Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2026-02-05 @ 7:28 PM
Study NCT ID:
NCT02925494
Status:
COMPLETED
Last Update Posted:
2021-07-13
First Post:
2016-09-24
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
An Extension Study to Evaluate the Efficacy and Safety of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007889', 'term': 'Leiomyoma'}, {'id': 'D008595', 'term': 'Menorrhagia'}], 'ancestors': [{'id': 'D009379', 'term': 'Neoplasms, Muscle Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D014592', 'term': 'Uterine Hemorrhage'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D008599', 'term': 'Menstruation Disturbances'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C418365', 'term': 'estradiol, norethindrone drug combination'}, {'id': 'C539351', 'term': 'elagolix'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'abbvieclinicaltrials@abbvie.com', 'phone': '800-633-9110', 'title': 'Global Medical Services', 'organization': 'AbbVie'}, 'certainAgreement': {'otherDetails': 'AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively', 'description': 'Treatment-emergent adverse events are presented.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo->Elagolix', 'description': 'Placebo in pivotal study and elagolix 300 mg BID in extension study.', 'otherNumAtRisk': 59, 'deathsNumAtRisk': 59, 'otherNumAffected': 38, 'seriousNumAtRisk': 59, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Placebo->Elagolix + E2/NETA', 'description': 'Placebo in pivotal study and elagolix 300 mg BID plus E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD in extension study.', 'otherNumAtRisk': 58, 'deathsNumAtRisk': 58, 'otherNumAffected': 26, 'seriousNumAtRisk': 58, 'deathsNumAffected': 1, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'Elagolix->Elagolix', 'description': 'Elagolix 300 mg BID in pivotal study and elagolix 300 mg BID in extension study.', 'otherNumAtRisk': 98, 'deathsNumAtRisk': 98, 'otherNumAffected': 25, 'seriousNumAtRisk': 98, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'Elagolix + E2/NETA->Elagolix + E2/NETA', 'description': 'Elagolix 300 mg BID plus E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD in pivotal study and elagolix 300 mg BID plus E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD in extension study.', 'otherNumAtRisk': 218, 'deathsNumAtRisk': 218, 'otherNumAffected': 50, 'seriousNumAtRisk': 218, 'deathsNumAffected': 0, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 218, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 98, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 218, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'NASOPHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 98, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 218, 'numEvents': 11, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'TOOTH INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'URINARY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 98, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 218, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'BONE DENSITY DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 98, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 218, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'ARTHRALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 218, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 98, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 218, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'ANXIETY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 218, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'MOOD SWINGS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 218, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'METRORRHAGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 218, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'ALOPECIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'NIGHT SWEATS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 16, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 98, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 218, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'HOT FLUSH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 33, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 98, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 218, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}], 'seriousEvents': [{'term': 'ABDOMINAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'CHOLECYSTITIS ACUTE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'CHOLELITHIASIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'PILONIDAL CYST', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 218, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'SEPSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'OBESITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'BREAST CANCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'BREAST CANCER STAGE II', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 218, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'FACIAL PARALYSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 218, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'ABORTION SPONTANEOUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 218, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'MENORRHAGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 218, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'METRORRHAGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'PELVIC PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 218, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'HYSTERECTOMY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 218, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Meeting the Criteria for Responder', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '94', 'groupId': 'OG002'}, {'value': '206', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo->Elagolix', 'description': 'Placebo in pivotal study and elagolix 300 mg BID in extension study.'}, {'id': 'OG001', 'title': 'Placebo->Elagolix + E2/NETA', 'description': 'Placebo in pivotal study and elagolix 300 mg BID plus E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD in extension study.'}, {'id': 'OG002', 'title': 'Elagolix->Elagolix', 'description': 'Elagolix 300 mg BID in pivotal study and elagolix 300 mg BID in extension study.'}, {'id': 'OG003', 'title': 'Elagolix + E2/NETA->Elagolix + E2/NETA', 'description': 'Elagolix 300 mg BID plus E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD in pivotal study and elagolix 300 mg BID plus E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD in extension study.'