Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2026-01-05 @ 3:08 PM
Study NCT ID:
NCT03343067
Status:
TERMINATED
Last Update Posted:
2019-11-27
First Post:
2017-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Evaluate Safety and Efficacy of Elagolix in Participants With Endometriosis With Associated Moderate to Severe Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Canada']}, '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': 'C539351', 'term': 'elagolix'}, {'id': 'D004958', 'term': 'Estradiol'}, {'id': 'D000077563', 'term': 'Norethindrone Acetate'}], 'ancestors': [{'id': 'D004963', 'term': 'Estrenes'}, {'id': 'D004962', 'term': 'Estranes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D045166', 'term': 'Estradiol Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009640', 'term': 'Norethindrone'}, {'id': 'D009652', 'term': 'Norpregnenes'}, {'id': 'D009650', 'term': 'Norpregnanes'}, {'id': 'D009654', 'term': 'Norsteroids'}]}}, '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}, 'limitationsAndCaveats': {'description': 'Due to early study termination at Treatment Month 6 with low subject enrollment, no clinically or statistically meaningful efficacy conclusions can be made. The study was terminated early for business reasons, not for safety concerns.'}}, 'adverseEventsModule': {'timeFrame': 'From first dose of study drug up to 6 months, plus 30 days.', 'eventGroups': [{'id': 'EG000', 'title': 'Group A', 'description': 'Day 1 through Month 3 (open-label): elagolix 150 mg QD\n\nParticipants discontinued prematurely during the open-label period.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 3, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Group B', 'description': 'Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD\n\nMonth 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD\n\nThe efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Group C', 'description': 'Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD\n\nMonth 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group\n\nThe efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: \\< 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'EAR DISCOMFORT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'ABDOMINAL PAIN UPPER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'VOMITING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'CHILLS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'FATIGUE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'ANAPHYLACTIC REACTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'DRUG HYPERSENSITIVITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'GARDNERELLA INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'ORAL HERPES', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'URINARY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'VAGINAL INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'POLYDIPSIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'IRRITABILITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'ADNEXA UTERI PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'DYSMENORRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'MENSTRUATION DELAYED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'PELVIC PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'THROAT TIGHTNESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'DERMATITIS ALLERGIC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'NIGHT SWEATS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'HOT FLUSH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Proportion of Responders at Month 6 Based on DYS Pain Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A', 'description': 'Day 1 through Month 3 (open-label): elagolix 150 mg QD\n\nParticipants discontinued prematurely during the open-label period.'}, {'id': 'OG001', 'title': 'Group B', 'description': 'Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD\n\nMonth 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD\n\nThe efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.'}, {'id': 'OG002', 'title': 'Group C', 'description': 'Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD\n\nMonth 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group\n\nThe efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: \\< 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.'}], 'timeFrame': 'Month 6', 'description': 'Proportion of responders at Month 6 based upon the scale for DYS pain scale (ranging from 0 \\[none\\] to 3 \\[severe\\]) using the daily e-Diary, as well as no increased analgesic rescue use for endometriosis-associated pain.', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was intended to be based on a receiver operating characteristic (ROC) threshold, which could not be calculated, since only 1 participant had a Month 6 assessment for this endpoint at the time of study termination.'}, {'type': 'PRIMARY', 'title': 'Proportion of Responders at Month 6 Based on NMPP Pain Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A', 'description': 'Day 1 through Month 3 (open-label): elagolix 150 mg QD\n\nParticipants discontinued prematurely during the open-label period.'}, {'id': 'OG001', 'title': 'Group B', 'description': 'Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD\n\nMonth 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD\n\nThe efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.'}, {'id': 'OG002', 'title': 'Group C', 'description': 'Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD\n\nMonth 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group\n\nThe efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: \\< 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.'}], 'timeFrame': 'Month 6', 'description': 'Proportion of responders at Month 6 based upon the scale for NMPP pain scale (ranging from 0 \\[none\\] to 3 \\[severe\\]) using the daily e-Diary, as well as no increased analgesic rescue use for endometriosis-associated pain.', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was intended to be based on ROC threshold, which could not be calculated, since only 1 participant had a Month 6 assessment for this endpoint at the time of study termination.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in DYS at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A', 'description': 'Day 1 through Month 3 (open-label): elagolix 150 mg QD\n\nParticipants discontinued prematurely during the open-label period.'}, {'id': 'OG001', 'title': 'Group B', 'description': 'Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD\n\nMonth 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD\n\nThe efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.'}, {'id': 'OG002', 'title': 'Group C', 'description': 'Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD\n\nMonth 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group\n\nThe efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: \\< 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.23', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 0 (baseline), Month 6', 'description': 'The DYS pain scale score ranged from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe), recorded in a daily eDiary and averaged monthly based on a 35-day window. A negative change from baseline indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with an assessment at baseline and given time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in NMPP at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A', 'description': 'Day 1 through Month 3 (open-label): elagolix 150 mg QD\n\nParticipants discontinued prematurely during the open-label period.'}, {'id': 'OG001', 'title': 'Group B', 'description': 'Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD\n\nMonth 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD\n\nThe efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.'}, {'id': 'OG002', 'title': 'Group C', 'description': 'Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD\n\nMonth 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group\n\nThe efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: \\< 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.13', 'spread': '0.061', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 0 (baseline), Month 6', 'description': 'The NMPP pain scale score ranged from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe), recorded in a daily eDiary and averaged monthly based on a 35-day window. A negative change from baseline indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with an assessment at baseline and given time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Dyspareunia at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A', 'description': 'Day 1 through Month 3 (open-label): elagolix 150 mg QD\n\nParticipants discontinued prematurely during the open-label period.'}, {'id': 'OG001', 'title': 'Group B', 'description': 'Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD\n\nMonth 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD\n\nThe efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.'}, {'id': 'OG002', 'title': 'Group C', 'description': 'Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD\n\nMonth 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group\n\nThe efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: \\< 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.29', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 0 (baseline), Month 6', 'description': 'The dyspareunia pain scale score ranged from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe), recorded in a daily eDiary and averaged monthly based on a 35-day window. A negative change from baseline indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with an assessment at baseline and given time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Daily Diary Endometriosis-Associated Pain Score Via Numeric Rating Scale (NRS) at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A', 'description': 'Day 1 through Month 3 (open-label): elagolix 150 mg QD\n\nParticipants discontinued prematurely during the open-label period.'}, {'id': 'OG001', 'title': 'Group B', 'description': 'Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD\n\nMonth 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD\n\nThe efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.'}, {'id': 'OG002', 'title': 'Group C', 'description': 'Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD\n\nMonth 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group\n\nThe efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: \\< 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.36', 'spread': '0.020', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 0 (baseline), Month 6', 'description': 'The NRS for overall endometriosis-associated pain ranges from 0 (none) to 10 (worst pain ever), recorded in a daily eDiary and averaged monthly based on a 35-day window. A negative change from baseline indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with an assessment at baseline and given time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Rescue Analgesic Use Across Both Classes of Rescue Analgesics (NSAIDs/Opioids) at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A', 'description': 'Day 1 through Month 3 (open-label): elagolix 150 mg QD\n\nParticipants discontinued prematurely during the open-label period.'}, {'id': 'OG001', 'title': 'Group B', 'description': 'Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD\n\nMonth 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD\n\nThe efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.'}, {'id': 'OG002', 'title': 'Group C', 'description': 'Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD\n\nMonth 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group\n\nThe efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: \\< 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.'}], 'classes': [{'title': 'NSAID: Change at Month 6', 'categories': [{'measurements': [{'value': '0.63', 'spread': '0.606', 'groupId': 'OG001'}]}]}, {'title': 'Opioid: Change at Month 6', 'categories': [{'measurements': [{'value': '0.09', 'spread': '0.121', 'groupId': 'OG001'}]}]}, {'title': 'NSAID + Opioid: Change at Month 6', 'categories': [{'measurements': [{'value': '0.71', 'spread': '0.485', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 0 (baseline), Month 6', 'description': 'Based on average pill counts and assessed using the daily e-Diary. Permitted non-steroidal anti-inflammatory drugs (NSAIDs) included naproxen, ibuprofen, diclofenac, and celecoxib. Permitted opioids included hydrocodone + acetaminophen and codeine phosphate + acetaminophen.', 'unitOfMeasure': 'pills/day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with an assessment at baseline and given time point.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With 30% or More Reduction From Baseline Based on the 35 Day Mean of the Daily Diary Endometriosis-Associated Pain Score Via NRS at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A', 'description': 'Day 1 through Month 3 (open-label): elagolix 150 mg QD\n\nParticipants discontinued prematurely during the open-label period.'}, {'id': 'OG001', 'title': 'Group B', 'description': 'Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD\n\nMonth 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD\n\nThe efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.'}, {'id': 'OG002', 'title': 'Group C', 'description': 'Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD\n\nMonth 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group\n\nThe efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: \\< 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.'}], 'classes': [{'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 6', 'description': 'The NRS for overall endometriosis-associated pain ranges from 0 (none) to 10 (worst pain ever), recorded in a daily eDiary and averaged monthly based on a 35-day window.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with both baseline and post-baseline values for Daily Diary Endometriosis-Associated Pain Score via NRS.'}, {'type': 'SECONDARY', 'title': 'Proportion of Responders Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A', 'description': 'Day 1 through Month 3 (open-label): elagolix 150 mg QD\n\nParticipants discontinued prematurely during the open-label period.'}, {'id': 'OG001', 'title': 'Group B', 'description': 'Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD\n\nMonth 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD\n\nThe efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.'