Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2026-03-29 @ 4:52 AM
Study NCT ID:
NCT03371251
Status:
COMPLETED
Last Update Posted:
2022-03-14
First Post:
2017-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of BOS161721 in Systemic Lupus Erythematosus (SLE) Patients on a Background of Limited Standard of Care
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-12-23', '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@bostonpharmaceuticals.com', 'phone': '(484) 986 8699', 'title': 'Etienne Dumont, MD', 'organization': 'Boston Pharmaceuticals, Inc.'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to Day 270', 'eventGroups': [{'id': 'EG000', 'title': 'Phase 1b: Placebo', 'description': 'Participants were randomized to receive a subcutaneous (SC) dose of placebo. Participants received a total of 7 SC monthly doses of placebo on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits at Days 210, 240, and 270.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 4, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Phase 1b: Cohort 1: BOS161721 20 mg', 'description': 'Participants were randomized to receive a 20 mg SC dose of BOS161721. Participants received a total of 7 SC monthly doses of BOS161721 on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270.', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 2, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Phase 1b: Cohort 2: BOS161721 60 mg', 'description': 'Participants were randomized to receive a 60 mg SC dose of BOS161721. Participants received a total of 7 SC monthly doses of BOS161721 on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 7, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'Phase 1b: Cohort 3: BOS161721 120 mg', 'description': 'Participants were randomized to receive a 120 mg SC dose of BOS161721. Participants received a total of 7 SC monthly doses of BOS161721 on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 8, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Phase 2: Placebo', 'description': 'Participants were randomized to receive a SC dose of placebo (as determined from Phase 1b of the study). Participants received a total of 7 SC monthly doses of placebo on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270.', 'otherNumAtRisk': 37, 'deathsNumAtRisk': 37, 'otherNumAffected': 22, 'seriousNumAtRisk': 37, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG005', 'title': 'Phase 2: BOS161721 120 mg', 'description': 'Participants were randomized to receive a 120 mg SC dose of BOS161721 (as determined from Phase 1b of the study). Participants received a total of 7 SC monthly doses of BOS161721 on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270.', 'otherNumAtRisk': 76, 'deathsNumAtRisk': 76, 'otherNumAffected': 44, 'seriousNumAtRisk': 76, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 37, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Iron Deficiency Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Bundle Branch Block Right', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Diplopia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 37, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 76, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 37, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 76, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Dental Caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Dry Mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Tongue Ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Non-Cardiac Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 37, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 76, 'numEvents': 9, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 37, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 76, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 37, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 76, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 76, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Escherichia Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 37, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Cervicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Vulvovaginal Mycotic Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Gastroenteritis Viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Herpes Zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Infected Bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Nasal Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Otitis Media Acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Viral Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Animal Bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Ankle Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Ligament Sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'White Blood Cells Urine Positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 37, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 76, 'numEvents': 5, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Blood Pressure Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Weight Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Type 2 Diabetes Mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 37, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 76, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Bursitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 76, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Fibromyalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Muscle Spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Pain In Extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': "Sjogren's Syndrome", 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 37, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 76, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Cervical Radiculopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Confusional State', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Menorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 37, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Adnexa Uteri Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Chronic Obstructive Pulmonary Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Pulmonary Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 76, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Deep Vein Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}], 'seriousEvents': [{'term': 'Acute Respiratory Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Chronic Obstructive Pulmonary Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Lupus Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Basal Cell Carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Intraductal Proliferative Breast Lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Squamous Cell Carcinoma of Skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Exomphalos', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Biliary Colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Pyelonephritis Acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Phase 1b: Number of Participants With Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1b: Placebo', 'description': 'Participants were randomized to receive a subcutaneous (SC) dose of placebo. Participants received a total of 7 SC monthly doses of placebo on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits at Days 210, 240, and 270.'}, {'id': 'OG001', 'title': 'Phase 1b: Cohort 1: BOS161721 20 mg', 'description': 'Participants were randomized to receive a 20 mg SC dose of BOS161721. Participants received a total of 7 SC monthly doses of BOS161721 on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270.'}, {'id': 'OG002', 'title': 'Phase 1b: Cohort 2: BOS161721 60 mg', 'description': 'Participants were randomized to receive a 60 mg SC dose of BOS161721. Participants received a total of 7 SC monthly doses of BOS161721 on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270'}, {'id': 'OG003', 'title': 'Phase 1b: Cohort 3: BOS161721 120 mg', 'description': 'Participants were randomized to receive a 120 mg SC dose of BOS161721. Participants received a total of 7 SC monthly doses of BOS161721 on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270'}], 'classes': [{'title': 'Any Treatment-Emergent Adverse Events (TEAE)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}]}, {'title': 'Related TEAE', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Serious TEAE', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Related Serious TEAE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Any Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 or Higher TEAE', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}]}, {'title': 'Any Related CTCAE Grade 2 or Higher TEAE', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Any CTCAE Grade 3 TEAE', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Any Related CTCAE Grade 3 or Higher TEAE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Any CTCAE Grade 4 TEAE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'TEAE Leading to Discontinuation of Study Treatment', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Related TEAE Leading to Discontinuation of Study Treatment', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'TEAE of Special Interest', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Related TEAE of Special Interest', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Dose-Limiting Toxicity', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Related Dose-Limiting Toxicity', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'TEAE Resulting in Death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Related TEAE Resulting in Death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Injection Site Reaction', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Day 270', 'description': 'The safety, tolerability, and immunogenicity of repeat doses of BOS161721 (20, 60, and 120 mg) administered SC were assessed in adult participants with moderate to severe SLE on limited background standard of care treatment, in order to estimate the optimal dose.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set (SS): Defined as all participants who received at least 1 dose (partial or complete) of study treatment and had at least one evaluable post-baseline safety evaluation.'}, {'type': 'PRIMARY', 'title': 'Phase 2: Number of Participants With an SLE Responder Index 4 (SRI-4) Response at Day 210', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: Placebo', 'description': 'Participants were randomized to receive a SC dose of placebo (as determined from Phase 1b of the study). Participants received a total of 7 SC monthly doses of placebo on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270.'}, {'id': 'OG001', 'title': 'Phase 2: BOS161721 120 mg', 'description': 'Participants were randomized to receive a 120 mg SC dose of BOS161721 (as determined from Phase 1b of the study). Participants received a total of 7 SC monthly doses of BOS161721 on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270.'}], 'classes': [{'title': 'SRI-4 Response', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}, {'title': '≥ 4-Point Reduction from Baseline in SLEDAI-2K Global Score', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}, {'title': 'No New BILAG A or More than One BILAG B Organ Score Compared with Baseline', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}]}, {'title': 'No Deterioration from Baseline in PGA by >=30mm', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.8434', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Observed Difference vs. Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '2.0', 'ciLowerLimit': '-14.5', 'ciUpperLimit': '18.5', 'groupDescription': 'Statistical Analysis: SRI-4 Response', 'statisticalMethod': "Pearson's chi-square test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8434', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Observed Difference vs. Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '2.0', 'ciLowerLimit': '-14.5', 'ciUpperLimit': '18.5', 'groupDescription': 'Statistical Analysis: \\>= 4-Point Reduction from Baseline in SLEDAI-2K Global Score', 'statisticalMethod': "Pearson's chi-square test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0141', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Observed Difference vs. Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '17.7', 'ciLowerLimit': '4.5', 'ciUpperLimit': '30.9', 'groupDescription': 'Statistical Analysis: No New BILAG A or More than One BILAG B Organ Score Compared with Baseline', 'statisticalMethod': "Pearson's chi-square test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0141', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Observed Difference vs. Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '17.7', 'ciLowerLimit': '4.5', 'ciUpperLimit': '30.9', 'groupDescription': 'Statistical Analysis: No Deterioration from Baseline in PGA by \\>=30mm', 'statisticalMethod': "Pearson's chi-square test", 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 210', 'description': "The SRI-4 is a composite index of SLE disease improvement that consists of scores derived from the SLE Disease Activity Index 2000 (SLEDAI-2K), the British Isles Lupus Assessment Group (BILAG) 2004 Index and the Physician's Global Assessment (PGA). Response based on the SRI-4 is defined by: 1) ≥ 4-point reduction in the SLEDAI-2K total score; 2) no new severe disease activity (BILAG A organ score) or more than 1 new moderate organ score (BILAG B) compared with baseline; and 3) no deterioration from baseline in the PGA by ≥ 30 millimeters. The SLEDAI-2K total score falls between 0 and 105, with higher scores representing increased disease activity.The SRI-4 response in participants with moderate to severe SLE is associated with broad improvements in clinical and participant-reported outcomes.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: Defined as all participants who received at least 1 dose (partial or complete) of study treatment and had at least 1 evaluable post-baseline efficacy evaluation.'}, {'type': 'SECONDARY', 'title': 'Phase 1b: Maximum Observed Concentration (Cmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1b: Cohort 1: BOS161721 20 mg', 'description': 'Participants were randomized to receive a 20 mg SC dose of BOS161721. Participants received a total of 7 SC monthly doses of BOS161721 on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270.'}, {'id': 'OG001', 'title': 'Phase 1b: Cohort 2: BOS161721 60 mg', 'description': 'Participants were randomized to receive a 60 mg SC dose of BOS161721. Participants received a total of 7 SC monthly doses of BOS161721 on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270'}, {'id': 'OG002', 'title': 'Phase 1b: Cohort 3: BOS161721 120 mg', 'description': 'Participants were randomized to receive a 120 mg SC dose of BOS161721. Participants received a total of 7 SC monthly doses of BOS161721 on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270'}], 'classes': [{'title': 'Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1160', 'spread': '42.0', 'groupId': 'OG000'}, {'value': '4610', 'spread': '54.8', 'groupId': 'OG001'}, {'value': '5500', 'spread': '52.3', 'groupId': 'OG002'}]}]}, {'title': 'Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1240', 'spread': '23.9', 'groupId': 'OG000'}, {'value': '5670', 'spread': '35.7', 'groupId': 'OG001'}, {'value': '7580', 'spread': '45.1', 'groupId': 'OG002'}]}]}, {'title': 'Dose 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2580', 'spread': '19.1', 'groupId': 'OG000'}, {'value': '7820', 'spread': '144', 'groupId': 'OG001'}, {'value': '20300', 'spread': '37.1', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose: Days 0, 30, 60, 90, 120, 150, and 180. Post-dose: Days 0, 7, 15, 30, 180, 187, 195, 210, 240, and 270. Post-dose samples were collected at 4, 8, and 24 hours after study drug administration on Days 0, 30, and 180', 'description': 'The PK of BOS161721 was characterized and the optimal dose of BOS161721 was selected based on safety, tolerability, PK and PD data in participants with moderate to severe SLE.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK population is defined as all participants who received at least 1 dose (partial or complete) of study treatment and had sufficient concentration data for the calculation of PK parameters. Here, number analyzed in each row signifies only the participants with available data for each dose.'}, {'type': 'SECONDARY', 'title': 'Phase 1b: First Time to Maximum Concentration (Tmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1b: Cohort 1: BOS161721 20 mg', 'description': 'Participants were randomized to receive a 20 mg SC dose of BOS161721. Participants received a total of 7 SC monthly doses of BOS161721 on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270.'