}], 'classes': [{'categories': [{'measurements': [{'value': '85.7', 'groupId': 'OG000'}, {'value': '66.7', 'groupId': 'OG001'}, {'value': '89.4', 'groupId': 'OG002'}, {'value': '87.9', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Month 0 (Baseline in Pivotal Study) to Final Month of Treatment Period (up through Month 6 in Extension Study)', 'description': 'Percentage of responders, defined as participants who met the following conditions:\n\n* Menstrual blood loss (MBL) volume \\< 80 mL during the Final Month (the last 28 days prior to and including the last dose date), and\n* ≥ 50% reduction in MBL volume from Baseline to the Final Month.\n\nParticipants who prematurely discontinued study drug due to "lack of efficacy," "requires surgery or invasive intervention for treatment of uterine fibroids," or "adverse events" were considered non-responders regardless of whether she meets the two aforementioned responder criteria or not.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of study drug and had an assessment.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '94', 'groupId': 'OG002'}, {'value': '206', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo->Elagolix', 'description': 'Placebo in pivotal study and elagolix 300 mg BID in extension study.'}, {'id': 'OG001', 'title': 'Placebo->Elagolix + E2/NETA', 'description': 'Placebo in pivotal study and elagolix 300 mg BID plus E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD in extension study.'}, {'id': 'OG002', 'title': 'Elagolix->Elagolix', 'description': 'Elagolix 300 mg BID in pivotal study and elagolix 300 mg BID in extension study.'}, {'id': 'OG003', 'title': 'Elagolix + E2/NETA->Elagolix + E2/NETA', 'description': 'Elagolix 300 mg BID plus E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD in pivotal study and elagolix 300 mg BID plus E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD in extension study.'}], 'classes': [{'title': 'Study Day 1 to 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '94', 'groupId': 'OG002'}, {'value': '205', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-151.7', 'spread': '184.76', 'groupId': 'OG000'}, {'value': '-61.7', 'spread': '212.01', 'groupId': 'OG001'}, {'value': '-253.4', 'spread': '190.07', 'groupId': 'OG002'}, {'value': '-186.5', 'spread': '164.38', 'groupId': 'OG003'}]}]}, {'title': 'Study Day 29 to 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '90', 'groupId': 'OG002'}, {'value': '205', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-210.9', 'spread': '234.01', 'groupId': 'OG000'}, {'value': '-203.1', 'spread': '188.15', 'groupId': 'OG001'}, {'value': '-249.7', 'spread': '189.81', 'groupId': 'OG002'}, {'value': '-191.9', 'spread': '166.38', 'groupId': 'OG003'}]}]}, {'title': 'Study Day 57 to 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '92', 'groupId': 'OG002'}, {'value': '196', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-236.9', 'spread': '162.33', 'groupId': 'OG000'}, {'value': '-209.0', 'spread': '184.90', 'groupId': 'OG001'}, {'value': '-255.9', 'spread': '175.43', 'groupId': 'OG002'}, {'value': '-200.6', 'spread': '159.77', 'groupId': 'OG003'}]}]}, {'title': 'Study Day 85 to 112', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}, {'value': '188', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-235.1', 'spread': '184.87', 'groupId': 'OG000'}, {'value': '-204.5', 'spread': '177.65', 'groupId': 'OG001'}, {'value': '-252.0', 'spread': '175.23', 'groupId': 'OG002'}, {'value': '-200.5', 'spread': '156.85', 'groupId': 'OG003'}]}]}, {'title': 'Study Day 113 to 140', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '181', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-237.3', 'spread': '234.00', 'groupId': 'OG000'}, {'value': '-194.5', 'spread': '213.69', 'groupId': 'OG001'}, {'value': '-253.9', 'spread': '173.50', 'groupId': 'OG002'}, {'value': '-192.9', 'spread': '165.42', 'groupId': 'OG003'}]}]}, {'title': 'Study Day 141 to 168', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '139', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-263.8', 'spread': '199.83', 'groupId': 'OG000'}, {'value': '-175.4', 'spread': '115.43', 'groupId': 'OG001'}, {'value': '-279.1', 'spread': '191.44', 'groupId': 'OG002'}, {'value': '-211.4', 'spread': '165.26', 'groupId': 'OG003'}]}]}, {'title': 'Final Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '94', 'groupId': 'OG002'}, {'value': '206', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-256.6', 'spread': '194.04', 'groupId': 'OG000'}, {'value': '-186.4', 'spread': '138.16', 'groupId': 'OG001'}, {'value': '-250.3', 'spread': '182.09', 'groupId': 'OG002'}, {'value': '-205.6', 'spread': '151.55', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 0 (Baseline in Pivotal Study), Extension Study: Day 1 to 28, Day 29 to 56, Day 57 to 84, Day 85 to 112, Day 113 to 140, Day 141 to 168, Final Month of Treatment Period (up through Month 6)', 'description': 'Baseline MBL volume was defined as the mean of total MBL volume from all the qualified menstrual cycles during the Screening Period of the pivotal study, in which the total MBL volume is from all validated and non-validated sanitary products and the MBL volume of validated sanitary products only (excluding non-validated sanitary products) was greater than 80 mL.', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of study drug and had an assessment at given time point.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '94', 'groupId': 'OG002'}, {'value': '206', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo->Elagolix', 'description': 'Placebo in pivotal study and elagolix 300 mg BID in extension study.'}, {'id': 'OG001', 'title': 'Placebo->Elagolix + E2/NETA', 'description': 'Placebo in pivotal study and elagolix 300 mg BID plus E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD in extension study.'}, {'id': 'OG002', 'title': 'Elagolix->Elagolix', 'description': 'Elagolix 300 mg BID in pivotal study and elagolix 300 mg BID in extension study.'}, {'id': 'OG003', 'title': 'Elagolix + E2/NETA->Elagolix + E2/NETA', 'description': 'Elagolix 300 mg BID plus E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD in pivotal study and elagolix 300 mg BID plus E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD in extension study.'