}, {'id': 'OG002', 'title': 'Group C', 'description': 'Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD\n\nMonth 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group\n\nThe efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: \\< 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.'}], 'timeFrame': 'Month 0 (baseline), Months 1, 2, 3, 4, 5, 6', 'description': 'As assessed by change and percent change from baseline in average pain score and rescue analgesic use monthly for DYS, NMPP, dyspareunia, and Daily Diary endometriosis-associated pain score via NRS, respectively.', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was intended to be based on ROC threshold, which could not be calculated for this endpoint due to low enrollment at the time of study termination.'}, {'type': 'SECONDARY', 'title': 'Proportion of Responders Over Time (Not Taking Into Consideration of Analgesic Use)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A', 'description': 'Day 1 through Month 3 (open-label): elagolix 150 mg QD\n\nParticipants discontinued prematurely during the open-label period.'}, {'id': 'OG001', 'title': 'Group B', 'description': 'Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD\n\nMonth 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD\n\nThe efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.'}, {'id': 'OG002', 'title': 'Group C', 'description': 'Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD\n\nMonth 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group\n\nThe efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: \\< 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.'}], 'timeFrame': 'Month 0 (baseline), Months 1, 2, 3, 4, 5, 6', 'description': 'As assessed by change and percent change from Baseline in average pain score and rescue analgesic use monthly for DYS, NMPP, dyspareunia, and Daily Diary endometriosis-associated pain score via NRS, respectively.', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was intended to be based on ROC threshold, which could not be calculated for this endpoint due to low enrollment at the time of study termination.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Over Time in Monthly Average DYS Pain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A', 'description': 'Day 1 through Month 3 (open-label): elagolix 150 mg QD\n\nParticipants discontinued prematurely during the open-label period.'}, {'id': 'OG001', 'title': 'Group B', 'description': 'Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD\n\nMonth 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD\n\nThe efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.'}, {'id': 'OG002', 'title': 'Group C', 'description': 'Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD\n\nMonth 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group\n\nThe efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: \\< 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.'}], 'classes': [{'title': 'Change at Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.05', 'spread': '0.655', 'groupId': 'OG000'}, {'value': '-0.04', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.18', 'spread': '0.124', 'groupId': 'OG000'}, {'value': '-0.26', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.50', 'spread': '0.263', 'groupId': 'OG000'}, {'value': '-0.34', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.69', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG000'}, {'value': '-0.06', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.16', 'spread': '0.141', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.23', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 0 (baseline), Months 1, 2, 3, 4, 5, 6', 'description': 'The DYS pain scale score ranged from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe), recorded in a daily eDiary and averaged monthly based on a 35-day window. A negative change from baseline indicates improvement.\n\nThe analysis was based on a 28-day window. If a participant prematurely discontinued during the open-label period, based on the analysis window, some data might fall into Month 4 analysis.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with an assessment at baseline and given time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Over Time in Monthly Average NMPP Pain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A', 'description': 'Day 1 through Month 3 (open-label): elagolix 150 mg QD\n\nParticipants discontinued prematurely during the open-label period.'}, {'id': 'OG001', 'title': 'Group B', 'description': 'Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD\n\nMonth 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD\n\nThe efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.'}, {'id': 'OG002', 'title': 'Group C', 'description': 'Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD\n\nMonth 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group\n\nThe efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: \\< 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.'}], 'classes': [{'title': 'Change at Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.13', 'spread': '0.252', 'groupId': 'OG000'}, {'value': '-0.07', 'spread': '0.508', 'groupId': 'OG001'}, {'value': '0.39', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}]}]}, {'title': 'Change at Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.48', 'spread': '0.394', 'groupId': 'OG000'}, {'value': '-0.30', 'spread': '0.167', 'groupId': 'OG001'}, {'value': '0.29', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}]}]}, {'title': 'Change at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.70', 'spread': '0.828', 'groupId': 'OG000'}, {'value': '-0.30', 'spread': '0.092', 'groupId': 'OG001'}, {'value': '0.54', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}]}]}, {'title': 'Change at Month 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.34', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG000'}, {'value': '-0.34', 'spread': '0.029', 'groupId': 'OG001'}, {'value': '0.46', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}]}]}, {'title': 'Change at Month 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.27', 'spread': '0.256', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.13', 'spread': '0.061', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 0 (baseline), Months 1, 2, 3, 4, 5, 6', 'description': 'The NMPP pain scale score ranged from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe), recorded in a daily eDiary and averaged monthly based on a 35-day window. A negative change from baseline indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with an assessment at baseline and given time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Over Time in Monthly Average Dyspareunia Pain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A', 'description': 'Day 1 through Month 3 (open-label): elagolix 150 mg QD\n\nParticipants discontinued prematurely during the open-label period.'}, {'id': 'OG001', 'title': 'Group B', 'description': 'Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD\n\nMonth 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD\n\nThe efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.'}, {'id': 'OG002', 'title': 'Group C', 'description': 'Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD\n\nMonth 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group\n\nThe efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: \\< 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.'}], 'classes': [{'title': 'Change at Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.50', 'spread': '0.741', 'groupId': 'OG000'}, {'value': '0.30', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG001'}, {'value': '-0.29', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}]}]}, {'title': 'Change at Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.44', 'spread': '1.071', 'groupId': 'OG000'}, {'value': '0.06', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG001'}, {'value': '-0.37', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}]}]}, {'title': 'Change at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-2.20', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG000'}, {'value': '0.07', 'spread': '0.101', 'groupId': 'OG001'}, {'value': '-0.03', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}]}]}, {'title': 'Change at Month 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-2.23', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG000'}, {'value': '0.09', 'spread': '0.040', 'groupId': 'OG001'}, {'value': '-0.03', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}]}]}, {'title': 'Change at Month 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.09', 'spread': '0.081', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.29', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 0 (baseline), Months 1, 2, 3, 4, 5, 6', 'description': 'The dyspareunia pain scale score ranged from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe), recorded in a daily eDiary and averaged monthly based on a 35-day window. A negative change from baseline indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with an assessment at baseline and given time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Over Time in Monthly Average Daily Diary Endometriosis-Associated Pain Score Via NRS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A', 'description': 'Day 1 through Month 3 (open-label): elagolix 150 mg QD\n\nParticipants discontinued prematurely during the open-label period.'}, {'id': 'OG001', 'title': 'Group B', 'description': 'Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD\n\nMonth 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD\n\nThe efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.'}, {'id': 'OG002', 'title': 'Group C', 'description': 'Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD\n\nMonth 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group\n\nThe efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: \\< 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.'}], 'classes': [{'title': 'Change at Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.86', 'spread': '1.975', 'groupId': 'OG000'}, {'value': '-0.89', 'spread': '1.159', 'groupId': 'OG001'}, {'value': '-0.84', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}]}]}, {'title': 'Change at Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-2.40', 'spread': '2.106', 'groupId': 'OG000'}, {'value': '-2.02', 'spread': '0.758', 'groupId': 'OG001'}, {'value': '-1.40', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}]}]}, {'title': 'Change at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-3.70', 'spread': '3.616', 'groupId': 'OG000'}, {'value': '-1.81', 'spread': '0.430', 'groupId': 'OG001'}, {'value': '-1.34', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}]}]}, {'title': 'Change at Month 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-6.43', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG000'}, {'value': '-1.43', 'spread': '1.078', 'groupId': 'OG001'}, {'value': '-1.06', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}]}]}, {'title': 'Change at Month 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.40', 'spread': '0.961', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.36', 'spread': '0.020', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 0 (baseline), Months 1, 2, 3, 4, 5, 6', 'description': 'The NRS for overall endometriosis-associated pain ranges from 0 (none) to 10 (worst pain ever), recorded in a daily eDiary and averaged monthly based on a 35-day window. A negative change from baseline indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with an assessment at baseline and given time point.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Each Month During the Treatment Period for DYS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A', 'description': 'Day 1 through Month 3 (open-label): elagolix 150 mg QD\n\nParticipants discontinued prematurely during the open-label period.'}, {'id': 'OG001', 'title': 'Group B', 'description': 'Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD\n\nMonth 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD\n\nThe efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.'}, {'id': 'OG002', 'title': 'Group C', 'description': 'Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD\n\nMonth 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group\n\nThe efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: \\< 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.'}], 'classes': [{'title': 'Percent Change at Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.67', 'spread': '109.961', 'groupId': 'OG000'}, {'value': '-7.89', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG001'}]}]}, {'title': 'Percent Change at Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-27.45', 'spread': '17.119', 'groupId': 'OG000'}, {'value': '-75.00', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG001'}]}]}, {'title': 'Percent Change at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-62.92', 'spread': '24.159', 'groupId': 'OG000'}, {'value': '-85.71', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG001'}]}]}, {'title': 'Percent Change at Month 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-80.00', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG000'}, {'value': '-16.67', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG001'}]}]}, {'title': 'Percent Change at Month 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-40.48', 'spread': '33.672', 'groupId': 'OG001'}]}]}, {'title': 'Percent Change at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-57.14', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 0 (baseline), Months 1, 2, 3, 4, 5, 6', 'description': 'The DYS pain scale score ranged from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe), recorded in a daily eDiary and averaged monthly based on a 35-day window. A negative change from baseline indicates improvement.', 'unitOfMeasure': 'percent change of units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with an assessment at baseline and given time point.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Each Month During the Treatment Period for NMPP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A', 'description': 'Day 1 through Month 3 (open-label): elagolix 150 mg QD\n\nParticipants discontinued prematurely during the open-label period.'