}, {'id': 'OG001', 'title': 'Phase 1b: Cohort 2: BOS161721 60 mg', 'description': 'Participants were randomized to receive a 60 mg SC dose of BOS161721. Participants received a total of 7 SC monthly doses of BOS161721 on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270'}, {'id': 'OG002', 'title': 'Phase 1b: Cohort 3: BOS161721 120 mg', 'description': 'Participants were randomized to receive a 120 mg SC dose of BOS161721. Participants received a total of 7 SC monthly doses of BOS161721 on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270'}], 'classes': [{'title': 'Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7.01', 'groupId': 'OG000', 'lowerLimit': '6.99', 'upperLimit': '12.00'}, {'value': '7.00', 'groupId': 'OG001', 'lowerLimit': '5.93', 'upperLimit': '15.00'}, {'value': '8.04', 'groupId': 'OG002', 'lowerLimit': '6.95', 'upperLimit': '17.04'}]}]}, {'title': 'Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.04', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '29.02'}, {'value': '1.00', 'groupId': 'OG001', 'lowerLimit': '0.99', 'upperLimit': '34.97'}, {'value': '1.00', 'groupId': 'OG002', 'lowerLimit': '1.00', 'upperLimit': '33.03'}]}]}, {'title': 'Dose 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6.18', 'groupId': 'OG000', 'lowerLimit': '5.03', 'upperLimit': '20.04'}, {'value': '3.55', 'groupId': 'OG001', 'lowerLimit': '0.91', 'upperLimit': '12.00'}, {'value': '8.96', 'groupId': 'OG002', 'lowerLimit': '1.00', 'upperLimit': '28.06'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose: Days 0, 30, 60, 90, 120, 150, and 180. Post-dose: Days 0, 7, 15, 30, 180, 187, 195, 210, 240, and 270. Post-dose samples were collected at 4, 8, and 24 hours after study drug administration on Days 0, 30, and 180', 'description': 'The PK of BOS161721 was characterized and the optimal dose of BOS161721 was selected based on safety, tolerability, PK and PD data in participants with moderate to severe SLE.', 'unitOfMeasure': 'Day', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK population is defined as all participants who received at least 1 dose (partial or complete) of study treatment and had sufficient concentration data for the calculation of PK parameters. Here, number analyzed in each row signifies only the participants with available data for each dose.'}, {'type': 'SECONDARY', 'title': 'Phase 1b: The Area Under the Plasma Concentration Versus Time Curve, From Time 0 to the Last Quantifiable Concentration (AUClast)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1b: Cohort 1: BOS161721 20 mg', 'description': 'Participants were randomized to receive a 20 mg SC dose of BOS161721. Participants received a total of 7 SC monthly doses of BOS161721 on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270.'}, {'id': 'OG001', 'title': 'Phase 1b: Cohort 2: BOS161721 60 mg', 'description': 'Participants were randomized to receive a 60 mg SC dose of BOS161721. Participants received a total of 7 SC monthly doses of BOS161721 on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270'}, {'id': 'OG002', 'title': 'Phase 1b: Cohort 3: BOS161721 120 mg', 'description': 'Participants were randomized to receive a 120 mg SC dose of BOS161721. Participants received a total of 7 SC monthly doses of BOS161721 on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270'}], 'classes': [{'title': 'Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '25100', 'spread': '40.4', 'groupId': 'OG000'}, {'value': '89400', 'spread': '51.7', 'groupId': 'OG001'}, {'value': '124000', 'spread': '40.5', 'groupId': 'OG002'}]}]}, {'title': 'Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '33600', 'spread': '18.2', 'groupId': 'OG000'}, {'value': '147000', 'spread': '29.7', 'groupId': 'OG001'}, {'value': '229000', 'spread': '47.9', 'groupId': 'OG002'}]}]}, {'title': 'Dose 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '155000', 'spread': '17.9', 'groupId': 'OG000'}, {'value': '460000', 'spread': '173', 'groupId': 'OG001'}, {'value': '1400000', 'spread': '38.7', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose: Days 0, 30, 60, 90, 120, 150, and 180. Post-dose: Days 0, 7, 15, 30, 180, 187, 195, 210, 240, and 270. Post-dose samples were collected at 4, 8, and 24 hours after study drug administration on Days 0, 30, and 180', 'description': 'The PK of BOS161721 was characterized and the optimal dose of BOS161721 was selected based on safety, tolerability, PK and PD data in participants with moderate to severe SLE.', 'unitOfMeasure': 'day*ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK population is defined as all participants who received at least 1 dose (partial or complete) of study treatment and had sufficient concentration data for the calculation of PK parameters. Here, number analyzed in each row signifies only the participants with available data for each dose.'}, {'type': 'SECONDARY', 'title': 'Phase 1b: Terminal Elimination Half-life (t1/2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1b: Cohort 1: BOS161721 20 mg', 'description': 'Participants were randomized to receive a 20 mg SC dose of BOS161721. Participants received a total of 7 SC monthly doses of BOS161721 on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270.'}, {'id': 'OG001', 'title': 'Phase 1b: Cohort 2: BOS161721 60 mg', 'description': 'Participants were randomized to receive a 60 mg SC dose of BOS161721. Participants received a total of 7 SC monthly doses of BOS161721 on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270'}, {'id': 'OG002', 'title': 'Phase 1b: Cohort 3: BOS161721 120 mg', 'description': 'Participants were randomized to receive a 120 mg SC dose of BOS161721. Participants received a total of 7 SC monthly doses of BOS161721 on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270'}], 'classes': [{'categories': [{'measurements': [{'value': '75.2', 'spread': '19.9', 'groupId': 'OG000'}, {'value': '66.3', 'spread': '35.4', 'groupId': 'OG001'}, {'value': '64.3', 'spread': 'NA', 'comment': 'Not calculated for 1 participant', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose: Days 0, 30, 60, 90, 120, 150, and 180. Post-dose: Days 0, 7, 15, 30, 180, 187, 195, 210, 240, and 270. Post-dose samples were collected at 4, 8, and 24 hours after study drug administration on Days 0, 30, and 180', 'description': 'The PK of BOS161721 was characterized and the optimal dose of BOS161721 was selected based on safety, tolerability, PK and PD data in participants with moderate to severe SLE.', 'unitOfMeasure': 'Day', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK population is defined as all participants who received at least 1 dose (partial or complete) of study treatment and had sufficient concentration data for the calculation of PK parameters. Here, overall number of participants analyzed signifies only the participants with available data for the outcome measure.'}, {'type': 'SECONDARY', 'title': 'Phase 1b: Apparent Plasma Clearance After Extravascular Administration (CL/F)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1b: Cohort 1: BOS161721 20 mg', 'description': 'Participants were randomized to receive a 20 mg SC dose of BOS161721. Participants received a total of 7 SC monthly doses of BOS161721 on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270.'}, {'id': 'OG001', 'title': 'Phase 1b: Cohort 2: BOS161721 60 mg', 'description': 'Participants were randomized to receive a 60 mg SC dose of BOS161721. Participants received a total of 7 SC monthly doses of BOS161721 on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270'}, {'id': 'OG002', 'title': 'Phase 1b: Cohort 3: BOS161721 120 mg', 'description': 'Participants were randomized to receive a 120 mg SC dose of BOS161721. Participants received a total of 7 SC monthly doses of BOS161721 on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270'}], 'classes': [{'categories': [{'measurements': [{'value': '0.289', 'spread': '18.3', 'groupId': 'OG000'}, {'value': '0.311', 'spread': '179', 'groupId': 'OG001'}, {'value': '0.218', 'spread': '38.8', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose: Days 0, 30, 60, 90, 120, 150, and 180. Post-dose: Days 0, 7, 15, 30, 180, 187, 195, 210, 240, and 270. Post-dose samples were collected at 4, 8, and 24 hours after study drug administration on Days 0, 30, and 180', 'description': 'The PK of BOS161721 was characterized and the optimal dose of BOS161721 was selected based on safety, tolerability, PK and PD data in participants with moderate to severe SLE.', 'unitOfMeasure': 'Liter/day', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK population is defined as all participants who received at least 1 dose (partial or complete) of study treatment and had sufficient concentration data for the calculation of PK parameters. Here, overall number of participants analyzed signifies only the participants with available data for the outcome measure.'}, {'type': 'SECONDARY', 'title': 'Phase 1b: Apparent Volume of Distribution After Extravascular Administration (Vz/F)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1b: Cohort 1: BOS161721 20 mg', 'description': 'Participants were randomized to receive a 20 mg SC dose of BOS161721. Participants received a total of 7 SC monthly doses of BOS161721 on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270.'}, {'id': 'OG001', 'title': 'Phase 1b: Cohort 2: BOS161721 60 mg', 'description': 'Participants were randomized to receive a 60 mg SC dose of BOS161721. Participants received a total of 7 SC monthly doses of BOS161721 on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270'}, {'id': 'OG002', 'title': 'Phase 1b: Cohort 3: BOS161721 120 mg', 'description': 'Participants were randomized to receive a 120 mg SC dose of BOS161721. Participants received a total of 7 SC monthly doses of BOS161721 on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270'}], 'classes': [{'categories': [{'measurements': [{'value': '31.4', 'spread': '33.2', 'groupId': 'OG000'}, {'value': '18.5', 'spread': '39.6', 'groupId': 'OG001'}, {'value': '23.0', 'spread': 'NA', 'comment': 'Not calculated for 1 participant', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose: Days 0, 30, 60, 90, 120, 150, and 180. Post-dose: Days 0, 7, 15, 30, 180, 187, 195, 210, 240, and 270. Post-dose samples were collected at 4, 8, and 24 hours after study drug administration on Days 0, 30, and 180', 'description': 'The PK of BOS161721 was characterized and the optimal dose of BOS161721 was selected based on safety, tolerability, PK and PD data in participants with moderate to severe SLE.', 'unitOfMeasure': 'Liter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK population is defined as all participants who received at least 1 dose (partial or complete) of study treatment and had sufficient concentration data for the calculation of PK parameters. Here, overall number of participants analyzed signifies only the participants with available data for the outcome measure.'}, {'type': 'SECONDARY', 'title': 'Phase 1b: Mean Change From Baseline in Phosphorylated Signal Transducer and Activator of Transcription 3 (pSTAT3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1b: Placebo', 'description': 'Participants were randomized to receive a subcutaneous (SC) dose of placebo. Participants received a total of 7 SC monthly doses of placebo on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits at Days 210, 240, and 270.'}, {'id': 'OG001', 'title': 'Phase 1b: Cohort 1: BOS161721 20 mg', 'description': 'Participants were randomized to receive a 20 mg SC dose of BOS161721. Participants received a total of 7 SC monthly doses of BOS161721 on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270.'}, {'id': 'OG002', 'title': 'Phase 1b: Cohort 2: BOS161721 60 mg', 'description': 'Participants were randomized to receive a 60 mg SC dose of BOS161721. Participants received a total of 7 SC monthly doses of BOS161721 on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270'}, {'id': 'OG003', 'title': 'Phase 1b: Cohort 3: BOS161721 120 mg', 'description': 'Participants were randomized to receive a 120 mg SC dose of BOS161721. Participants received a total of 7 SC monthly doses of BOS161721 on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270'}], 'classes': [{'title': '% pSTAT3+ Lymphocytes - Stimulated, Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '12.72', 'spread': '25.172', 'groupId': 'OG000'}, {'value': '-41.80', 'spread': '24.631', 'groupId': 'OG001'}, {'value': '-31.35', 'spread': '20.281', 'groupId': 'OG002'}, {'value': '-25.73', 'spread': '20.895', 'groupId': 'OG003'}]}]}, {'title': '% pSTAT3+ Lymphocytes - Stimulated, Day 44', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '18.45', 'spread': '24.025', 'groupId': 'OG000'}, {'value': '-60.00', 'spread': '19.672', 'groupId': 'OG001'}, {'value': '-32.99', 'spread': '19.899', 'groupId': 'OG002'}, {'value': '-26.57', 'spread': '20.856', 'groupId': 'OG003'}]}]}, {'title': '% pSTAT3+ Lymphocytes - Stimulated, Day 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.48', 'spread': '19.129', 'groupId': 'OG000'}, {'value': '-59.46', 'spread': '20.310', 'groupId': 'OG001'}, {'value': '-32.68', 'spread': '19.214', 'groupId': 'OG002'}, {'value': '-25.91', 'spread': '20.850', 'groupId': 'OG003'}]}]}, {'title': '% pSTAT3+ Lymphocytes - Stimulated, Day 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-15.94', 'spread': '34.757', 'groupId': 'OG000'}, {'value': '-67.48', 'spread': '15.630', 'groupId': 'OG001'}, {'value': '-33.03', 'spread': '19.637', 'groupId': 'OG002'}, {'value': '-26.74', 'spread': '20.962', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 0); Days 30, 44, 60, and 90 (pre-dose [trough] samples only)', 'description': 'The optimal dose of BOS161721 was selected based on safety, tolerability, PK and pharmacodynamic (PD) data in participants with moderate to severe SLE.', 'unitOfMeasure': 'Percentage', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: Defined as all participants who received at least 1 dose (partial or complete) of study treatment and had at least 1 evaluable post baseline efficacy evaluation. Here, number analyzed in each row signifies only the participants with available data for each time point.'}, {'type': 'SECONDARY', 'title': 'Phase 1b: Mean Change From Baseline in Complement 3 (C3) and Complement (C4) Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1b: Placebo', 'description': 'Participants were randomized to receive a subcutaneous (SC) dose of placebo. Participants received a total of 7 SC monthly doses of placebo on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits at Days 210, 240, and 270.'}, {'id': 'OG001', 'title': 'Phase 1b: Cohort 1: BOS161721 20 mg', 'description': 'Participants were randomized to receive a 20 mg SC dose of BOS161721. Participants received a total of 7 SC monthly doses of BOS161721 on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270.'}, {'id': 'OG002', 'title': 'Phase 1b: Cohort 2: BOS161721 60 mg', 'description': 'Participants were randomized to receive a 60 mg SC dose of BOS161721. Participants received a total of 7 SC monthly doses of BOS161721 on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270'}, {'id': 'OG003', 'title': 'Phase 1b: Cohort 3: BOS161721 120 mg', 'description': 'Participants were randomized to receive a 120 mg SC dose of BOS161721. Participants received a total of 7 SC monthly doses of BOS161721 on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270'}], 'classes': [{'title': 'C3, Day 210', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.094', 'spread': '0.2289', 'groupId': 'OG000'}, {'value': '-0.032', 'spread': '0.0876', 'groupId': 'OG001'}, {'value': '0.050', 'spread': '0.3424', 'groupId': 'OG002'}, {'value': '-0.078', 'spread': '0.2879', 'groupId': 'OG003'}]}]}, {'title': 'C4, Day 210', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.024', 'spread': '0.0391', 'groupId': 'OG000'}, {'value': '-0.038', 'spread': '0.0370', 'groupId': 'OG001'}, {'value': '-0.007', 'spread': '0.0783', 'groupId': 'OG002'}, {'value': '-0.024', 'spread': '0.0410', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 0); Day 210', 'description': 'The optimal dose of BOS161721 was selected based on safety, tolerability, PK and PD data in participants with moderate to severe SLE.', 'unitOfMeasure': 'gram/Litre', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: Defined as all participants who received at least 1 dose (partial or complete) of study treatment and had at least 1 evaluable post baseline efficacy evaluation. Here, number analyzed in each row signifies only the participants with available data for each time point.'}, {'type': 'SECONDARY', 'title': 'Phase 1b: Mean Change From Baseline in Leukocyte Immunophenotype', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1b: Placebo', 'description': 'Participants were randomized to receive a subcutaneous (SC) dose of placebo. Participants received a total of 7 SC monthly doses of placebo on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits at Days 210, 240, and 270.'}, {'id': 'OG001', 'title': 'Phase 1b: Cohort 1: BOS161721 20 mg', 'description': 'Participants were randomized to receive a 20 mg SC dose of BOS161721. Participants received a total of 7 SC monthly doses of BOS161721 on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270.'