}], 'classes': [{'title': 'Study Day 1 to 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '94', 'groupId': 'OG002'}, {'value': '205', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-46.5', 'spread': '66.57', 'groupId': 'OG000'}, {'value': '-28.2', 'spread': '72.69', 'groupId': 'OG001'}, {'value': '-94.0', 'spread': '24.90', 'groupId': 'OG002'}, {'value': '-87.7', 'spread': '36.24', 'groupId': 'OG003'}]}]}, {'title': 'Study Day 29 to 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '90', 'groupId': 'OG002'}, {'value': '205', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-87.2', 'spread': '46.33', 'groupId': 'OG000'}, {'value': '-79.4', 'spread': '41.80', 'groupId': 'OG001'}, {'value': '-93.3', 'spread': '28.77', 'groupId': 'OG002'}, {'value': '-87.8', 'spread': '43.17', 'groupId': 'OG003'}]}]}, {'title': 'Study Day 57 to 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '92', 'groupId': 'OG002'}, {'value': '196', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-89.9', 'spread': '37.62', 'groupId': 'OG000'}, {'value': '-82.9', 'spread': '34.79', 'groupId': 'OG001'}, {'value': '-96.9', 'spread': '16.88', 'groupId': 'OG002'}, {'value': '-90.6', 'spread': '32.60', 'groupId': 'OG003'}]}]}, {'title': 'Study Day 85 to 112', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}, {'value': '188', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-90.3', 'spread': '30.26', 'groupId': 'OG000'}, {'value': '-82.7', 'spread': '32.76', 'groupId': 'OG001'}, {'value': '-95.2', 'spread': '19.38', 'groupId': 'OG002'}, {'value': '-91.2', 'spread': '28.42', 'groupId': 'OG003'}]}]}, {'title': 'Study Day 113 to 140', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '181', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-90.0', 'spread': '40.38', 'groupId': 'OG000'}, {'value': '-75.0', 'spread': '65.97', 'groupId': 'OG001'}, {'value': '-97.7', 'spread': '13.01', 'groupId': 'OG002'}, {'value': '-87.5', 'spread': '40.67', 'groupId': 'OG003'}]}]}, {'title': 'Study Day 141 to 168', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '139', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-91.8', 'spread': '30.77', 'groupId': 'OG000'}, {'value': '-79.3', 'spread': '32.25', 'groupId': 'OG001'}, {'value': '-99.2', 'spread': '4.31', 'groupId': 'OG002'}, {'value': '-89.7', 'spread': '36.67', 'groupId': 'OG003'}]}]}, {'title': 'Final Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '94', 'groupId': 'OG002'}, {'value': '206', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-91.0', 'spread': '28.74', 'groupId': 'OG000'}, {'value': '-78.5', 'spread': '36.76', 'groupId': 'OG001'}, {'value': '-96.6', 'spread': '18.29', 'groupId': 'OG002'}, {'value': '-90.8', 'spread': '33.01', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 0 (Baseline in Pivotal Study), Extension Study: Day 1 to 28, Day 29 to 56, Day 57 to 84, Day 85 to 112, Day 113 to 140, Day 141 to 168, Final Month of Treatment Period (up through Month 6)', 'description': 'Baseline MBL volume was defined as the mean of total MBL volume from all the qualified menstrual cycles during the Screening Period of the pivotal study, in which the total MBL volume is from all validated and non-validated sanitary products and the MBL volume of validated sanitary products only (excluding non-validated sanitary products) was greater than 80 mL.', 'unitOfMeasure': 'percentage change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of study drug and had an assessment at given time point.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Suppression of Bleeding at the Final Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}, {'value': '206', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo->Elagolix', 'description': 'Placebo in pivotal study and elagolix 300 mg BID in extension study.'}, {'id': 'OG001', 'title': 'Placebo->Elagolix + E2/NETA', 'description': 'Placebo in pivotal study and elagolix 300 mg BID plus E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD in extension study.'}, {'id': 'OG002', 'title': 'Elagolix->Elagolix', 'description': 'Elagolix 300 mg BID in pivotal study and elagolix 300 mg BID in extension study.'}, {'id': 'OG003', 'title': 'Elagolix->Elagolix + E2/NETA', 'description': 'Elagolix 300 mg BID plus E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD in pivotal study and elagolix 300 mg BID plus E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD in extension study.'}], 'classes': [{'categories': [{'measurements': [{'value': '88.7', 'groupId': 'OG000'}, {'value': '56.0', 'groupId': 'OG001'}, {'value': '89.2', 'groupId': 'OG002'}, {'value': '74.8', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Final Month of Treatment Period (up through Month 6)', 'description': 'Suppression of bleeding is defined as having 0 days of bleeding (spotting is allowed) during the Final Month with the interval starting from Study Day 11.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of study drug and had an assessment.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Baseline Hemoglobin Concentration ≤ 10.5 g/dL and an Increase From Baseline > 2 g/dL at Month 6 During the Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo->Elagolix', 'description': 'Placebo in pivotal study and elagolix 300 mg BID in extension study.'}, {'id': 'OG001', 'title': 'Placebo->Elagolix + E2/NETA', 'description': 'Placebo in pivotal study and elagolix 300 mg BID plus E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD in extension study.'}, {'id': 'OG002', 'title': 'Elagolix->Elagolix', 'description': 'Elagolix 300 mg BID in pivotal study and elagolix 300 mg BID in extension study.'}, {'id': 'OG003', 'title': 'Elagolix + E2/NETA->Elagolix + E2/NETA', 'description': 'Elagolix 300 mg BID plus E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD in pivotal study and elagolix 300 mg BID plus E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD in extension study.'}], 'classes': [{'categories': [{'measurements': [{'value': '70.6', 'groupId': 'OG000'}, {'value': '36.4', 'groupId': 'OG001'}, {'value': '71.4', 'groupId': 'OG002'}, {'value': '72.5', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 6', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of study drug, had a baseline hemoglobin concentration of \\<= 10.5 g/dL and had an assessment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo->Elagolix', 'description': 'Placebo in pivotal study and elagolix 300 mg twice daily (BID) in extension study.'}, {'id': 'FG001', 'title': 'Placebo->Elagolix + E2/NETA', 'description': 'Placebo in pivotal study and elagolix 300 mg BID plus E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) once daily (QD) in extension study.'}, {'id': 'FG002', 'title': 'Elagolix->Elagolix', 'description': 'Elagolix 300 mg BID in pivotal study and elagolix 300 mg BID in extension study.'}, {'id': 'FG003', 'title': 'Elagolix + E2/NETA->Elagolix + E2/NETA', 'description': 'Elagolix 300 mg BID plus E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD in pivotal study and elagolix 300 mg BID plus E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD in extension study.'