}, {'id': 'OG001', 'title': 'Group B', 'description': 'Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD\n\nMonth 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD\n\nThe efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.'}, {'id': 'OG002', 'title': 'Group C', 'description': 'Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD\n\nMonth 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group\n\nThe efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: \\< 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.'}], 'classes': [{'title': 'Percent Change at Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-11.81', 'spread': '26.677', 'groupId': 'OG000'}, {'value': '4.22', 'spread': '53.238', 'groupId': 'OG001'}, {'value': '16.07', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}]}]}, {'title': 'Percent Change at Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-37.53', 'spread': '31.150', 'groupId': 'OG000'}, {'value': '-34.21', 'spread': '18.044', 'groupId': 'OG001'}, {'value': '11.90', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}]}]}, {'title': 'Percent Change at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-38.26', 'spread': '42.319', 'groupId': 'OG000'}, {'value': '-38.03', 'spread': '20.343', 'groupId': 'OG001'}, {'value': '22.62', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}]}]}, {'title': 'Percent Change at Month 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-71.21', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG000'}, {'value': '-44.49', 'spread': '20.725', 'groupId': 'OG001'}, {'value': '19.05', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}]}]}, {'title': 'Percent Change at Month 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-28.40', 'spread': '33.641', 'groupId': 'OG001'}]}]}, {'title': 'Percent Change at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-17.23', 'spread': '16.044', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 0 (baseline), Months 1, 2, 3, 4, 5, 6', 'description': 'The NMPP pain scale score ranged from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe), recorded in a daily eDiary and averaged monthly based on a 35-day window. A negative change from baseline indicates improvement.', 'unitOfMeasure': 'percentage change of units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with an assessment at baseline and given time point.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Each Month During the Treatment Period for Dyspareunia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A', 'description': 'Day 1 through Month 3 (open-label): elagolix 150 mg QD\n\nParticipants discontinued prematurely during the open-label period.'}, {'id': 'OG001', 'title': 'Group B', 'description': 'Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD\n\nMonth 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD\n\nThe efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.'}, {'id': 'OG002', 'title': 'Group C', 'description': 'Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD\n\nMonth 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group\n\nThe efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: \\< 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.'}], 'classes': [{'title': 'Percent Change at Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.14', 'spread': '18.180', 'groupId': 'OG000'}, {'value': '-15.27', 'spread': '26.791', 'groupId': 'OG001'}, {'value': '-9.52', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}]}]}, {'title': 'Percent Change at Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6.60', 'spread': '15.719', 'groupId': 'OG000'}, {'value': '-15.26', 'spread': '21.840', 'groupId': 'OG001'}, {'value': '-12.38', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}]}]}, {'title': 'Percent Change at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '60.88', 'spread': '65.632', 'groupId': 'OG000'}, {'value': '-21.63', 'spread': '24.719', 'groupId': 'OG001'}, {'value': '-0.95', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}]}]}, {'title': 'Percent Change at Month 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '106.25', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG000'}, {'value': '-12.67', 'spread': '20.433', 'groupId': 'OG001'}, {'value': '-0.95', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}]}]}, {'title': 'Percent Change at Month 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-14.86', 'spread': '16.002', 'groupId': 'OG001'}]}]}, {'title': 'Percent Change at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-18.08', 'spread': '25.571', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 0 (baseline), Months 1, 2, 3, 4, 5, 6', 'description': 'The dyspareunia pain scale score ranged from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe), recorded in a daily eDiary and averaged monthly based on a 35-day window. A negative change from baseline indicates improvement.', 'unitOfMeasure': 'percentage change of units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with an assessment at baseline and given time point.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Each Month During the Treatment Period for Daily Diary Endometriosis-Associated Pain Score Via NRS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A', 'description': 'Day 1 through Month 3 (open-label): elagolix 150 mg QD\n\nParticipants discontinued prematurely during the open-label period.'}, {'id': 'OG001', 'title': 'Group B', 'description': 'Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD\n\nMonth 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD\n\nThe efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.'}, {'id': 'OG002', 'title': 'Group C', 'description': 'Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD\n\nMonth 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group\n\nThe efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: \\< 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.'}], 'classes': [{'title': 'Percent Change at Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-14.10', 'spread': '37.146', 'groupId': 'OG000'}, {'value': '-19.61', 'spread': '35.468', 'groupId': 'OG001'}, {'value': '-11.34', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}]}]}, {'title': 'Percent Change at Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-37.82', 'spread': '18.066', 'groupId': 'OG000'}, {'value': '-56.25', 'spread': '4.507', 'groupId': 'OG001'}, {'value': '-18.99', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}]}]}, {'title': 'Percent Change at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-43.98', 'spread': '35.509', 'groupId': 'OG000'}, {'value': '-53.05', 'spread': '13.803', 'groupId': 'OG001'}, {'value': '-18.22', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}]}]}, {'title': 'Percent Change at Month 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-70.98', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG000'}, {'value': '-38.00', 'spread': '31.275', 'groupId': 'OG001'}, {'value': '-14.34', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}]}]}, {'title': 'Percent Change at Month 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-35.81', 'spread': '9.326', 'groupId': 'OG001'}]}]}, {'title': 'Percent Change at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-33.56', 'spread': '11.357', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 0 (baseline), Months 1, 2, 3, 4, 5, 6', 'description': 'The NRS for overall endometriosis-associated pain ranges from 0 (none) to 10 (worst pain ever), recorded in a daily eDiary and averaged monthly based on a 35-day window. A negative change from baseline indicates improvement.', 'unitOfMeasure': 'percentage change of score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with an assessment at baseline and given time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Over Time in Daily Rescue Analgesic Use Across Both Classes of Rescue Analgesics', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A', 'description': 'Day 1 through Month 3 (open-label): elagolix 150 mg QD\n\nParticipants discontinued prematurely during the open-label period.'}, {'id': 'OG001', 'title': 'Group B', 'description': 'Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD\n\nMonth 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD\n\nThe efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.'}, {'id': 'OG002', 'title': 'Group C', 'description': 'Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD\n\nMonth 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group\n\nThe efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: \\< 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.'}], 'classes': [{'title': 'NSAID: Change at Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.84', 'spread': '0.796', 'groupId': 'OG000'}, {'value': '0.09', 'spread': '0.388', 'groupId': 'OG001'}, {'value': '-0.67', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}]}]}, {'title': 'NSAID: Change at Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.15', 'spread': '0.785', 'groupId': 'OG000'}, {'value': '-0.17', 'spread': '0.834', 'groupId': 'OG001'}, {'value': '0.63', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}]}]}, {'title': 'NSAID: Change at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.96', 'spread': '1.030', 'groupId': 'OG000'}, {'value': '-0.43', 'spread': '1.091', 'groupId': 'OG001'}, {'value': '-0.71', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}]}]}, {'title': 'NSAID: Change at Month 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.69', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG000'}, {'value': '0.01', 'spread': '0.845', 'groupId': 'OG001'}, {'value': '-0.63', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}]}]}, {'title': 'NSAID: Change at Month 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.23', 'spread': '1.197', 'groupId': 'OG001'}]}]}, {'title': 'NSAID: Change at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.63', 'spread': '0.606', 'groupId': 'OG001'}]}]}, {'title': 'Opioid: Change at Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.12', 'spread': '0.552', 'groupId': 'OG000'}, {'value': '-0.06', 'spread': '0.099', 'groupId': 'OG001'}, {'value': '-0.43', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}]}]}, {'title': 'Opioid: Change at Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.17', 'spread': '0.263', 'groupId': 'OG000'}, {'value': '-0.03', 'spread': '0.049', 'groupId': 'OG001'}, {'value': '-0.51', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}]}]}, {'title': 'Opioid: Change at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.17', 'spread': '0.242', 'groupId': 'OG000'}, {'value': '0.02', 'spread': '0.016', 'groupId': 'OG001'}, {'value': '-0.49', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}]}]}, {'title': 'Opioid: Change at Month 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.34', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG000'}, {'value': '-0.01', 'spread': '0.044', 'groupId': 'OG001'}, {'value': '-0.40', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}]}]}, {'title': 'Opioid: Change at Month 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.05', 'spread': '0.082', 'groupId': 'OG001'}]}]}, {'title': 'Opioid: Change at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.09', 'spread': '0.121', 'groupId': 'OG001'}]}]}, {'title': 'NSAID + Opioid: Change at Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.72', 'spread': '1.178', 'groupId': 'OG000'}, {'value': '0.03', 'spread': '0.436', 'groupId': 'OG001'}, {'value': '-1.10', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}]}]}, {'title': 'NSAID + Opioid: Change at Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.33', 'spread': '0.767', 'groupId': 'OG000'}, {'value': '-0.20', 'spread': '0.830', 'groupId': 'OG001'}, {'value': '-1.14', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}]}]}, {'title': 'NSAID + Opioid: Change at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.13', 'spread': '1.273', 'groupId': 'OG000'}, {'value': '-0.41', 'spread': '1.107', 'groupId': 'OG001'}, {'value': '-1.20', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}]}]}, {'title': 'NSAID + Opioid: Change at Month 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-2.03', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG000'}, {'value': '-0.00', 'spread': '0.863', 'groupId': 'OG001'}, {'value': '-1.03', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}]}]}, {'title': 'NSAID + Opioid: Change at Month 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.18', 'spread': '1.217', 'groupId': 'OG001'}]}]}, {'title': 'NSAID + Opioid: Change at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.71', 'spread': '0.485', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 0 (baseline), Months 1, 2, 3, 4, 5, 6', 'description': 'Based on average pill counts and assessed using a daily e-Diary. Permitted non-steroidal anti-inflammatory drugs (NSAIDs) included naproxen, ibuprofen, diclofenac, and celecoxib. Permitted opioids included hydrocodone + acetaminophen and codeine phosphate + acetaminophen.', 'unitOfMeasure': 'pills/day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with an assessment at baseline and given time point.'}, {'type': 'SECONDARY', 'title': 'Number of Analgesic Use Responders and Non-Responders Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A', 'description': 'Day 1 through Month 3 (open-label): elagolix 150 mg QD\n\nParticipants discontinued prematurely during the open-label period.'}, {'id': 'OG001', 'title': 'Group B', 'description': 'Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD\n\nMonth 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD\n\nThe efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.'}, {'id': 'OG002', 'title': 'Group C', 'description': 'Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD\n\nMonth 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group\n\nThe efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: \\< 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.'