}, {'id': 'OG002', 'title': 'Phase 1b: Cohort 2: BOS161721 60 mg', 'description': 'Participants were randomized to receive a 60 mg SC dose of BOS161721. Participants received a total of 7 SC monthly doses of BOS161721 on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270'}, {'id': 'OG003', 'title': 'Phase 1b: Cohort 3: BOS161721 120 mg', 'description': 'Participants were randomized to receive a 120 mg SC dose of BOS161721. Participants received a total of 7 SC monthly doses of BOS161721 on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270'}], 'classes': [{'title': 'CD19+% of CD45+ Lymphocytes', 'categories': [{'measurements': [{'value': '-2.07', 'spread': '3.201', 'groupId': 'OG000'}, {'value': '-5.34', 'spread': '4.663', 'groupId': 'OG001'}, {'value': '-0.39', 'spread': '4.201', 'groupId': 'OG002'}, {'value': '0.27', 'spread': '3.481', 'groupId': 'OG003'}]}]}, {'title': 'CD25+CD127-% of CD4+CD8-', 'categories': [{'measurements': [{'value': '-1.03', 'spread': '1.388', 'groupId': 'OG000'}, {'value': '-0.22', 'spread': '2.406', 'groupId': 'OG001'}, {'value': '-0.38', 'spread': '1.495', 'groupId': 'OG002'}, {'value': '-1.08', 'spread': '2.266', 'groupId': 'OG003'}]}]}, {'title': 'CD4+CD8-% of CD3+', 'categories': [{'measurements': [{'value': '-1.01', 'spread': '10.866', 'groupId': 'OG000'}, {'value': '-3.08', 'spread': '5.272', 'groupId': 'OG001'}, {'value': '0.88', 'spread': '7.434', 'groupId': 'OG002'}, {'value': '-5.04', 'spread': '7.671', 'groupId': 'OG003'}]}]}, {'title': 'CD56+% OF CD45+ Lymphocytes', 'categories': [{'measurements': [{'value': '-0.56', 'spread': '2.093', 'groupId': 'OG000'}, {'value': '-5.76', 'spread': '4.231', 'groupId': 'OG001'}, {'value': '-2.38', 'spread': '2.461', 'groupId': 'OG002'}, {'value': '2.04', 'spread': '7.984', 'groupId': 'OG003'}]}]}, {'title': 'CD8+CD4-% of CD3+', 'categories': [{'measurements': [{'value': '-3.00', 'spread': '7.792', 'groupId': 'OG000'}, {'value': '-1.38', 'spread': '4.467', 'groupId': 'OG001'}, {'value': '-2.92', 'spread': '5.010', 'groupId': 'OG002'}, {'value': '-0.24', 'spread': '6.517', 'groupId': 'OG003'}]}]}, {'title': 'CXCR5+% of CD25+CD127-', 'categories': [{'measurements': [{'value': '0.20', 'spread': '4.676', 'groupId': 'OG000'}, {'value': '7.02', 'spread': '3.371', 'groupId': 'OG001'}, {'value': '10.62', 'spread': '11.963', 'groupId': 'OG002'}, {'value': '0.63', 'spread': '5.915', 'groupId': 'OG003'}]}]}, {'title': 'CXCR5+% of CD4+CD8-', 'categories': [{'measurements': [{'value': '0.81', 'spread': '12.373', 'groupId': 'OG000'}, {'value': '15.18', 'spread': '7.564', 'groupId': 'OG001'}, {'value': '13.14', 'spread': '16.091', 'groupId': 'OG002'}, {'value': '-0.69', 'spread': '7.208', 'groupId': 'OG003'}]}]}, {'title': 'ICOS+% of CD25+CD127-', 'categories': [{'measurements': [{'value': '8.59', 'spread': '10.618', 'groupId': 'OG000'}, {'value': '1.56', 'spread': '3.840', 'groupId': 'OG001'}, {'value': '12.93', 'spread': '11.905', 'groupId': 'OG002'}, {'value': '4.27', 'spread': '17.059', 'groupId': 'OG003'}]}]}, {'title': 'ICOS+% of CD4+CD8-', 'categories': [{'measurements': [{'value': '3.93', 'spread': '6.906', 'groupId': 'OG000'}, {'value': '0.14', 'spread': '5.227', 'groupId': 'OG001'}, {'value': '5.01', 'spread': '5.053', 'groupId': 'OG002'}, {'value': '0.54', 'spread': '15.534', 'groupId': 'OG003'}]}]}, {'title': 'IgD+C27-% of CD19+', 'categories': [{'measurements': [{'value': '0.20', 'spread': '7.127', 'groupId': 'OG000'}, {'value': '2.42', 'spread': '5.882', 'groupId': 'OG001'}, {'value': '-1.07', 'spread': '4.748', 'groupId': 'OG002'}, {'value': '-0.80', 'spread': '6.031', 'groupId': 'OG003'}]}]}, {'title': 'IgD+CD27+% of CD19+', 'categories': [{'measurements': [{'value': '1.29', 'spread': '1.785', 'groupId': 'OG000'}, {'value': '-3.24', 'spread': '6.080', 'groupId': 'OG001'}, {'value': '-1.24', 'spread': '2.823', 'groupId': 'OG002'}, {'value': '1.00', 'spread': '3.260', 'groupId': 'OG003'}]}]}, {'title': 'IgD+CD27-CD38++CD24++% of CD19+', 'categories': [{'measurements': [{'value': '0.50', 'spread': '1.262', 'groupId': 'OG000'}, {'value': '0.56', 'spread': '1.688', 'groupId': 'OG001'}, {'value': '-0.42', 'spread': '2.351', 'groupId': 'OG002'}, {'value': '0.16', 'spread': '1.385', 'groupId': 'OG003'}]}]}, {'title': 'IgD-CD27+% of CD19+', 'categories': [{'measurements': [{'value': '-0.21', 'spread': '3.866', 'groupId': 'OG000'}, {'value': '-0.48', 'spread': '3.891', 'groupId': 'OG001'}, {'value': '2.02', 'spread': '3.751', 'groupId': 'OG002'}, {'value': '0.70', 'spread': '3.740', 'groupId': 'OG003'}]}]}, {'title': 'IgD-CD27+CD38++CD138+% of CD19+', 'categories': [{'measurements': [{'value': '0.03', 'spread': '0.049', 'groupId': 'OG000'}, {'value': '0.04', 'spread': '0.089', 'groupId': 'OG001'}, {'value': '0.08', 'spread': '0.172', 'groupId': 'OG002'}, {'value': '-0.02', 'spread': '0.130', 'groupId': 'OG003'}]}]}, {'title': 'IgD-CD27+CD38++CD138-% of CD19+', 'categories': [{'measurements': [{'value': '-0.20', 'spread': '0.432', 'groupId': 'OG000'}, {'value': '-0.20', 'spread': '0.354', 'groupId': 'OG001'}, {'value': '0.59', 'spread': '1.437', 'groupId': 'OG002'}, {'value': '-0.63', 'spread': '1.081', 'groupId': 'OG003'}]}]}, {'title': 'IgD-CD27-% of CD19+', 'categories': [{'measurements': [{'value': '-1.29', 'spread': '2.963', 'groupId': 'OG000'}, {'value': '1.36', 'spread': '2.373', 'groupId': 'OG001'}, {'value': '0.32', 'spread': '2.059', 'groupId': 'OG002'}, {'value': '-0.83', 'spread': '1.648', 'groupId': 'OG003'}]}]}, {'title': 'PD-1+% of CD25+CD127-', 'categories': [{'measurements': [{'value': '0.31', 'spread': '6.093', 'groupId': 'OG000'}, {'value': '3.30', 'spread': '5.039', 'groupId': 'OG001'}, {'value': '7.41', 'spread': '6.064', 'groupId': 'OG002'}, {'value': '-8.49', 'spread': '13.258', 'groupId': 'OG003'}]}]}, {'title': 'PD-1+% of CD4+CD8-', 'categories': [{'measurements': [{'value': '-0.07', 'spread': '6.366', 'groupId': 'OG000'}, {'value': '4.14', 'spread': '4.146', 'groupId': 'OG001'}, {'value': '6.39', 'spread': '5.882', 'groupId': 'OG002'}, {'value': '-9.01', 'spread': '13.036', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 0); Day 180', 'description': 'The optimal dose of BOS161721 was selected based on safety, tolerability, PK and PD data in participants with moderate to severe SLE.', 'unitOfMeasure': 'Change in percentage of cells', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: Defined as all participants who received at least 1 dose (partial or complete) of study treatment and had at least 1 evaluable post baseline efficacy evaluation.'}, {'type': 'SECONDARY', 'title': 'Phase 1b: Mean Change From Baseline in Anti-double-stranded DNA (dsDNA) Autoantibodies at Each Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1b: Placebo', 'description': 'Participants were randomized to receive a subcutaneous (SC) dose of placebo. Participants received a total of 7 SC monthly doses of placebo on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits at Days 210, 240, and 270.'}, {'id': 'OG001', 'title': 'Phase 1b: Cohort 1: BOS161721 20 mg', 'description': 'Participants were randomized to receive a 20 mg SC dose of BOS161721. Participants received a total of 7 SC monthly doses of BOS161721 on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270.'}, {'id': 'OG002', 'title': 'Phase 1b: Cohort 2: BOS161721 60 mg', 'description': 'Participants were randomized to receive a 60 mg SC dose of BOS161721. Participants received a total of 7 SC monthly doses of BOS161721 on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270'}, {'id': 'OG003', 'title': 'Phase 1b: Cohort 3: BOS161721 120 mg', 'description': 'Participants were randomized to receive a 120 mg SC dose of BOS161721. Participants received a total of 7 SC monthly doses of BOS161721 on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270'}], 'classes': [{'title': 'Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.11', 'spread': '3.504', 'groupId': 'OG000'}, {'value': '0.48', 'spread': '0.410', 'groupId': 'OG001'}, {'value': '5.34', 'spread': '9.053', 'groupId': 'OG002'}, {'value': '-11.51', 'spread': '32.444', 'groupId': 'OG003'}]}]}, {'title': 'Day 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.81', 'spread': '5.048', 'groupId': 'OG000'}, {'value': '0.40', 'spread': '0.376', 'groupId': 'OG001'}, {'value': '8.06', 'spread': '18.430', 'groupId': 'OG002'}, {'value': '-6.11', 'spread': '15.612', 'groupId': 'OG003'}]}]}, {'title': 'Day 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.15', 'spread': '0.448', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.187', 'groupId': 'OG001'}, {'value': '19.31', 'spread': '48.594', 'groupId': 'OG002'}, {'value': '-13.44', 'spread': '35.152', 'groupId': 'OG003'}]}]}, {'title': 'Day 120', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.02', 'spread': '0.270', 'groupId': 'OG000'}, {'value': '0.41', 'spread': '0.598', 'groupId': 'OG001'}, {'value': '12.30', 'spread': '35.583', 'groupId': 'OG002'}, {'value': '-15.58', 'spread': '47.248', 'groupId': 'OG003'}]}]}, {'title': 'Day 150', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.03', 'spread': '0.199', 'groupId': 'OG000'}, {'value': '0.62', 'spread': '0.709', 'groupId': 'OG001'}, {'value': '17.39', 'spread': '50.086', 'groupId': 'OG002'}, {'value': '-11.18', 'spread': '38.152', 'groupId': 'OG003'}]}]}, {'title': 'Day 180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-2.13', 'spread': '5.905', 'groupId': 'OG000'}, {'value': '0.52', 'spread': '0.584', 'groupId': 'OG001'}, {'value': '8.00', 'spread': '21.169', 'groupId': 'OG002'}, {'value': '-17.13', 'spread': '49.897', 'groupId': 'OG003'}]}]}, {'title': 'Day 210', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.05', 'spread': '0.359', 'groupId': 'OG000'}, {'value': '0.07', 'spread': '0.540', 'groupId': 'OG001'}, {'value': '6.76', 'spread': '20.173', 'groupId': 'OG002'}, {'value': '-17.96', 'spread': '50.274', 'groupId': 'OG003'}]}]}, {'title': 'Day 240', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.07', 'spread': '0.428', 'groupId': 'OG000'}, {'value': '0.34', 'spread': '1.117', 'groupId': 'OG001'}, {'value': '6.81', 'spread': '21.903', 'groupId': 'OG002'}, {'value': '-18.35', 'spread': '47.898', 'groupId': 'OG003'}]}]}, {'title': 'Day 270', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.94', 'spread': '4.974', 'groupId': 'OG000'}, {'value': '0.37', 'spread': '0.700', 'groupId': 'OG001'}, {'value': '7.99', 'spread': '24.116', 'groupId': 'OG002'}, {'value': '-9.71', 'spread': '27.833', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 0); Days 30, 60, 90, 120, 150, 180, 210, 240, and 270', 'description': 'The optimal dose of BOS161721 was selected based on safety, tolerability, PK and PD data in participants with moderate to severe SLE..', 'unitOfMeasure': 'International units per millilitre', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: Defined as all participants who received at least 1 dose (partial or complete) of study treatment and had at least 1 evaluable post baseline efficacy evaluation. Here, number analyzed in each row signifies only the participants with available data for each time point.'}, {'type': 'SECONDARY', 'title': "Phase 1b: Mean Change From Baseline in Anti-Sjögren's Syndrome A and B (SSA, SSB)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1b: Placebo', 'description': 'Participants were randomized to receive a subcutaneous (SC) dose of placebo. Participants received a total of 7 SC monthly doses of placebo on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits at Days 210, 240, and 270.'}, {'id': 'OG001', 'title': 'Phase 1b: Cohort 1: BOS161721 20 mg', 'description': 'Participants were randomized to receive a 20 mg SC dose of BOS161721. Participants received a total of 7 SC monthly doses of BOS161721 on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270.'}, {'id': 'OG002', 'title': 'Phase 1b: Cohort 2: BOS161721 60 mg', 'description': 'Participants were randomized to receive a 60 mg SC dose of BOS161721. Participants received a total of 7 SC monthly doses of BOS161721 on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270'}, {'id': 'OG003', 'title': 'Phase 1b: Cohort 3: BOS161721 120 mg', 'description': 'Participants were randomized to receive a 120 mg SC dose of BOS161721. Participants received a total of 7 SC monthly doses of BOS161721 on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270'}], 'classes': [{'title': 'La Antibody', 'categories': [{'measurements': [{'value': '0.04', 'spread': '0.175', 'groupId': 'OG000'}, {'value': '0.11', 'spread': '0.108', 'groupId': 'OG001'}, {'value': '1.02', 'spread': '2.639', 'groupId': 'OG002'}, {'value': '0.47', 'spread': '1.668', 'groupId': 'OG003'}]}]}, {'title': 'Sjogrens SS-A52 Antibody', 'categories': [{'measurements': [{'value': '-0.04', 'spread': '0.128', 'groupId': 'OG000'}, {'value': '0.05', 'spread': '0.112', 'groupId': 'OG001'}, {'value': '0.19', 'spread': '0.567', 'groupId': 'OG002'}, {'value': '-2.25', 'spread': '4.861', 'groupId': 'OG003'}]}]}, {'title': 'Sjogrens SS-A60 Antibody', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.000', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.000', 'groupId': 'OG001'}, {'value': '-2.62', 'spread': '7.867', 'groupId': 'OG002'}, {'value': '-4.36', 'spread': '8.684', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 0); Day 180', 'description': 'The optimal dose of BOS161721 was selected based on safety, tolerability, PK and PD data in subjects with moderate to severe SLE.', 'unitOfMeasure': 'U/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: Defined as all participants who received at least 1 dose (partial or complete) of study treatment and have at least 1 evaluable post baseline efficacy evaluation.'}, {'type': 'SECONDARY', 'title': 'Phase 1b: Mean Change From Baseline in Anti-Smith Antibody (Sm)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1b: Placebo', 'description': 'Participants were randomized to receive a subcutaneous (SC) dose of placebo. Participants received a total of 7 SC monthly doses of placebo on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits at Days 210, 240, and 270.'}, {'id': 'OG001', 'title': 'Phase 1b: Cohort 1: BOS161721 20 mg', 'description': 'Participants were randomized to receive a 20 mg SC dose of BOS161721. Participants received a total of 7 SC monthly doses of BOS161721 on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270.'}, {'id': 'OG002', 'title': 'Phase 1b: Cohort 2: BOS161721 60 mg', 'description': 'Participants were randomized to receive a 60 mg SC dose of BOS161721. Participants received a total of 7 SC monthly doses of BOS161721 on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270'}, {'id': 'OG003', 'title': 'Phase 1b: Cohort 3: BOS161721 120 mg', 'description': 'Participants were randomized to receive a 120 mg SC dose of BOS161721. Participants received a total of 7 SC monthly doses of BOS161721 on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.87', 'spread': '4.827', 'groupId': 'OG000'}, {'value': '0.74', 'spread': '0.391', 'groupId': 'OG001'}, {'value': '-3.21', 'spread': '9.419', 'groupId': 'OG002'}, {'value': '3.61', 'spread': '19.504', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 0); Day 180', 'description': 'The optimal dose of BOS161721 was selected based on safety, tolerability, PK and PD data in subjects with moderate to severe SLE.', 'unitOfMeasure': 'U/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: Defined as all participants who received at least 1 dose (partial or complete) of study treatment and have at least 1 evaluable post baseline efficacy evaluation.'}, {'type': 'SECONDARY', 'title': 'Phase 1b: Mean Change From Baseline in Antiphospholipid (APL) Autoantibodies (Beta 2 Glycoprotein, Cardiolipin IgG)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1b: Placebo', 'description': 'Participants were randomized to receive a subcutaneous (SC) dose of placebo. Participants received a total of 7 SC monthly doses of placebo on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits at Days 210, 240, and 270.'}, {'id': 'OG001', 'title': 'Phase 1b: Cohort 1: BOS161721 20 mg', 'description': 'Participants were randomized to receive a 20 mg SC dose of BOS161721. Participants received a total of 7 SC monthly doses of BOS161721 on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270.'}, {'id': 'OG002', 'title': 'Phase 1b: Cohort 2: BOS161721 60 mg', 'description': 'Participants were randomized to receive a 60 mg SC dose of BOS161721. Participants received a total of 7 SC monthly doses of BOS161721 on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270'}, {'id': 'OG003', 'title': 'Phase 1b: Cohort 3: BOS161721 120 mg', 'description': 'Participants were randomized to receive a 120 mg SC dose of BOS161721. Participants received a total of 7 SC monthly doses of BOS161721 on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270'}], 'classes': [{'title': 'Anti-Cardiolipin IgG Antibody', 'categories': [{'measurements': [{'value': '-0.03', 'spread': '0.412', 'groupId': 'OG000'}, {'value': '3.55', 'spread': '5.559', 'groupId': 'OG001'}, {'value': '0.07', 'spread': '0.585', 'groupId': 'OG002'}, {'value': '-0.42', 'spread': '0.180', 'groupId': 'OG003'}]}]}, {'title': 'Beta-2 Glycoprotein 1 IgG Antibody', 'categories': [{'measurements': [{'value': '-0.11', 'spread': '0.358', 'groupId': 'OG000'}, {'value': '-7.48', 'spread': '23.684', 'groupId': 'OG001'}, {'value': '-0.14', 'spread': '0.882', 'groupId': 'OG002'}, {'value': '0.02', 'spread': '0.787', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 0); Day 180', 'description': 'The optimal dose of BOS161721 was selected based on safety, tolerability, PK and PD data in participants with moderate to severe SLE.', 'unitOfMeasure': 'U/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: Defined as all participants who received at least 1 dose (partial or complete) of study treatment and have at least 1 evaluable post baseline efficacy evaluation.'}, {'type': 'SECONDARY', 'title': 'Phase 1b: Mean Change From Baseline in Abrogation of IL-21 Gene Signature', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1b: Placebo', 'description': 'Participants were randomized to receive a subcutaneous (SC) dose of placebo. Participants received a total of 7 SC monthly doses of placebo on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits at Days 210, 240, and 270.'}, {'id': 'OG001', 'title': 'Phase 1b: Cohort 1: BOS161721 20 mg', 'description': 'Participants were randomized to receive a 20 mg SC dose of BOS161721. Participants received a total of 7 SC monthly doses of BOS161721 on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270.'}, {'id': 'OG002', 'title': 'Phase 1b: Cohort 2: BOS161721 60 mg', 'description': 'Participants were randomized to receive a 60 mg SC dose of BOS161721. Participants received a total of 7 SC monthly doses of BOS161721 on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270'}, {'id': 'OG003', 'title': 'Phase 1b: Cohort 3: BOS161721 120 mg', 'description': 'Participants were randomized to receive a 120 mg SC dose of BOS161721. Participants received a total of 7 SC monthly doses of BOS161721 on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270'}], 'timeFrame': 'Baseline (Day 0); Days 15, 90, 180, and 270', 'description': 'The optimal dose of BOS161721 was selected based on safety, tolerability, PK and PD data in participants with moderate to severe SLE.', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: Defined as all participants who received at least 1 dose (partial or complete) of study treatment and have at least 1 evaluable post baseline efficacy evaluation. Data were not collected for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Phase 2: Number of Participants With an SRI-4, SRI-5, and SRI-6 Response at Each Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: Placebo', 'description': 'Participants were randomized to receive a SC dose of placebo (as determined from Phase 1b of the study). Participants received a total of 7 SC monthly doses of placebo on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270.'