 Assessed With NRS', 'timeFrame': 'Baseline, Month 6', 'description': "The NRS measured endometriosis-associated pain with and without menstruation on an 11-point scale from 0 = no pain to 10 = worst pain ever. Site staff administered the Overall Endometriosis-Associated Pain questionnaire assessing pain over a 7-day recall period, and recorded the participant's response electronically via a tablet at the time of visit. Pain scores were averaged over the 35 days prior to each visit."}, {'measure': 'Change From Baseline in Endometriosis-Associated Pain Score at Month 3 Assessed With NRS', 'timeFrame': 'Baseline, Month 3', 'description': "The NRS measured endometriosis-associated pain with and without menstruation on an 11-point scale from 0 = no pain to 10 = worst pain ever. Site staff administered the Overall Endometriosis-Associated Pain questionnaire assessing pain over a 7-day recall period, and recorded the participant's response electronically via a tablet at the time of visit. Pain scores were averaged over the 35 days prior to each visit."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Elagolix', 'Endometriosis associated pain', 'Dysmenorrhea (DYS)', 'Non-menstrual pelvic pain (NMPP)', 'ORILISSA'], 'conditions': ['Endometriosis']}, 'referencesModule': {'references': [{'pmid': '34435897', 'type': 'DERIVED', 'citation': 'Watts NB, Binkley N, Owens CD, Al-Hendy A, Puscheck EE, Shebley M, Schlaff WD, Simon JA. Bone Mineral Density Changes Associated With Pregnancy, Lactation, and Medical Treatments in Premenopausal Women and Effects Later in Life. J Womens Health (Larchmt). 2021 Oct;30(10):1416-1430. doi: 10.1089/jwh.2020.8989. Epub 2021 Aug 25.'}], 'seeAlsoLinks': [{'url': 'https://www.rxabbvie.com/', 'label': 'Related info'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate safety and efficacy of elagolix in the management of moderate to severe endometriosis-associated pain in adult premenopausal female participants including the safety and efficacy of elagolix in combination with concomitant hormonal add-back therapy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant is a premenopausal female 18 to 49 years of age (inclusive) at the time of Screening.\n* Participant has a documented surgical diagnosis (e.g., laparoscopy or laparotomy) of endometriosis established by visualization within 10 years prior to entry into Washout or Screening.\n* Participant must agree to use only protocol specified rescue analgesics during the Screening and Treatment Periods for endometriosis-associated pain.\n* Participant must have the following documented in the e-Diary during the last 35 days prior to Study Day 1:\n\n 1. At least 2 days of "moderate" or "severe" dysmenorrhea (DYS) AND either\n 2. At least 2 days of "moderate" or "severe" non-menstrual pelvic pain (NMPP) and an average NMPP score of at least 1.0, OR\n 3. At least 4 days of "moderate" or "severe" NMPP and an average NMPP score of at least 0.5.\n\nExclusion Criteria:\n\n* Participant has chronic pelvic pain that is not caused by endometriosis, that requires chronic analgesic therapy, which would interfere with the assessment of endometriosis-related pain.\n* Participant is using any systemic corticosteroids for over 14 days within 3 months prior to Screening or is likely to require treatment with systemic corticosteroids during the course of the study. Over-the-counter and prescription topical, inhaled or intranasal corticosteroids are allowed.\n* Participant has a history of any major depression or post-traumatic stress disorder (PTSD) within 2 years of the screening visit or other major psychiatric disorder at any time.\n* Participant has a history of suicide attempts or answered "yes" to questions 4 or 5 on the suicidal ideation portion of the Columbia-Suicide Severity Rating Scale (C-SSRS) within the last 1 year at Screening or prior to randomization on Day 1.\n* Participant has any history of osteoporosis or other metabolic bone disease or any condition that would interfere with obtaining adequate dual energy x-ray absorptiometry (DXA) measurements\n* Screening DXA results of the lumbar spine (L1-L4), femoral neck or total hip bone mineral density (BMD) corresponding to less than 2.0 or more standard deviations below normal.\n* Participant has either:\n\n 1. a newly diagnosed, clinically significant medical condition that requires therapeutic intervention (e.g., new onset hypertension), that has not been stabilized 30 days prior to randomization on Day 1 OR\n 2. a clinically significant medical condition that is anticipated to require intervention during the course of study participation (e.g., anticipated major elective surgery) OR\n 3. an unstable medical condition that makes the subject an unsuitable candidate for the study in the opinion of the Investigator, (including, but not limited to, uncontrolled diabetes mellitus, uncontrolled hypertension, epilepsy requiring anti-epileptic medication, unstable angina, confirmed inflammatory bowel disease, hyperprolactinemia, clinically significant infection or injury).