Ignite Creation Date:
2025-12-26 @ 10:45 PM
Ignite Modification Date:
2026-03-04 @ 6:35 AM
Study NCT ID:
NCT03616912
Status:
TERMINATED
Last Update Posted:
2023-01-30
First Post:
2018-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Baricitinib (LY3009104) in Participants With Systemic Lupus Erythematosus
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Ukraine'], 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-11-07', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D008180', 'term': 'Lupus Erythematosus, Systemic'}], 'ancestors': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000596027', 'term': 'baricitinib'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov@lilly.com', 'phone': '800-595-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'One investigational site with seven participants was excluded from analysis due to confirmed misconduct.\n\nStudy terminated due to insufficient evidence to support a positive benefit: risk profile in systemic lupus erythematosus patients.'}}, 'adverseEventsModule': {'timeFrame': 'Baseline through Follow-up (Up to 56 Weeks)', 'description': 'All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Participants received two placebo tablets: one matching baricitinib 4 mg and one matching baricitinib 2 mg administered orally QD for 52 weeks.', 'otherNumAtRisk': 253, 'deathsNumAtRisk': 253, 'otherNumAffected': 129, 'seriousNumAtRisk': 253, 'deathsNumAffected': 1, 'seriousNumAffected': 19}, {'id': 'EG001', 'title': '2 mg Baricitinib', 'description': 'Participants received one Baricitinib 2 mg tablet and one placebo tablet matching Baricitinib 4 mg administered QD for 52 weeks.', 'otherNumAtRisk': 255, 'deathsNumAtRisk': 255, 'otherNumAffected': 144, 'seriousNumAtRisk': 255, 'deathsNumAffected': 1, 'seriousNumAffected': 27}, {'id': 'EG002', 'title': '4 mg Baricitinib', 'description': 'Participants received one Baricitinib 4 mg tablet and one placebo tablet matching baricitinib 2 mg administered orally QD for 52 weeks.', 'otherNumAtRisk': 252, 'deathsNumAtRisk': 252, 'otherNumAffected': 144, 'seriousNumAtRisk': 252, 'deathsNumAffected': 0, 'seriousNumAffected': 31}, {'id': 'EG003', 'title': 'Placebo Maximum Extended Enrollment (MEE)', 'description': 'Participants received two placebo tablets: one matching baricitinib 4 mg and one matching baricitinib 2 mg administered orally QD for 52 weeks', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 17, 'seriousNumAtRisk': 21, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG004', 'title': '2 mg Baricitinib (MEE)', 'description': 'Participants received one Baricitinib 2 mg tablet and 1 placebo tablet matching Baricitinib 4 mg administered QD for 52 weeks.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 14, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG005', 'title': '4 mg Baricitinib (MEE)', 'description': 'Participants received one Baricitinib 4 mg tablet and one placebo tablet matching baricitinib 2 mg administered orally QD for 52 weeks.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 17, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 16, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 13, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 14, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Mouth ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 14, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hepatic function abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Covid-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Gingivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 18, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 24, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 21, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 24, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 19, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 30, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 27, 'numAffected': 19}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 11, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 17, 'numAffected': 9}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 38, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 41, 'numAffected': 32}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 47, 'numAffected': 37}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Vulvitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 237, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 5, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 20, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hepatic enzyme increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hyperlipidaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hypertriglyceridaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hyperuricaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 26, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 19, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 23, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Prostatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 18, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 18, 'numAffected': 17}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Arteriosclerosis coronary artery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pericarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Abdominal adhesions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Epiploic appendagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Gastric ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Gastritis erosive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Haematochezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Haemorrhoidal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Obstructive pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Upper gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Bile duct stone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Cholecystitis chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Drug hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Anal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Arthritis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Atypical pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Covid-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Covid-19 pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Escherichia urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Laryngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pyelonephritis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Tubo-ovarian abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 237, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Viral myocarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Viral pericarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Device use issue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Fibula fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Foot fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Tendon rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hypoalbuminaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Osteonecrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Spinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Systemic lupus erythematosus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Adenocarcinoma of the cervix', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 237, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': "Burkitt's lymphoma", 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Haemangioma of liver', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Lung carcinoma cell type unspecified stage 0', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Melanocytic naevus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Papillary thyroid cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Uterine leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 237, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Abortion spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 237, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Major depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Lupus nephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Ureterolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Adnexal torsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 237, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Cervical dysplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 237, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hydrosalpinx', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 237, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Ovarian cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 237, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Bronchitis chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pleurisy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pulmonary hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Cutaneous lupus erythematosus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Dermatitis bullous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Vasculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 253, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 252, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Achieving a Systemic Lupus Erythematosus Responder Index 4 (SRI-4) Response (4 mg Baricitinib)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'OG000'}, {'value': '252', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received two placebo tablets: one matching baricitinib 4 mg and one matching baricitinib 2 mg administered orally QD for 52 weeks.'}, {'id': 'OG001', 'title': '4 mg Baricitinib', 'description': 'Participants received one Baricitinib 4 mg tablet and one placebo tablet matching baricitinib 2 mg administered orally QD for 52 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '45.9', 'groupId': 'OG000'}, {'value': '56.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.016', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.57', 'ciLowerLimit': '1.09', 'ciUpperLimit': '2.27', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 52', 'description': 'SRI-4 response defined as 1)greater than or equal to (\\>=) 4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) total score 2)no new British Isles Lupus Assessment Group (BILAG) A and no more than 1 new BILAG B domain score and 3)no worsening in Physician Global Assessment (PGA) of Disease Activity (worsening defined as an increase of \\>=0.3 from baseline on a 0-3 visual analogue scale).\n\nSLEDAI-2K assessment consists of 24 items with total score of 0(no symptoms) to 105 (presence of all defined symptoms) with higher scores representing increased disease activity. BILAG Index: assessing clinical signs, symptoms,or laboratory parameters related to Systemic Lupus Erythematosus (SLE),divided into 9 organ systems. For each organ system A=severe disease,B=moderate disease,C=mild stable disease,D=inactive,but previously active,E=inactive and never affected. PGA assess disease activity on a visual analogue scale from 0 to 3 (1=mild, 2=moderate, 3=severe).