}, {'id': 'OG001', 'title': 'Phase 2: BOS161721 120 mg', 'description': 'Participants were randomized to receive a 120 mg SC dose of BOS161721 (as determined from Phase 1b of the study). Participants received a total of 7 SC monthly doses of BOS161721 on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270.'}], 'classes': [{'title': 'SRI-4, Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'SRI-4, Day 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'SRI-4, Day 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}, {'title': 'SRI-4, Day 120', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}, {'title': 'SRI-4, Day 150', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}, {'title': 'SRI-4, Day 180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}, {'title': 'SRI-4, Day 210', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}, {'title': 'SRI-5, Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'SRI-5, Day 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'SRI-5, Day 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'SRI-5, Day 120', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'SRI-5, Day 150', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': 'SRI-5, Day 180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}, {'title': 'SRI-5, Day 210', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}, {'title': 'SRI-6, Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'SRI-6, Day 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'SRI-6, Day 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'SRI-6, Day 120', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'SRI-6, Day 150', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': 'SRI-6, Day 180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}, {'title': 'SRI-6, Day 210', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Days 30, 60, 90, 120, 150, 180, 210, 240, and 270', 'description': "The SRI-4 is a composite index of SLE disease improvement that consists of scores derived from the SLE Disease Activity Index 2000 (SLEDAI-2K) and the British Isles Lupus Assessment Group (BILAG) 2004 Index. Response based on the SRI-4 is defined by: 1) ≥ 4-point reduction in the SLEDAI-2K global score; 2) no new severe disease activity (BILAG A organ score) or more than 1 new moderate organ score (BILAG B); and 3) no deterioration from baseline in the Physician's Global Assessment (PGA) by ≥ 30 millimeters. The SRI-4 response in participants with moderate to severe SLE is associated with broad improvements in clinical and participant-reported outcomes. SRI-5 and SRI-6 are composite indices of SLE disease improvement that consist of scores derived from the SLEDAI-2K and the BILAG 2004 Index. The SRI-5 and SRI-6 are computed with a minimal five-point or six-point improvement in SLEDAI-2K being required, respectively.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: Defined as all participants who received at least 1 dose (partial or complete) of study treatment and had at least 1 evaluable post baseline efficacy evaluation. Here, number analyzed in each row signifies only the participants with available data for each time point.'}, {'type': 'SECONDARY', 'title': 'Phase 2: Number of Participants With a Sustained Reduction From Baseline of Oral Corticosteroid (CS) (≤ 7.5 mg/Day and < Day 0 Dose) Between Day 150 and Day 210', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: Placebo', 'description': 'Participants were randomized to receive a SC dose of placebo (as determined from Phase 1b of the study). Participants received a total of 7 SC monthly doses of placebo on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270.'}, {'id': 'OG001', 'title': 'Phase 2: BOS161721 120 mg', 'description': 'Participants were randomized to receive a 120 mg SC dose of BOS161721 (as determined from Phase 1b of the study). Participants received a total of 7 SC monthly doses of BOS161721 on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270.'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.7985', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Observed Difference vs. Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-2.6', 'ciLowerLimit': '-19.8', 'ciUpperLimit': '14.5', 'statisticalMethod': "Pearson's chi-square test", 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 150 to Day 210', 'description': 'Effect of BOS161721 compared with placebo for response on clinical indicators of SLE activity was assessed in adult participants with moderate to severe SLE on limited background standard of care treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: Defined as all participants who received at least 1 dose (partial or complete) of study treatment and had at least 1 evaluable post baseline efficacy evaluation. Here, overall number of participants analyzed signifies only the number of participants taking oral corticosteroids at baseline.'}, {'type': 'SECONDARY', 'title': 'Phase 2: Number of Participants With New or Recurrent BILAG Flares (≥ 1 Qualifying BILAG A or > 1 Qualifying BILAG B) Through Day 210', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: Placebo', 'description': 'Participants were randomized to receive a SC dose of placebo (as determined from Phase 1b of the study). Participants received a total of 7 SC monthly doses of placebo on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270.'}, {'id': 'OG001', 'title': 'Phase 2: BOS161721 120 mg', 'description': 'Participants were randomized to receive a 120 mg SC dose of BOS161721 (as determined from Phase 1b of the study). Participants received a total of 7 SC monthly doses of BOS161721 on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270.'}], 'classes': [{'title': 'Overall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Day 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 120', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 150', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Day 180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Day 210', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.3498', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Observed Difference vs. Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-6.9', 'ciLowerLimit': '-22.9', 'ciUpperLimit': '9.8', 'groupDescription': 'Statistical Analysis for Overall', 'statisticalMethod': "Pearson's chi-square test", 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Days 30, 60, 90, 120, 150, 180, 210', 'description': "The BILAG-2004 index is an organ-specific 97-question assessment based on the principle of the doctor's intent to treat. Only clinical features attributable to SLE disease activity were recorded and based on the participant's condition in the last 4 weeks compared with the previous 4 weeks. It was scored as not present (0), improved (1), the same (2), worse (3), or new (4). Disease activity was graded separately for 9 body systems to 5 different grades (A to E) as follows: A is very active disease, B is moderate activity, C is mild stable disease, D is inactive now but previously active, and E indicates the organ was never involved. A shift from BILAG-2004 Grade A or B to a lower grade indicates a clinically relevant change in disease activity as the BILAG-2004 grades mirror the decision points for treatment interventions.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: Defined as all participants who received at least 1 dose (partial or complete) of study treatment and had at least 1 evaluable post baseline efficacy evaluation. Here, number analyzed in each row signifies only the number of participants with a post-baseline BILAG assessment at any time (overall assessment) or at the given timepoint.'}, {'type': 'SECONDARY', 'title': "Phase 2: Number of Participants With Physician's Global Assessment (PGA) Worsening", 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: Placebo', 'description': 'Participants were randomized to receive a SC dose of placebo (as determined from Phase 1b of the study). Participants received a total of 7 SC monthly doses of placebo on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270.'}, {'id': 'OG001', 'title': 'Phase 2: BOS161721 120 mg', 'description': 'Participants were randomized to receive a 120 mg SC dose of BOS161721 (as determined from Phase 1b of the study). Participants received a total of 7 SC monthly doses of BOS161721 on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270.'}], 'classes': [{'title': 'Overall', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Day 210', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0072', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Observed Difference vs. Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-21.8', 'ciLowerLimit': '-36.2', 'ciUpperLimit': '-7.4', 'groupDescription': 'Statistical analysis for Overall', 'statisticalMethod': "Pearson's chi-square test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0141', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Observed Difference vs. Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-17.7', 'ciLowerLimit': '-30.9', 'ciUpperLimit': '-4.5', 'groupDescription': 'Statistical Analysis for Day 210', 'statisticalMethod': "Pearson's chi-square test", 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Days 30, 60, 90, 120, 150, 180, and 210', 'description': 'The PGA is used to assess Investigator\'s general impression on the patient\'s overall status of SLE disease activity via visual analogue scale (100 mm) with 0 being "very good, asymptomatic and no limitation of normal activities" with 100 mm being "most severe possible disease ever seen in all SLE patients". PGA worsening is defined as an increase of ≥ 30 mm from baseline.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: Defined as all participants who received at least 1 dose (partial or complete) of study treatment and had at least 1 evaluable post baseline efficacy evaluation. Here, number analyzed in each row signifies the number of participants with a post-baseline PGA assessment at any time (overall assessment) or at the given timepoint (by visit assessment).'}, {'type': 'SECONDARY', 'title': 'Phase 2: Number of Participants With a BILAG-based Composite Lupus Assessment (BICLA) Response at Day 210', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: Placebo', 'description': 'Participants were randomized to receive a SC dose of placebo (as determined from Phase 1b of the study). Participants received a total of 7 SC monthly doses of placebo on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270.'}, {'id': 'OG001', 'title': 'Phase 2: BOS161721 120 mg', 'description': 'Participants were randomized to receive a 120 mg SC dose of BOS161721 (as determined from Phase 1b of the study). Participants received a total of 7 SC monthly doses of BOS161721 on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270.'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.6107', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Observed Difference vs. Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '4.9', 'ciLowerLimit': '-10.7', 'ciUpperLimit': '20.5', 'statisticalMethod': "Pearson's chi-square test", 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 210', 'description': "The BICLA is a responder index developed to measure response to therapy, and it includes scores from the BILAG, SLEDAI-2K, and Physician's Global Assessment (PGA). BICLA response is defined as: 1) at least 1 gradation of improvement in baseline BILAG 2004 scores in all body systems with moderate disease activity at entry (eg, all B \\[moderate disease\\] scores falling to C \\[mild\\], or D \\[no activity\\]); 2) no new BILAG A or more than 1 new BILAG B scores; 3) no worsening of total SLEDAI-2K score from baseline; 4) ≤ 10% deterioration in PGA score; and 5) no treatment failure. The PGA is measured on a 0 to 100 mm scale with score 0 to be No Disease Activity and score 100 to be the most Severe Disease Activity.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: Defined as all participants who received at least 1 dose (partial or complete) of study treatment and had at least 1 evaluable post baseline efficacy evaluation.'}, {'type': 'SECONDARY', 'title': 'Phase 2: Number of Participants With a Cutaneous Lupus Erythematosus Area and Severity Index (CLASI) Response at Day 210', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: Placebo', 'description': 'Participants were randomized to receive a SC dose of placebo (as determined from Phase 1b of the study). Participants received a total of 7 SC monthly doses of placebo on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270.'}, {'id': 'OG001', 'title': 'Phase 2: BOS161721 120 mg', 'description': 'Participants were randomized to receive a 120 mg SC dose of BOS161721 (as determined from Phase 1b of the study). Participants received a total of 7 SC monthly doses of BOS161721 on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270.'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1237', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Observed Difference vs. Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '15.4', 'ciLowerLimit': '-0.9', 'ciUpperLimit': '31.8', 'statisticalMethod': "Pearson's chi-square test", 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 210', 'description': 'The CLASI is a comprehensive tool for assessment of disease activity (CLASI-A) in cutaneous lupus, shown to be valid, reliable, and sensitive to changes in disease activity. Response is defined as at least 50% improvement from baseline in "A" scores. This assessment was applied to all participants as all were required to have cutaneous disease activity. 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': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: Defined as all participants who received at least 1 dose (partial or complete) of study treatment and had at least 1 evaluable post baseline efficacy evaluation.'}, {'type': 'SECONDARY', 'title': 'Phase 2: Number of Participants With Medication Failures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: Placebo', 'description': 'Participants were randomized to receive a SC dose of placebo (as determined from Phase 1b of the study). Participants received a total of 7 SC monthly doses of placebo on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270.'}, {'id': 'OG001', 'title': 'Phase 2: BOS161721 120 mg', 'description': 'Participants were randomized to receive a 120 mg SC dose of BOS161721 (as determined from Phase 1b of the study). Participants received a total of 7 SC monthly doses of BOS161721 on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270.'}], 'classes': [{'title': 'Overall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Day 210', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0581', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Observed Difference vs. Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-13.7', 'ciLowerLimit': '-26.7', 'ciUpperLimit': '-0.7', 'groupDescription': 'Statistical Analysis for Overall', 'statisticalMethod': "Pearson's chi-square test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0471', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Observed Difference vs. Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-14.3', 'ciLowerLimit': '-31.2', 'ciUpperLimit': '3.2', 'groupDescription': 'Statistical Analysis for Day 210', 'statisticalMethod': "Pearson's chi-square test", 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Days 30, 60, 90, 120, 150, 180, and 210', 'description': 'Effect of BOS161721 compared with placebo for response on clinical indicators of SLE activity was assessed in adult participants with moderate to severe SLE on limited background standard of care treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: Defined as all participants who received at least 1 dose (partial or complete) of study treatment and had at least 1 evaluable post baseline efficacy evaluation. Here, number analyzed in each row signifies the number of participants evaluable at any time (overall assessment) or at the given timepoint (by visit assessment).'}, {'type': 'SECONDARY', 'title': 'Phase 2: Mean Change From Baseline in CLASI at Day 210', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: Placebo', 'description': 'Participants were randomized to receive a SC dose of placebo (as determined from Phase 1b of the study). Participants received a total of 7 SC monthly doses of placebo on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270.'}, {'id': 'OG001', 'title': 'Phase 2: BOS161721 120 mg', 'description': 'Participants were randomized to receive a 120 mg SC dose of BOS161721 (as determined from Phase 1b of the study). Participants received a total of 7 SC monthly doses of BOS161721 on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270.'