}], 'periods': [{'title': 'Treatment Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}, {'groupId': 'FG001', 'numSubjects': '58'}, {'groupId': 'FG002', 'numSubjects': '98'}, {'groupId': 'FG003', 'numSubjects': '218'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '43'}, {'groupId': 'FG002', 'numSubjects': '79'}, {'groupId': 'FG003', 'numSubjects': '182'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '19'}, {'groupId': 'FG003', 'numSubjects': '36'}]}]}, {'title': 'Post-Treatment Follow-Up Period', 'milestones': [{'type': 'STARTED', 'comment': 'Completed or prematurely discontinued the Treatment Period and entered the follow-up period.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '54'}, {'groupId': 'FG001', 'numSubjects': '47'}, {'groupId': 'FG002', 'numSubjects': '88'}, {'groupId': 'FG003', 'numSubjects': '184'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '37'}, {'groupId': 'FG002', 'numSubjects': '64'}, {'groupId': 'FG003', 'numSubjects': '134'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '24'}, {'groupId': 'FG003', 'numSubjects': '50'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '23'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '10'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '6'}]}, {'type': 'Required Surgery/ Invasive Intervention', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '6'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Non-Compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'A total of 433 participants who completed the 6-month Treatment Period in pivotal studies M12-815 (NCT02654054) or M12-817 (NCT02691494) were enrolled in this extension study at 114 sites in 2 countries (US \\[including Puerto Rico\\] and Canada).', 'preAssignmentDetails': 'A total of 433 participants were treated in this extension study and were grouped according to the treatment assignments in pivotal studies M12-815 and M12-817 and this extension study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}, {'value': '218', 'groupId': 'BG003'}, {'value': '433', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo->Elagolix', 'description': 'Placebo in pivotal study and elagolix 300 mg BID in extension study.'}, {'id': 'BG001', 'title': 'Placebo->Elagolix + E2/NETA', 'description': 'Placebo in pivotal study and elagolix 300 mg BID plus E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD in extension study.'}, {'id': 'BG002', 'title': 'Elagolix->Elagolix', 'description': 'Elagolix 300 mg BID in pivotal study and elagolix 300 mg BID in extension study.'}, {'id': 'BG003', 'title': 'Elagolix + E2/NETA->Elagolix + E2/NETA', 'description': 'Elagolix 300 mg BID plus E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD in pivotal study and elagolix 300 mg BID plus E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD in extension study.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'categories': [{'title': '25 to < 30 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}]}, {'title': '30 to < 35 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}, {'value': '32', 'groupId': 'BG004'}]}, {'title': '35 to < 40 years', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}, {'value': '74', 'groupId': 'BG004'}]}, {'title': '40 to < 45 years', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '74', 'groupId': 'BG003'}, {'value': '151', 'groupId': 'BG004'}]}, {'title': '45 to < 50 years', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '77', 'groupId': 'BG003'}, {'value': '139', 'groupId': 'BG004'}]}, {'title': '>= 50 years', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '29', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}, {'value': '218', 'groupId': 'BG003'}, {'value': '433', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}, {'value': '56', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}, {'value': '185', 'groupId': 'BG003'}, {'value': '377', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}, {'value': '146', 'groupId': 'BG003'}, {'value': '298', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '65', 'groupId': 'BG003'}, {'value': '122', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-12-18', 'size': 2350722, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-06-10T15:56', 'hasProtocol': True}, {'date': '2018-05-24', 'size': 927670, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-06-10T15:57', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 433}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'dispFirstSubmitDate': '2019-04-09', 'completionDateStruct': {'date': '2019-03-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-09', 'studyFirstSubmitDate': '2016-09-24', 'dispFirstSubmitQcDate': '2019-04-09', 'resultsFirstSubmitDate': '2020-06-12', 'studyFirstSubmitQcDate': '2016-10-04', 'dispFirstPostDateStruct': {'date': '2019-04-12', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2021-07-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-06-12', 'studyFirstPostDateStruct': {'date': '2016-10-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Meeting the Criteria for Responder', 'timeFrame': 'From Month 0 (Baseline in Pivotal Study) to Final Month of Treatment Period (up through Month 6 in Extension Study)', 'description': 'Percentage of responders, defined as participants who met the following conditions:\n\n* Menstrual blood loss (MBL) volume \\< 80 mL during the Final Month (the last 28 days prior to and including the last dose date), and\n* ≥ 50% reduction in MBL volume from Baseline to the Final Month.\n\nParticipants who prematurely discontinued study drug due to "lack of efficacy," "requires surgery or invasive intervention for treatment of uterine fibroids," or "adverse events" were considered non-responders regardless of whether she meets the two aforementioned responder criteria or not.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period', 'timeFrame': 'Month 0 (Baseline in Pivotal Study), Extension Study: Day 1 to 28, Day 29 to 56, Day 57 to 84, Day 85 to 112, Day 113 to 140, Day 141 to 168, Final Month of Treatment Period (up through Month 6)', 'description': 'Baseline MBL volume was defined as the mean of total MBL volume from all the qualified menstrual cycles during the Screening Period of the pivotal study, in which the total MBL volume is from all validated and non-validated sanitary products and the MBL volume of validated sanitary products only (excluding non-validated sanitary products) was greater than 80 mL.'