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug (Modified intent to treat (mITT population). Missing data was imputed using the hybrid imputation method \\[nonresponder imputation (NRI) + multiple imputation (MI)\\]. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving SRI-4 Response - 2 mg Baricitinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'OG000'}, {'value': '255', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received two placebo tablets: one matching baricitinib 4 mg and one matching baricitinib 2 mg administered orally QD for 52 weeks.'}, {'id': 'OG001', 'title': '2 mg Baricitinib', 'description': 'Participants received one Baricitinib 2 mg tablet and one placebo tablet matching Baricitinib 4 mg administered QD for 52 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '45.9', 'groupId': 'OG000'}, {'value': '49.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.470', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.14', 'ciLowerLimit': '0.79', 'ciUpperLimit': '1.65', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 52', 'description': 'SRI-4 response defined as 1)greater than or equal to (\\>=) 4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) total score 2)no new British Isles Lupus Assessment Group (BILAG) A and no more than 1 new BILAG B domain score and 3)no worsening in Physician Global Assessment (PGA) of Disease Activity (worsening defined as an increase of \\>=0.3 from baseline on a 0-3 visual analogue scale).\n\nSLEDAI-2K assessment consists of 24 items with total score of 0(no symptoms) to 105 (presence of all defined symptoms) with higher scores representing increased disease activity. BILAG Index: assessing clinical signs, symptoms,or laboratory parameters related to Systemic Lupus Erythematosus (SLE),divided into 9 organ systems. For each organ system A=severe disease,B=moderate disease,C=mild stable disease,D=inactive,but previously active,E=inactive and never affected. PGA assess disease activity on a visual analogue scale from 0 to 3 (1=mild, 2=moderate, 3=severe).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug (mITT population). Missing data was imputed using the hybrid imputation method \\[nonresponder imputation (NRI) + multiple imputation (MI)\\]. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving a Lupus Low Disease Activity State (LLDAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'OG000'}, {'value': '255', 'groupId': 'OG001'}, {'value': '252', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received two placebo tablets: one matching baricitinib 4 mg and one matching baricitinib 2 mg administered orally QD for 52 weeks.'}, {'id': 'OG001', 'title': '2 mg Baricitinib', 'description': 'Participants received one Baricitinib 2 mg tablet and one placebo tablet matching Baricitinib 4 mg administered QD for 52 weeks.'}, {'id': 'OG002', 'title': '4 mg Baricitinib', 'description': 'Participants received one Baricitinib 4 mg tablet and one placebo tablet matching baricitinib 2 mg administered orally QD for 52 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '26.2', 'groupId': 'OG000'}, {'value': '25.7', 'groupId': 'OG001'}, {'value': '29.7', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.839', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.96', 'ciLowerLimit': '0.63', 'ciUpperLimit': '1.45', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.391', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.19', 'ciLowerLimit': '0.80', 'ciUpperLimit': '1.79', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 52', 'description': 'The LLDAS is a composite measure designed to identify patients achieving a state of low disease activity. The LLDAS response criteria were: (1) SLEDAI-2K \\<=4, with no activity in major organ systems (CNS, vascular, renal, cardiorespiratory and constitutional); where "no activity" is defined as all items of SLEDAI-2K within these major organ systems equal to 0. (2) no new features of lupus disease activity compared to previous occurred visit, where the "new feature" is defined as any of the SLEDAI-2K 24 items changed from 0 to greater than 0; (3) PGA (scale 0-3), \\<=1; (4) current prednisolone (or equivalent) dose \\<=7.5 mg daily.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug (mITT population). Missing data was imputed using the hybrid imputation method \\[nonresponder imputation (NRI) + multiple imputation (MI)\\]. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups.'}, {'type': 'SECONDARY', 'title': 'Time to First Severe Flare', 'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'OG000'}, {'value': '255', 'groupId': 'OG001'}, {'value': '252', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received two placebo tablets: one matching baricitinib 4 mg and one matching baricitinib 2 mg administered orally QD for 52 weeks.'}, {'id': 'OG001', 'title': '2 mg Baricitinib', 'description': 'Participants received one Baricitinib 2 mg tablet and one placebo tablet matching Baricitinib 4 mg administered QD for 52 weeks.'}, {'id': 'OG002', 'title': '4 mg Baricitinib', 'description': 'Participants received one Baricitinib 4 mg tablet and one placebo tablet matching baricitinib 2 mg administered orally QD for 52 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data not available (NA) as \\< 50% of participants experienced first flare, median was not reached and 95% confidence interval could not be calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Data not available (NA) as \\< 50% of participants experienced first flare, median was not reached and 95% confidence interval could not be calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Data not available (NA) as \\< 50% of participants experienced first flare, median was not reached and 95% confidence interval could not be calculated.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to Week 52', 'description': 'Time to first severe flare was analyzed using a Cox proportional hazards model with treatment group, baseline disease activity (Systemic Lupus Erythematosus Disease Activity Index 2000 \\[SLEDAI-2K \\] \\<10; SLEDAI-2K ≥10), baseline corticosteroid dose (\\<10 mg/day; ≥10 mg/day prednisone or equivalent), and region fitted as explanatory variables. Participants who did not have severe flare during the flare exposure time period were censored at the end of the flare exposure time.', 'unitOfMeasure': 'weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug (mITT population). As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Whose Average Prednisone Dose Had Been Reduced by >=25% From Baseline to <=7.5 mg/Day During Weeks 40 Through 52 in Participants Receiving Greater Than 7.5 mg/Day at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received two placebo tablets: one matching baricitinib 4 mg and one matching baricitinib 2 mg administered orally QD for 52 weeks.'}, {'id': 'OG001', 'title': '2 mg Baricitinib', 'description': 'Participants received one Baricitinib 2 mg tablet and one placebo tablet matching Baricitinib 4 mg administered QD for 52 weeks.'}, {'id': 'OG002', 'title': '4 mg Baricitinib', 'description': 'Participants received one Baricitinib 4 mg tablet and one placebo tablet matching baricitinib 2 mg administered orally QD for 52 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '30.8', 'groupId': 'OG000'}, {'value': '29.2', 'groupId': 'OG001'}, {'value': '34.0', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.820', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.94', 'ciLowerLimit': '0.53', 'ciUpperLimit': '1.66', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.565', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.18', 'ciLowerLimit': '0.67', 'ciUpperLimit': '2.08', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 40 through Week 52', 'description': 'For the analysis of steroid use, steroid dosages were converted to a prednisone equivalent in mg. A responder was defined as having a prednisone reduction by \\>=25% from Baseline to \\<=7.5 mg/day during Weeks 40 through 52.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug (mITT population) and received \\>7.5 mg prednisone at baseline. Missing data was imputed using the hybrid imputation method \\[NRI + modified last observation carried forward\\]. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Worst Pain Numeric Rating Scale (NRS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}, {'value': '182', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received two placebo tablets: one matching baricitinib 4 mg and one matching baricitinib 2 mg administered orally QD for 52 weeks.'}, {'id': 'OG001', 'title': '2 mg Baricitinib', 'description': 'Participants received one Baricitinib 2 mg tablet and one placebo tablet matching Baricitinib 4 mg administered QD for 52 weeks.'}, {'id': 'OG002', 'title': '4 mg Baricitinib', 'description': 'Participants received one Baricitinib 4 mg tablet and one placebo tablet matching baricitinib 2 mg administered orally QD for 52 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.62', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '-1.73', 'spread': '0.15', 'groupId': 'OG001'}, {'value': '-1.71', 'spread': '0.15', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.598', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference Final Values', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.11', 'ciLowerLimit': '-0.52', 'ciUpperLimit': '0.30', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.21', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.674', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference Final Values', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.09', 'ciLowerLimit': '-0.50', 'ciUpperLimit': '0.32', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.21', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'Participants assessed their worst pain in the last 24 hours on an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (pain as bad as you can imagine). The average worst daily pain score was calculated as the mean of the scores over the last 7 days prior to each assessment time point. Higher score indicated severe pain. Least Squares (LS) mean was calculated using Mixed Model Repeated Measures (MMRM) analysis with treatment, baseline disease activity (total SLEDAI-2K \\<10; \\>=10), baseline corticosteroid dose (\\<10 mg/day; \\>= 10 mg/day prednisone or equivalent), region (North America, Central/South, America/Mexico, Europe, Asia Rest of World), visit (as categorical variable), baseline value, treatment-by-visit interaction, and baseline value-by-visit interaction.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug (mITT population) and had baseline and post-baseline values at the specified time point. Missing data was imputed using the hybrid imputation method (NRI + MMRM). As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '201', 'groupId': 'OG001'}, {'value': '204', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received two placebo tablets: one matching baricitinib 4 mg and one matching baricitinib 2 mg administered orally every day QD for 52 weeks.'