}], 'classes': [{'title': 'CLASI-A (Total Activity)', 'categories': [{'measurements': [{'value': '-4.8', 'spread': '4.08', 'groupId': 'OG000'}, {'value': '-5.2', 'spread': '4.62', 'groupId': 'OG001'}]}]}, {'title': 'CLASI-B (Total Damage)', 'categories': [{'measurements': [{'value': '-0.6', 'spread': '2.61', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '0.90', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.6596', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment Difference (BOS161721-Placebo)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.3', 'ciLowerLimit': '-1.63', 'ciUpperLimit': '0.94', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.78', 'estimateComment': 'This is based on LS Means', 'groupDescription': 'Statistical Analysis for CLASI-A (Total Activity)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4105', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment Difference (BOS161721-Placebo)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.3', 'ciLowerLimit': '-0.27', 'ciUpperLimit': '0.81', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.33', 'estimateComment': 'This is based on LS Means', 'groupDescription': 'Statistical Analysis for CLASI-B (Total Damage)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 210', 'description': 'The CLASI is a comprehensive tool for the assessment of disease activity (CLASI-A) and damage (CLASI-B) in cutaneous lupus, shown to be valid, reliable, and sensitive to changes in disease activity. Response is defined as 50% improvement from baseline in "A" or "B" scores. This assessment was applied to all participants as all were required to have cutaneous disease activity. The total score represents the sum of the individual scores and ranges from 0 to 70 (CLASI-A) and 0 to 58 (CLASI-B). Higher scores are awarded for more severe manifestations. Change from baseline was calculated as the post-baseline value minus the baseline value.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: Defined as all participants who received at least 1 dose (partial or complete) of study treatment and had at least 1 evaluable post baseline efficacy evaluation.'}, {'type': 'SECONDARY', 'title': 'Phase 2: Mean Change From Baseline in PGA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: Placebo', 'description': 'Participants were randomized to receive a SC dose of placebo (as determined from Phase 1b of the study). Participants received a total of 7 SC monthly doses of placebo on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270.'}, {'id': 'OG001', 'title': 'Phase 2: BOS161721 120 mg', 'description': 'Participants were randomized to receive a 120 mg SC dose of BOS161721 (as determined from Phase 1b of the study). Participants received a total of 7 SC monthly doses of BOS161721 on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270.'}], 'classes': [{'categories': [{'measurements': [{'value': '-29.2', 'spread': '20.69', 'groupId': 'OG000'}, {'value': '-28.7', 'spread': '20.35', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.8546', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment Difference (BOS161721-Placebo)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.8', 'ciLowerLimit': '-6.07', 'ciUpperLimit': '7.58', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.11', 'estimateComment': 'This is based on LS Means', 'groupDescription': 'Statistical Analysis for Day 210', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 210', 'description': 'The PGA is used to assess Investigator\'s general impression on the patient\'s overall status of SLE disease activity via visual analogue scale (100 mm) with 0 being "very good, asymptomatic and no limitation of normal activities" with 100 mm being "most severe possible disease ever seen in all SLE patients".', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: Defined as all participants who received at least 1 dose (partial or complete) of study treatment and had at least 1 evaluable post baseline efficacy evaluation.'}, {'type': 'SECONDARY', 'title': 'Phase 2: Mean Change From Baseline in the Total Number of Swollen Joints, Tender Joints, and Active Joints (Swelling and Tenderness in the Same Joint) in the American College of Rheumatology-28 (ACR-28) Joint Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: Placebo', 'description': 'Participants were randomized to receive a SC dose of placebo (as determined from Phase 1b of the study). Participants received a total of 7 SC monthly doses of placebo on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270.'}, {'id': 'OG001', 'title': 'Phase 2: BOS161721 120 mg', 'description': 'Participants were randomized to receive a 120 mg SC dose of BOS161721 (as determined from Phase 1b of the study). Participants received a total of 7 SC monthly doses of BOS161721 on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270.'}], 'classes': [{'title': 'Sum of Swelling', 'categories': [{'measurements': [{'value': '-6.8', 'spread': '5.17', 'groupId': 'OG000'}, {'value': '-5.9', 'spread': '5.05', 'groupId': 'OG001'}]}]}, {'title': 'Sum of Tenderness', 'categories': [{'measurements': [{'value': '-8.3', 'spread': '7.00', 'groupId': 'OG000'}, {'value': '-7.2', 'spread': '5.57', 'groupId': 'OG001'}]}]}, {'title': 'Sum of Active Joints', 'categories': [{'measurements': [{'value': '-6.5', 'spread': '5.54', 'groupId': 'OG000'}, {'value': '-5.6', 'spread': '4.65', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.4455', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment Difference (BOS161721-Placebo)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.5', 'ciLowerLimit': '-0.63', 'ciUpperLimit': '1.71', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.70', 'estimateComment': 'This is based on LS Means', 'groupDescription': 'Statistical Analysis for Sum of Swelling for Day 210', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3367', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment Difference (BOS161721-Placebo)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.9', 'ciLowerLimit': '-0.65', 'ciUpperLimit': '2.47', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.94', 'estimateComment': 'This is based on LS Means', 'groupDescription': 'Statistical Analysis for Sum of Tenderness for Day 210', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2550', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment Difference (BOS161721-Placebo)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.8', 'ciLowerLimit': '-0.34', 'ciUpperLimit': '1.86', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.66', 'estimateComment': 'This is based on LS Means', 'groupDescription': 'Statistical Analysis for Sum of Active Joints for Day 210', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 210', 'description': 'The ACR-28 joint count evaluated the number of tender and swollen joints in the shoulder, elbow, wrist, hand, and knee joints. Joints of the feet were excluded. Change from baseline was calculated as the post-baseline value minus the baseline value.', 'unitOfMeasure': 'Number of swollen/tender/active joints', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: Defined as all participants who received at least 1 dose (partial or complete) of study treatment and had at least 1 evaluable post baseline efficacy evaluation.'}, {'type': 'SECONDARY', 'title': 'Phase 2: Mean Change From Baseline in SLEDAI-2K at Day 210', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: Placebo', 'description': 'Participants were randomized to receive a SC dose of placebo (as determined from Phase 1b of the study). Participants received a total of 7 SC monthly doses of placebo on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270.'}, {'id': 'OG001', 'title': 'Phase 2: BOS161721 120 mg', 'description': 'Participants were randomized to receive a 120 mg SC dose of BOS161721 (as determined from Phase 1b of the study). Participants received a total of 7 SC monthly doses of BOS161721 on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270.'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.7', 'spread': '3.71', 'groupId': 'OG000'}, {'value': '-3.9', 'spread': '3.31', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2498', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment Difference (BOS161721-Placebo)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.8', 'ciLowerLimit': '-0.34', 'ciUpperLimit': '1.93', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.68', 'estimateComment': 'This is based on LS Means', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 210', 'description': 'The SLEDAI-2K is a validated instrument that measures disease activity in SLE participants at the time of the visit and in the previous 30 days. It is a global index and includes 24 clinical and laboratory variables that are weighted by the type of manifestation, but not by severity. The total score falls between 0 and 105, with higher scores representing increased disease activity. A SLEDAI -2K of 6 or more generally represents moderately to severely active disease.\n\nChange from baseline was calculated as the post-baseline value minus the baseline value.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: Defined as all participants who received at least 1 dose (partial or complete) of study treatment and had at least 1 evaluable post baseline efficacy evaluation.'}, {'type': 'SECONDARY', 'title': 'Phase 2: Mean Change From Baseline in Systemic Lupus International Collaborating Clinics/American College of Rheumatology (SLICC/ACR) Damage Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: Placebo', 'description': 'Participants were randomized to receive a SC dose of placebo (as determined from Phase 1b of the study). Participants received a total of 7 SC monthly doses of placebo on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270.'}, {'id': 'OG001', 'title': 'Phase 2: BOS161721 120 mg', 'description': 'Participants were randomized to receive a 120 mg SC dose of BOS161721 (as determined from Phase 1b of the study). Participants received a total of 7 SC monthly doses of BOS161721 on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.24', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2558', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment Difference (BOS161721-Placebo)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.0', 'ciLowerLimit': '-0.02', 'ciUpperLimit': '0.12', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.04', 'estimateComment': 'This is based on LS Means', 'groupDescription': 'Statistical Analysis for Day 180', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Day 180', 'description': 'The SLICC/ACR damage index is a validated instrument to assess damage, defined as irreversible impairment, continuously persistent for 6 months (ascertained by clinical assessment), occurring since the onset of lupus, and it is based on a weighted scoring system. This index records damage occurring in participants with SLE regardless of cause, with demonstrated content, face, criterion, and discriminant validity. A score of 0=no damage. Total maximum score is 47 and increasing score indicates increasing disease severity.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: Defined as all participants who received at least 1 dose (partial or complete) of study treatment and had at least 1 evaluable post baseline efficacy evaluation. Here, overall number of participants analyzed signifies only the participants with available data for the outcome measure.'}, {'type': 'SECONDARY', 'title': 'Phase 2: Time to Medication Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: Placebo', 'description': 'Participants were randomized to receive a SC dose of placebo (as determined from Phase 1b of the study). Participants received a total of 7 SC monthly doses of placebo on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270.'}, {'id': 'OG001', 'title': 'Phase 2: BOS161721 120 mg', 'description': 'Participants were randomized to receive a 120 mg SC dose of BOS161721 (as determined from Phase 1b of the study). Participants received a total of 7 SC monthly doses of BOS161721 on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median was not established based on the number of medication failures observed.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median was not established based on the number of medication failures observed.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.0479', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.39', 'ciLowerLimit': '0.18', 'ciUpperLimit': '0.88', 'estimateComment': 'Hazard rate of BOS161721 120 mg / Hazard rate of placebo', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to Day 270', 'description': 'Participants who received prohibited medications or undergo unallowable corticosteroid (CS) usage were considered "medication failures".', 'unitOfMeasure': 'Days', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: Defined as all participants who received at least 1 dose (partial or complete) of study treatment and had at least 1 evaluable post baseline efficacy evaluation.'}, {'type': 'SECONDARY', 'title': 'Mean Percent Change in CS Administration From the Baseline Day 0 Dose Through Day 210 in Participants Receiving ≥ 7.5 mg/Day Prednisone Equivalent at Day 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: Placebo', 'description': 'Participants were randomized to receive a SC dose of placebo (as determined from Phase 1b of the study). Participants received a total of 7 SC monthly doses of placebo on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270.'}, {'id': 'OG001', 'title': 'Phase 2: BOS161721 120 mg', 'description': 'Participants were randomized to receive a 120 mg SC dose of BOS161721 (as determined from Phase 1b of the study). Participants received a total of 7 SC monthly doses of BOS161721 on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270.'}], 'classes': [{'categories': [{'measurements': [{'value': '-36.61', 'spread': '22.389', 'groupId': 'OG000'}, {'value': '-21.49', 'spread': '26.950', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Day 210', 'description': 'The percent reduction in CS administration from Day 0 through Day 210 was determined based on the average daily CS usage.', 'unitOfMeasure': 'Percent Reduction in Dose (mg/day)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: Defined as all participants who received at least 1 dose (partial or complete) of study treatment and had at least 1 evaluable post baseline efficacy evaluation. Participants in the Full Analysis Set who received \\>= 7.5 mg/day prednisone equivalent at Day 0 were included. Here, overall number of participants analyzed signifies only the participants with available data for the outcome measure.'}, {'type': 'SECONDARY', 'title': 'Phase 2: Duration of Longest SRI-4 Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: Placebo', 'description': 'Participants were randomized to receive a SC dose of placebo (as determined from Phase 1b of the study). Participants received a total of 7 SC monthly doses of placebo on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270.'}, {'id': 'OG001', 'title': 'Phase 2: BOS161721 120 mg', 'description': 'Participants were randomized to receive a 120 mg SC dose of BOS161721 (as determined from Phase 1b of the study). Participants received a total of 7 SC monthly doses of BOS161721 on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270.'}], 'classes': [{'categories': [{'measurements': [{'value': '119.8', 'spread': '68.26', 'groupId': 'OG000'}, {'value': '124.2', 'spread': '68.48', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.7898', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment Difference (BOS161721-Placebo)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '4.4', 'ciLowerLimit': '-22.92', 'ciUpperLimit': '31.70', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '16.40', 'estimateComment': 'This is based on LS Means', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Up to Day 270', 'description': 'The SRI-4 is a composite index of SLE disease improvement that consists of scores derived from SLEDAI-2K, BILAG 2004 Index and PGA. Response based on the SRI-4 is defined by: 1) ≥ 4-point reduction in the SLEDAI-2K total score; 2) no new severe disease activity (BILAG A organ score) or more than 1 new moderate organ score (BILAG B) compare with baseline; and 3) no deterioration from baseline in the PGA by ≥ 30 millimeters. The total SLEDAI-2K score falls between 0 and 105, with higher scores representing increased disease activity. The PGA is used to assess Investigator\'s general impression on the patient\'s overall status of SLE disease activity via visual analogue scale (100 mm) with 0 being "very good, asymptomatic and no limitation of normal activities" with 100 mm being "most severe possible disease ever seen in all SLE patients". The SRI-4 response in participants with moderate to severe SLE is associated with broad improvements in clinical and participant-reported outcomes.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: Defined as all participants who received at least 1 dose (partial or complete) of study treatment and had at least 1 evaluable post baseline efficacy evaluation.'}, {'type': 'SECONDARY', 'title': 'Phase 2: Time to First BILAG Flare (≥ 1 New or Recurrent BILAG A or > 1 New or Recurrent BILAG B) Relative to Baseline Through Day 210', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: Placebo', 'description': 'Participants were randomized to receive a SC dose of placebo (as determined from Phase 1b of the study). Participants received a total of 7 SC monthly doses of placebo on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270.'}, {'id': 'OG001', 'title': 'Phase 2: BOS161721 120 mg', 'description': 'Participants were randomized to receive a 120 mg SC dose of BOS161721 (as determined from Phase 1b of the study). Participants received a total of 7 SC monthly doses of BOS161721 on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median was not established based on the number of BILAG flares observed.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median was not established based on the number of BILAG flares observed.