\n* Participant has any conditions contraindicated with use of E2/NETA.'}, 'identificationModule': {'nctId': 'NCT03213457', 'briefTitle': 'A Clinical Study to Evaluate the Safety and Efficacy of Elagolix in Participants With Moderate to Severe Endometriosis-Associated Pain', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'A Phase 3 Study to Evaluate the Safety and Efficacy of Elagolix in Combination With Estradiol/Norethindrone Acetate in Subjects With Moderate to Severe Endometriosis-Associated Pain', 'orgStudyIdInfo': {'id': 'M14-702'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo for elagolix administered twice daily (BID) plus placebo for estradiol/norethindrone acetate (E2/NETA) administered once daily (QD) for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.', 'interventionNames': ['Drug: Placebo for Elagolix', 'Drug: Placebo for E2/NETA']}, {'type': 'EXPERIMENTAL', 'label': 'Elagolix / Elagolix + E2/NETA', 'description': 'Elagolix 200 mg BID alone for the first 6 months of the 12-month placebo-controlled Treatment Period and elagolix 200 mg BID+E2/NETA 1 mg/0.5 mg QD for the second 6 months, followed by elagolix 200 mg BID+E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.', 'interventionNames': ['Drug: Estradiol/Norethindrone Acetate', 'Drug: Elagolix']}, {'type': 'EXPERIMENTAL', 'label': 'Elagolix + E2/NETA', 'description': 'Elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.', 'interventionNames': ['Drug: Estradiol/Norethindrone Acetate', 'Drug: Elagolix']}], 'interventions': [{'name': 'Estradiol/Norethindrone Acetate', 'type': 'DRUG', 'otherNames': ['Activella', 'E2/NETA'], 'description': 'Tablets', 'armGroupLabels': ['Elagolix + E2/NETA', 'Elagolix / Elagolix + E2/NETA']}, {'name': 'Placebo for Elagolix', 'type': 'DRUG', 'description': 'Tablet', 'armGroupLabels': ['Placebo']}, {'name': 'Elagolix', 'type': 'DRUG', 'otherNames': ['ABT-620', 'Elagolix Sodium', 'ORILISSA'], 'description': 'Tablet', 'armGroupLabels': ['Elagolix + E2/NETA', 'Elagolix / Elagolix + E2/NETA']}, {'name': 'Placebo for E2/NETA', 'type': 'DRUG', 'description': 'Tablets', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35205', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Central Research Associates /ID# 163087', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35235-3430', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Alabama Clinical Therapeutics, LLC /ID# 145503', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35235-3430', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Alabama Clinical Therapeutics, LLC /ID# 151468', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '36532-3029', 'city': 'Fairhope', 'state': 'Alabama', 'country': 'United States', 'facility': 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Frisco /ID# 145245', 'geoPoint': {'lat': 33.15067, 'lon': -96.82361}}, {'zip': '77004-6031', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Next Innovative Clinical Research /ID# 203863', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Advances in Health, Inc. /ID# 145425', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Houston Methodist Hospital /ID# 170586', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77036', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Precision Research Institute - Houston /ID# 154370', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77054', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': "The Woman's Hospital of Texas /ID# 145316", 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77058-2705', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Centex Studies, Inc /ID# 148776', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '76550', 'city': 'Lampasas', 'state': 'Texas', 'country': 'United States', 'facility': 'FMC Science /ID# 150981', 'geoPoint': {'lat': 31.06378, 'lon': -98.1817}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Clinical Trials of Texas, Inc /ID# 147100', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78230', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'VIP Trials /ID# 151745', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78258', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Discovery Clinical Trials-San Antonio /ID# 145363', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '77479', 'city': 'Sugar Land', 'state': 'Texas', 'country': 'United States', 'facility': 'Houston Ctr for Clin Research /ID# 148799', 'geoPoint': {'lat': 29.61968, 'lon': -95.63495}}, {'zip': '77598', 'city': 'Webster', 'state': 'Texas', 'country': 'United