}], 'classes': [{'title': 'Month 1: Responder', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Month 1: Non-Responder', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Month 2: Responder', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Month 2: Non-Responder', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Month 3: Responder', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Month 3: Non-Responder', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Month 4: Responder', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Month 4: Non-Responder', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Month 5: Responder', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Month 5: Non-Responder', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Month 6: Responder', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Month 6: Non-Responder', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Months 1, 2, 3, 4, 5, 6', 'description': 'Based only on reduction of rescue analgesics used. Responders were defined as:\n\n* participants with no analgesic use at screening and no analgesic use added\n* participants with NSAID only use at screening and NSAID dose stopped, decreased, or stable (\\<15% increase) and no opioid use added\n* participants with opioid only use at screening and opioid dose stopped, decreased, or stable (\\<15% increase), opioid dose stopped and NSAID substituted (any dose), opioid dose decreased and NSAID added (any dose)\n* participants with NSAID + opioid use at screening and any of the following: NSAID dose stopped + opioid analgesic use stopped, decreased, or stable (\\<15% increase); NSAID dose decreased + opioid analgesic use stopped, decreased, or stable (\\<15% increase); NSAID dose stable (\\< 15% increase) + opioid analgesic use stopped, decreased, or stable (\\<15% increase); NSAID dose increased by \\>15% + opioid analgesic use stopped; NSAID dose increased by \\>15% + opioid analgesic dose decreases.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Patient Global Impression of Change (PGIC) Scores Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A', 'description': 'Day 1 through Month 3 (open-label): elagolix 150 mg QD\n\nParticipants discontinued prematurely during the open-label period.'}, {'id': 'OG001', 'title': 'Group B', 'description': 'Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD\n\nMonth 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD\n\nThe efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.'}, {'id': 'OG002', 'title': 'Group C', 'description': 'Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD\n\nMonth 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group\n\nThe efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: \\< 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.'}], 'classes': [{'title': 'Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.9', 'spread': '1.35', 'groupId': 'OG000'}, {'value': '2.3', 'spread': '0.58', 'groupId': 'OG001'}, {'value': '2.0', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}]}]}, {'title': 'Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.0', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '0.58', 'groupId': 'OG001'}, {'value': '2.0', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.0', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '1.00', 'groupId': 'OG001'}, {'value': '5.0', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}]}]}, {'title': 'Month 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.0', 'spread': '1.00', 'groupId': 'OG001'}, {'value': '2.0', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}]}]}, {'title': 'Month 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.5', 'spread': '0.71', 'groupId': 'OG001'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Months 1, 2, 3, 4, 5, 6', 'description': 'The PGIC is a 7-point response scale where participants rate their endometriosis related pain as: very much improved (1), much improved (2), minimally improved (3), not changed (4), minimally worse (5), much worse (6), very much worse (7).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with an assessment at given time point.'}, {'type': 'SECONDARY', 'title': 'Overall Endometriosis-Associated Pain Via NRS (7-Day Recall) Scores Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A', 'description': 'Day 1 through Month 3 (open-label): elagolix 150 mg QD\n\nParticipants discontinued prematurely during the open-label period.'}, {'id': 'OG001', 'title': 'Group B', 'description': 'Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD\n\nMonth 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD\n\nThe efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.'}, {'id': 'OG002', 'title': 'Group C', 'description': 'Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD\n\nMonth 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group\n\nThe efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: \\< 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8.2', 'spread': '1.79', 'groupId': 'OG000'}, {'value': '9.0', 'spread': '1.00', 'groupId': 'OG001'}, {'value': '7.0', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}]}]}, {'title': 'Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.7', 'spread': '3.04', 'groupId': 'OG000'}, {'value': '7.7', 'spread': '1.15', 'groupId': 'OG001'}, {'value': '8.0', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}]}]}, {'title': 'Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.5', 'spread': '0.71', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '1.15', 'groupId': 'OG001'}, {'value': '5.0', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '9.0', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG000'}, {'value': '5.3', 'spread': '2.31', 'groupId': 'OG001'}, {'value': '8.0', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}]}]}, {'title': 'Month 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.3', 'spread': '0.58', 'groupId': 'OG001'}, {'value': '7.0', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}]}]}, {'title': 'Month 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8.0', 'spread': '0.00', 'groupId': 'OG001'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.0', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 0 (baseline), Months 1, 2, 3, 4, 5, 6', 'description': 'The endometriosis-associated pain questionnaire is an 11-point NRS assessing overall endometriosis-associated pain over a 7-day recall period. Participants assessed their endometriosis-associated pain on a scale of 0 to 10, with 0 = no pain and 10 = worst pain ever.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with an assessment at given time point.'}, {'type': 'SECONDARY', 'title': 'Endometriosis Health Profile-30 (EHP-30) Scores Over Time: Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A', 'description': 'Day 1 through Month 3 (open-label): elagolix 150 mg QD\n\nParticipants discontinued prematurely during the open-label period.'}, {'id': 'OG001', 'title': 'Group B', 'description': 'Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD\n\nMonth 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD\n\nThe efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.'}, {'id': 'OG002', 'title': 'Group C', 'description': 'Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD\n\nMonth 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group\n\nThe efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: \\< 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '59.42', 'spread': '11.694', 'groupId': 'OG000'}, {'value': '47.73', 'spread': '14.193', 'groupId': 'OG001'}, {'value': '59.09', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '38.07', 'spread': '26.529', 'groupId': 'OG000'}, {'value': '17.42', 'spread': '22.422', 'groupId': 'OG001'}, {'value': '38.64', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '27.27', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 0 (baseline), Months 3, 6', 'description': 'The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Domains used in the study included Pain, Control and Powerlessness, Well-Being, Social Support, Self-Image, and Sexual Intercourse. Each domain is calculated on a scale from 0 = best possible health status to 100 = worst possible health status.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with an assessment at given time point.'}, {'type': 'SECONDARY', 'title': 'EHP-30 Scores Over Time: Control and Powerlessness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A', 'description': 'Day 1 through Month 3 (open-label): elagolix 150 mg QD\n\nParticipants discontinued prematurely during the open-label period.'}, {'id': 'OG001', 'title': 'Group B', 'description': 'Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD\n\nMonth 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD\n\nThe efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.'}, {'id': 'OG002', 'title': 'Group C', 'description': 'Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD\n\nMonth 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group\n\nThe efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: \\< 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '71.43', 'spread': '19.159', 'groupId': 'OG000'}, {'value': '56.94', 'spread': '19.691', 'groupId': 'OG001'}, {'value': '41.67', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '36.46', 'spread': '32.874', 'groupId': 'OG000'}, {'value': '26.39', 'spread': '21.382', 'groupId': 'OG001'}, {'value': '25.00', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8.33', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 0 (baseline), Months 3, 6', 'description': 'The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Domains used in the study included Pain, Control and Powerlessness, Well-Being, Social Support, Self-Image, and Sexual Intercourse. Each domain is calculated on a scale from 0 = best possible health status to 100 = worst possible health status.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with an assessment at given time point.'}, {'type': 'SECONDARY', 'title': 'EHP-30 Scores Over Time: Emotional Well-Being', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A', 'description': 'Day 1 through Month 3 (open-label): elagolix 150 mg QD\n\nParticipants discontinued prematurely during the open-label period.'}, {'id': 'OG001', 'title': 'Group B', 'description': 'Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD\n\nMonth 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD\n\nThe efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.'}, {'id': 'OG002', 'title': 'Group C', 'description': 'Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD\n\nMonth 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group\n\nThe efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: \\< 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '29.76', 'spread': '8.815', 'groupId': 'OG000'}, {'value': '50.00', 'spread': '8.333', 'groupId': 'OG001'}, {'value': '45.83', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '18.75', 'spread': '12.500', 'groupId': 'OG000'}, {'value': '23.61', 'spread': '17.347', 'groupId': 'OG001'}, {'value': '37.50', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '25.00', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 0 (baseline), Months 3, 6', 'description': 'The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Domains used in the study included Pain, Control and Powerlessness, Well-Being, Social Support, Self-Image, and Sexual Intercourse. Each domain is calculated on a scale from 0 = best possible health status to 100 = worst possible health status.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with an assessment at given time point.'}, {'type': 'SECONDARY', 'title': 'EHP-30 Scores Over Time: Social Support', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A', 'description': 'Day 1 through Month 3 (open-label): elagolix 150 mg QD\n\nParticipants discontinued prematurely during the open-label period.'}, {'id': 'OG001', 'title': 'Group B', 'description': 'Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD\n\nMonth 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD\n\nThe efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.'}, {'id': 'OG002', 'title': 'Group C', 'description': 'Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD\n\nMonth 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group\n\nThe efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: \\< 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '48.21', 'spread': '21.565', 'groupId': 'OG000'}, {'value': '45.83', 'spread': '19.094', 'groupId': 'OG001'}, {'value': '50.00', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '17.19', 'spread': '11.831', 'groupId': 'OG000'}, {'value': '16.67', 'spread': '28.868', 'groupId': 'OG001'}, {'value': '18.75', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '25.00', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 0 (baseline), Months 3, 6', 'description': 'The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Domains used in the study included Pain, Control and Powerlessness, Well-Being, Social Support, Self-Image, and Sexual Intercourse. Each domain is calculated on a scale from 0 = best possible health status to 100 = worst possible health status.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with an assessment at given time point.'}, {'type': 'SECONDARY', 'title': 'EHP-30 Scores Over Time: Self-Image', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A', 'description': 'Day 1 through Month 3 (open-label): elagolix 150 mg QD\n\nParticipants discontinued prematurely during the open-label period.'}, {'id': 'OG001', 'title': 'Group B', 'description': 'Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD\n\nMonth 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD\n\nThe efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.'}, {'id': 'OG002', 'title': 'Group C', 'description': 'Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD\n\nMonth 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group\n\nThe efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: \\< 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '50.00', 'spread': '22.048', 'groupId': 'OG000'}, {'value': '36.11', 'spread': '31.549', 'groupId': 'OG001'}, {'value': '75.00', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '43.75', 'spread': '41.597', 'groupId': 'OG000'}, {'value': '8.33', 'spread': '14.434', 'groupId': 'OG001'}, {'value': '8.33', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '16.67', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 0 (baseline), Months 3, 6', 'description': 'The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Domains used in the study included Pain, Control and Powerlessness, Well-Being, Social Support, Self-Image, and Sexual Intercourse. Each domain is calculated on a scale from 0 = best possible health status to 100 = worst possible health status.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with an assessment at given time point.'}, {'type': 'SECONDARY', 'title': 'EHP-30 Scores Over Time: Sexual Intercourse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A', 'description': 'Day 1 through Month 3 (open-label): elagolix 150 mg QD\n\nParticipants discontinued prematurely during the open-label period.'