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.0083', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.33', 'ciLowerLimit': '0.16', 'ciUpperLimit': '0.68', 'estimateComment': 'Hazard rate of BOS161721 120mg / Hazard rate of placebo', 'statisticalMethod': 'Log-Rank Test (2-Sided)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline; Day 210', 'description': "The BILAG-2004 index is an organ-specific 97-question assessment based on the principle of the doctor's intent to treat. Only clinical features attributable to SLE disease activity were recorded and based on the participant's condition in the last 4 weeks compared with the previous 4 weeks. It was scored as not present (0), improved (1), the same (2), worse (3), or new (4). Disease activity was graded separately for 9 body systems to 5 different grades (A to E) as follows: A is very active disease, B is moderate activity, C is mild stable disease, D is inactive now but previously active, and E indicates the organ was never involved. A shift from BILAG-2004 Grade A or B to a lower grade indicates a clinically relevant change in disease activity as the BILAG-2004 grades mirror the decision points for treatment interventions.", 'unitOfMeasure': 'Days', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: Defined as all participants who received at least 1 dose (partial or complete) of study treatment and had at least 1 evaluable post baseline efficacy evaluation.'}, {'type': 'SECONDARY', 'title': 'Phase 2: Number of Participants With AEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: Placebo', 'description': 'Participants were randomized to receive a SC dose of placebo (as determined from Phase 1b of the study). Participants received a total of 7 SC monthly doses of placebo on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270.'}, {'id': 'OG001', 'title': 'Phase 2: BOS161721 120 mg', 'description': 'Participants were randomized to receive a 120 mg SC dose of BOS161721 (as determined from Phase 1b of the study). Participants received a total of 7 SC monthly doses of BOS161721 on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270.'}], 'classes': [{'title': 'Any TEAE', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}]}, {'title': 'Related TEAE', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Serious TEAE', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Related Serious TEAE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any CTCAE Grade 2 or Higher TEAE', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}, {'title': 'Any Related CTCAE Grade 2 or Higher TEAE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Any CTCAE Grade 3 TEAE', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Any Related CTCAE Grade 3 or Higher TEAE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any CTCAE Grade 4 TEAE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Related CTCAE Grade 4 TEAE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'TEAE Leading to Discontinuation of Study Treatment', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related TEAE Leading to Discontinuation of Study Treatment', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'TEAE of Special Interest', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Related TEAE of Special Interest', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Dose-Limiting Toxicity', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related Dose-Limiting Toxicity', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'TEAE Resulting in Death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related TEAE Resulting in Death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Injection Site Reaction', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Day 270', 'description': 'The safety and tolerability of repeat doses of BOS161721 (120 mg) administered SC were assessed in adult participants with moderate to severe SLE on limited background standard of care treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set (SS): Defined as all participants who received at least 1 dose (partial or complete) of study treatment and had at least one evaluable post-baseline safety evaluation.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Phase 1b: Placebo', 'description': 'Participants were randomized to receive subcutaneous (SC) dose of placebo. Participants received a total of 7 SC monthly doses of placebo on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits at Days 210, 240, and 270.'}, {'id': 'FG001', 'title': 'Phase 1b: Cohort 1: BOS161721 20 mg', 'description': 'Participants were randomized to receive a 20 mg SC dose of BOS161721. Participants received a total of 7 SC monthly doses of BOS161721 on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270.'}, {'id': 'FG002', 'title': 'Phase 1b: Cohort 2: BOS161721 60 mg', 'description': 'Participants were randomized to receive a 60 mg SC dose of BOS161721. Participants received a total of 7 SC monthly doses of BOS161721 on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270'}, {'id': 'FG003', 'title': 'Phase 1b: Cohort 3: BOS161721 120 mg', 'description': 'Participants were randomized to receive a 120 mg SC dose of BOS161721. Participants received a total of 7 SC monthly doses of BOS161721 on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270'}, {'id': 'FG004', 'title': 'Phase 2: Placebo', 'description': 'Participants were randomized to receive a SC dose of placebo (as determined from Phase 1b of the study). Participants received a total of 7 SC monthly doses of placebo on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270.'}, {'id': 'FG005', 'title': 'Phase 2: BOS161721 120 mg', 'description': 'Participants were randomized to receive a 120 mg SC dose of BOS161721 (as determined from Phase 1b of the study). Participants received a total of 7 SC monthly doses of BOS161721 on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'groupId': 'FG004', 'numSubjects': '37'}, {'groupId': 'FG005', 'numSubjects': '76'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'groupId': 'FG004', 'numSubjects': '30'}, {'groupId': 'FG005', 'numSubjects': '71'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '7'}, {'groupId': 'FG005', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'Phase 1b: Pregnancy, Phase 2: fear of COVID-19 or local restrictions', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '3'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Decision by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The study was conducted in in the United States, Georgia, Bulgaria, Hungary, Poland, Argentina, Columbia, Mexico, Romania, Ukraine, Philippines and Peru. The first participant was screened on 10 January 2018 and last participant last visit occurred on 26, November 2020.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '37', 'groupId': 'BG004'}, {'value': '76', 'groupId': 'BG005'}, {'value': '143', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Phase 1b: Placebo', 'description': 'Participants were randomized to receive a subcutaneous (SC) dose of placebo. Participants received a total of 7 SC monthly doses of placebo on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits at Days 210, 240, and 270.'}, {'id': 'BG001', 'title': 'Phase 1b: Cohort 1: BOS161721 20 mg', 'description': 'Participants were randomized to receive a 20 mg SC dose of BOS161721. Participants received a total of 7 SC monthly doses of BOS161721 on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270.'}, {'id': 'BG002', 'title': 'Phase 1b: Cohort 2: BOS161721 60 mg', 'description': 'Participants were randomized to receive a 60 mg SC dose of BOS161721. Participants received a total of 7 SC monthly doses of BOS161721 on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270'}, {'id': 'BG003', 'title': 'Phase 1b: Cohort 3: BOS161721 120 mg', 'description': 'Participants were randomized to receive a 120 mg SC dose of BOS161721. Participants received a total of 7 SC monthly doses of BOS161721 on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270'}, {'id': 'BG004', 'title': 'Phase 2: Placebo', 'description': 'Participants were randomized to receive a SC dose of placebo (as determined from Phase 1b of the study). Participants received a total of 7 SC monthly doses of placebo on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270.'}, {'id': 'BG005', 'title': 'Phase 2: BOS161721 120 mg', 'description': 'Participants were randomized to receive a 120 mg SC dose of BOS161721 (as determined from Phase 1b of the study). Participants received a total of 7 SC monthly doses of BOS161721 on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270.'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'title': 'Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '37', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '44', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '48.1', 'spread': '17.67', 'groupId': 'BG000'}, {'value': '45.7', 'spread': '12.52', 'groupId': 'BG004'}, {'value': '46.1', 'spread': '13.25', 'groupId': 'BG006'}]}]}, {'title': 'BOS161721', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '76', 'groupId': 'BG005'}, {'value': '99', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '50.0', 'spread': '8.51', 'groupId': 'BG001'}, {'value': '49.3', 'spread': '11.31', 'groupId': 'BG002'}, {'value': '47.3', 'spread': '10.43', 'groupId': 'BG003'}, {'value': '44.5', 'spread': '12.52', 'groupId': 'BG005'}, {'value': '45.5', 'spread': '12.07', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'In order to present the total data, the data for placebo (44 participants) and the data for BOS161721 (99 participants) have been presented in separate rows.'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '37', 'groupId': 'BG004'}, {'value': '76', 'groupId': 'BG005'}, {'value': '143', 'groupId': 'BG006'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '36', 'groupId': 'BG004'}, {'value': '69', 'groupId': 'BG005'}, {'value': '133', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '7', 'groupId': 'BG005'}, {'value': '10', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '37', 'groupId': 'BG004'}, {'value': '76', 'groupId': 'BG005'}, {'value': '143', 'groupId': 'BG006'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}, {'value': '32', 'groupId': 'BG005'}, {'value': '53', 'groupId': 'BG006'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}, {'value': '44', 'groupId': 'BG005'}, {'value': '90', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '37', 'groupId': 'BG004'}, {'value': '76', 'groupId': 'BG005'}, {'value': '143', 'groupId': 'BG006'}]}], 'categories': [{'title': 'American Indian or Alaska Native', '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': 'Asian', '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': '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': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '7', 'groupId': 'BG005'}, {'value': '18', 'groupId': 'BG006'}]}, {'title': 'White', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}, {'value': '45', 'groupId': 'BG005'}, {'value': '90', 'groupId': 'BG006'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}, {'value': '24', 'groupId': 'BG005'}, {'value': '35', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-04-30', 'size': 10329549, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-11-11T02:21', 'hasProtocol': True}, {'date': '2021-04-23', 'size': 4668583, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-11-11T02:22', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 143}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2020-11-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-16', 'studyFirstSubmitDate': '2017-12-08', 'resultsFirstSubmitDate': '2021-11-24', 'studyFirstSubmitQcDate': '2017-12-08', 'lastUpdatePostDateStruct': {'date': '2022-03-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-02-16', 'studyFirstPostDateStruct': {'date': '2017-12-13', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-03-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Phase 1b: Number of Participants With Adverse Events (AEs)', 'timeFrame': 'Up to Day 270', 'description': 'The safety, tolerability, and immunogenicity of repeat doses of BOS161721 (20, 60, and 120 mg) administered SC were assessed in adult participants with moderate to severe SLE on limited background standard of care treatment, in order to estimate the optimal dose.'}, {'measure': 'Phase 2: Number of Participants With an SLE Responder Index 4 (SRI-4) Response at Day 210', 'timeFrame': 'Day 210', 'description': "The SRI-4 is a composite index of SLE disease improvement that consists of scores derived from the SLE Disease Activity Index 2000 (SLEDAI-2K), the British Isles Lupus Assessment Group (BILAG) 2004 Index and the Physician's Global Assessment (PGA). Response based on the SRI-4 is defined by: 1) ≥ 4-point reduction in the SLEDAI-2K total score; 2) no new severe disease activity (BILAG A organ score) or more than 1 new moderate organ score (BILAG B) compared with baseline; and 3) no deterioration from baseline in the PGA by ≥ 30 millimeters. The SLEDAI-2K total score falls between 0 and 105, with higher scores representing increased disease activity.The SRI-4 response in participants with moderate to severe SLE is associated with broad improvements in clinical and participant-reported outcomes."}], 'secondaryOutcomes': [{'measure': 'Phase 1b: Maximum Observed Concentration (Cmax)', 'timeFrame': 'Pre-dose: Days 0, 30, 60, 90, 120, 150, and 180. Post-dose: Days 0, 7, 15, 30, 180, 187, 195, 210, 240, and 270. Post-dose samples were collected at 4, 8, and 24 hours after study drug administration on Days 0, 30, and 180', 'description': 'The PK of BOS161721 was characterized and the optimal dose of BOS161721 was selected based on safety, tolerability, PK and PD data in participants with moderate to severe SLE.'}, {'measure': 'Phase 1b: First Time to Maximum Concentration (Tmax)', 'timeFrame': 'Pre-dose: Days 0, 30, 60, 90, 120, 150, and 180. Post-dose: Days 0, 7, 15, 30, 180, 187, 195, 210, 240, and 270. Post-dose samples were collected at 4, 8, and 24 hours after study drug administration on Days 0, 30, and 180', 'description': 'The PK of BOS161721 was characterized and the optimal dose of BOS161721 was selected based on safety, tolerability, PK and PD data in participants with moderate to severe SLE.'}, {'measure': 'Phase 1b: The Area Under the Plasma Concentration Versus Time Curve, From Time 0 to the Last Quantifiable Concentration (AUClast)', 'timeFrame': 'Pre-dose: Days 0, 30, 60, 90, 120, 150, and 180. Post-dose: Days 0, 7, 15, 30, 180, 187, 195, 210, 240, and 270. Post-dose samples were collected at 4, 8, and 24 hours after study drug administration on Days 0, 30, and 180', 'description': 'The PK of BOS161721 was characterized and the optimal dose of BOS161721 was selected based on safety, tolerability, PK and PD data in participants with moderate to severe SLE.'}, {'measure': 'Phase 1b: Terminal Elimination Half-life (t1/2)', 'timeFrame': 'Pre-dose: Days 0, 30, 60, 90, 120, 150, and 180. Post-dose: Days 0, 7, 15, 30, 180, 187, 195, 210, 240, and 270. Post-dose samples were collected at 4, 8, and 24 hours after study drug administration on Days 0, 30, and 180', 'description': 'The PK of BOS161721 was characterized and the optimal dose of BOS161721 was selected based on safety, tolerability, PK and PD data in participants with moderate to severe SLE.'}, {'measure': 'Phase 1b: Apparent Plasma Clearance After Extravascular Administration (CL/F)', 'timeFrame': 'Pre-dose: Days 0, 30, 60, 90, 120, 150, and 180. Post-dose: Days 0, 7, 15, 30, 180, 187, 195, 210, 240, and 270. Post-dose samples were collected at 4, 8, and 24 hours after study drug administration on Days 0, 30, and 180', 'description': 'The PK of BOS161721 was characterized and the optimal dose of BOS161721 was selected based on safety, tolerability, PK and PD data in participants with moderate to severe SLE.'}, {'measure': 'Phase 1b: Apparent Volume of Distribution After Extravascular Administration (Vz/F)', 'timeFrame': 'Pre-dose: Days 0, 30, 60, 90, 120, 150, and 180. Post-dose: Days 0, 7, 15, 30, 180, 187, 195, 210, 240, and 270. Post-dose samples were collected at 4, 8, and 24 hours after study drug administration on Days 0, 30, and 180', 'description': 'The PK of BOS161721 was characterized and the optimal dose of BOS161721 was selected based on safety, tolerability, PK and PD data in participants with moderate to severe SLE.'}, {'measure': 'Phase 1b: Mean Change From Baseline in Phosphorylated Signal Transducer and Activator of Transcription 3 (pSTAT3)', 'timeFrame': 'Baseline (Day 0); Days 30, 44, 60, and 90 (pre-dose [trough] samples only)', 'description': 'The optimal dose of BOS161721 was selected based on safety, tolerability, PK and pharmacodynamic (PD) data in participants with moderate to severe SLE.'}, {'measure': 'Phase 1b: Mean Change From Baseline in Complement 3 (C3) and Complement (C4) Levels', 'timeFrame': 'Baseline (Day 0); Day 210', 'description': 'The optimal dose of BOS161721 was selected based on safety, tolerability, PK and PD data in participants with moderate to severe SLE.'}, {'measure': 'Phase 1b: Mean Change From Baseline in Leukocyte Immunophenotype', 'timeFrame': 'Baseline (Day 0); Day 180', 'description': 'The optimal dose of BOS161721 was selected based on safety, tolerability, PK and PD data in participants with moderate to severe SLE.'}, {'measure': 'Phase 1b: Mean Change From Baseline in Anti-double-stranded DNA (dsDNA) Autoantibodies at Each Visit', 'timeFrame': 'Baseline (Day 0); Days 30, 60, 90, 120, 150, 180, 210, 240, and 270', 'description': 'The optimal dose of BOS161721 was selected based on safety, tolerability, PK and PD data in participants with moderate to severe SLE..'}, {'measure': "Phase 1b: Mean Change From Baseline in Anti-Sjögren's Syndrome A and B (SSA, SSB)", 'timeFrame': 'Baseline (Day 0); Day 180', 'description': 'The optimal dose of BOS161721 was selected based on safety, tolerability, PK and PD data in subjects with moderate to severe SLE.'