}, {'id': 'OG001', 'title': '2 mg Baricitinib', 'description': 'Participants received one Baricitinib 2 mg tablet and one placebo tablet matching Baricitinib 4 mg administered QD for 52 weeks.'}, {'id': 'OG002', 'title': '4 mg Baricitinib', 'description': 'Participants received one Baricitinib 4 mg tablet and one placebo tablet matching baricitinib 2 mg administered orally QD for 52 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.44', 'spread': '0.62', 'groupId': 'OG000'}, {'value': '7.46', 'spread': '0.60', 'groupId': 'OG001'}, {'value': '7.08', 'spread': '0.61', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.979', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference Final Values', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.02', 'ciLowerLimit': '-1.65', 'ciUpperLimit': '1.70', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.85', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.678', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference Final Values', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.36', 'ciLowerLimit': '-2.03', 'ciUpperLimit': '1.32', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.86', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 52', 'description': "FACIT-Fatigue score calculated according to a 13-item questionnaire that assess self reported fatigue and its impact upon daily activities and function. It uses a 5-point Likert-type scale (0 = not at all; 1 = a little bit; 2 = somewhat; 3 = quite a bit; 4 = very much). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse possible score) to 52 (best score). A higher score reflected an improvement in the participant's health status. Least Squares (LS) mean was calculated using Mixed Model Repeated Measures (MMRM) analysis with treatment, baseline disease activity (total SLEDAI-2K \\<10; \\>=10), baseline corticosteroid dose (\\<10 mg/day; \\>= 10 mg/day prednisone or equivalent), region (North America, Central/South, America/Mexico, Europe, Asia Rest of World), visit (as categorical variable), baseline value, treatment-by-visit interaction, and baseline value-by-visit interaction.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug (mITT population) and had baseline and post-baseline values at the specified time-point. Missing data was imputed using the hybrid imputation method (NRI + MMRM). As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Total Activity Score ≥10 at Baseline With ≥50% Reduction in CLASI Total Activity Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received two placebo tablets: one matching baricitinib 4 mg and one matching baricitinib 2 mg administered orally every day QD for 52 weeks.'}, {'id': 'OG001', 'title': '2 mg Baricitinib', 'description': 'Participants received one Baricitinib 2 mg tablet and one placebo tablet matching Baricitinib 4 mg administered QD for 52 weeks.'}, {'id': 'OG002', 'title': '4 mg Baricitinib', 'description': 'Participants received one Baricitinib 4 mg tablet and one placebo tablet matching baricitinib 2 mg administered orally QD for 52 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '49.0', 'groupId': 'OG000'}, {'value': '54.3', 'groupId': 'OG001'}, {'value': '55.8', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.965', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.02', 'ciLowerLimit': '0.43', 'ciUpperLimit': '2.42', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.661', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.22', 'ciLowerLimit': '0.51', 'ciUpperLimit': '2.92', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 52', 'description': 'The CLASI is a single-page tool that separately quantifies disease activity and damage. For the activity score, points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. The total score represents the sum of the individual scores and ranges from 0 to 70. Higher scores are awarded for more severe manifestations.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug (mITT population) and had baseline CLASI score of \\>= 10. Missing data was imputed using NRI method. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Tender Joints Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}, {'value': '195', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received two placebo tablets: one matching baricitinib 4 mg and one matching baricitinib 2 mg administered orally every day QD for 52 weeks.'}, {'id': 'OG001', 'title': '2 mg Baricitinib', 'description': 'Participants received one Baricitinib 2 mg tablet and one placebo tablet matching Baricitinib 4 mg administered QD for 52 weeks.'}, {'id': 'OG002', 'title': '4 mg Baricitinib', 'description': 'Participants received one Baricitinib 4 mg tablet and one placebo tablet matching baricitinib 2 mg administered orally QD for 52 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.50', 'spread': '0.312', 'groupId': 'OG000'}, {'value': '-7.26', 'spread': '0.305', 'groupId': 'OG001'}, {'value': '-7.94', 'spread': '0.307', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.578', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference Final Values', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.24', 'ciLowerLimit': '-0.61', 'ciUpperLimit': '1.08', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.430', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.309', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference Final Values', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.44', 'ciLowerLimit': '-1.29', 'ciUpperLimit': '0.41', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.433', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'The number of tender and painful joints is determined by examination of 28 joints (14 on each side) which include: the 2 shoulders, the 2 elbows, the 2 wrists, the 10 metacarpophalangeal joints, the 2 interphalangeal joints of the thumb, the 8 proximal interphalangeal joints, and the 2 knees. The joints are assessed and classified as tender or not tender. LS mean was calculated using Mixed Model Repeated Measures (MMRM) analysis with treatment, baseline disease activity (total SLEDAI-2K \\<10; \\>=10), baseline corticosteroid dose (\\<10 mg/day; \\>=10 mg/day prednisone or equivalent), region (North America, Central/South America/Mexico, Europe, Asia and Rest of World), visit (as categorical variable), baseline value, treatment-by-visit interaction, and baseline value-by-visit interaction.', 'unitOfMeasure': 'tender joint count', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug (mITT population) and had baseline and post-baseline values at specified time point. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Swollen Joint Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}, {'value': '195', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received two placebo tablets: one matching baricitinib 4 mg and one matching baricitinib 2 mg administered orally every day QD for 52 weeks.'}, {'id': 'OG001', 'title': '2 mg Baricitinib', 'description': 'Participants received one Baricitinib 2 mg tablet and one placebo tablet matching Baricitinib 4 mg administered QD for 52 weeks.'}, {'id': 'OG002', 'title': '4 mg Baricitinib', 'description': 'Participants received one Baricitinib 4 mg tablet and one placebo tablet matching baricitinib 2 mg administered orally QD for 52 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.37', 'spread': '0.201', 'groupId': 'OG000'}, {'value': '-5.67', 'spread': '0.196', 'groupId': 'OG001'}, {'value': '-5.81', 'spread': '0.198', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.287', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference Final Values', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.29', 'ciLowerLimit': '-0.84', 'ciUpperLimit': '0.25', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.277', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.113', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference Final Values', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.44', 'ciLowerLimit': '-0.99', 'ciUpperLimit': '0.11', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.278', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'The number of swollen joints is determined by examination of 28 joints (14 on each side) which include: the 2 shoulders, the 2 elbows, the 2 wrists, the 10 metacarpophalangeal joints, the 2 interphalangeal joints of the thumb, the 8 proximal interphalangeal joints, and the 2 knees. The joints are assessed and classified as swollen or not swollen. LS mean was calculated using MMRM analysis with treatment, baseline disease activity (total SLEDAI-2K \\<10; \\>=10), baseline corticosteroid dose (\\<10 mg/day; \\>=10 mg/day prednisone or equivalent), region (North America, Central/South America/Mexico, Europe, Asia and Rest of World), visit (as categorical variable), baseline value, treatment-by-visit interaction, and baseline value-by-visit interaction.', 'unitOfMeasure': 'swollen joint count', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug (mITT population) and had baseline and post-baseline values at the specified time point. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups.'}, {'type': 'SECONDARY', 'title': 'Population Pharmacokinetics (PK): Area Under the Concentration-Time Curve of Baricitinib at Steady State (AUCτ, ss)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '2 mg Baricitinib', 'description': 'Participants received one Baricitinib 2 mg tablet and one placebo tablet matching Baricitinib 4 mg administered QD for 52 weeks.'}, {'id': 'OG001', 'title': '4 mg Baricitinib', 'description': 'Participants received one Baricitinib 4 mg tablet and one placebo tablet matching baricitinib 2 mg administered orally QD for 52 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '256', 'spread': '52', 'groupId': 'OG000'}, {'value': '502', 'spread': '52', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 0 (Baseline): 15 minutes (min) and 60 min postdose; Week 4: 2 to 4 hours (hr) postdose; Week 8: 4 to 6 hr postdose; Week 12 and Week 16 predose', 'description': 'PK: Area Under the Concentration-Time Curve of Baricitinib at Steady State (AUCτ, ss) was evaluated using population PK approach.', 'unitOfMeasure': 'hour*nanograms per milliliter (h*ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and had evaluable PK data. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups.'}, {'type': 'SECONDARY', 'title': 'Population PK: Maximum Observed Drug Concentration at Steady State (Cmax,ss)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '2 mg Baricitinib', 'description': 'Participants received one Baricitinib 2 mg tablet and one placebo tablet matching Baricitinib 4 mg administered QD for 52 weeks.'