}, {'id': 'OG001', 'title': 'Group B', 'description': 'Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD\n\nMonth 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD\n\nThe efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.'}, {'id': 'OG002', 'title': 'Group C', 'description': 'Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD\n\nMonth 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group\n\nThe efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: \\< 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '70.00', 'spread': '22.361', 'groupId': 'OG000'}, {'value': '62.50', 'spread': '31.820', 'groupId': 'OG001'}, {'value': '60.00', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '45.00', 'spread': '23.452', 'groupId': 'OG000'}, {'value': '45.00', 'spread': '42.426', 'groupId': 'OG001'}, {'value': '60.00', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '30.00', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 0 (baseline), Months 3, 6', 'description': 'The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Domains used in the study included Pain, Control and Powerlessness, Well-Being, Social Support, Self-Image, and Sexual Intercourse. Each domain is calculated on a scale from 0 = best possible health status to 100 = worst possible health status.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with an assessment at given time point.'}, {'type': 'SECONDARY', 'title': 'EuroQol-5D 5 Level (EQ-5D-5L) Scores Over Time: Mobility', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A', 'description': 'Day 1 through Month 3 (open-label): elagolix 150 mg QD\n\nParticipants discontinued prematurely during the open-label period.'}, {'id': 'OG001', 'title': 'Group B', 'description': 'Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD\n\nMonth 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD\n\nThe efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.'}, {'id': 'OG002', 'title': 'Group C', 'description': 'Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD\n\nMonth 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group\n\nThe efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: \\< 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.4', 'spread': '0.53', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '0.00', 'groupId': 'OG001'}, {'value': '1.0', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.3', 'spread': '0.50', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '0.00', 'groupId': 'OG001'}, {'value': '2.0', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 0 (baseline), Months 3, 6', 'description': "The EQ-5D-5L is a health state utility instrument with 5 items that comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each of which is rated on 5 levels of severity (1=no problem, 2=slight problems, 3=moderate problems, 4=severe problems, 5=extreme problems) and a separate visual analog scale (VAS) indicating a participant's rating of their current health status (health today) on a scale of from 0 (worst health imaginable) to 100 (best health imaginable).", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with an assessment at given time point.'}, {'type': 'SECONDARY', 'title': 'EQ-5D-5L Scores Over Time: Self-Care', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A', 'description': 'Day 1 through Month 3 (open-label): elagolix 150 mg QD\n\nParticipants discontinued prematurely during the open-label period.'}, {'id': 'OG001', 'title': 'Group B', 'description': 'Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD\n\nMonth 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD\n\nThe efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.'}, {'id': 'OG002', 'title': 'Group C', 'description': 'Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD\n\nMonth 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group\n\nThe efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: \\< 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '0.00', 'groupId': 'OG001'}, {'value': '1.0', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '0.00', 'groupId': 'OG001'}, {'value': '1.0', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 0 (baseline), Months 3, 6', 'description': "The EQ-5D-5L is a health state utility instrument with 5 items that comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each of which is rated on 5 levels of severity (1=no problem, 2=slight problems, 3=moderate problems, 4=severe problems, 5=extreme problems) and a separate visual analog scale (VAS) indicating a participant's rating of their current health status (health today) on a scale of from 0 (worst health imaginable) to 100 (best health imaginable).", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with an assessment at given time point.'}, {'type': 'SECONDARY', 'title': 'EQ-5D-5L Scores Over Time: Usual Activities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A', 'description': 'Day 1 through Month 3 (open-label): elagolix 150 mg QD\n\nParticipants discontinued prematurely during the open-label period.'}, {'id': 'OG001', 'title': 'Group B', 'description': 'Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD\n\nMonth 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD\n\nThe efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.'}, {'id': 'OG002', 'title': 'Group C', 'description': 'Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD\n\nMonth 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group\n\nThe efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: \\< 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.0', 'spread': '0.82', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '0.58', 'groupId': 'OG001'}, {'value': '1.0', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.5', 'spread': '0.58', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '1.15', 'groupId': 'OG001'}, {'value': '2.0', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 0 (baseline), Months 3, 6', 'description': "The EQ-5D-5L is a health state utility instrument with 5 items that comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each of which is rated on 5 levels of severity (1=no problem, 2=slight problems, 3=moderate problems, 4=severe problems, 5=extreme problems) and a separate visual analog scale (VAS) indicating a participant's rating of their current health status (health today) on a scale of from 0 (worst health imaginable) to 100 (best health imaginable).", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with an assessment at given time point.'}, {'type': 'SECONDARY', 'title': 'EQ-5D-5L Scores Over Time: Pain/Discomfort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A', 'description': 'Day 1 through Month 3 (open-label): elagolix 150 mg QD\n\nParticipants discontinued prematurely during the open-label period.'}, {'id': 'OG001', 'title': 'Group B', 'description': 'Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD\n\nMonth 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD\n\nThe efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.'}, {'id': 'OG002', 'title': 'Group C', 'description': 'Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD\n\nMonth 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group\n\nThe efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: \\< 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.7', 'spread': '0.76', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '0.58', 'groupId': 'OG001'}, {'value': '4.0', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.0', 'spread': '1.15', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '0.58', 'groupId': 'OG001'}, {'value': '3.0', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 0 (baseline), Months 3, 6', 'description': "The EQ-5D-5L is a health state utility instrument with 5 items that comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each of which is rated on 5 levels of severity (1=no problem, 2=slight problems, 3=moderate problems, 4=severe problems, 5=extreme problems) and a separate visual analog scale (VAS) indicating a participant's rating of their current health status (health today) on a scale of from 0 (worst health imaginable) to 100 (best health imaginable).", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with an assessment at given time point.'}, {'type': 'SECONDARY', 'title': 'EQ-5D-5L Scores Over Time: Anxiety/Depression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A', 'description': 'Day 1 through Month 3 (open-label): elagolix 150 mg QD\n\nParticipants discontinued prematurely during the open-label period.'}, {'id': 'OG001', 'title': 'Group B', 'description': 'Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD\n\nMonth 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD\n\nThe efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.'}, {'id': 'OG002', 'title': 'Group C', 'description': 'Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD\n\nMonth 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group\n\nThe efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: \\< 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '0.58', 'groupId': 'OG001'}, {'value': '1.0', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '0.00', 'groupId': 'OG001'}, {'value': '1.0', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 0 (baseline), Months 3, 6', 'description': "The EQ-5D-5L is a health state utility instrument with 5 items that comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each of which is rated on 5 levels of severity (1=no problem, 2=slight problems, 3=moderate problems, 4=severe problems, 5=extreme problems) and a separate visual analog scale (VAS) indicating a participant's rating of their current health status (health today) on a scale of from 0 (worst health imaginable) to 100 (best health imaginable).", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with an assessment at given time point.'}, {'type': 'SECONDARY', 'title': 'EQ-5D-5L VAS Scores Over Time: Health Today', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A', 'description': 'Day 1 through Month 3 (open-label): elagolix 150 mg QD\n\nParticipants discontinued prematurely during the open-label period.'}, {'id': 'OG001', 'title': 'Group B', 'description': 'Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD\n\nMonth 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD\n\nThe efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.'}, {'id': 'OG002', 'title': 'Group C', 'description': 'Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD\n\nMonth 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group\n\nThe efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: \\< 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '79.7', 'spread': '15.16', 'groupId': 'OG000'}, {'value': '53.3', 'spread': '35.12', 'groupId': 'OG001'}, {'value': '72.0', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '72.8', 'spread': '17.63', 'groupId': 'OG000'}, {'value': '85.0', 'spread': '15.00', 'groupId': 'OG001'}, {'value': '70.0', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '94.0', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 0 (baseline), Months 3, 6', 'description': "The EQ-5D-5L is a health state utility instrument with 5 items that comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each of which is rated on 5 levels of severity (1=no problem, 2=slight problems, 3=moderate problems, 4=severe problems, 5=extreme problems) and a separate VAS indicating a participant's rating of their current health status (health today) on a scale of from 0 (worst health imaginable) to 100 (best health imaginable).", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with an assessment at given time point.'}, {'type': 'SECONDARY', 'title': 'Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP) Scores Over Time: Percent Work Missed Due to Problem', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A', 'description': 'Day 1 through Month 3 (open-label): elagolix 150 mg QD\n\nParticipants discontinued prematurely during the open-label period.'}, {'id': 'OG001', 'title': 'Group B', 'description': 'Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD\n\nMonth 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD\n\nThe efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.'}, {'id': 'OG002', 'title': 'Group C', 'description': 'Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD\n\nMonth 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group\n\nThe efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: \\< 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.16', 'spread': '0.205', 'groupId': 'OG000'}, {'value': '0.08', 'spread': '0.144', 'groupId': 'OG001'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.000', 'groupId': 'OG000'}, {'value': '0.00', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 0 (baseline), Month 6', 'description': 'Absenteeism is presented as the mean percentage of work time missed due to health problem (as reported on the WPAI:SHP), and is calculated as: 100\\*number of hours of work missed due to health problem / (number of hours of work missed due to health problem + number of hours worked). WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity.', 'unitOfMeasure': 'percent of work time missed', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with an assessment at given time point.'}, {'type': 'SECONDARY', 'title': 'WPAI:SHP Scores Over Time: Percent Impairment While Working Due to Problem', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A', 'description': 'Day 1 through Month 3 (open-label): elagolix 150 mg QD\n\nParticipants discontinued prematurely during the open-label period.'}, {'id': 'OG001', 'title': 'Group B', 'description': 'Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD\n\nMonth 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD\n\nThe efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.'}, {'id': 'OG002', 'title': 'Group C', 'description': 'Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD\n\nMonth 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group\n\nThe efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: \\< 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.57', 'spread': '0.273', 'groupId': 'OG000'}, {'value': '0.53', 'spread': '0.153', 'groupId': 'OG001'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.30', 'spread': '0.265', 'groupId': 'OG000'}, {'value': '0.30', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 0 (baseline), Month 6', 'description': 'Presenteeism (the extent to which health problem decreased productivity) is presented as the mean percentage of impairment while working due to health problem, and is calculated as: 100\\*scale value of question 5 on the WPAI (between 0 and 10) / 10. WPAI:SHP is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity.', 'unitOfMeasure': 'percent impairment while working', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with an assessment at given time point.'