}, {'measure': 'Phase 1b: Mean Change From Baseline in Anti-Smith Antibody (Sm)', 'timeFrame': 'Baseline (Day 0); Day 180', 'description': 'The optimal dose of BOS161721 was selected based on safety, tolerability, PK and PD data in subjects with moderate to severe SLE.'}, {'measure': 'Phase 1b: Mean Change From Baseline in Antiphospholipid (APL) Autoantibodies (Beta 2 Glycoprotein, Cardiolipin IgG)', 'timeFrame': 'Baseline (Day 0); Day 180', 'description': 'The optimal dose of BOS161721 was selected based on safety, tolerability, PK and PD data in participants with moderate to severe SLE.'}, {'measure': 'Phase 1b: Mean Change From Baseline in Abrogation of IL-21 Gene Signature', 'timeFrame': 'Baseline (Day 0); Days 15, 90, 180, and 270', 'description': 'The optimal dose of BOS161721 was selected based on safety, tolerability, PK and PD data in participants with moderate to severe SLE.'}, {'measure': 'Phase 2: Number of Participants With an SRI-4, SRI-5, and SRI-6 Response at Each Visit', 'timeFrame': 'Days 30, 60, 90, 120, 150, 180, 210, 240, and 270', 'description': "The SRI-4 is a composite index of SLE disease improvement that consists of scores derived from the SLE Disease Activity Index 2000 (SLEDAI-2K) and the British Isles Lupus Assessment Group (BILAG) 2004 Index. Response based on the SRI-4 is defined by: 1) ≥ 4-point reduction in the SLEDAI-2K global score; 2) no new severe disease activity (BILAG A organ score) or more than 1 new moderate organ score (BILAG B); and 3) no deterioration from baseline in the Physician's Global Assessment (PGA) by ≥ 30 millimeters. The SRI-4 response in participants with moderate to severe SLE is associated with broad improvements in clinical and participant-reported outcomes. SRI-5 and SRI-6 are composite indices of SLE disease improvement that consist of scores derived from the SLEDAI-2K and the BILAG 2004 Index. The SRI-5 and SRI-6 are computed with a minimal five-point or six-point improvement in SLEDAI-2K being required, respectively."}, {'measure': 'Phase 2: Number of Participants With a Sustained Reduction From Baseline of Oral Corticosteroid (CS) (≤ 7.5 mg/Day and < Day 0 Dose) Between Day 150 and Day 210', 'timeFrame': 'Day 150 to Day 210', 'description': 'Effect of BOS161721 compared with placebo for response on clinical indicators of SLE activity was assessed in adult participants with moderate to severe SLE on limited background standard of care treatment.'}, {'measure': 'Phase 2: Number of Participants With New or Recurrent BILAG Flares (≥ 1 Qualifying BILAG A or > 1 Qualifying BILAG B) Through Day 210', 'timeFrame': 'Days 30, 60, 90, 120, 150, 180, 210', 'description': "The BILAG-2004 index is an organ-specific 97-question assessment based on the principle of the doctor's intent to treat. Only clinical features attributable to SLE disease activity were recorded and based on the participant's condition in the last 4 weeks compared with the previous 4 weeks. It was scored as not present (0), improved (1), the same (2), worse (3), or new (4). Disease activity was graded separately for 9 body systems to 5 different grades (A to E) as follows: A is very active disease, B is moderate activity, C is mild stable disease, D is inactive now but previously active, and E indicates the organ was never involved. A shift from BILAG-2004 Grade A or B to a lower grade indicates a clinically relevant change in disease activity as the BILAG-2004 grades mirror the decision points for treatment interventions."}, {'measure': "Phase 2: Number of Participants With Physician's Global Assessment (PGA) Worsening", 'timeFrame': 'Days 30, 60, 90, 120, 150, 180, and 210', 'description': 'The PGA is used to assess Investigator\'s general impression on the patient\'s overall status of SLE disease activity via visual analogue scale (100 mm) with 0 being "very good, asymptomatic and no limitation of normal activities" with 100 mm being "most severe possible disease ever seen in all SLE patients". PGA worsening is defined as an increase of ≥ 30 mm from baseline.'}, {'measure': 'Phase 2: Number of Participants With a BILAG-based Composite Lupus Assessment (BICLA) Response at Day 210', 'timeFrame': 'Day 210', 'description': "The BICLA is a responder index developed to measure response to therapy, and it includes scores from the BILAG, SLEDAI-2K, and Physician's Global Assessment (PGA). BICLA response is defined as: 1) at least 1 gradation of improvement in baseline BILAG 2004 scores in all body systems with moderate disease activity at entry (eg, all B \\[moderate disease\\] scores falling to C \\[mild\\], or D \\[no activity\\]); 2) no new BILAG A or more than 1 new BILAG B scores; 3) no worsening of total SLEDAI-2K score from baseline; 4) ≤ 10% deterioration in PGA score; and 5) no treatment failure. The PGA is measured on a 0 to 100 mm scale with score 0 to be No Disease Activity and score 100 to be the most Severe Disease Activity."}, {'measure': 'Phase 2: Number of Participants With a Cutaneous Lupus Erythematosus Area and Severity Index (CLASI) Response at Day 210', 'timeFrame': 'Day 210', 'description': 'The CLASI is a comprehensive tool for assessment of disease activity (CLASI-A) in cutaneous lupus, shown to be valid, reliable, and sensitive to changes in disease activity. Response is defined as at least 50% improvement from baseline in "A" scores. This assessment was applied to all participants as all were required to have cutaneous disease activity. 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': 'Phase 2: Number of Participants With Medication Failures', 'timeFrame': 'Days 30, 60, 90, 120, 150, 180, and 210', 'description': 'Effect of BOS161721 compared with placebo for response on clinical indicators of SLE activity was assessed in adult participants with moderate to severe SLE on limited background standard of care treatment.'}, {'measure': 'Phase 2: Mean Change From Baseline in CLASI at Day 210', 'timeFrame': 'Baseline, Day 210', 'description': 'The CLASI is a comprehensive tool for the assessment of disease activity (CLASI-A) and damage (CLASI-B) in cutaneous lupus, shown to be valid, reliable, and sensitive to changes in disease activity. Response is defined as 50% improvement from baseline in "A" or "B" scores. This assessment was applied to all participants as all were required to have cutaneous disease activity. The total score represents the sum of the individual scores and ranges from 0 to 70 (CLASI-A) and 0 to 58 (CLASI-B). Higher scores are awarded for more severe manifestations. Change from baseline was calculated as the post-baseline value minus the baseline value.'}, {'measure': 'Phase 2: Mean Change From Baseline in PGA', 'timeFrame': 'Baseline, Day 210', 'description': 'The PGA is used to assess Investigator\'s general impression on the patient\'s overall status of SLE disease activity via visual analogue scale (100 mm) with 0 being "very good, asymptomatic and no limitation of normal activities" with 100 mm being "most severe possible disease ever seen in all SLE patients".'}, {'measure': 'Phase 2: Mean Change From Baseline in the Total Number of Swollen Joints, Tender Joints, and Active Joints (Swelling and Tenderness in the Same Joint) in the American College of Rheumatology-28 (ACR-28) Joint Count', 'timeFrame': 'Baseline, Day 210', 'description': 'The ACR-28 joint count evaluated the number of tender and swollen joints in the shoulder, elbow, wrist, hand, and knee joints. Joints of the feet were excluded. Change from baseline was calculated as the post-baseline value minus the baseline value.'}, {'measure': 'Phase 2: Mean Change From Baseline in SLEDAI-2K at Day 210', 'timeFrame': 'Baseline, Day 210', 'description': 'The SLEDAI-2K is a validated instrument that measures disease activity in SLE participants at the time of the visit and in the previous 30 days. It is a global index and includes 24 clinical and laboratory variables that are weighted by the type of manifestation, but not by severity. The total score falls between 0 and 105, with higher scores representing increased disease activity. A SLEDAI -2K of 6 or more generally represents moderately to severely active disease.\n\nChange from baseline was calculated as the post-baseline value minus the baseline value.'}, {'measure': 'Phase 2: Mean Change From Baseline in Systemic Lupus International Collaborating Clinics/American College of Rheumatology (SLICC/ACR) Damage Index', 'timeFrame': 'Baseline; Day 180', 'description': 'The SLICC/ACR damage index is a validated instrument to assess damage, defined as irreversible impairment, continuously persistent for 6 months (ascertained by clinical assessment), occurring since the onset of lupus, and it is based on a weighted scoring system. This index records damage occurring in participants with SLE regardless of cause, with demonstrated content, face, criterion, and discriminant validity. A score of 0=no damage. Total maximum score is 47 and increasing score indicates increasing disease severity.'}, {'measure': 'Phase 2: Time to Medication Failure', 'timeFrame': 'Up to Day 270', 'description': 'Participants who received prohibited medications or undergo unallowable corticosteroid (CS) usage were considered "medication failures".'}, {'measure': 'Mean Percent Change in CS Administration From the Baseline Day 0 Dose Through Day 210 in Participants Receiving ≥ 7.5 mg/Day Prednisone Equivalent at Day 0', 'timeFrame': 'Baseline; Day 210', 'description': 'The percent reduction in CS administration from Day 0 through Day 210 was determined based on the average daily CS usage.'}, {'measure': 'Phase 2: Duration of Longest SRI-4 Response', 'timeFrame': 'Up to Day 270', 'description': 'The SRI-4 is a composite index of SLE disease improvement that consists of scores derived from SLEDAI-2K, BILAG 2004 Index and PGA. Response based on the SRI-4 is defined by: 1) ≥ 4-point reduction in the SLEDAI-2K total score; 2) no new severe disease activity (BILAG A organ score) or more than 1 new moderate organ score (BILAG B) compare with baseline; and 3) no deterioration from baseline in the PGA by ≥ 30 millimeters. The total SLEDAI-2K score falls between 0 and 105, with higher scores representing increased disease activity. The PGA is used to assess Investigator\'s general impression on the patient\'s overall status of SLE disease activity via visual analogue scale (100 mm) with 0 being "very good, asymptomatic and no limitation of normal activities" with 100 mm being "most severe possible disease ever seen in all SLE patients". The SRI-4 response in participants with moderate to severe SLE is associated with broad improvements in clinical and participant-reported outcomes.'}, {'measure': 'Phase 2: Time to First BILAG Flare (≥ 1 New or Recurrent BILAG A or > 1 New or Recurrent BILAG B) Relative to Baseline Through Day 210', 'timeFrame': 'Baseline; Day 210', 'description': "The BILAG-2004 index is an organ-specific 97-question assessment based on the principle of the doctor's intent to treat. Only clinical features attributable to SLE disease activity were recorded and based on the participant's condition in the last 4 weeks compared with the previous 4 weeks. It was scored as not present (0), improved (1), the same (2), worse (3), or new (4). Disease activity was graded separately for 9 body systems to 5 different grades (A to E) as follows: A is very active disease, B is moderate activity, C is mild stable disease, D is inactive now but previously active, and E indicates the organ was never involved. A shift from BILAG-2004 Grade A or B to a lower grade indicates a clinically relevant change in disease activity as the BILAG-2004 grades mirror the decision points for treatment interventions."}, {'measure': 'Phase 2: Number of Participants With AEs', 'timeFrame': 'Up to Day 270', 'description': 'The safety and tolerability of repeat doses of BOS161721 (120 mg) administered SC were assessed in adult participants with moderate to severe SLE on limited background standard of care treatment.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Adults', 'BOS161721', 'standard of care', 'moderately to severely active Systemic Lupus Erythematosus'], 'conditions': ['Systemic Lupus Erythematosus']}, 'referencesModule': {'references': [{'pmid': '40465397', 'type': 'DERIVED', 'citation': 'Ahmad SB, Jefferson JA. Targeting B Cells and Plasma Cells in Glomerular Disease. J Am Soc Nephrol. 2025 Jun 4;36(9):1844-1857. doi: 10.1681/ASN.0000000772.'}]}, 'descriptionModule': {'briefSummary': 'This study will be conducted to assess the safety, tolerability, and immunogenicity of repeat doses of BOS161721 (20 milligrams \\[mg\\], 60 mg, and 120 mg) administered subcutaneously in adult participants with moderately to severely active Systemic Lupus Erythematosus (SLE) on limited background standard of care treatment, in order to estimate the optimal dose.\n\nBOS161721 at the chosen dose will be compared to placebo for response on the SLE Responder Index 4, with sustained reduction of oral corticosteroids, in the same participant population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women, ages 18 to 70 years, inclusive\n* Participants must be mentally capable of giving consent and there must be evidence of a personally signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study\n* Participants must have Systemic Lupus Erythematosus (SLE) as defined by meeting 4 of the Systemic Lupus International Collaborating Clinics classification criteria for SLE (with at least 1 clinical and 1 immunologic criterion OR Lupus nephritis as the sole clinical criterion in the presence of anti-nuclear antibodies (ANA) or anti-double stranded deoxyribonucleic acid (dsDNA) antibodies), either sequentially or simultaneously\n* At screening, participants must have at least 1 of the following:\n\n 1. Elevated ANA ≥ 1:80 via immunofluorescent assay at the central laboratory\n 2. Positive anti-dsDNA or anti-Smith (anti-Sm) above the normal level as determined by the central laboratory\n* At screening, the total Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score must be ≥ 8, including points from at least 1 of the following clinical components:\n\n a. Arthritis, rash, myositis, mucosal ulcers, pleurisy, pericarditis, and vasculitis Note: Points from lupus headache and organic brain syndrome will also be excluded from qualifying total and clinical SLEDAI-2K scores at screening and Day 0.\n* A clinical SLEDAI-2K score of ≥ 6 at screening at Day 0. Clinical SLEDAI-2K score is defined as follows:\n\n 1. Contains points from arthritis, rash, myositis, mucosal ulcers, pleurisy, pericarditis, or vasculitis\n 2. Excludes parameters which require central laboratory results: hematuria, pyuria, urinary casts, proteinuria, positive anti-dsDNA, decreased complement, thrombocytopenia, and leukopenia Note: Points from lupus headache and organic brain syndrome will also be excluded from qualifying total and clinical SLEDAI-2K scores at screening and Day 0.\n* Participants must have at least 1 qualifying A or 2Bs from the following manifestations of SLE, as defined by the British Isles Lupus Assessment Group (BILAG) criteria as modified for use in this study, which must be confirmed by the central data reviewer:\n\n 1. BILAG A or B score in the mucocutaneous body system. If a BILAG B score is due to BILAG number 6, mild skin eruption, the CLASI activity score including erythema and scale/hypertrophy must be ≥ 3 excluding points from mucosal ulcers and alopecia.\n 2. BILAG A or B score in the musculoskeletal body system due to active polyarthritis Note: Hips, shoulders, back, neck, and temporomandibular joints do not count towards the total number of joints with active synovitis.\n\nIf only one "B" and no "A" score is present in the mucocutaneous body system or in the musculoskeletal body system due to arthritis, then at least 1 "B" must be present in at least 1 other body system for a total of 2 "B" BILAG body system scores.\n\n\\- Participants must be currently receiving at least 1 of the following:\n\n1. Administration for a minimum of 12 weeks, and a stable dose for at least 56 days (8 weeks prior to Day 0) of the following permitted steroid sparing agents: azathioprine (AZA), mycophenolate mofetil or mycophenolic acid, chloroquine, hydroxychloroquine, or methotrexate\n2. If AZA, myocophenolate mofetil, mycophenolic acid, hydroxychloroquine, or MTX were discontinued prior to screening, the washout period must be ≥ 12 weeks.\n3. Corticosteroids (CSs) (prednisone or prednisone-equivalent) at a stable dose of up to 30 mg/day for at least 6 weeks prior to Day 0\n\ni. For participants whose only SLE treatment is CSs, the stable CS dose must be ≥ 10 mg/day for at least 6 weeks prior to Day 0 and no more than 30 mg/day at the time of randomization.\n\nii. Topical steroids may be used, but the dose must be stable for at least 6 weeks prior to Day 0. PRN topical steroids are not permitted.\n\n* Women of childbearing potential (WOCBP):\n\n 1. Must have a negative serum pregnancy test at screening. Urine pregnancy test must be negative prior to first dose\n 2. Must not be breastfeeding\n 3. Must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug plus 52 weeks\n* Men who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug plus 52 weeks\n* Participants must demonstrate willingness and ability to comply with the scheduled study visits, treatment plans, laboratory tests, and other procedures\n\nExclusion Criteria:\n\nParticipants presenting with any of the following will not be included in this study:\n\n* Drug-induced SLE, rather than "idiopathic" SLE\n* Other systemic autoimmune disease (eg, erosive arthritis, rheumatoid arthritis \\[RA\\], multiple sclerosis \\[MS\\], systemic sclerosis, or vasculitis not related to SLE). RA-Lupus overlap (Rupus), and secondary Sjogren syndrome are allowed.