}, {'id': 'OG001', 'title': '4 mg Baricitinib', 'description': 'Participants received one Baricitinib 4 mg tablet and one placebo tablet matching baricitinib 2 mg administered orally QD for 52 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '26.7', 'spread': '24', 'groupId': 'OG000'}, {'value': '53.0', 'spread': '23', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 0 (Baseline): 15 minutes (min) and 60 min postdose; Week 4: 2 to 4 hours (hr) postdose; Week 8: 4 to 6 hr postdose; Week 12 and Week 16 predose', 'description': 'Population PK: Maximum Observed Drug Concentration at Steady State (Cmax,ss) was evaluated using population PK approach.', 'unitOfMeasure': 'nanograms per milliliter (ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and had evaluable PK data. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Participants received two placebo tablets: one matching baricitinib 4 milligram (mg) and one matching baricitinib 2 mg administered orally every day (QD) for 52 weeks.'}, {'id': 'FG001', 'title': '2 mg Baricitinib', 'description': 'Participants received one Baricitinib 2 mg tablet and one placebo tablet matching Baricitinib 4 mg administered orally QD for 52 weeks.'}, {'id': 'FG002', 'title': '4 mg Baricitinib', 'description': 'Participants received one Baricitinib 4 mg tablet and one placebo tablet matching baricitinib 2 mg administered orally QD for 52 weeks.'}, {'id': 'FG003', 'title': 'Placebo (MEE)', 'description': 'Participants received two placebo tablets: one matching baricitinib 4 mg and one matching baricitinib 2 mg administered orally QD for 52 weeks.'}, {'id': 'FG004', 'title': '2 mg Baricitinib (MEE)', 'description': 'Participants received one Baricitinib 2 mg tablet and one placebo tablet matching Baricitinib 4 mg administered QD for 52 weeks.'}, {'id': 'FG005', 'title': '4 mg Baricitinib (MEE)', 'description': 'Participants received one Baricitinib 4 mg tablet and one placebo tablet matching baricitinib 2 mg administered orally QD for 52 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '257'}, {'groupId': 'FG001', 'numSubjects': '258'}, {'groupId': 'FG002', 'numSubjects': '254'}, {'groupId': 'FG003', 'numSubjects': '21'}, {'groupId': 'FG004', 'numSubjects': '20'}, {'groupId': 'FG005', 'numSubjects': '20'}]}, {'type': 'Received at Least One Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '257'}, {'groupId': 'FG001', 'numSubjects': '256'}, {'groupId': 'FG002', 'numSubjects': '254'}, {'groupId': 'FG003', 'numSubjects': '21'}, {'groupId': 'FG004', 'numSubjects': '20'}, {'groupId': 'FG005', 'numSubjects': '20'}]}, {'type': 'Excluded Due to Site Misconduct', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '204'}, {'groupId': 'FG001', 'numSubjects': '211'}, {'groupId': 'FG002', 'numSubjects': '208'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}, {'groupId': 'FG001', 'numSubjects': '47'}, {'groupId': 'FG002', 'numSubjects': '46'}, {'groupId': 'FG003', 'numSubjects': '16'}, {'groupId': 'FG004', 'numSubjects': '15'}, {'groupId': 'FG005', 'numSubjects': '14'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Due to Epidemic/Pandemic', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '15'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'Study Terminated by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '10'}, {'groupId': 'FG004', 'numSubjects': '9'}, {'groupId': 'FG005', 'numSubjects': '11'}]}, {'type': 'Protocol Deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Randomized But Never Treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'One investigational site with seven participants was excluded from analysis due to confirmed misconduct.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'BG000'}, {'value': '255', 'groupId': 'BG001'}, {'value': '252', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}, {'value': '20', 'groupId': 'BG005'}, {'value': '821', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Participants received two placebo tablets: one matching baricitinib 4 mg and one matching baricitinib 2 mg administered orally QD for 52 weeks.'}, {'id': 'BG001', 'title': '2 mg Baricitinib', 'description': 'Participants received one Baricitinib 2 mg tablet and one placebo tablet matching Baricitinib 4 mg administered QD for 52 weeks.'}, {'id': 'BG002', 'title': '4 mg Baricitinib', 'description': 'Participants received one Baricitinib 4 mg tablet and one placebo tablet matching baricitinib 2 mg administered orally QD for 52 weeks.'}, {'id': 'BG003', 'title': 'Placebo Maximum Extended Enrollment (MEE)', 'description': 'Participants received two placebo tablets: one matching baricitinib 4 mg and one matching baricitinib 2 mg administered orally QD for 52 weeks.'}, {'id': 'BG004', 'title': '2 mg Baricitinib MEE', 'description': 'Participants received one Baricitinib 2 mg tablet and one placebo tablet matching Baricitinib 4 mg administered QD for 52 weeks.'}, {'id': 'BG005', 'title': '4 mg Baricitinib MEE', 'description': 'Participants received one Baricitinib 4 mg tablet and one placebo tablet matching baricitinib 2 mg administered orally QD for 52 weeks.'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '42.00', 'spread': '11.98', 'groupId': 'BG000'}, {'value': '42.90', 'spread': '12.44', 'groupId': 'BG001'}, {'value': '41.50', 'spread': '12.88', 'groupId': 'BG002'}, {'value': '32.90', 'spread': '10.83', 'groupId': 'BG003'}, {'value': '37.70', 'spread': '11.38', 'groupId': 'BG004'}, {'value': '34.60', 'spread': '8.31', 'groupId': 'BG005'}, {'value': '41.60', 'spread': '12.43', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '237', 'groupId': 'BG000'}, {'value': '238', 'groupId': 'BG001'}, {'value': '237', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}, {'value': '20', 'groupId': 'BG005'}, {'value': '771', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '50', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '28', 'groupId': 'BG006'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '115', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '207', 'groupId': 'BG000'}, {'value': '207', 'groupId': 'BG001'}, {'value': '203', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}, {'value': '20', 'groupId': 'BG005'}, {'value': '678', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '34', 'groupId': 'BG006'}]}, {'title': 'Asian', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}, {'value': '20', 'groupId': 'BG005'}, {'value': '167', 'groupId': 'BG006'}]}, {'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'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Black or African American', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '89', 'groupId': 'BG006'}]}, {'title': 'White', 'measurements': [{'value': '168', 'groupId': 'BG000'}, {'value': '172', 'groupId': 'BG001'}, {'value': '177', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '517', 'groupId': 'BG006'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '11', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Australia', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '31', 'groupId': 'BG006'}]}]}, {'title': 'Austria', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}]}]}, {'title': 'Belgium', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}]}]}, {'title': 'Brazil', 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '83', 'groupId': 'BG006'}]}]}, {'title': 'China', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}, {'value': '20', 'groupId': 'BG005'}, {'value': '116', 'groupId': 'BG006'}]}]}, {'title': 'Croatia', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '10', 'groupId': 'BG006'}]}]}, {'title': 'Czechia', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '38', 'groupId': 'BG006'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '45', 'groupId': 'BG006'}]}]}, {'title': 'Greece', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '18', 'groupId': 'BG006'}]}]}, {'title': 'Hungary', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '50', 'groupId': 'BG006'}]}]}, {'title': 'Israel', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '8', 'groupId': 'BG006'}]}]}, {'title': 'Mexico', 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '136', 'groupId': 'BG006'}]}]}, {'title': 'Netherlands', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}]}]}, {'title': 'Russia', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '71', 'groupId': 'BG006'}]}]}, {'title': 'Switzerland', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '8', 'groupId': 'BG006'}]}]}, {'title': 'Taiwan', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '39', 'groupId': 'BG006'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '13', 'groupId': 'BG006'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '146', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All randomized participants who receive at least one dose of study drug. One investigational site with seven participants was excluded from analysis due to confirmed misconduct.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-04-20', 'size': 1114314, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-07-13T08:26', 'hasProtocol': True}, {'date': '2021-11-30', 'size': 5561818, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-08-04T09:37', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 830}}, 'statusModule': {'whyStopped': 'Study terminated due to insufficient evidence to support a positive benefit: risk profile in systemic lupus erythematosus patients.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-08-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-03-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-04', 'studyFirstSubmitDate': '2018-08-01', 'resultsFirstSubmitDate': '2022-10-11', 'studyFirstSubmitQcDate': '2018-08-01', 'lastUpdatePostDateStruct': {'date': '2023-01-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-01-04', 'studyFirstPostDateStruct': {'date': '2018-08-06', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Achieving a Systemic Lupus Erythematosus Responder Index 4 (SRI-4) Response (4 mg Baricitinib)', 'timeFrame': 'Week 52', 'description': 'SRI-4 response defined as 1)greater than or equal to (\\>=) 4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) total score 2)no new British Isles Lupus Assessment Group (BILAG) A and no more than 1 new BILAG B domain score and 3)no worsening in Physician Global Assessment (PGA) of Disease Activity (worsening defined as an increase of \\>=0.3 from baseline on a 0-3 visual analogue scale).\n\nSLEDAI-2K assessment consists of 24 items with total score of 0(no symptoms) to 105 (presence of all defined symptoms) with higher scores representing increased disease activity. BILAG Index: assessing clinical signs, symptoms,or laboratory parameters related to Systemic Lupus Erythematosus (SLE),divided into 9 organ systems. For each organ system A=severe disease,B=moderate disease,C=mild stable disease,D=inactive,but previously active,E=inactive and never affected. PGA assess disease activity on a visual analogue scale from 0 to 3 (1=mild, 2=moderate, 3=severe).'