States', 'facility': 'Center of Reproductive Medicin /ID# 145467', 'geoPoint': {'lat': 29.53773, 'lon': -95.11826}}, {'zip': '84020', 'city': 'Draper', 'state': 'Utah', 'country': 'United States', 'facility': 'Corner Canyon Obstetrics and G /ID# 145519', 'geoPoint': {'lat': 40.52467, 'lon': -111.86382}}, {'zip': '84041', 'city': 'Layton', 'state': 'Utah', 'country': 'United States', 'facility': 'Tanner Clinic /ID# 148786', 'geoPoint': {'lat': 41.06022, 'lon': -111.97105}}, {'zip': '84062', 'city': 'Pleasant Grove', 'state': 'Utah', 'country': 'United States', 'facility': 'Revere Health /ID# 145540', 'geoPoint': {'lat': 40.36412, 'lon': -111.73854}}, {'zip': '23851', 'city': 'Franklin', 'state': 'Virginia', 'country': 'United States', 'facility': "Southampton Women's Health /ID# 151691", 'geoPoint': {'lat': 36.67765, 'lon': -76.92246}}, {'zip': '23606', 'city': 'Newport News', 'state': 'Virginia', 'country': 'United States', 'facility': 'Health Research of Hampton Roads, Inc. (HRHR) /ID# 156477', 'geoPoint': {'lat': 36.98038, 'lon': -76.42975}}, {'zip': '23235-4722', 'city': 'North Chesterfield', 'state': 'Virginia', 'country': 'United States', 'facility': 'Clinical Research Partners, LL /ID# 145392', 'geoPoint': {'lat': 37.38, 'lon': -77.59}}, {'zip': '23235-4722', 'city': 'North Chesterfield', 'state': 'Virginia', 'country': 'United States', 'facility': 'Clinical Research Partners, LL /ID# 145416', 'geoPoint': {'lat': 37.38, 'lon': -77.59}}, {'zip': '23225', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Clinical Trials Virginia, Inc. /ID# 145430', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '23226-1930', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Alliance Womens Health /ID# 148770', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '23456', 'city': 'Virginia Beach', 'state': 'Virginia', 'country': 'United States', 'facility': 'Tidewater Clinical Research /ID# 145397', 'geoPoint': {'lat': 36.85293, 'lon': -75.97799}}, {'zip': '98372', 'city': 'Puyallup', 'state': 'Washington', 'country': 'United States', 'facility': 'Clinical Research Adv, Inc. /ID# 149257', 'geoPoint': {'lat': 47.18538, 'lon': -122.2929}}, {'zip': '98101', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Virginia Mason Medical Center /ID# 145387', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '98105', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': "Seattle Women's Health, Research, Gynecology /ID# 145341", 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '99207', 'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'facility': "North Spokane Women's Health /ID# 145382", 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}, {'zip': '98431', 'city': 'Tacoma', 'state': 'Washington', 'country': 'United States', 'facility': 'Madigan Army Medical Center /ID# 145186', 'geoPoint': {'lat': 47.25288, 'lon': -122.44429}}, {'zip': 'A1A 4Y3', 'city': "St. John's", 'state': 'Newfoundland and Labrador', 'country': 'Canada', 'facility': 'Strand Clinic /ID# 152582', 'geoPoint': {'lat': 47.56494, 'lon': -52.70931}}, {'zip': 'P3E 5M4', 'city': 'Greater Sudbury', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Medicor Research Inc /ID# 151453', 'geoPoint': {'lat': 46.49, 'lon': -80.99001}}, {'zip': 'K1H 8L6', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The Ottawa Hospital /ID# 148927', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'M5G 1X5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Mount Sinai Hosp.-Toronto /ID# 148972', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'N8W 5R7', 'city': 'Windsor', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Victory Reproductive Care /ID# 149016', 'geoPoint': {'lat': 42.30008, 'lon': -83.01654}}, {'zip': '00717', 'city': 'Ponce', 'country': 'Puerto Rico', 'facility': 'Puerto Rico Medical Research /ID# 152040', 'geoPoint': {'lat': 18.01031, 'lon': -66.62398}}, {'zip': '00909', 'city': 'San Juan', 'country': 'Puerto Rico', 'facility': 'Clinical Research Puerto Rico /ID# 149018', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}, {'zip': '00917', 'city': 'San Juan', 'country': 'Puerto Rico', 'facility': 'Rodriguez-Ginorio, San Juan /ID# 145545', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}, {'zip': '00935', 'city': 'San Juan', 'country': 'Puerto Rico', 'facility': 'School of Medicine University of Puerto Rico-Medical Science Campus /ID# 145546', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}], 'overallOfficials': [{'name': 'AbbVie Inc.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'ipdSharingStatementModule': {'url': 'https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.', 'ipdSharing': 'YES', 'description': 'AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.', 'accessCriteria': 'Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}