}, {'type': 'SECONDARY', 'title': 'WPAI:SHP Scores Over Time: Percent Overall Work Impairment Due to Problem', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A', 'description': 'Day 1 through Month 3 (open-label): elagolix 150 mg QD\n\nParticipants discontinued prematurely during the open-label period.'}, {'id': 'OG001', 'title': 'Group B', 'description': 'Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD\n\nMonth 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD\n\nThe efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.'}, {'id': 'OG002', 'title': 'Group C', 'description': 'Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD\n\nMonth 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group\n\nThe efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: \\< 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.61', 'spread': '0.307', 'groupId': 'OG000'}, {'value': '0.56', 'spread': '0.194', 'groupId': 'OG001'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.30', 'spread': '0.265', 'groupId': 'OG000'}, {'value': '0.30', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 0 (baseline), Month 6', 'description': 'The mean percentage of overall work impairment due to health problem (based on the WPAI questionnaire) is presented, and is calculated as: Absenteeism (%) + extent to which health problem decreased productivity (%)\\* \\[number of hours worked / (number of hours of work missed due to health problem + number of hours worked)\\]. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity.', 'unitOfMeasure': 'percent overall work impairment', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with an assessment at given time point.'}, {'type': 'SECONDARY', 'title': 'WPAI:SHP Scores Over Time: Percent Activity Impairment Due to Problem', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A', 'description': 'Day 1 through Month 3 (open-label): elagolix 150 mg QD\n\nParticipants discontinued prematurely during the open-label period.'}, {'id': 'OG001', 'title': 'Group B', 'description': 'Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD\n\nMonth 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD\n\nThe efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.'}, {'id': 'OG002', 'title': 'Group C', 'description': 'Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD\n\nMonth 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group\n\nThe efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: \\< 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.66', 'spread': '0.237', 'groupId': 'OG000'}, {'value': '0.67', 'spread': '0.058', 'groupId': 'OG001'}, {'value': '0.70', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.40', 'spread': '0.346', 'groupId': 'OG000'}, {'value': '0.30', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG001'}, {'value': '0.70', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 0 (baseline), Month 6', 'description': 'Activity impairment due to health problem (the extent to which health problem affected the ability to perform usual daily activities) is presented as the mean percentage of activity impairment, and is calculated as 100\\*scale value of WPAI question 6 (between 0 and 10) / 10. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity.', 'unitOfMeasure': 'percentage impairment of activity', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with an assessment at given time point.'}, {'type': 'SECONDARY', 'title': 'Health Endometriosis Treatment Satisfaction Questionnaire (ETSQ) Scores Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A', 'description': 'Day 1 through Month 3 (open-label): elagolix 150 mg QD\n\nParticipants discontinued prematurely during the open-label period.'}, {'id': 'OG001', 'title': 'Group B', 'description': 'Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD\n\nMonth 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD\n\nThe efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.'}, {'id': 'OG002', 'title': 'Group C', 'description': 'Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD\n\nMonth 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group\n\nThe efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: \\< 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '19.71', 'spread': '4.536', 'groupId': 'OG000'}, {'value': '18.00', 'spread': '0.000', 'groupId': 'OG001'}, {'value': '18.00', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '22.25', 'spread': '9.430', 'groupId': 'OG000'}, {'value': '25.47', 'spread': '6.652', 'groupId': 'OG001'}, {'value': '25.00', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '31.00', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 0 (baseline), Months 3, 6', 'description': 'The 6-item ETSQ was developed to assess patient-reported satisfaction with effects on endometriosis pain, dysmenorrhea, dyspareunia, amount of bleeding tolerability and overall treatment satisfaction. The ETSQ has a 7 point response scale. The range for this scale is 0 to 36, with lower ETSQ scores reflecting lower levels of satisfaction with endometriosis treatment.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with an assessment at given time point.'}, {'type': 'SECONDARY', 'title': 'PROMIS Fatigue Short Form 6a Scores Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A', 'description': 'Day 1 through Month 3 (open-label): elagolix 150 mg QD\n\nParticipants discontinued prematurely during the open-label period.'}, {'id': 'OG001', 'title': 'Group B', 'description': 'Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD\n\nMonth 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD\n\nThe efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.'}, {'id': 'OG002', 'title': 'Group C', 'description': 'Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD\n\nMonth 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group\n\nThe efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: \\< 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '22.1', 'spread': '4.10', 'groupId': 'OG000'}, {'value': '19.3', 'spread': '6.11', 'groupId': 'OG001'}, {'value': '27.0', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '15.3', 'spread': '7.77', 'groupId': 'OG000'}, {'value': '11.0', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG001'}, {'value': '21.0', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 0 (baseline), Month 6', 'description': 'The PROMIS Fatigue Short Form 6a is self-administered and composed of 6 questions to evaluate fatigue. Possible scores range from 6 to 30, 6 = not at all (no fatigue), and 30 = very much (most fatigue).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with an assessment at given time point.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group A', 'description': 'Day 1 through Month 3 (open-label): elagolix 150 mg QD\n\nParticipants discontinued prematurely during the open-label period.'}, {'id': 'FG001', 'title': 'Group B', 'description': 'Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD\n\nMonth 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD\n\nThe efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.'}, {'id': 'FG002', 'title': 'Group C', 'description': 'Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD\n\nMonth 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group\n\nThe efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: \\< 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window'}], 'periods': [{'title': 'Open Label Period: Day 1 to Month 3', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Double Blind Period: Month 3 to Month 6', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Study Terminated by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'The study was terminated early for business reasons, not for safety concerns. There are no subject data past Treatment Month 6.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Group A', 'description': 'Day 1 through Month 3 (open-label): elagolix 150 mg QD\n\nParticipants discontinued prematurely during the open-label period.'}, {'id': 'BG001', 'title': 'Group B', 'description': 'Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD\n\nMonth 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD\n\nThe efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.'}, {'id': 'BG002', 'title': 'Group C', 'description': 'Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD\n\nMonth 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group\n\nThe efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: \\< 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '20 to < 25 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}, {'title': '25 to < 30 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': '30 to < 35 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}, {'title': '35 to < 40 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': '40 to < 45 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}, {'title': '45 to < 50 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '8', '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': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', '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': 'Dysmenorrhea (DYS) Pain Scale', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0.641', 'spread': '0.1689', 'groupId': 'BG000'}, {'value': '0.429', 'spread': '0.1030', 'groupId': 'BG001'}, {'value': '0.600', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'BG002'}, {'value': '0.579', 'spread': '0.1696', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'The DYS pain scale score ranged from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe), recorded in a daily eDiary. A minimum of 45 days of daily e-Diary entries were required to be completed during the Screening Period.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Non-Menstrual Pelvic Pain (NMPP) Pain Scale', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '1.053', 'spread': '0.4534', 'groupId': 'BG000'}, {'value': '0.914', 'spread': '0.4721', 'groupId': 'BG001'}, {'value': '2.400', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'BG002'}, {'value': '1.138', 'spread': '0.5893', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'The NMPP pain scale score ranged from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe), recorded in a daily eDiary. A minimum of 45 days of daily e-Diary entries were required to be completed during the Screening Period.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Dyspareunia Pain Scale', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0.539', 'spread': '0.9064', 'groupId': 'BG000'}, {'value': '0.043', 'spread': '0.0202', 'groupId': 'BG001'}, {'value': '3.000', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'BG002'}, {'value': '0.686', 'spread': '1.1187', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'The dyspareunia pain scale score ranged from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe), recorded in a daily eDiary. A minimum of 45 days of daily e-Diary entries were required to be completed during the Screening Period.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': '1 subject did not complete assessment'}, {'title': 'Daily Diary Endometriosis-Associated Pain Score Via Numeric Rating Scale (NRS)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '5.176', 'spread': '1.9302', 'groupId': 'BG000'}, {'value': '3.638', 'spread': '1.5692', 'groupId': 'BG001'}, {'value': '7.371', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'BG002'}, {'value': '4.956', 'spread': '1.9663', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'The NRS for overall endometriosis-associated pain ranges from 0 (none) to 10 (worst pain ever), recorded in a daily eDiary. A minimum of 45 days of daily e-Diary entries were required to be completed during the Screening Period.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Rescue Analgesic Use Across Both Classes of Rescue Analgesics (NSAIDs/Opioids)', 'classes': [{'title': 'NSAID', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '2.388', 'spread': '2.7765', 'groupId': 'BG000'}, {'value': '0.581', 'spread': '0.9330', 'groupId': 'BG001'}, {'value': '0.743', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'BG002'}, {'value': '1.745', 'spread': '2.3655', 'groupId': 'BG003'}]}]}, {'title': 'Opioid', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0.241', 'spread': '0.3750', 'groupId': 'BG000'}, {'value': '0.057', 'spread': '0.0990', 'groupId': 'BG001'}, {'value': '0.571', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'BG002'}, {'value': '0.221', 'spread': '0.3270', 'groupId': 'BG003'}]}]}, {'title': 'NSAID + Opioid', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '2.629', 'spread': '2.6903', 'groupId': 'BG000'}, {'value': '0.638', 'spread': '0.8918', 'groupId': 'BG001'}, {'value': '1.314', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'BG002'}, {'value': '1.966', 'spread': '2.3196', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Based on average pill counts and assessed using the daily e-Diary. Participants were allowed to take protocol-specified analgesic rescue medication for endometriosis-associated pain and recorded use daily in the e-Diary. A minimum of 45 days of daily e-Diary entries were required to be completed during the Screening Period. Permitted non-steroidal anti-inflammatory drugs (NSAIDs) included naproxen, ibuprofen, diclofenac, and celecoxib. Permitted opioids included hydrocodone + acetaminophen and codeine phosphate + acetaminophen.', 'unitOfMeasure': 'pills/day', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-09-29', 'size': 1599466, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-11-08T15:42', 'hasProtocol': True}]}}, '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': 11}}, 'statusModule': {'whyStopped': 'The study was terminated early for business reasons, not for safety concerns.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-12-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2018-10-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-08', 'studyFirstSubmitDate': '2017-11-13', 'resultsFirstSubmitDate': '2019-10-22', 'studyFirstSubmitQcDate': '2017-11-13', 'lastUpdatePostDateStruct': {'date': '2019-11-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-11-08', 'studyFirstPostDateStruct': {'date': '2017-11-17', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-11-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Responders at Month 6 Based on DYS Pain Scale', 'timeFrame': 'Month 6', 'description': 'Proportion of responders at Month 6 based upon the scale for DYS pain scale (ranging from 0 \\[none\\] to 3 \\[severe\\]) using the daily e-Diary, as well as no increased analgesic rescue use for endometriosis-associated pain.'