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Achieving SRI-4 Response - 2 mg Baricitinib', 'timeFrame': 'Week 52', 'description': 'SRI-4 response defined as 1)greater than or equal to (\\>=) 4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) total score 2)no new British Isles Lupus Assessment Group (BILAG) A and no more than 1 new BILAG B domain score and 3)no worsening in Physician Global Assessment (PGA) of Disease Activity (worsening defined as an increase of \\>=0.3 from baseline on a 0-3 visual analogue scale).\n\nSLEDAI-2K assessment consists of 24 items with total score of 0(no symptoms) to 105 (presence of all defined symptoms) with higher scores representing increased disease activity. BILAG Index: assessing clinical signs, symptoms,or laboratory parameters related to Systemic Lupus Erythematosus (SLE),divided into 9 organ systems. For each organ system A=severe disease,B=moderate disease,C=mild stable disease,D=inactive,but previously active,E=inactive and never affected. PGA assess disease activity on a visual analogue scale from 0 to 3 (1=mild, 2=moderate, 3=severe).'}, {'measure': 'Percentage of Participants Achieving a Lupus Low Disease Activity State (LLDAS)', 'timeFrame': 'Week 52', 'description': 'The LLDAS is a composite measure designed to identify patients achieving a state of low disease activity. The LLDAS response criteria were: (1) SLEDAI-2K \\<=4, with no activity in major organ systems (CNS, vascular, renal, cardiorespiratory and constitutional); where "no activity" is defined as all items of SLEDAI-2K within these major organ systems equal to 0. (2) no new features of lupus disease activity compared to previous occurred visit, where the "new feature" is defined as any of the SLEDAI-2K 24 items changed from 0 to greater than 0; (3) PGA (scale 0-3), \\<=1; (4) current prednisolone (or equivalent) dose \\<=7.5 mg daily.'}, {'measure': 'Time to First Severe Flare', 'timeFrame': 'Baseline to Week 52', 'description': 'Time to first severe flare was analyzed using a Cox proportional hazards model with treatment group, baseline disease activity (Systemic Lupus Erythematosus Disease Activity Index 2000 \\[SLEDAI-2K \\] \\<10; SLEDAI-2K ≥10), baseline corticosteroid dose (\\<10 mg/day; ≥10 mg/day prednisone or equivalent), and region fitted as explanatory variables. Participants who did not have severe flare during the flare exposure time period were censored at the end of the flare exposure time.'}, {'measure': 'Percentage of Participants Whose Average Prednisone Dose Had Been Reduced by >=25% From Baseline to <=7.5 mg/Day During Weeks 40 Through 52 in Participants Receiving Greater Than 7.5 mg/Day at Baseline', 'timeFrame': 'Baseline, Week 40 through Week 52', 'description': 'For the analysis of steroid use, steroid dosages were converted to a prednisone equivalent in mg. A responder was defined as having a prednisone reduction by \\>=25% from Baseline to \\<=7.5 mg/day during Weeks 40 through 52.'}, {'measure': 'Change From Baseline in Worst Pain Numeric Rating Scale (NRS)', 'timeFrame': 'Baseline, Week 52', 'description': 'Participants assessed their worst pain in the last 24 hours on an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (pain as bad as you can imagine). The average worst daily pain score was calculated as the mean of the scores over the last 7 days prior to each assessment time point. Higher score indicated severe pain. Least Squares (LS) mean was calculated using Mixed Model Repeated Measures (MMRM) analysis with treatment, baseline disease activity (total SLEDAI-2K \\<10; \\>=10), baseline corticosteroid dose (\\<10 mg/day; \\>= 10 mg/day prednisone or equivalent), region (North America, Central/South, America/Mexico, Europe, Asia Rest of World), visit (as categorical variable), baseline value, treatment-by-visit interaction, and baseline value-by-visit interaction.'}, {'measure': 'Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Total Score', 'timeFrame': 'Baseline, Week 52', 'description': "FACIT-Fatigue score calculated according to a 13-item questionnaire that assess self reported fatigue and its impact upon daily activities and function. It uses a 5-point Likert-type scale (0 = not at all; 1 = a little bit; 2 = somewhat; 3 = quite a bit; 4 = very much). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse possible score) to 52 (best score). A higher score reflected an improvement in the participant's health status. Least Squares (LS) mean was calculated using Mixed Model Repeated Measures (MMRM) analysis with treatment, baseline disease activity (total SLEDAI-2K \\<10; \\>=10), baseline corticosteroid dose (\\<10 mg/day; \\>= 10 mg/day prednisone or equivalent), region (North America, Central/South, America/Mexico, Europe, Asia Rest of World), visit (as categorical variable), baseline value, treatment-by-visit interaction, and baseline value-by-visit interaction."}, {'measure': 'Percentage of Participants With Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Total Activity Score ≥10 at Baseline With ≥50% Reduction in CLASI Total Activity Score', 'timeFrame': 'Week 52', 'description': 'The CLASI is a single-page tool that separately quantifies disease activity and damage. For the activity score, points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. The total score represents the sum of the individual scores and ranges from 0 to 70. Higher scores are awarded for more severe manifestations.'}, {'measure': 'Change From Baseline in Tender Joints Count', 'timeFrame': 'Baseline, Week 52', 'description': 'The number of tender and painful joints is determined by examination of 28 joints (14 on each side) which include: the 2 shoulders, the 2 elbows, the 2 wrists, the 10 metacarpophalangeal joints, the 2 interphalangeal joints of the thumb, the 8 proximal interphalangeal joints, and the 2 knees. The joints are assessed and classified as tender or not tender. LS mean was calculated using Mixed Model Repeated Measures (MMRM) analysis with treatment, baseline disease activity (total SLEDAI-2K \\<10; \\>=10), baseline corticosteroid dose (\\<10 mg/day; \\>=10 mg/day prednisone or equivalent), region (North America, Central/South America/Mexico, Europe, Asia and Rest of World), visit (as categorical variable), baseline value, treatment-by-visit interaction, and baseline value-by-visit interaction.'}, {'measure': 'Change From Baseline in Swollen Joint Count', 'timeFrame': 'Baseline, Week 52', 'description': 'The number of swollen joints is determined by examination of 28 joints (14 on each side) which include: the 2 shoulders, the 2 elbows, the 2 wrists, the 10 metacarpophalangeal joints, the 2 interphalangeal joints of the thumb, the 8 proximal interphalangeal joints, and the 2 knees. The joints are assessed and classified as swollen or not swollen. LS mean was calculated using MMRM analysis with treatment, baseline disease activity (total SLEDAI-2K \\<10; \\>=10), baseline corticosteroid dose (\\<10 mg/day; \\>=10 mg/day prednisone or equivalent), region (North America, Central/South America/Mexico, Europe, Asia and Rest of World), visit (as categorical variable), baseline value, treatment-by-visit interaction, and baseline value-by-visit interaction.'}, {'measure': 'Population Pharmacokinetics (PK): Area Under the Concentration-Time Curve of Baricitinib at Steady State (AUCτ, ss)', 'timeFrame': 'Week 0 (Baseline): 15 minutes (min) and 60 min postdose; Week 4: 2 to 4 hours (hr) postdose; Week 8: 4 to 6 hr postdose; Week 12 and Week 16 predose', 'description': 'PK: Area Under the Concentration-Time Curve of Baricitinib at Steady State (AUCτ, ss) was evaluated using population PK approach.'}, {'measure': 'Population PK: Maximum Observed Drug Concentration at Steady State (Cmax,ss)', 'timeFrame': 'Week 0 (Baseline): 15 minutes (min) and 60 min postdose; Week 4: 2 to 4 hours (hr) postdose; Week 8: 4 to 6 hr postdose; Week 12 and Week 16 predose', 'description': 'Population PK: Maximum Observed Drug Concentration at Steady State (Cmax,ss) was evaluated using population PK approach.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['SLE'], 'conditions': ['Systemic Lupus Erythematosus']}, 'referencesModule': {'references': [{'pmid': '40305472', 'type': 'DERIVED', 'citation': 'Yin J, Hou Y, Wang C, Qin C. Clinical outcomes of baricitinib in patients with systemic lupus erythematosus: Pooled analysis of SLE-BRAVE-I and SLE-BRAVE-II trials. PLoS One. 2025 Apr 30;20(4):e0320179. doi: 10.1371/journal.pone.0320179. eCollection 2025.'}, {'pmid': '36848918', 'type': 'DERIVED', 'citation': 'Morand EF, Vital EM, Petri M, van Vollenhoven R, Wallace DJ, Mosca M, Furie RA, Silk ME, Dickson CL, Meszaros G, Jia B, Crowe B, de la Torre I, Dorner T. Baricitinib for systemic lupus erythematosus: a double-blind, randomised, placebo-controlled, phase 3 trial (SLE-BRAVE-I). Lancet. 2023 Mar 25;401(10381):1001-1010. doi: 10.1016/S0140-6736(22)02607-1. Epub 2023 Feb 24.'}, {'pmid': '33687069', 'type': 'DERIVED', 'citation': 'Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.'}], 'seeAlsoLinks': [{'url': 'https://trials.lillytrialguide.com/en-US/trial/64a5deI4M0sSScwYIMISsI', 'label': 'A Study of Baricitinib (LY3009104) in Participants With Systemic Lupus Erythematosus'}]}, 'descriptionModule': {'briefSummary': 'The reason for this study is to see how effective and safe the study drug known as baricitinib is in participants with systemic lupus erythematosus (SLE).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have a clinical diagnosis of SLE at least 24 weeks prior to screening.\n* Have documentation of having met at least 4 of 11 Revised Criteria for Classification of Systemic Lupus Erythematosus according to the 1997 Update of the 1982 American College of Rheumatology (ACR) criteria for classification of SLE prior to randomization.\n* Have a positive antinuclear antibody (ANA) (titer ≥1:80) and/or a positive anti-double-stranded deoxyribonucleic acid (dsDNA), and/or a positive anti-Smith (anti-Sm) as assessed by a central laboratory during screening.\n* Have a total Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score ≥6 during screening.\n* Have a clinical SLEDAI-2K score ≥4 at randomization.\n* Have at least 1 British Isles Lupus Assessment Group (BILAG) A score or 2 BILAG B scores during screening.\n* Are receiving at least one of the following standard of care medications for SLE:\n\n * A single antimalarial at a stable dose for at least 8 weeks prior to screening\n * A single immunosuppressant at a stable dose for at least 8 weeks prior to screening\n * An oral corticosteroid, initiated at least 4 weeks prior to screening, at a stable dose ≤40 milligrams/day prednisone (or equivalent) for at least 2 weeks prior to screening. If the participant is not receiving an antimalarial or immunosuppressant, the dose of corticosteroid must be ≥7.5 milligrams/day prednisone (or equivalent)\n\nExclusion Criteria:\n\n* Have severe active lupus nephritis.\n* Have active central nervous system (CNS) lupus.\n* Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness that, in the opinion of the investigator, could constitute an unacceptable risk when taking investigational product or interfere with the interpretation of data.