}, {'measure': 'Percent Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period', 'timeFrame': 'Month 0 (Baseline in Pivotal Study), Extension Study: Day 1 to 28, Day 29 to 56, Day 57 to 84, Day 85 to 112, Day 113 to 140, Day 141 to 168, Final Month of Treatment Period (up through Month 6)', 'description': 'Baseline MBL volume was defined as the mean of total MBL volume from all the qualified menstrual cycles during the Screening Period of the pivotal study, in which the total MBL volume is from all validated and non-validated sanitary products and the MBL volume of validated sanitary products only (excluding non-validated sanitary products) was greater than 80 mL.'}, {'measure': 'Percentage of Participants With Suppression of Bleeding at the Final Month', 'timeFrame': 'Final Month of Treatment Period (up through Month 6)', 'description': 'Suppression of bleeding is defined as having 0 days of bleeding (spotting is allowed) during the Final Month with the interval starting from Study Day 11.'}, {'measure': 'Percentage of Participants With Baseline Hemoglobin Concentration ≤ 10.5 g/dL and an Increase From Baseline > 2 g/dL at Month 6 During the Treatment Period', 'timeFrame': 'Month 6'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Uterine Fibroids', 'Elagolix', 'Heavy Menstrual Bleeding', 'Elagolix Sodium', 'Elagolix plus Norethindrone Acetate'], 'conditions': ['Uterine Fibroids', 'Heavy Menstrual Bleeding']}, 'referencesModule': {'references': [{'pmid': '32459423', 'type': 'BACKGROUND', 'citation': 'Simon JA, Al-Hendy A, Archer DF, Barnhart KT, Bradley LD, Carr BR, Dayspring T, Feinberg EC, Gillispie V, Hurtado S, Kim J, Liu R, Owens CD, Muneyyirci-Delale O, Wang A, Watts NB, Schlaff WD. Elagolix Treatment for Up to 12 Months in Women With Heavy Menstrual Bleeding and Uterine Leiomyomas. Obstet Gynecol. 2020 Jun;135(6):1313-1326. doi: 10.1097/AOG.0000000000003869.'}, {'pmid': '34878624', 'type': 'DERIVED', 'citation': 'Beck D, Winzenborg I, Liu M, Degner J, Mostafa NM, Noertersheuser P, Shebley M. Population Pharmacokinetics of Elagolix in Combination with Low-Dose Estradiol/Norethindrone Acetate in Women with Uterine Fibroids. Clin Pharmacokinet. 2022 Apr;61(4):577-587. doi: 10.1007/s40262-021-01096-w. Epub 2021 Dec 8.'}]}, 'descriptionModule': {'briefSummary': 'This is an extension study for women who have already received six months of treatment in the phase III clinical trial M12-815 (NCT02654054) or M12-817 (NCT02691494), and will evaluate the long-term efficacy and safety of elagolix administered alone and in combination with estradiol/norethindrone acetate for an additional six months in the treatment of heavy menstrual bleeding associated with uterine fibroids.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '51 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participant has completed the 6-Month Treatment Period of their respective Pivotal Study (either Study M12-815 or Study M12-817).\n* Participant did not meet removal criteria in bone mineral density (BMD) decrease in the spine, total hip and femoral neck at Month 6 of the Treatment Period of their respective Pivotal Study\n* Participant has negative urine and/or serum pregnancy test(s) results were consistently negative during the Treatment Period of their respective Pivotal Study and prior to first dose in this study.\n* Participant's endometrial biopsy from the Month 6 Visit of their respective Pivotal Study shows no clinically significant endometrial pathology.\n\nExclusion Criteria:\n\n* Participant met criteria for removal from therapy in her respective Pivotal Study.\n* Participant is planning a pregnancy within the next 18 months.\n* Participant has current suicidal markers as noted at the Month 6 visit of her respective pivotal study.\n* Participant has any new medical conditions that may be unsuitable for participation.\n* Participant is using any systemic corticosteroids for over 14 days or is likely to require treatment with systemic corticosteroids during the course of the study. Over-the-counter and prescription topical, inhaled, intranasal or injectable (for occasional use) corticosteroids are allowed."}, 'identificationModule': {'nctId': 'NCT02925494', 'briefTitle': 'An Extension Study to Evaluate the Efficacy and Safety of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'Extension Study to Evaluate the Efficacy and Safety of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids', 'orgStudyIdInfo': {'id': 'M12-816'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Elagolix plus Estradiol/Norethindrone Acetate (E2/NETA)', 'description': 'Elagolix 300 mg twice daily (BID) and E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) once daily (QD)', 'interventionNames': ['Drug: Estradiol/Norethindrone Acetate', 'Drug: Elagolix']}, {'type': 'EXPERIMENTAL', 'label': 'Elagolix', 'description': 'Elagolix 300 mg BID and placebo for E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD', 'interventionNames': ['Drug: Elagolix']}], 'interventions': [{'name': 'Estradiol/Norethindrone Acetate', 'type': 'DRUG', 'description': 'capsules', 'armGroupLabels': ['Elagolix plus Estradiol/Norethindrone Acetate (E2/NETA)']}, {'name': 'Elagolix', 'type': 'DRUG', 'otherNames': ['ABT-620', 'elagolix sodium'], 'description': 'film-coated tablets', 'armGroupLabels': ['Elagolix', 'Elagolix plus Estradiol/Norethindrone Acetate (E2/NETA)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35235-3430', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Alabama Clinical Therapeutics, LLC /ID# 153217', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35235-3430', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Alabama Clinical Therapeutics, LLC /ID# 153336', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '36303', 'city': 'Dothan', 'state': 'Alabama', 'country': 'United States', 'facility': 'Choice Research, LLC /ID# 153492', 'geoPoint': {'lat': 31.22323, 'lon': -85.39049}}, {'zip': '36532', 'city': 'Fairhope', 'state': 'Alabama', 'country': 'United States', 'facility': 'Brown, Pearson, Guepet Gynecology /ID# 153278', 'geoPoint': {'lat': 30.52297, 'lon': -87.90333}}, {'zip': '36604-3302', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of South Alabama /ID# 153415', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '36608', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'Mobile, Ob-Gyn, P.C. /ID# 153442', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '85209', 'city': 'Mesa', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mesa Obstetricians and Gynecol /ID# 153269', 'geoPoint': {'lat': 33.42227, 'lon': -111.82264}}, {'zip': '90703', 'city': 'Cerritos', 'state': 'California', 'country': 'United States', 'facility': 'Core Healthcare Group /ID# 153282', 'geoPoint': {'lat': 33.85835, 'lon': -118.06479}}, {'zip': '92024', 'city': 'Encinitas', 'state': 'California', 