}, {'measure': 'Proportion of Responders at Month 6 Based on NMPP Pain Scale', 'timeFrame': 'Month 6', 'description': 'Proportion of responders at Month 6 based upon the scale for NMPP pain scale (ranging from 0 \\[none\\] to 3 \\[severe\\]) using the daily e-Diary, as well as no increased analgesic rescue use for endometriosis-associated pain.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in DYS at Month 6', 'timeFrame': 'Month 0 (baseline), Month 6', 'description': 'The DYS pain scale score ranged from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe), recorded in a daily eDiary and averaged monthly based on a 35-day window. A negative change from baseline indicates improvement.'}, {'measure': 'Change From Baseline in NMPP at Month 6', 'timeFrame': 'Month 0 (baseline), Month 6', 'description': 'The NMPP pain scale score ranged from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe), recorded in a daily eDiary and averaged monthly based on a 35-day window. A negative change from baseline indicates improvement.'}, {'measure': 'Change From Baseline in Dyspareunia at Month 6', 'timeFrame': 'Month 0 (baseline), Month 6', 'description': 'The dyspareunia pain scale score ranged from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe), recorded in a daily eDiary and averaged monthly based on a 35-day window. A negative change from baseline indicates improvement.'}, {'measure': 'Change From Baseline in Daily Diary Endometriosis-Associated Pain Score Via Numeric Rating Scale (NRS) at Month 6', 'timeFrame': 'Month 0 (baseline), Month 6', 'description': 'The NRS for overall endometriosis-associated pain ranges from 0 (none) to 10 (worst pain ever), recorded in a daily eDiary and averaged monthly based on a 35-day window. A negative change from baseline indicates improvement.'}, {'measure': 'Change From Baseline in Rescue Analgesic Use Across Both Classes of Rescue Analgesics (NSAIDs/Opioids) at Month 6', 'timeFrame': 'Month 0 (baseline), Month 6', 'description': 'Based on average pill counts and assessed using the daily e-Diary. Permitted non-steroidal anti-inflammatory drugs (NSAIDs) included naproxen, ibuprofen, diclofenac, and celecoxib. Permitted opioids included hydrocodone + acetaminophen and codeine phosphate + acetaminophen.'}, {'measure': 'Percentage of Participants With 30% or More Reduction From Baseline Based on the 35 Day Mean of the Daily Diary Endometriosis-Associated Pain Score Via NRS at Month 6', 'timeFrame': 'Month 6', 'description': 'The NRS for overall endometriosis-associated pain ranges from 0 (none) to 10 (worst pain ever), recorded in a daily eDiary and averaged monthly based on a 35-day window.'}, {'measure': 'Proportion of Responders Over Time', 'timeFrame': 'Month 0 (baseline), Months 1, 2, 3, 4, 5, 6', 'description': 'As assessed by change and percent change from baseline in average pain score and rescue analgesic use monthly for DYS, NMPP, dyspareunia, and Daily Diary endometriosis-associated pain score via NRS, respectively.'}, {'measure': 'Proportion of Responders Over Time (Not Taking Into Consideration of Analgesic Use)', 'timeFrame': 'Month 0 (baseline), Months 1, 2, 3, 4, 5, 6', 'description': 'As assessed by change and percent change from Baseline in average pain score and rescue analgesic use monthly for DYS, NMPP, dyspareunia, and Daily Diary endometriosis-associated pain score via NRS, respectively.'}, {'measure': 'Change From Baseline Over Time in Monthly Average DYS Pain Score', 'timeFrame': 'Month 0 (baseline), Months 1, 2, 3, 4, 5, 6', 'description': 'The DYS pain scale score ranged from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe), recorded in a daily eDiary and averaged monthly based on a 35-day window. A negative change from baseline indicates improvement.\n\nThe analysis was based on a 28-day window. If a participant prematurely discontinued during the open-label period, based on the analysis window, some data might fall into Month 4 analysis.'}, {'measure': 'Change From Baseline Over Time in Monthly Average NMPP Pain Score', 'timeFrame': 'Month 0 (baseline), Months 1, 2, 3, 4, 5, 6', 'description': 'The NMPP pain scale score ranged from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe), recorded in a daily eDiary and averaged monthly based on a 35-day window. A negative change from baseline indicates improvement.'}, {'measure': 'Change From Baseline Over Time in Monthly Average Dyspareunia Pain Score', 'timeFrame': 'Month 0 (baseline), Months 1, 2, 3, 4, 5, 6', 'description': 'The dyspareunia pain scale score ranged from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe), recorded in a daily eDiary and averaged monthly based on a 35-day window. A negative change from baseline indicates improvement.'}, {'measure': 'Change From Baseline Over Time in Monthly Average Daily Diary Endometriosis-Associated Pain Score Via NRS', 'timeFrame': 'Month 0 (baseline), Months 1, 2, 3, 4, 5, 6', 'description': 'The NRS for overall endometriosis-associated pain ranges from 0 (none) to 10 (worst pain ever), recorded in a daily eDiary and averaged monthly based on a 35-day window. A negative change from baseline indicates improvement.'}, {'measure': 'Percent Change From Baseline to Each Month During the Treatment Period for DYS', 'timeFrame': 'Month 0 (baseline), Months 1, 2, 3, 4, 5, 6', 'description': 'The DYS pain scale score ranged from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe), recorded in a daily eDiary and averaged monthly based on a 35-day window. A negative change from baseline indicates improvement.'}, {'measure': 'Percent Change From Baseline to Each Month During the Treatment Period for NMPP', 'timeFrame': 'Month 0 (baseline), Months 1, 2, 3, 4, 5, 6', 'description': 'The NMPP pain scale score ranged from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe), recorded in a daily eDiary and averaged monthly based on a 35-day window. A negative change from baseline indicates improvement.'}, {'measure': 'Percent Change From Baseline to Each Month During the Treatment Period for Dyspareunia', 'timeFrame': 'Month 0 (baseline), Months 1, 2, 3, 4, 5, 6', 'description': 'The dyspareunia pain scale score ranged from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe), recorded in a daily eDiary and averaged monthly based on a 35-day window. A negative change from baseline indicates improvement.'}, {'measure': 'Percent Change From Baseline to Each Month During the Treatment Period for Daily Diary Endometriosis-Associated Pain Score Via NRS', 'timeFrame': 'Month 0 (baseline), Months 1, 2, 3, 4, 5, 6', 'description': 'The NRS for overall endometriosis-associated pain ranges from 0 (none) to 10 (worst pain ever), recorded in a daily eDiary and averaged monthly based on a 35-day window. A negative change from baseline indicates improvement.'}, {'measure': 'Change From Baseline Over Time in Daily Rescue Analgesic Use Across Both Classes of Rescue Analgesics', 'timeFrame': 'Month 0 (baseline), Months 1, 2, 3, 4, 5, 6', 'description': 'Based on average pill counts and assessed using a daily e-Diary. Permitted non-steroidal anti-inflammatory drugs (NSAIDs) included naproxen, ibuprofen, diclofenac, and celecoxib. Permitted opioids included hydrocodone + acetaminophen and codeine phosphate + acetaminophen.'}, {'measure': 'Number of Analgesic Use Responders and Non-Responders Over Time', 'timeFrame': 'Months 1, 2, 3, 4, 5, 6', 'description': 'Based only on reduction of rescue analgesics used. Responders were defined as:\n\n* participants with no analgesic use at screening and no analgesic use added\n* participants with NSAID only use at screening and NSAID dose stopped, decreased, or stable (\\<15% increase) and no opioid use added\n* participants with opioid only use at screening and opioid dose stopped, decreased, or stable (\\<15% increase), opioid dose stopped and NSAID substituted (any dose), opioid dose decreased and NSAID added (any dose)\n* participants with NSAID + opioid use at screening and any of the following: NSAID dose stopped + opioid analgesic use stopped, decreased, or stable (\\<15% increase); NSAID dose decreased + opioid analgesic use stopped, decreased, or stable (\\<15% increase); NSAID dose stable (\\< 15% increase) + opioid analgesic use stopped, decreased, or stable (\\<15% increase); NSAID dose increased by \\>15% + opioid analgesic use stopped; NSAID dose increased by \\>15% + opioid analgesic dose decreases.'}, {'measure': 'Patient Global Impression of Change (PGIC) Scores Over Time', 'timeFrame': 'Months 1, 2, 3, 4, 5, 6', 'description': 'The PGIC is a 7-point response scale where participants rate their endometriosis related pain as: very much improved (1), much improved (2), minimally improved (3), not changed (4), minimally worse (5), much worse (6), very much worse (7).'}, {'measure': 'Overall Endometriosis-Associated Pain Via NRS (7-Day Recall) Scores Over Time', 'timeFrame': 'Month 0 (baseline), Months 1, 2, 3, 4, 5, 6', 'description': 'The endometriosis-associated pain questionnaire is an 11-point NRS assessing overall endometriosis-associated pain over a 7-day recall period. Participants assessed their endometriosis-associated pain on a scale of 0 to 10, with 0 = no pain and 10 = worst pain ever.'}, {'measure': 'Endometriosis Health Profile-30 (EHP-30) Scores Over Time: Pain', 'timeFrame': 'Month 0 (baseline), Months 3, 6', 'description': 'The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Domains used in the study included Pain, Control and Powerlessness, Well-Being, Social Support, Self-Image, and Sexual Intercourse. Each domain is calculated on a scale from 0 = best possible health status to 100 = worst possible health status.'}, {'measure': 'EHP-30 Scores Over Time: Control and Powerlessness', 'timeFrame': 'Month 0 (baseline), Months 3, 6', 'description': 'The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Domains used in the study included Pain, Control and Powerlessness, Well-Being, Social Support, Self-Image, and Sexual Intercourse. Each domain is calculated on a scale from 0 = best possible health status to 100 = worst possible health status.'}, {'measure': 'EHP-30 Scores Over Time: Emotional Well-Being', 'timeFrame': 'Month 0 (baseline), Months 3, 6', 'description': 'The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Domains used in the study included Pain, Control and Powerlessness, Well-Being, Social Support, Self-Image, and Sexual Intercourse. Each domain is calculated on a scale from 0 = best possible health status to 100 = worst possible health status.'}, {'measure': 'EHP-30 Scores Over Time: Social Support', 'timeFrame': 'Month 0 (baseline), Months 3, 6', 'description': 'The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Domains used in the study included Pain, Control and Powerlessness, Well-Being, Social Support, Self-Image, and Sexual Intercourse. Each domain is calculated on a scale from 0 = best possible health status to 100 = worst possible health status.'}, {'measure': 'EHP-30 Scores Over Time: Self-Image', 'timeFrame': 'Month 0 (baseline), Months 3, 6', 'description': 'The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Domains used in the study included Pain, Control and Powerlessness, Well-Being, Social Support, Self-Image, and Sexual Intercourse. Each domain is calculated on a scale from 0 = best possible health status to 100 = worst possible health status.'}, {'measure': 'EHP-30 Scores Over Time: Sexual Intercourse', 'timeFrame': 'Month 0 (baseline), Months 3, 6', 'description': 'The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Domains used in the study included Pain, Control and Powerlessness, Well-Being, Social Support, Self-Image, and Sexual Intercourse. Each domain is calculated on a scale from 0 = best possible health status to 100 = worst possible health status.'}, {'measure': 'EuroQol-5D 5 Level (EQ-5D-5L) Scores Over Time: Mobility', 'timeFrame': 'Month 0 (baseline), Months 3, 6', 'description': "The EQ-5D-5L is a health state utility instrument with 5 items that comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each of which is rated on 5 levels of severity (1=no problem, 2=slight problems, 3=moderate problems, 4=severe problems, 5=extreme problems) and a separate visual analog scale (VAS) indicating a participant's rating of their current health status (health today) on a scale of from 0 (worst health imaginable) to 100 (best health imaginable)."}, {'measure': 'EQ-5D-5L Scores Over Time: Self-Care', 'timeFrame': 'Month 0 (baseline), Months 3, 6', 'description': "The EQ-5D-5L is a health state utility instrument with 5 items that comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each of which is rated on 5 levels of severity (1=no problem, 2=slight problems, 3=moderate problems, 4=severe problems, 5=extreme problems) and a separate visual analog scale (VAS) indicating a participant's rating of their current health status (health today) on a scale of from 0 (worst health imaginable) to 100 (best health imaginable)."}, {'measure': 'EQ-5D-5L Scores Over Time: Usual Activities', 'timeFrame': 'Month 0 (baseline), Months 3, 6', 'description': "The EQ-5D-5L is a health state utility instrument with 5 items that comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each of which is rated on 5 levels of severity (1=no problem, 2=slight problems, 3=moderate problems, 4=severe problems, 5=extreme problems) and a separate visual analog scale (VAS) indicating a participant's rating of their current health status (health today) on a scale of from 0 (worst health imaginable) to 100 (best health imaginable)."}, {'measure': 'EQ-5D-5L Scores Over Time: Pain/Discomfort', 'timeFrame': 'Month 0 (baseline), Months 3, 6', 'description': "The EQ-5D-5L is a health state utility instrument with 5 items that comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each of which is rated on 5 levels of severity (1=no problem, 2=slight problems, 3=moderate problems, 4=severe problems, 5=extreme problems) and a separate visual analog scale (VAS) indicating a participant's rating of their current health status (health today) on a scale of from 0 (worst health imaginable) to 100 (best health imaginable)."