\n* Have a current or recent clinically serious viral, bacterial, fungal, or parasitic infection.\n* Have received cyclophosphamide (or any other cytotoxic agent) within 12 weeks prior to screening.'}, 'identificationModule': {'nctId': 'NCT03616912', 'acronym': 'SLE-BRAVE I', 'briefTitle': 'A Study of Baricitinib (LY3009104) in Participants With Systemic Lupus Erythematosus', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients With Systemic Lupus Erythematosus', 'orgStudyIdInfo': {'id': '16676'}, 'secondaryIdInfos': [{'id': 'I4V-MC-JAHZ', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}, {'id': '2017-005026-37', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants received two placebo tablets: one matching baricitinib 4 milligram (mg) and one matching baricitinib 2 mg administered orally every day (QD) for 52 weeks.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': '2 mg Baricitinib', 'description': 'Participants received one Baricitinib 2 mg tablet and one placebo tablet matching Baricitinib 4 mg administered QD for 52 weeks.', 'interventionNames': ['Drug: Baricitinib', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': '4 mg Baricitinib', 'description': 'Participants received one Baricitinib 4 mg tablet and one placebo tablet matching baricitinib 2 mg administered orally every day (QD) for 52 weeks.', 'interventionNames': ['Drug: Baricitinib', 'Drug: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Maximum Extended Enrollment (MEE)', 'description': 'Participants received two placebo tablets: one matching baricitinib 4 mg and one matching baricitinib 2 mg administered orally QD for 52 weeks.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': '2 mg Baricitinib (MEE)', 'description': 'Participants received one Baricitinib 2 mg tablet and 1 placebo tablet matching Baricitinib 4 mg administered QD for 52 weeks.', 'interventionNames': ['Drug: Baricitinib', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': '4 mg Baricitinib (MEE)', 'description': 'Participants received one Baricitinib 4 mg tablet and one placebo tablet matching baricitinib 2 mg administered orally every day (QD) for 52 weeks.', 'interventionNames': ['Drug: Baricitinib', 'Drug: Placebo']}], 'interventions': [{'name': 'Baricitinib', 'type': 'DRUG', 'otherNames': ['LY3009104'], 'description': 'Administered orally.', 'armGroupLabels': ['2 mg Baricitinib', '2 mg Baricitinib (MEE)', '4 mg Baricitinib', '4 mg Baricitinib (MEE)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered orally.', 'armGroupLabels': ['2 mg Baricitinib', '2 mg Baricitinib (MEE)', '4 mg Baricitinib', '4 mg Baricitinib (MEE)', 'Placebo', 'Placebo Maximum Extended Enrollment (MEE)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35216', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Achieve Clinical Research, LLC', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85306', 'city': 'Glendale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Arthritis & Rheumatology Research, PLLC', 'geoPoint': {'lat': 33.53865, 'lon': -112.18599}}, {'zip': '85711', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'University of Arizona', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '92835', 'city': 'Fullerton', 'state': 'California', 'country': 'United States', 'facility': 'St. Joseph Heritage Medical Group', 'geoPoint': {'lat': 33.87029, 'lon': -117.92534}}, {'zip': '92543', 'city': 'Hemet', 'state': 'California', 'country': 'United States', 'facility': 'MD Medical Corporation', 'geoPoint': {'lat': 33.74761, 'lon': -116.97307}}, {'zip': '92064', 'city': 'Poway', 'state': 'California', 'country': 'United States', 'facility': 'ACRC Studies', 'geoPoint': {'lat': 32.96282, 'lon': -117.03586}}, {'zip': '93108', 'city': 'Santa Barbara', 'state': 'California', 'country': 'United States', 'facility': 'Office: Hans R Barthel M.D.', 'geoPoint': {'lat': 34.42083, 'lon': -119.69819}}, {'zip': '90602', 'city': 'Whittier', 'state': 'California', 'country': 'United States', 'facility': 'Medvin Clinical Research - Weidmann', 'geoPoint': {'lat': 33.97918, 'lon': -118.03284}}, {'zip': '80230', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Denver Arthritis Clinic - Lowry', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '06606', 'city': 'Bridgeport', 'state': 'Connecticut', 'country': 'United States', 'facility': 'New England Research Associates', 'geoPoint': {'lat': 41.17923, 'lon': -73.18945}}, {'zip': '06519', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale University School of Medicine', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '33180', 'city': 'Aventura', 'state': 'Florida', 'country': 'United States', 'facility': 'Arthritis and Rheumatic Disease', 'geoPoint': {'lat': 25.95648, 'lon': -80.13921}}, {'zip': '33486', 'city': 'Boca Raton', 'state': 'Florida', 'country': 'United States', 'facility': 'Rheumatology Associates of South Florida', 'geoPoint': {'lat': 26.35869, 'lon': -80.0831}}, {'zip': '33765', 'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Research of West Florida, Inc. (Clearwater)', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '33063', 'city': 'Margate', 'state': 'Florida', 'country': 'United States', 'facility': 'Arthritis and Rheumatology Center of South Florida', 'geoPoint': {'lat': 26.24453, 'lon': -80.20644}}, {'zip': '33014', 'city': 'Miami Lakes', 'state': 'Florida', 'country': 'United States', 'facility': 'Lakes Research, LLC', 'geoPoint': {'lat': 25.90871, 'lon': -80.30866}}, {'zip': '32174', 'city': 'Ormond Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Millennium Research', 'geoPoint': {'lat': 29.28581, 'lon': -81.05589}}, {'zip': '33324', 'city': 'Plantation', 'state': 'Florida', 'country': 'United States', 'facility': 'IRIS Research and Development, LLC', 'geoPoint': {'lat': 26.13421, 'lon': -80.23184}}, {'zip': '33613-1244', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'ForCare Clinical Research', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30318', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Piedmont Healthcare', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30342', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Atlanta Center for Clinical Research', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '83702', 'city': 'Boise', 'state': 'Idaho', 'country': 'United States', 'facility': "St Luke's Clinic - Intermountain Orthopaedics", 'geoPoint': {'lat': 43.6135, 'lon': -116.20345}}, {'zip': '61114', 'city': 'Rockford', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rockford Orthopedic Associates', 'geoPoint': {'lat': 42.27113, 'lon': -89.094}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Health System', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '48081', 'city': 'Saint Clair Shores', 'state': 'Michigan', 'country': 'United States', 'facility': 'Clinical Research Institute of Michigan, LLC', 'geoPoint': {'lat': 42.49698, 'lon': -82.88881}}, {'zip': '63119', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'St. Louis Rheumatology', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '59901', 'city': 'Kalispell', 'state': 'Montana', 'country': 'United States', 'facility': 'Glacier View Research Institute - Endocrinology', 'geoPoint': {'lat': 48.19579, 'lon': -114.31291}}, {'zip': '89519', 'city': 'Reno', 'state': 'Nevada', 'country': 'United States', 'facility': 'Allied Clinical Research', 'geoPoint': {'lat': 39.52963, 'lon': -119.8138}}, {'zip': '87102', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'Albuquerque Center for Rheumatology', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '11203', 'city': 'Brooklyn', 'state': 'New York', 'country': 'United States', 'facility': 'SUNY Health Science Center', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}, {'zip': '13617', 'city': 'Canton', 'state': 'New York', 'country': 'United States', 'facility': 'St. Lawrence Health System', 'geoPoint': {'lat': 44.59562, 'lon': -75.16909}}, {'zip': '11021', 'city': 'Great Neck', 'state': 'New York', 'country': 'United States', 'facility': 'Northwell Health', 'geoPoint': {'lat': 40.80066, 'lon': -73.72846}}, {'zip': '11030', 'city': 'Manhasset', 'state': 'New York', 'country': 'United States', 'facility': 'The Feinstein Institute for Medical Research', 'geoPoint': {'lat': 40.79788, 'lon': -73.69957}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '14127', 'city': 'Orchard Park', 'state': 'New York', 'country': 'United States', 'facility': 'Buffalo Rheumatology', 'geoPoint': {'lat': 42.76756, 'lon': -78.74392}}, {'zip': '28204', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Joint and Muscle Medical Care', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '27408', 'city': 'Greensboro', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Medication Management, LLC', 'geoPoint': {'lat': 36.07264, 'lon': -79.79198}}, {'zip': '28401', 'city': 'Wilmington', 'state': 'North Carolina', 'country': 'United States', 'facility': 'PMG Research of Wilmington', 'geoPoint': {'lat': 34.23556, 'lon': -77.94604}}, {'zip': '45242', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cincinnati Arthritis Associates', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Ohio State University', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '44130', 'city': 'Middleburg Heights', 'state': 'Ohio', 'country': 'United States', 'facility': 'Paramount Medical Research', 'geoPoint': {'lat': 41.36144, 'lon': -81.81291}}, {'zip': '73102', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Arthritis & Rheumatology Center of Oklahoma PLLC', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '18015', 'city': 'Bethlehem', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'East Penn Rheumatology Associates', 'geoPoint': {'lat': 40.62593, 'lon': -75.37046}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'UPMC Lupus Center of Excellence', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '38305', 'city': 'Jackson', 'state': 'Tennessee', 'country': 'United States', 'facility': 'West Tennessee Research Institute', 'geoPoint': {'lat': 35.61452, 'lon': -88.81395}}, {'zip': '79124', 'city': 'Amarillo', 'state': 'Texas', 'country': 'United States', 'facility': 'Amarillo Center for Clinical Research', 'geoPoint': {'lat': 35.222, 'lon': -101.8313}}, {'zip': '77521', 'city': 'Baytown', 'state': 'Texas', 'country': 'United States', 'facility': 'Accurate Clinical Management', 'geoPoint': {'lat': 29.7355, 'lon': -94.97743}}, {'zip': '76034', 'city': 'Colleyville', 'state': 'Texas', 'country': 'United States', 'facility': 'Dr. Dhiman Basu Private Practice', 'geoPoint': {'lat': 32.88096, 'lon': -97.15501}}, {'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Metroplex Clinical Research Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '76107', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'Precision Comprehensive Clinical Research Solutions', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '77004', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Rheumatology