'country': 'United States', 'facility': 'Diagnamics Inc. /ID# 153347', 'geoPoint': {'lat': 33.03699, 'lon': -117.29198}}, {'zip': '91942', 'city': 'La Mesa', 'state': 'California', 'country': 'United States', 'facility': 'Grossmont Ctr Clin Research /ID# 153324', 'geoPoint': {'lat': 32.76783, 'lon': -117.02308}}, {'zip': '90650', 'city': 'Norwalk', 'state': 'California', 'country': 'United States', 'facility': 'Futura Research, Inc. /ID# 153345', 'geoPoint': {'lat': 33.90224, 'lon': -118.08173}}, {'zip': '91340', 'city': 'San Fernando', 'state': 'California', 'country': 'United States', 'facility': 'Farid Yasharpour MD Medical Co /ID# 153482', 'geoPoint': {'lat': 34.28195, 'lon': -118.43897}}, {'zip': '80111', 'city': 'Greenwood Village', 'state': 'Colorado', 'country': 'United States', 'facility': "Advanced Women's Health Institution /ID# 153401", 'geoPoint': {'lat': 39.61721, 'lon': -104.95081}}, {'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Medstar Health Research Institute /ID# 153321', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '20011', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Emerson Clinical Research Inst /ID# 162755', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '20036', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'James A. Simon, MD, PC /ID# 153323', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33436-6634', 'city': 'Boynton Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Helix Biomedics, LLC /ID# 153440', 'geoPoint': {'lat': 26.52535, 'lon': -80.06643}}, {'zip': '33510-3107', 'city': 'Brandon', 'state': 'Florida', 'country': 'United States', 'facility': 'Brandon Premier Health Care, PA /ID# 165791', 'geoPoint': {'lat': 27.9378, 'lon': -82.28592}}, {'zip': '33759', 'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Fertility Institute /ID# 153308', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '32713-2260', 'city': 'DeBary', 'state': 'Florida', 'country': 'United States', 'facility': 'Omega Research Consultants, LLC /ID# 153381', 'geoPoint': {'lat': 28.88305, 'lon': -81.30868}}, {'zip': '33316', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'KO Clinical Research, LLC /ID# 153198', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '33916', 'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Physiology Assoc. /ID# 153444', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'zip': '32256', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Solutions Through Adv Rch /ID# 153283', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33709-3113', 'city': 'Kenneth City', 'state': 'Florida', 'country': 'United States', 'facility': 'Meridien Research /ID# 153310', 'geoPoint': {'lat': 27.81558, 'lon': -82.7201}}, {'zip': '33461', 'city': 'Lake Worth', 'state': 'Florida', 'country': 'United States', 'facility': 'Altus Research, Inc /ID# 153307', 'geoPoint': {'lat': 26.61708, 'lon': -80.07231}}, {'zip': '33063', 'city': 'Margate', 'state': 'Florida', 'country': 'United States', 'facility': 'South Florida Wellness & Clinic /ID# 153420', 'geoPoint': {'lat': 26.24453, 'lon': -80.20644}}, {'zip': '33126', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'LCC Medical Research Institute /ID# 153296', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33144', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Invictus Clinical Research Group,LLC /ID# 153196', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33161', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Healthcare Clinical Data, Inc /ID# 153425', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33166', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Ocean Blue Med Research Ctr /ID# 153225', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33016-1501', 'city': 'Miami Lakes', 'state': 'Florida', 'country': 'United States', 'facility': 'Precision Research Org, LLC /ID# 153276', 'geoPoint': {'lat': 25.90871, 'lon': -80.30866}}, {'zip': '34652', 'city': 'New Port Richey', 'state': 'Florida', 'country': 'United States', 'facility': 'Suncoast Clinical Research /ID# 153206', 'geoPoint': {'lat': 28.24418, 'lon': -82.71927}}, {'zip': '34653', 'city': 'New Port Richey', 'state': 'Florida', 'country': 'United States', 'facility': 'Advanced Research Institute /ID# 153413', 'geoPoint': {'lat': 28.24418, 'lon': -82.71927}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Associates of Orlando /ID# 153427', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '32045', 'city': 'Panama City', 'state': 'Florida', 'country': 'United States', 'facility': 'Unified Womens Clin Research /ID# 153229', 'geoPoint': {'lat': 30.15946, 'lon': -85.65983}}, {'zip': '33324', 'city': 'Plantation', 'state': 'Florida', 'country': 'United States', 'facility': 'All Wmns HC of West Broward /ID# 153434', 'geoPoint': {'lat': 26.13421, 'lon': -80.23184}}, {'zip': '34769', 'city': 'Saint Cloud', 'state': 'Florida', 'country': 'United States', 'facility': 'Oncova Clinical Research, Inc. /ID# 153497', 'geoPoint': {'lat': 28.2489, 'lon': -81.28118}}, {'zip': '34239', 'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'facility': 'Physician Care Clin. Res., LLC /ID# 153210', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '33143', 'city': 'South Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Qps-Mra, Llc /Id# 153456', 'geoPoint': {'lat': 25.7076, 'lon': -80.29338}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'University of South Florida /ID# 153271', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '33414', 'city': 'Wellington', 'state': 'Florida', 'country': 'United States', 'facility': 'Axcess Medical Research /ID# 153500', 'geoPoint': {'lat': 26.65868, 'lon': -80.24144}}, {'zip': '33414', 'city': 'Wellington', 'state': 'Florida', 'country': 'United States', 'facility': 'Virtus Research Consultant,LLC /ID# 153398', 'geoPoint': {'lat': 26.65868, 'lon': -80.24144}}, {'zip': '33409', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Comprehensive Clinical Trials /ID# 153350', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '30005-4419', 'city': 'Alpharetta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Atlanta Medical Research Insti /ID# 153298', 'geoPoint': {'lat': 34.07538, 'lon': -84.29409}}, {'zip': '30005', 'city': 'Alpharetta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Paramount Research Solutions /ID# 153424', 'geoPoint': {'lat': 34.07538, 'lon': -84.29409}}, {'zip': '30005', 'city': 'Alpharetta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Paramount Research Solutions /ID# 160974', 'geoPoint': {'lat': 34.07538, 'lon': -84.29409}}, {'zip': '30328', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Mount Vernon Clinical Res, LLC /ID# 