}, {'measure': 'EQ-5D-5L Scores Over Time: Anxiety/Depression', 'timeFrame': 'Month 0 (baseline), Months 3, 6', 'description': "The EQ-5D-5L is a health state utility instrument with 5 items that comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each of which is rated on 5 levels of severity (1=no problem, 2=slight problems, 3=moderate problems, 4=severe problems, 5=extreme problems) and a separate visual analog scale (VAS) indicating a participant's rating of their current health status (health today) on a scale of from 0 (worst health imaginable) to 100 (best health imaginable)."}, {'measure': 'EQ-5D-5L VAS Scores Over Time: Health Today', 'timeFrame': 'Month 0 (baseline), Months 3, 6', 'description': "The EQ-5D-5L is a health state utility instrument with 5 items that comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each of which is rated on 5 levels of severity (1=no problem, 2=slight problems, 3=moderate problems, 4=severe problems, 5=extreme problems) and a separate VAS indicating a participant's rating of their current health status (health today) on a scale of from 0 (worst health imaginable) to 100 (best health imaginable)."}, {'measure': 'Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP) Scores Over Time: Percent Work Missed Due to Problem', 'timeFrame': 'Month 0 (baseline), Month 6', 'description': 'Absenteeism is presented as the mean percentage of work time missed due to health problem (as reported on the WPAI:SHP), and is calculated as: 100\\*number of hours of work missed due to health problem / (number of hours of work missed due to health problem + number of hours worked). WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity.'}, {'measure': 'WPAI:SHP Scores Over Time: Percent Impairment While Working Due to Problem', 'timeFrame': 'Month 0 (baseline), Month 6', 'description': 'Presenteeism (the extent to which health problem decreased productivity) is presented as the mean percentage of impairment while working due to health problem, and is calculated as: 100\\*scale value of question 5 on the WPAI (between 0 and 10) / 10. WPAI:SHP is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity.'}, {'measure': 'WPAI:SHP Scores Over Time: Percent Overall Work Impairment Due to Problem', 'timeFrame': 'Month 0 (baseline), Month 6', 'description': 'The mean percentage of overall work impairment due to health problem (based on the WPAI questionnaire) is presented, and is calculated as: Absenteeism (%) + extent to which health problem decreased productivity (%)\\* \\[number of hours worked / (number of hours of work missed due to health problem + number of hours worked)\\]. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity.'}, {'measure': 'WPAI:SHP Scores Over Time: Percent Activity Impairment Due to Problem', 'timeFrame': 'Month 0 (baseline), Month 6', 'description': 'Activity impairment due to health problem (the extent to which health problem affected the ability to perform usual daily activities) is presented as the mean percentage of activity impairment, and is calculated as 100\\*scale value of WPAI question 6 (between 0 and 10) / 10. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity.'}, {'measure': 'Health Endometriosis Treatment Satisfaction Questionnaire (ETSQ) Scores Over Time', 'timeFrame': 'Month 0 (baseline), Months 3, 6', 'description': 'The 6-item ETSQ was developed to assess patient-reported satisfaction with effects on endometriosis pain, dysmenorrhea, dyspareunia, amount of bleeding tolerability and overall treatment satisfaction. The ETSQ has a 7 point response scale. The range for this scale is 0 to 36, with lower ETSQ scores reflecting lower levels of satisfaction with endometriosis treatment.'}, {'measure': 'PROMIS Fatigue Short Form 6a Scores Over Time', 'timeFrame': 'Month 0 (baseline), Month 6', 'description': 'The PROMIS Fatigue Short Form 6a is self-administered and composed of 6 questions to evaluate fatigue. Possible scores range from 6 to 30, 6 = not at all (no fatigue), and 30 = very much (most fatigue).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Endometriosis associated pain', 'Elagolix', 'Non-menstrual pelvic pain (NMPP)', 'Dysmenorrhea (DYS)'], 'conditions': ['Endometriosis']}, 'descriptionModule': {'briefSummary': 'This is a Phase 3, dose-escalation study designed to evaluate the safety and efficacy of both elagolix alone and elagolix plus estradiol/norethindrone acetate (E2/NETA) over 24 months in the management of endometriosis with associated moderate to severe pain in premenopausal women.'}, '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 or histology within 10 years prior to entry into Washout or Screening,\n* Participant must agree to use only those rescue analgesics permitted by the protocol during the Screening and Treatment Periods for her 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" DYS, AND either,\n 2. At least 2 days of "moderate" or "severe" 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-associated 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 major depression or post-traumatic stress disorder (PTSD) within 2 years prior to screening 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) at Screening or prior to study drug dosing on Day 1.\n* Participant has 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 or more standard deviations below normal (Z-score \\< -2.0 for participants \\< 40 years of age, T-score for participants \\>= 40 years of age).\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 enrollment on Day 1 OR\n 2. a clinically significant medical condition that is anticipated to required intervention during the course of study participation (e.g., anticipated major elective surgery) OR\n 3. an unstable medical condition that makes the participant an unsuitable candidate for the study in the opinion of the Investigator\n* Participant has any conditions contraindicated with use of E2/NETA'}, 'identificationModule': {'nctId': 'NCT03343067', 'briefTitle': 'A Study to Evaluate Safety and Efficacy of Elagolix in Participants With Endometriosis With Associated Moderate to Severe Pain', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'A Study to Evaluate Safety and Efficacy of Elagolix Alone or Elagolix With Hormonal Add-Back in Subjects With Endometriosis With Associated Moderate to Severe Pain', 'orgStudyIdInfo': {'id': 'M16-383'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A', 'description': 'Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD\n\nMonth 4 Through Month 24 (Double-Blind): Efficacy responders to elagolix 150 mg QD at Month 3 and continue treatment through Month 24', 'interventionNames': ['Drug: elagolix']}, {'type': 'EXPERIMENTAL', 'label': 'Arm C', 'description': 'Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD\n\nMonth 4 Through Month 24 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group and continue treatment through Month 24.', 'interventionNames': ['Drug: elagolix', 'Drug: estradiol/norethindrone acetate (E2/NETA)']}, {'type': 'EXPERIMENTAL', 'label': 'Arm D', 'description': 'Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD\n\nMonth 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 150 mg QD treatment group\n\nMonth 7 Through Month 24 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 6 and assigned to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group and continue treatment through Month 24.', 'interventionNames': ['Drug: elagolix', 'Drug: estradiol/norethindrone acetate (E2/NETA)']}, {'type': 'EXPERIMENTAL', 'label': 'Arm B', 'description': 'Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD\n\nMonth 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 150 mg QD treatment group\n\nMonth 7 Through Month 24 (Double-Blind): Efficacy responders to elagolix 150 mg QD at Month 6 and continue treatment through Month 24.', 'interventionNames': ['Drug: elagolix']}], 'interventions': [{'name': 'elagolix', 'type': 'DRUG', 'description': 'Tablets', 'armGroupLabels': ['Arm A', 'Arm B', 'Arm C', 'Arm D']}, {'name': 'estradiol/norethindrone acetate (E2/NETA)', 'type': 'DRUG', 'description': 'Capsules', 'armGroupLabels': ['Arm C', 'Arm D']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36207', 'city': 'Anniston', 'state': 'Alabama', 'country': 'United States', 'facility': 'Pinnacle Research Group /ID# 202016', 'geoPoint': {'lat': 33.65983, 'lon': -85.83163}}, {'zip': '85704', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Noble Clinical Research /ID# 170628', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Lynn Institute of the Ozarks /ID# 165052', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '92844', 'city': 'Garden Grove', 'state': 'California', 'country': 'United States', 'facility': 'SC Clinical Research /ID# 165049', 'geoPoint': {'lat': 33.77391, 'lon': -117.94145}}, {'zip': '92647', 'city': 'Huntington Beach', 'state': 'California', 'country': 'United States', 'facility': 'Marvel Clinical Research /ID# 169633', 'geoPoint': {'lat': 33.6603, 'lon': -117.99923}}, {'zip': '92704', 'city': 'Santa Ana', 'state': 'California', 'country': 'United States', 'facility': 'Health care Affiliates Medical Group /ID# 165048', 'geoPoint': {'lat': 33.74557, 'lon': -117.86783}}, {'zip': '80033-2896', 'city': 'Wheat Ridge', 'state': 'Colorado', 'country': 'United States', 'facility': 'Western States Clinical Res /ID# 169809', 'geoPoint': {'lat': 39.7661, 'lon': -105.07721}}, {'zip': '34209-4616', 'city': 'Bradenton', 'state': 'Florida', 'country': 'United States', 'facility': 'Nova Clinical Research, LLC /ID# 202227', 'geoPoint': {'lat': 27.49893, 'lon': -82.57482}}, {'zip': '32720-0920', 'city': 'DeLand', 'state': 'Florida', 'country': 'United States', 'facility': 'Midland Florida Clinical Research Center /ID# 201327', 'geoPoint': {'lat': 29.02832, 'lon': -81.30312}}, {'zip': '32607', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'Southeastern Integrated Med /ID# 203109', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '32277', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Care Partners Clinical Researc /ID# 168395', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33126', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'LCC Medical Research Institute /ID# 168888', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32763-2833', 'city': 'Orange City', 'state': 'Florida', 'country': 'United States', 'facility': 'A Premier Clinical Research of Florida, LLC /ID# 201887', 'geoPoint': {'lat': 28.94888, 'lon': -81.29867}}, {'zip': '33609-4044', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'GCP Clinical Research, LLC /ID# 169774', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '33407-3100', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Triple O Research Institute /ID# 201128', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '83221', 'city': 'Blackfoot', 'state': 'Idaho', 'country': 'United States', 'facility': 'Bingham Memorial Hospital /ID# 170110', 'geoPoint': {'lat': 43.19047, 'lon': -112.34498}}, {'zip': '83404-8322', 'city': 'Idaho Falls', 'state': 'Idaho', 'country': 'United States', 'facility': 'Leavitt Womens Healthcare /ID# 169495', 'geoPoint': {'lat': 43.46658, 'lon': -112.03414}}, {'zip': '60605', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Quad Clinical Research, LLC /ID# 168294', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60605', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Quad Clinical Research, LLC /ID# 170629', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '47630-8940', 'city': 'Newburgh', 'state': 'Indiana', 'country': 'United States', 'facility': "Women's Health Care, PC /ID# 165033", 'geoPoint': {'lat': 37.94449, 'lon': -87.40529}}, {'zip': '70115', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Delricht Research /ID# 200219', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '63108-3204', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Quad Clinical Research, LLC /ID# 200180', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '59102', 'city': 'Billings', 'state': 'Montana', 'country': 'United States', 'facility': 'Montana Health Research Inst /ID# 170624', 'geoPoint': {'lat': 45.78329, 'lon': -108.50069}}, {'zip': '89109', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Excel Clinical Research /ID# 170620', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '11030-3816', 'city': 'Manhasset', 'state': 'New York', 'country': 'United States', 'facility': 'Northwell health system /ID# 200162', 'geoPoint': {'lat': 40.79788, 'lon': -73.69957}}, {'zip': '44311', 'city': 'Akron', 'state': 'Ohio', 'country': 'United States', 'facility': 'Radiant Research, Inc /ID# 200045', 'geoPoint': {'lat': 41.08144, 'lon': -81.51901}}, {'zip': '43213-3399', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Central Ohio Clinical Research /ID# 170750', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '43235', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Optimed Research /ID# 167642', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '29601', 'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'VitaLink Research /ID# 168401', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'zip': '29601', 'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'VitaLink Research /ID# 170625', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'zip': '29301-5642', 'city': 'Spartanburg', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Fusion Clinical Research of Spartanburg /ID# 200010', 'geoPoint': {'lat': 34.94957, 'lon': -81.93205}}, {'zip': '77058-2705', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Centex Studies, Inc /ID# 169897', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77080', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': "America's Adv. Wellness Center /ID# 170005", 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '75024-5280', 'city': 'Plano', 'state': 'Texas', 'country': 'United States', 'facility': 'ClinRx Research, LLC /ID# 201189', 'geoPoint': {'lat': 33.01984, 'lon': -96.69889}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Progressive Clinical Research /ID# 205565', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '23507-1627', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'Eastern Virginia Med School /ID# 165016', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}, {'zip': '98109', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Seattle Reproductive Medicine /ID# 171079', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'AbbVie Inc.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'ipdSharingStatementModule': {'url': 'https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.', 'ipdSharing': 'YES', 'description': 'AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.', 'accessCriteria': 'Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}