Center of Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77089', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Accurate Clinical Research', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '75150', 'city': 'Mesquite', 'state': 'Texas', 'country': 'United States', 'facility': 'Southwest Rheumatology, P.A.', 'geoPoint': {'lat': 32.7668, 'lon': -96.59916}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Accurate Clinical Research, Inc.', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Univ of Texas Health Science Center at San Antonio', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78666', 'city': 'San Marcos', 'state': 'Texas', 'country': 'United States', 'facility': 'Arthritis Clinic Of Central Texas', 'geoPoint': {'lat': 29.88327, 'lon': -97.94139}}, {'zip': '24541', 'city': 'Danville', 'state': 'Virginia', 'country': 'United States', 'facility': 'Spectrum Medical Inc.', 'geoPoint': {'lat': 36.58597, 'lon': -79.39502}}, {'zip': '98122', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Swedish Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '53217', 'city': 'Glendale', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Rheumatic Disease Center', 'geoPoint': {'lat': 43.13529, 'lon': -87.93564}}, {'zip': '2019', 'city': 'Botany', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Emeritus Research', 'geoPoint': {'lat': -33.94599, 'lon': 151.19591}}, {'zip': '4558', 'city': 'Maroochydore', 'state': 'Queensland', 'country': 'Australia', 'facility': 'The Rheumatology Research Unit Sunshine Coast', 'geoPoint': {'lat': -26.66008, 'lon': 153.09953}}, {'zip': '3124', 'city': 'Camberwell', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Emeritus Research', 'geoPoint': {'lat': -37.84205, 'lon': 145.0694}}, {'zip': '3168', 'city': 'Clayton', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Monash Medical Centre', 'geoPoint': {'lat': -37.91667, 'lon': 145.11667}}, {'zip': '3065', 'city': 'Fitzroy', 'state': 'Victoria', 'country': 'Australia', 'facility': 'St Vincents Hospital Melbourne', 'geoPoint': {'lat': -37.79839, 'lon': 144.97833}}, {'zip': '4215', 'city': 'Southport', 'country': 'Australia', 'facility': 'Griffith University', 'geoPoint': {'lat': -27.96724, 'lon': 153.39796}}, {'zip': '4020', 'city': 'Linz', 'state': 'Upper Austria', 'country': 'Austria', 'facility': 'Ordensklinikum Linz GmbH Elisabethinen', 'geoPoint': {'lat': 48.30639, 'lon': 14.28611}}, {'zip': '8036', 'city': 'Graz', 'country': 'Austria', 'facility': 'Medizinische Universität Graz', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'zip': '1130', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Klinik Hietzing', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '1200', 'city': 'Brussels', 'state': 'Brussels Capital', 'country': 'Belgium', 'facility': 'Cliniques Universitaires Saint-Luc', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '3000', 'city': 'Leuven', 'state': 'Vlaams Brabant', 'country': 'Belgium', 'facility': 'UZ Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '4000', 'city': 'Liège', 'country': 'Belgium', 'facility': 'CHU de Liège', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'zip': '40150-150', 'city': 'Salvador', 'state': 'Estado de Bahia', 'country': 'Brazil', 'facility': 'SER - Serviços Especializados em Reumatologia da Bahia S/S - ME', 'geoPoint': {'lat': -12.97563, 'lon': -38.49096}}, {'zip': '74110-120', 'city': 'Goiânia', 'state': 'Goiás', 'country': 'Brazil', 'facility': 'CIP-Centro Internacional de Pesquisa', 'geoPoint': {'lat': -16.67861, 'lon': -49.25389}}, {'zip': '30150-221', 'city': 'Belo Horizonte', 'state': 'Minas Gerais', 'country': 'Brazil', 'facility': 'Santa Casa de Misericordia de Belo Horizonte', 'geoPoint': {'lat': -19.92083, 'lon': -43.93778}}, {'zip': '80030-110', 'city': 'Curitiba', 'state': 'Paraná', 'country': 'Brazil', 'facility': 'Centro de Estudos em Terapias Inovadoras-CETI', 'geoPoint': {'lat': -25.42778, 'lon': -49.27306}}, {'zip': '80440-080', 'city': 'Curitiba', 'state': 'Paraná', 'country': 'Brazil', 'facility': 'EDUMED - Educação em Saúde Ltda.', 'geoPoint': {'lat': -25.42778, 'lon': -49.27306}}, {'zip': '90035-003', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Hospital de Clinicas de Porto Alegre', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'zip': '90540-000', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'LMK Serviços Médicos S/S', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'zip': '13083-970', 'city': 'Campinas', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Hospital de Clinicas UNICAMP', 'geoPoint': {'lat': -22.90556, 'lon': -47.06083}}, {'zip': '78043-142', 'city': 'Cuiabá', 'country': 'Brazil', 'facility': 'Oncovida- Centro de Onco-Hematologia de Mato Grosso', 'geoPoint': {'lat': -15.59611, 'lon': -56.09667}}, {'zip': '01323-903', 'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Hospital Alemao Oswaldo Cruz', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '215000', 'city': 'Suzhou', 'state': 'China', 'country': 'China', 'facility': 'The First Affliated Hospital of Soochow University', 'geoPoint': {'lat': 31.30408, 'lon': 120.59538}}, {'zip': '510080', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'First affiliated Hospital of Sun Yat-Sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '150001', 'city': 'Harbin', 'state': 'Heilongjiang', 'country': 'China', 'facility': 'First Affiliated Hospital of the Harbin Medical University', 'geoPoint': {'lat': 45.75, 'lon': 126.65}}, {'zip': '450000', 'city': 'Zhengzhou', 'state': 'Henan', 'country': 'China', 'facility': 'The First Affiliated Hospital of Zhengzhou Universtiy', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'zip': '430022', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Wuhan Union Hospital', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '210000', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'zip': '337055', 'city': 'Pingxiang', 'state': 'Jiangxi', 'country': 'China', 'facility': "Jiangxi Pingxiang People's Hospital", 'geoPoint': {'lat': 27.61672, 'lon': 113.85353}}, {'zip': '100853', 'city': 'Changchun', 'state': 'Jilin', 'country': 'China', 'facility': 'China-Japan Union Hospital of Jilin University', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}, {'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Zhongshan Hospital, Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '300052', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'country': 'China', 'facility': 'Tianjin Medical University General Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'zip': '310009', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'The Second Affiliated Hospital of Zhejiang University School of Medicine', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'zip': '315010', 'city': 'Ningbo', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Ningbo First Hospital', 'geoPoint': {'lat': 29.87819, 'lon': 121.54945}}, {'zip': '100034', 'city': 'Beijing', 'country': 'China', 'facility': 'Peking University First Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100730', 'city': 'Beijing', 'country': 'China', 'facility': 'Beijing Peking Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '200040', 'city': 'Shanghai', 'country': 'China', 'facility': 'Shanghai Huashan Hospital Affil to Fu Dan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '110001', 'city': 'Shenyang', 'country': 'China', 'facility': 'China Medical University (CMU) - First Affiliated Hospital', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'zip': '830001', 'city': 'Ürümqi', 'country': 'China', 'facility': "People's Hospital of Xinjiang Uygur Autonomous Region", 'geoPoint': {'lat': 43.80096, 'lon': 87.60046}}, {'zip': '51000', 'city': 'Rijeka', 'country': 'Croatia', 'facility': 'Klinicki Bolnicki Centar Rijeka', 'geoPoint': {'lat': 45.32673, 'lon': 14.44241}}, {'zip': '21000', 'city': 'Split', 'country': 'Croatia', 'facility': 'University Hospital Split', 'geoPoint': {'lat': 43.50891, 'lon': 16.43915}}, {'zip': '10000', 'city': 'Zagreb', 'country': 'Croatia', 'facility': 'Clinical Hospital Dubrava', 'geoPoint': {'lat': 45.81444, 'lon': 15.97798}}, {'zip': '12850', 'city': 'Prague', 'state': 'Praha, Hlavní Mešto', 'country': 'Czechia', 'facility': 'Revmatologicky ustav', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '63800', 'city': 'Brno', 'country': 'Czechia', 'facility': 'Revmatologie.s.r.o.', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}, {'zip': '775 20', 'city': 'Olomouc', 'country': 'Czechia', 'facility': 'Fakultni nemocnice Olomouc', 'geoPoint': {'lat': 49.59552, 'lon': 17.25175}}, {'zip': '53002', 'city': 'Pardubice', 'country': 'Czechia', 'facility': 'ARTHROHELP s.r.o.', 'geoPoint': {'lat': 50.04075, 'lon': 15.77659}}, {'zip': '128 08', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Vseobecna fakultni nemocnice', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '79106', 'city': 'Freiburg im Breisgau', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'Universitätsklinikum Freiburg', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}, {'zip': '72076', 'city': 'Tübingen', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'Universitätsklinikum Tübingen', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}, {'zip': '80336', 'city': 'München', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Klinikum der Universität München', 'geoPoint': {'lat': 48.69668, 'lon': 13.46314}}, {'zip': '97080', 'city': 'Würzburg', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Universitätsklinikum Würzburg A. ö. R.', 'geoPoint': {'lat': 49.79391, 'lon': 9.95121}}, {'zip': '50937', 'city': 'Cologne', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Universitätsklinikum Köln', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '55131', 'city': 'Mainz', 'state': 'Rhineland-Palatinate', 'country': 'Germany', 'facility': 'Universitatsmedizin der Johannes Gutenberg-Universitat Mainz', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'zip': '01307', 'city': 'Dresden', 'state': 'Saxony', 'country': 'Germany', 'facility': 'Universitätsklinikum Carl Gustav Carus', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '04103', 'city': 'Leipzig', 'state': 'Saxony', 'country': 'Germany', 'facility': 'Universität Leipzig - Universitätsklinikum', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': '10117', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Charité Universitätsmedizin Berlin Campus Buch', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '13125', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Immanuel Krankenhaus Rheuma Klinik Berlin Buch', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '14059', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Schlosspark Klinik', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '11527', 'city': 'Athens', 'state': 'Attica', 'country': 'Greece', 'facility': 'Gen Hospital of Athens G Gennimatas', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'zip': '71110', 'city': 'Heraklion', 'state': 'Crete', 'country': 