153403', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30342', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': "Atlanta Women's Research Inst /ID# 153212", 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30909', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Masters of Clinical Research, Inc. /ID# 153295', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '30349', 'city': 'College Park', 'state': 'Georgia', 'country': 'United States', 'facility': 'Paramount Research Solutions /ID# 153351', 'geoPoint': {'lat': 33.65344, 'lon': -84.44937}}, {'zip': '31406', 'city': 'Savannah', 'state': 'Georgia', 'country': 'United States', 'facility': 'Fellows Research Alliance, Inc /ID# 153227', 'geoPoint': {'lat': 32.08354, 'lon': -81.09983}}, {'zip': '30024-6988', 'city': 'Suwanee', 'state': 'Georgia', 'country': 'United States', 'facility': 'Clinical Research Consultants of Atlanta /ID# 153285', 'geoPoint': {'lat': 34.05149, 'lon': -84.0713}}, {'zip': '30024-7159', 'city': 'Suwanee', 'state': 'Georgia', 'country': 'United States', 'facility': 'Atlanta Gynecology Research Institute /ID# 200074', 'geoPoint': {'lat': 34.05149, 'lon': -84.0713}}, {'zip': '83646-1144', 'city': 'Meridian', 'state': 'Idaho', 'country': 'United States', 'facility': 'Sonora Clinical Research /ID# 153231', 'geoPoint': {'lat': 43.61211, 'lon': -116.39151}}, {'zip': '60523', 'city': 'Oak Brook', 'state': 'Illinois', 'country': 'United States', 'facility': 'Affinity Clinical Research /ID# 153417', 'geoPoint': {'lat': 41.83281, 'lon': -87.92895}}, {'zip': '40291', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Bluegrass Clinical Research /ID# 153280', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '70433', 'city': 'Covington', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Clinical Trials Management, LLC - Covington /ID# 153211', 'geoPoint': {'lat': 30.47549, 'lon': -90.10042}}, {'zip': '70433', 'city': 'Covington', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Clinical Trials Management, LLC - Covington /ID# 153439', 'geoPoint': {'lat': 30.47549, 'lon': -90.10042}}, {'zip': '70115', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Ochsner Baptist Medical Center /ID# 153459', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '71118', 'city': 'Shreveport', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Omni Fertility and Laser Insti /ID# 153228', 'geoPoint': {'lat': 32.52515, 'lon': -93.75018}}, {'zip': '21208', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Baltimore Suburban Health /ID# 168386', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02720-2972', 'city': 'Fall River', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'NECCR Fall River LLC /ID# 153274', 'geoPoint': {'lat': 41.70149, 'lon': -71.15505}}, {'zip': '02720', 'city': 'Fall River', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Genesis Clinical Research /ID# 153379', 'geoPoint': {'lat': 41.70149, 'lon': -71.15505}}, {'zip': '48706', 'city': 'Bay City', 'state': 'Michigan', 'country': 'United States', 'facility': 'Great Lakes Research Group,Inc /ID# 153302', 'geoPoint': {'lat': 43.59447, 'lon': -83.88886}}, {'zip': '48604', 'city': 'Saginaw', 'state': 'Michigan', 'country': 'United States', 'facility': 'Saginaw Valley Med Res Group /ID# 153498', 'geoPoint': {'lat': 43.41947, 'lon': -83.95081}}, {'zip': '48034', 'city': 'Southfield', 'state': 'Michigan', 'country': 'United States', 'facility': 'Wayne State University Physician Group - Southfield /ID# 153418', 'geoPoint': {'lat': 42.47337, 'lon': -83.22187}}, {'zip': '89106-4017', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Accent Clinical Trials /ID# 153474', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '89113', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Office of Edmond E. Pack, MD /ID# 153411', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '89128', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Mabey, Las Vegas, NV /ID# 153314', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '08648', 'city': 'Lawrenceville', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Lawrence OB/GYN /ID# 153218', 'geoPoint': {'lat': 40.29733, 'lon': -74.7296}}, {'zip': '07753-4859', 'city': 'Neptune City', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Jersey Shore University Medical Center /ID# 153495', 'geoPoint': {'lat': 40.20011, 'lon': -74.02792}}, {'zip': '87109', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': "Bosque Women's Care /ID# 153223", 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '11203', 'city': 'Brooklyn', 'state': 'New York', 'country': 'United States', 'facility': 'SUNY Downstate Medical Center /ID# 153344', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}, {'zip': '10016-6023', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Manhattan Medical Research /ID# 153386', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10032-3725', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Weill Cornell Medicine /ID# 153275', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27713', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Cwrwc /Id# 153313', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '27408', 'city': 'Greensboro', 'state': 'North Carolina', 'country': 'United States', 'facility': "Unified Women's Clinical Research-Greensboro /ID# 153499", 'geoPoint': {'lat': 36.07264, 'lon': -79.79198}}, {'zip': '27262', 'city': 'High Point', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Pinewest Ob-Gyn, Inc. /ID# 153197', 'geoPoint': {'lat': 35.95569, 'lon': -80.00532}}, {'zip': '28562', 'city': 'New Bern', 'state': 'North Carolina', 'country': 'United States', 'facility': "Eastern Carolina Women's Centr /ID# 153341", 'geoPoint': {'lat': 35.10849, 'lon': -77.04411}}, {'zip': '27607', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': "Unified Women's Clinical Resea /ID# 153312", 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '27612', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Research Associates, LLC /ID# 153402', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '27103', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': "Unified Women's Clinical Resea /ID# 153297", 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '45432', 'city': 'Beavercreek', 'state': 'Ohio', 'country': 'United States', 'facility': 'Clinical Inquest Center Ltd /ID# 153436', 'geoPoint': {'lat': 39.70923, 'lon': -84.06327}}, {'zip': '45212', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'CTI Clinical Research Center /ID# 153201', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'University Hospitals Cleveland /ID# 153450', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43614', 