'Greece', 'facility': 'University General Hospital of Heraklion', 'geoPoint': {'lat': 35.32787, 'lon': 25.14341}}, {'zip': '41110', 'city': 'Larissa', 'country': 'Greece', 'facility': 'University General Hospital of Larissa', 'geoPoint': {'lat': 39.62847, 'lon': 22.42112}}, {'zip': '54636', 'city': 'Thessaloniki', 'country': 'Greece', 'facility': 'Euromedica Kyanous Stavros General Hospital', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}, {'zip': '54642', 'city': 'Thessaloniki', 'country': 'Greece', 'facility': 'Hippokration University Hopsital', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}, {'zip': '5700', 'city': 'Gyula', 'state': 'Bekes County', 'country': 'Hungary', 'facility': 'Bekes Megyei Pandy Kalman Korhaz', 'geoPoint': {'lat': 46.65, 'lon': 21.28333}}, {'zip': '8200', 'city': 'Veszprém', 'state': 'Veszprém City', 'country': 'Hungary', 'facility': 'Vital Medical Center', 'geoPoint': {'lat': 47.09327, 'lon': 17.91149}}, {'zip': '1027', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Budai Irgalmasrendi Korhaz', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '1036', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Qualiclinic Kft', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '1097', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Egyesitett Szent Istvan es Szent Laszlo Korhaz-Rendelointeze', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '4032', 'city': 'Debrecen', 'country': 'Hungary', 'facility': 'Debreceni Egyetem Klinikai Kozpont Reumatologiai Tanszek', 'geoPoint': {'lat': 47.53167, 'lon': 21.62444}}, {'zip': '4032', 'city': 'Debrecen', 'country': 'Hungary', 'facility': 'Debreceni Egyetem Klinikai Kozpont', 'geoPoint': {'lat': 47.53167, 'lon': 21.62444}}, {'zip': '7632', 'city': 'Pécs', 'country': 'Hungary', 'facility': 'Pecsi Tudomanyegyetem Klinikai Kozpont', 'geoPoint': {'lat': 46.07617, 'lon': 18.22814}}, {'zip': '6725', 'city': 'Szeged', 'country': 'Hungary', 'facility': 'Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont I. Belgyogyaszati Klinika', 'geoPoint': {'lat': 46.253, 'lon': 20.14824}}, {'zip': '8000', 'city': 'Székesfehérvár', 'country': 'Hungary', 'facility': 'Vita Verum Egeszsegugyi Szolgaltato Bt', 'geoPoint': {'lat': 47.18995, 'lon': 18.41034}}, {'zip': '4428164', 'city': 'Kfar Saba', 'country': 'Israel', 'facility': 'Meir Medical Center', 'geoPoint': {'lat': 32.175, 'lon': 34.90694}}, {'zip': '5262100', 'city': 'Ramat Gan', 'country': 'Israel', 'facility': 'Chaim Sheba Medical Center', 'geoPoint': {'lat': 32.08227, 'lon': 34.81065}}, {'zip': '3436212', 'city': 'Haifa', 'state': 'Ḥeifā', 'country': 'Israel', 'facility': 'Carmel Hospital', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'zip': '27000', 'city': 'Torreón', 'state': 'Coahuila', 'country': 'Mexico', 'facility': 'CIMAB SA de CV', 'geoPoint': {'lat': 25.54389, 'lon': -103.41898}}, {'zip': '37000', 'city': 'León', 'state': 'Guanajuato', 'country': 'Mexico', 'facility': 'Morales Vargas Centro de Investigacion, S.C.', 'geoPoint': {'lat': 21.12908, 'lon': -101.67374}}, {'zip': '44160', 'city': 'Guadalajara', 'state': 'Jalisco', 'country': 'Mexico', 'facility': 'Centro Integral en Reumatologia SA de CV', 'geoPoint': {'lat': 20.67738, 'lon': -103.34749}}, {'zip': '44650', 'city': 'Guadalajara', 'state': 'Jalisco', 'country': 'Mexico', 'facility': 'Clinica de Investigacion en Reumatologia y Obesidad S. C.', 'geoPoint': {'lat': 20.67738, 'lon': -103.34749}}, {'zip': '44690', 'city': 'Guadalajara', 'state': 'Jalisco', 'country': 'Mexico', 'facility': 'Centro de Estudios de Investigacion Metabolicos y Cardiovasculares', 'geoPoint': {'lat': 20.67738, 'lon': -103.34749}}, {'zip': '45070', 'city': 'Zapopan', 'state': 'Jalisco', 'country': 'Mexico', 'facility': 'Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V.', 'geoPoint': {'lat': 20.72111, 'lon': -103.38742}}, {'zip': '06700', 'city': 'Mexico City', 'state': 'Mexico City', 'country': 'Mexico', 'facility': 'Cliditer Sa de CV', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'zip': '07760', 'city': 'Mexico City', 'state': 'Mexico City', 'country': 'Mexico', 'facility': 'Hospital Angeles Lindavista', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'zip': '97000', 'city': 'Mérida', 'state': 'Yucatán', 'country': 'Mexico', 'facility': 'Centro Peninsular de Investigacion S.C.P', 'geoPoint': {'lat': 20.967, 'lon': -89.62318}}, {'zip': '97070', 'city': 'Mérida', 'state': 'Yucatán', 'country': 'Mexico', 'facility': 'Köhler & Milstein Research', 'geoPoint': {'lat': 20.967, 'lon': -89.62318}}, {'zip': '97130', 'city': 'Mérida', 'state': 'Yucatán', 'country': 'Mexico', 'facility': 'Cemdeicy S.C.P.', 'geoPoint': {'lat': 20.967, 'lon': -89.62318}}, {'zip': '06760', 'city': 'Mexico City', 'country': 'Mexico', 'facility': 'Clinosar Mexico S.A. de C.V', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'zip': '11850', 'city': 'Mexico City', 'country': 'Mexico', 'facility': 'Centro de Investigación y Tratamiento Reumatológico S.C', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'zip': '78213', 'city': 'San Luis Potosí City', 'country': 'Mexico', 'facility': 'Centro de Alta Especialidad Reumatologia e Inv Potosi, S.C.', 'geoPoint': {'lat': 22.15234, 'lon': -100.97135}}, {'zip': '8934 AD', 'city': 'Leeuwarden', 'state': 'Provincie Friesland', 'country': 'Netherlands', 'facility': 'Medische Centrum Leeuwarden', 'geoPoint': {'lat': 53.20271, 'lon': 5.80973}}, {'zip': '1081 HV', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Vrije Universiteit Medisch Centrum Amsterdam', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '197372', 'city': 'Saint Petersburg', 'state': 'Sankt-Peterburg', 'country': 'Russia', 'facility': 'LLC MK Med', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '454076', 'city': 'Chelyabinsk', 'country': 'Russia', 'facility': 'Chelyabinsk Regional Clinical Hospital', 'geoPoint': {'lat': 55.1611, 'lon': 61.42877}}, {'zip': '420103', 'city': "Kazan'", 'country': 'Russia', 'facility': 'City Hospital # 7', 'geoPoint': {'lat': 55.78874, 'lon': 49.12214}}, {'zip': '305007', 'city': 'Kursk', 'country': 'Russia', 'facility': 'Regional Clinical Hospital', 'geoPoint': {'lat': 51.72689, 'lon': 36.18457}}, {'zip': '117997', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Russian State Medical University', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '119049', 'city': 'Moscow', 'country': 'Russia', 'facility': 'City Clinical Hospital 1 named after N.I. Pirogov', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Moscow', 'country': 'Russia', 'facility': 'Rheumatology Institute RAMS', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '630061', 'city': 'Novosibirsk', 'country': 'Russia', 'facility': 'Healthy Family', 'geoPoint': {'lat': 55.02259, 'lon': 82.93175}}, {'zip': '630099', 'city': 'Novosibirsk', 'country': 'Russia', 'facility': 'Reafan', 'geoPoint': {'lat': 55.02259, 'lon': 82.93175}}, {'zip': '630117', 'city': 'Novosibirsk', 'country': 'Russia', 'facility': 'Institute of Cytology and Genetics of Siberian Branch of Russian Academy of Medical Sciences', 'geoPoint': {'lat': 55.02259, 'lon': 82.93175}}, {'zip': '644111', 'city': 'Omsk', 'country': 'Russia', 'facility': 'Regional Hospital - Omsk', 'geoPoint': {'lat': 54.99244, 'lon': 73.36859}}, {'zip': '460018', 'city': 'Orenburg', 'country': 'Russia', 'facility': 'Orenburg State Medical Academy of Roszdrav', 'geoPoint': {'lat': 51.76712, 'lon': 55.09883}}, {'zip': '390026', 'city': 'Ryazan', 'country': 'Russia', 'facility': 'Ryazan State Medical University', 'geoPoint': {'lat': 54.62696, 'lon': 39.70415}}, {'zip': '194044', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Russian Medical Military Academy n.a. S.M. Kirov', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '214025', 'city': 'Smolensk', 'country': 'Russia', 'facility': 'Departmental Hospital at Smolensk Station "rzhd" JSC', 'geoPoint': {'lat': 54.77826, 'lon': 32.05088}}, {'zip': '450005', 'city': 'Ufa', 'country': 'Russia', 'facility': 'Kuvatov Republican Clinical Hospital', 'geoPoint': {'lat': 54.74306, 'lon': 55.96779}}, {'zip': '4031', 'city': 'Basel', 'state': 'Canton of Basel-City', 'country': 'Switzerland', 'facility': 'Universitätsspital Basel', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}, {'zip': '9007', 'city': 'Sankt Gallen', 'state': 'Canton of St. Gallen', 'country': 'Switzerland', 'facility': 'Cantonal Hospital St.Gallen', 'geoPoint': {'lat': 47.42391, 'lon': 9.37477}}, {'zip': '33305', 'city': 'Kuei Shan Hsiang', 'state': 'Taoyuan Hsien', 'country': 'Taiwan', 'facility': 'Chang Gung Memorial Hospital - Linkou'}, {'zip': '622', 'city': 'Dalin Township', 'country': 'Taiwan', 'facility': 'Hualien Tzu-Chi Hospital'}, {'zip': '81346', 'city': 'Kaohsiung City', 'country': 'Taiwan', 'facility': 'Kaohsiung Veterans General Hospital', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}, {'zip': '833401', 'city': 'Kaohsiung City', 'country': 'Taiwan', 'facility': 'Chang Gung Memorial Hospital - Kaohsiung Branch', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}, {'zip': '40447', 'city': 'Taichung', 'country': 'Taiwan', 'facility': 'China Medical University Hospital', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}, {'zip': '40705', 'city': 'Taichung', 'country': 'Taiwan', 'facility': 'Taichung Veterans General Hospital', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}, {'zip': '71004', 'city': 'Tainan', 'country': 'Taiwan', 'facility': 'Chi-Mei Medical Center', 'geoPoint': {'lat': 22.99083, 'lon': 120.21333}}, {'zip': '10002', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '110', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Taipei Medical University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': 'ME16 9QQ', 'city': 'Maidstone', 'state': 'Kent', 'country': 'United Kingdom', 'facility': 'Maidstone Hospital', 'geoPoint': {'lat': 51.26667, 'lon': 0.51667}}, {'zip': 'E11 1NR', 'city': 'London', 'state': 'Surrey', 'country': 'United Kingdom', 'facility': 'Whipps Cross University Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'DN2 5LT', 'city': 'Doncaster', 'country': 'United Kingdom', 'facility': 'Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust', 'geoPoint': {'lat': 53.52285, 'lon': -1.13116}}, {'zip': 'SE1 9RT', 'city': 'London', 'country': 'United Kingdom', 'facility': "Guy's Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SW17 0QT', 'city': 'London', 'country': 'United Kingdom', 'facility': "St. George's University Hospitals NHS Foundation Trust", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'ipdSharingStatementModule': {'url': 'https://trials.lillytrialguide.com/en-US/trial/64a5deI4M0sSScwYIMISsIDescriptionAStudyofBaricitinib(LY3009104)inParticipantsWithSystemicLupusErythematosus', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.', 'ipdSharing': 'YES', 'description': 'Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.', 'accessCriteria': 'A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Incyte Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}