'city': 'Toledo', 'state': 'Ohio', 'country': 'United States', 'facility': 'University of Toledo /ID# 153409', 'geoPoint': {'lat': 41.66394, 'lon': -83.55521}}, {'zip': '43081', 'city': 'Westerville', 'state': 'Ohio', 'country': 'United States', 'facility': 'Comprehensive Womens Care /ID# 153396', 'geoPoint': {'lat': 40.12617, 'lon': -82.92907}}, {'zip': '97210', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Legacy Medical Group-Portland /ID# 168286', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '19010', 'city': 'Bryn Mawr', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Main Line Fertility Center /ID# 153410', 'geoPoint': {'lat': 40.30396, 'lon': -80.08672}}, {'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Penn State University and Milton S. Hershey Medical Center /ID# 153443', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}, {'zip': '19104-5502', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania /ID# 153203', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19107-4414', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson University /ID# 153319', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19114', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Clinical Research of Philadelphia, LLC /ID# 153279', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19611', 'city': 'West Reading', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Reading Hosp Clncl Trials Ofc /ID# 153475', 'geoPoint': {'lat': 40.3337, 'lon': -75.94743}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina /ID# 153325', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '29201', 'city': 'Columbia', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Vista Clinical Research /ID# 153399', 'geoPoint': {'lat': 34.00071, 'lon': -81.03481}}, {'zip': '37404', 'city': 'Chattanooga', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Chattanooga Medical Research /ID# 153405', 'geoPoint': {'lat': 35.04563, 'lon': -85.30968}}, {'zip': '37421-1605', 'city': 'Chattanooga', 'state': 'Tennessee', 'country': 'United States', 'facility': 'WR-ClinSearch /ID# 153404', 'geoPoint': {'lat': 35.04563, 'lon': -85.30968}}, {'zip': '38119-3895', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Research Memphis Associates, LLC /ID# 153322', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '38104', 'city': 'Menphis', 'state': 'Tennessee', 'country': 'United States', 'facility': "Women's Health Trials /ID# 153426"}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Access Clinical Trials, Inc. /ID# 153441', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '78703-1448', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Lotus Gynecology /ID# 153476', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Health Presbyterian Hosp /ID# 153339', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75390-7208', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'UT Southwestern Medical Center /ID# 153400', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '76104-4110', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor Scott & White /ID# 153273', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '75035', 'city': 'Frisco', 'state': 'Texas', 'country': 'United States', 'facility': 'Willowbend Health and Wellness /ID# 153458', 'geoPoint': {'lat': 33.15067, 'lon': -96.82361}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Advances in Health, Inc. /ID# 153414', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77054', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': "The Woman's Hospital of Texas /ID# 153270", 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '76550', 'city': 'Lampasas', 'state': 'Texas', 'country': 'United States', 'facility': 'FMC Science /ID# 153289', 'geoPoint': {'lat': 31.06378, 'lon': -98.1817}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Clinical Trials of Texas,Inc. /ID# 153209', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78258', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Discovery Clinical Trials-San Antonio /ID# 153315', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '77479', 'city': 'Sugar Land', 'state': 'Texas', 'country': 'United States', 'facility': 'Houston Ctr for Clin Research /ID# 153221', 'geoPoint': {'lat': 29.61968, 'lon': -95.63495}}, {'zip': '77598', 'city': 'Webster', 'state': 'Texas', 'country': 'United States', 'facility': 'Center of Reproductive Medicin /ID# 153320', 'geoPoint': {'lat': 29.53773, 'lon': -95.11826}}, {'zip': '23502', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'Tidewater Physicians for Women /ID# 153432', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}, {'zip': '23507-1627', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'Eastern Virginia Med School /ID# 153380', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}, {'zip': '23235-4722', 'city': 'North Chesterfield', 'state': 'Virginia', 'country': 'United States', 'facility': 'Clinical Research Partners, LL /ID# 153412', 'geoPoint': {'lat': 37.38, 'lon': -77.59}}, {'zip': '23220-4459', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Clinical Research Partners, LLC /ID# 153343', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '23225', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Clinical Trials Virginia, Inc. /ID# 153419', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '22182', 'city': 'Vienna', 'state': 'Virginia', 'country': 'United States', 'facility': 'Emerson Clinical Research Inst /ID# 153416', 'geoPoint': {'lat': 38.90122, 'lon': -77.26526}}, {'zip': '98101', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Virginia Mason Medical Center /ID# 153342', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '98105', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': "Seattle Women's Health, Research, Gynecology /ID# 153306", 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': 'N8W 5R7', 'city': 'Windsor', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Victory Reproductive Care /ID# 153299', 'geoPoint': {'lat': 42.30008, 'lon': -83.01654}}, {'zip': '00917', 'city': 'San Juan', 'country': 'Puerto Rico', 'facility': 'Rodriguez-Ginorio, San Juan /ID# 153328', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}, {'zip': '00935', 'city': 'San Juan', 'country': 'Puerto Rico', 'facility': 'School of Medicine University of Puerto Rico-Medical Sciences Campus /ID# 153329', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}], 'overallOfficials': [{'name': 'AbbVie Inc.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'ipdSharingStatementModule': {'url': 'https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR', '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'}}}}