\n* Any major surgery within 6 weeks of study drug administration (Day 0) or any elective surgery planned during the course of the study\n* Any history or risk for tuberculosis (TB), specifically those with:\n\n 1. Current clinical, radiographic, or laboratory evidence of active TB\n 2. History of active TB\n 3. Latent TB defined as positive QuantiFERON-TB Gold In Tube or other diagnostic test in the absence of clinical manifestations. Latent TB is not excluded if the participant has documented completion of adequate course of prophylactic treatment with regimen recommended by local health authority guideline, or the participant has started treatment with isoniazid, or other regimen recommended by local health authority guidelines for at least 1 month before Day 0 and continues to receive the prophylactic treatment during study until the treatment course is completed\n* Active or unstable lupus neuropsychiatric manifestations, including but not limited to any condition defined by BILAG A criteria, with the exception of mononeuritis multiplex and polyneuropathy, which are allowed\n* Severe proliferative lupus nephritis (World Health Organization Class III, IV), which requires or may require induction treatment with cytotoxic agents or high dose CSs\n* Concomitant illness that, in the opinion of the investigator or the Sponsor or their designee, is likely to require additional systemic glucocorticosteroid therapy during the study, (eg, asthma), is exclusionary. However, treatment for asthma with inhalational CSs therapy is allowed.\n* Use or planned use of concomitant medication outside of standard of baseline treatment for SLE from Day -1 or for any time during the study\n* Active and clinically significant infection (bacterial, fungal, viral, or other) within 60 days prior to first dose of study drug. Clinically significant is defined as requiring systemic parenteral antibiotics or hospitalization\n* A history of opportunistic infection, or a history of recurrent or severe disseminated herpes zoster or disseminated herpes simplex within the last 3 years\n* Chronic viral hepatitis B (HBV) and hepatitis C (HCV), unless participant received curative treatment for HCV and has a documented negative viral load, known human immunodeficiency virus (HIV), or acquired immunodeficiency syndrome (AIDS)-related illness\n* Cryptosporidium in the stool sample at screening\n* White blood cells \\< 1,200/millimeters cubed (mm\\^3) (1.2 × 10\\^9/Liter \\[L\\]) at screening\n* Absolute neutrophil count \\< 500/mm\\^3 at screening\n* CD4+ count \\< 150/microliter (µL) at screening\n* Platelets \\< 50,000/mm\\^3 (50 × 10\\^9/L) or \\< 35,000/mm\\^3 (35 × 10\\^9/L) if related to SLE, at screening\n* Hemoglobin \\< 8 grams per deciliter (g/dL) or \\< 7 g/dL at screening if related to SLE\n* Proteinuria \\> 3.0 g/day (3000 milligrams per day \\[mg/day\\]) at screening or equivalent level of proteinuria as assessed by protein/creatinine ratio (3 mg/mg or 339 milligrams per millimole \\[mg/mmol\\])\n* Serum creatinine \\> 2.0 mg/dL at screening or creatinine clearance \\< 40 milliliters per minute (mL/minute) based on Cockcroft-Gault calculation\n* Serum alanine aminotransferase and/or serum aspartate aminotransferase \\> 2 × the upper limit of normal (ULN) at screening, unless explicitly related to lupus based on the investigator\'s judgment\n* Creatinine kinase \\> 3.0 × ULN at screening unless related to lupus myositis\n* Total bilirubin \\> 1.5 × ULN at screening (unless related to Gilbert\'s syndrome)\n* Any other laboratory test results that, in the opinion of the Investigator or the Sponsor or Sponsor\'s designee, might place a participant at unacceptable risk for participating in this study\n* History of allergic or anaphylactic reaction to any therapeutic or diagnostic monoclonal antibodies (mAb) (eg, IgG protein) or molecules made of components of mAbs\n* History substance and/or alcohol abuse, or dependence within the past 1 year, at the investigator\'s judgment\n* History of cancer within the last 5 years (except for cutaneous basal cell or squamous cell cancer, or cervical cancer in situ resolved by excision)\n* Any other severe acute or chronic medical or psychiatric condition, including recent (within the past year) medical conditions (eg, cardiovascular conditions, respiratory illnesses) that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, Sponsor, or Sponsor\'s designee, would make the participant inappropriate for entry into this study\n* Investigational site staff members directly involved in the conduct of the trial and their family members, site staff members otherwise supervised by the investigator, or participants who are employees of the sponsor or directly involved in the conduct of the trial\n* Currently participating in, or who have participated in other interventional (drug or device) clinical study within 30 days or 5 half-lives of baseline, whichever is longer\n* Recent (within the past 12 months) or active suicidal ideation or behavior based on participant responding "yes" to question 3, 4, or 5 on the Columbia Suicide severity Rating Scale\n* Current or pending incarceration\n* Current or pending compulsory detainment for treatment of either a psychiatric or physical (eg, infectious disease) illness\n* Currently taking a total daily dose of \\> 30 mg morphine or morphine equivalent\n* Body mass index (BMI) ≥ 40.0'}, 'identificationModule': {'nctId': 'NCT03371251', 'briefTitle': 'Study of BOS161721 in Systemic Lupus Erythematosus (SLE) Patients on a Background of Limited Standard of Care', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boston Pharmaceuticals'}, 'officialTitle': 'A Randomized Double-Blind Phase 1b/2 Combined Staggered Multiple Dose Escalation Study of BOS161721 in Systemic Lupus Erythematosus (SLE) Patients on a Background of Limited Standard of Care', 'orgStudyIdInfo': {'id': 'BOS161721-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Phase 1b: BOS161721 20, 60, 120 mg', 'description': 'Participants will be randomized to receive a 20 milligram (mg), 60 mg, or 120 mg subcutaneous (SC) dose of BOS161721. Participants may receive a total of 7 SC monthly doses of BOS161721 on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270.', 'interventionNames': ['Drug: BOS161721']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Phase 1b: Placebo 20, 60, 120 mg', 'description': 'Participants will be randomized to receive a 20 mg, 60 mg, or 120 mg SC dose of placebo. Participants may receive a total of 7 SC monthly doses of placebo on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 2: BOS161721', 'description': 'Participants will be randomized to receive a 120 mg SC dose of BOS161721 (as determined from Phase 1b of the study). Participants may receive a total of 7 SC monthly doses of BOS161721 on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270.', 'interventionNames': ['Drug: BOS161721']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Phase 2: Placebo', 'description': 'Participants will be randomized to receive a 120 mg SC dose of placebo (as determined from Phase 1b of the study). Participants may receive a total of 7 SC monthly doses of placebo on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'BOS161721', 'type': 'DRUG', 'description': 'SC administration', 'armGroupLabels': ['Phase 1b: BOS161721 20, 60, 120 mg', 'Phase 2: BOS161721']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'SC administration', 'armGroupLabels': ['Phase 1b: Placebo 20, 60, 120 mg', 'Phase 2: Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36207', 'city': 'Anniston', 'state': 'Alabama', 'country': 'United States', 'facility': 'Pinnacle Research Group', 'geoPoint': {'lat': 33.65983, 'lon': -85.83163}}, {'zip': '92020-4124', 'city': 'El Cajon', 'state': 'California', 'country': 'United States', 'facility': 'TriWest Research Associates', 'geoPoint': {'lat': 32.79477, 'lon': -116.96253}}, {'zip': '90720-5403', 'city': 'Los Alamitos', 'state': 'California', 'country': 'United States', 'facility': 'Valerius Medical Group and Research Center', 'geoPoint': {'lat': 33.80307, 'lon': -118.07256}}, {'zip': '91360-3994', 'city': 'Thousand Oaks', 'state': 'California', 'country': 'United States', 'facility': 'Westlake Medical Research', 'geoPoint': {'lat': 34.17056, 'lon': -118.83759}}, {'zip': '33765-2616', 'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Research of West Florida', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '32713-2260', 'city': 'DeBary', 'state': 'Florida', 'country': 'United States', 'facility': 'Omega Research Consultants', 'geoPoint': {'lat': 28.88305, 'lon': -81.30868}}, {'zip': '33309-1715', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Centre for Rheumatology Immunology and Arthritis', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '32174', 'city': 'Ormond Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Millennium Research', 'geoPoint': {'lat': 29.28581, 'lon': -81.05589}}, {'zip': '34684', 'city': 'Palm Harbor', 'state': 'Florida', 'country': 'United States', 'facility': 'The Arthritis Center', 'geoPoint': {'lat': 28.07807, 'lon': -82.76371}}, {'zip': '33603', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Research of West Florida', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '60076-1238', 'city': 'Skokie', 'state': 'Illinois', 'country': 'United States', 'facility': 'Clinic of Robert Hozman/Clinical Investigation Specialists, Inc.', 'geoPoint': {'lat': 42.03336, 'lon': -87.73339}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University School of Medicine', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '48439', 'city': 'Grand Blanc', 'state': 'Michigan', 'country': 'United States', 'facility': 'Aa Mrc Llc', 'geoPoint': {'lat': 42.92753, 'lon': -83.62995}}, {'zip': '48910-8595', 'city': 'Lansing', 'state': 'Michigan', 'country': 'United States', 'facility': 'June DO PC', 'geoPoint': {'lat': 42.73253, 'lon': -84.55553}}, {'zip': '28204-3130', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Joint and Muscle Research Institute', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '38119-5214', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Ramesh C. Gupta M.D.', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '77089', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Accurate Clinical Research Inc', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': 'C1426BOR', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Hospital Militar Central - Servicio de Reumatología', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'B1902COS', 'city': 'La Plata', 'country': 'Argentina', 'facility': 'Framingham Centro Medico', 'geoPoint': {'lat': -34.92126, 'lon': -57.95442}}, {'zip': 'T4000AXL', 'city': 'San Miguel de Tucumán', 'country': 'Argentina', 'facility': 'Centro Medico Privado de Reumatologia', 'geoPoint': {'lat': -26.81601, 'lon': -65.21051}}, {'zip': 'T4000BRD', 'city': 'San Miguel de Tucumán', 'country': 'Argentina', 'facility': 'Centro de Investigaciones Reumatologicas', 'geoPoint': {'lat': -26.81601, 'lon': -65.21051}}, {'zip': '4000', 'city': 'Plovdiv', 'country': 'Bulgaria', 'facility': 'Diagnostic Consultative Center Sveti Georgi EOOD', 'geoPoint': {'lat': 42.15387, 'lon': 24.75001}}, {'zip': '4001', 'city': 'Plovdiv', 'country': 'Bulgaria', 'facility': 'University Multiprofile Hospital for Active Treatment Plovdiv', 'geoPoint': {'lat': 42.15387, 'lon': 24.75001}}, {'zip': '5400', 'city': 'Sevlievo', 'country': 'Bulgaria', 'facility': 'Medical Center - 1 - Sevlievo EOOD', 'geoPoint': {'lat': 43.02295, 'lon': 25.10364}}, {'zip': '080002', 'city': 'Barranquilla', 'country': 'Colombia', 'facility': 'Centro Integral de Reumatologia del Caribe CIRCARIBE S.A.S', 'geoPoint': {'lat': 10.96854, 'lon': -74.78132}}, {'zip': '110311', 'city': 'Bogotá', 'country': 'Colombia', 'facility': 'Preventive Care S.A.S.', 'geoPoint': {'lat': 4.60971, 'lon': -74.08175}}, {'zip': '680003', 'city': 'Bucaramanga', 'country': 'Colombia', 'facility': 'Medicity S.A.S.', 'geoPoint': {'lat': 7.125, 'lon': -73.11895}}, {'zip': '680003', 'city': 'Bucaramanga', 'country': 'Colombia', 'facility': 'Servimed S.A.S.', 'geoPoint': {'lat': 7.125, 'lon': -73.11895}}, {'zip': '760043', 'city': 'Cali', 'country': 'Colombia', 'facility': 'Clinica de Artritis Temprana', 'geoPoint': {'lat': 3.43054, 'lon': -76.5199}}, {'zip': '050034', 'city': 'Medellín', 'country': 'Colombia', 'facility': 'Hospital Pablo Tobon Uribe', 'geoPoint': {'lat': 6.245, 'lon': -75.57151}}, {'zip': '0102', 'city': 'Tbilisi', 'country': 'Georgia', 'facility': 'V. Tsitlanadze Scientifically-Practical Rheumatology Center Ltd', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'zip': '0112', 'city': 'Tbilisi', 'country': 'Georgia', 'facility': 'Research Institute of Clinical Medicine Ltd', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'zip': '0114', 'city': 'Tbilisi', 'country': 'Georgia', 'facility': 'LTD New Hospitals', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'zip': '0179', 'city': 'Tbilisi', 'country': 'Georgia', 'facility': 'Mtskheta Street Clinic Ltd', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'zip': '0180', 'city': 'Tbilisi', 'country': 'Georgia', 'facility': 'First Medical Center', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'zip': '0186', 'city': 'Tbilisi', 'country': 'Georgia', 'facility': 'Multiprofile Clinic Consilium Medulla Ltd', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'zip': '1036', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Qualiclinic Kft.', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '4032', 'city': 'Debrecen', 'country': 'Hungary', 'facility': 'DE Klinikai Központ', 'geoPoint': {'lat': 47.53167, 'lon': 21.62444}}, {'zip': '5700', 'city': 'Gyula', 'country': 'Hungary', 'facility': 'Békés Megyei Központi Kórház Pándy Kálmán Tagkórház', 'geoPoint': {'lat': 46.65, 'lon': 21.28333}}, {'zip': '44160', 'city': 'Guadalajara', 'country': 'Mexico', 'facility': 'Centro Integral en Reumatología S.A. de C.V. (CIRSA)', 'geoPoint': {'lat': 20.67738, 'lon': -103.34749}}, {'zip': '44280', 'city': 'Guadalajara', 'country': 'Mexico', 'facility': 'Hospital Civil de Guadalajara Fray Antonio Alcalde', 'geoPoint': {'lat': 20.67738, 'lon': -103.34749}}, {'zip': '06700', 'city': 'Mexico City', 'country': 'Mexico', 'facility': 'CLIDITER S.A. de C.V. (Centro de Investigación y Tratamiento de las Enfermedades Reumaticas)', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'zip': '04000', 'city': 'Cayma', 'country': 'Peru', 'facility': 'Hogar Clinica San Juan De Dios', 'geoPoint': {'lat': -16.38305, 'lon': -71.55086}}, {'zip': '13001', 'city': 'La Libertad', 'country': 'Peru', 'facility': 'Centro de Investigación Clínica Trujillo E.I.R.L.', 'geoPoint': {'lat': -11.84178, 'lon': -75.30261}}, {'zip': '15102', 'city': 'Lima', 'country': 'Peru', 'facility': 'Hospital Nacional Cayetano Heredia', 'geoPoint': {'lat': -12.04318, 'lon': -77.02824}}, {'zip': '15431', 'city': 'Lima', 'country': 'Peru', 'facility': 'Clinica San Juan Bautista', 'geoPoint': {'lat': -12.04318, 'lon': -77.02824}}, {'zip': '15023', 'city': 'Santiago de Surco', 'country': 'Peru', 'facility': 'Instituto de Ginecología y Reproducción', 'geoPoint': {'lat': -12.13588, 'lon': -77.00742}}, {'zip': '2009', 'city': 'Angeles City', 'country': 'Philippines', 'facility': 'Angeles University Foundation Medical Center', 'geoPoint': {'lat': 15.15, 'lon': 120.58333}}, {'zip': '8000', 'city': 'Davao City', 'country': 'Philippines', 'facility': 'Southern Philippines Medical Center', 'geoPoint': {'lat': 7.07306, 'lon': 125.61278}}, {'zip': '4217', 'city': 'Lipa City', 'country': 'Philippines', 'facility': 'Mary Mediatrix Medical Center', 'geoPoint': {'lat': 13.9411, 'lon': 121.1631}}, {'zip': '1000', 'city': 'Manila', 'country': 'Philippines', 'facility': 'Philippine General Hospital', 'geoPoint': {'lat': 14.6042, 'lon': 120.9822}}, {'zip': '1015', 'city': 'Manila', 'country': 'Philippines', 'facility': 'University of Santo Tomas Hospital', 'geoPoint': {'lat': 14.6042, 'lon': 120.9822}}, {'zip': '82-300', 'city': 'Elblag', 'country': 'Poland', 'facility': 'Centrum Kliniczno - Badawcze J. Brzezicki, B. Gronkiewicz Brzezicka Spółka Lekarska', 'geoPoint': {'lat': 54.1522, 'lon': 19.40884}}, {'zip': '30-363', 'city': 'Krakow', 'country': 'Poland', 'facility': 'Centrum Medyczne Plejady', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '31-011', 'city': 'Krakow', 'country': 'Poland', 'facility': 'Centrum Nowoczesnych Terapii Dobry Lekarz sp. z o.o', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '91-363', 'city': 'Lodz', 'country': 'Poland', 'facility': 'Centrum Medyczne AMED oddział w Łodzi', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'zip': '05-830', 'city': 'Nadarzyn', 'country': 'Poland', 'facility': 'NZOZ Lecznica MAK-MED', 'geoPoint': {'lat': 52.09438, 'lon': 20.80776}}, {'zip': '61-397', 'city': 'Poznan', 'country': 'Poland', 'facility': 'Prywatna Praktyka Lekarska Prof. UM dr hab. med Pawel Hrycaj', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'zip': '37-450', 'city': 'Stalowa Wola', 'country': 'Poland', 'facility': 'SANUS Szpital Specjalistyczny sp. z o.o', 'geoPoint': {'lat': 50.58286, 'lon': 22.05334}}, {'zip': '02-691', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Reumatika-Centrum Reumatologii', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '500283', 'city': 'Brasov', 'country': 'Romania', 'facility': 'Centrul Medical de Diagnostic si Tratament Ambulatoriu Neomed SRL', 'geoPoint': {'lat': 45.64861, 'lon': 25.60613}}, {'zip': '400006', 'city': 'Cluj-Napoca', 'country': 'Romania', 'facility': 'Spitalul Clinic Judetean De Urgenta Cluj Napoca', 'geoPoint': {'lat': 46.76667, 'lon': 23.6}}, {'zip': '700661', 'city': 'Iași', 'country': 'Romania', 'facility': 'Spitalul Clinic de Recuperare Iasi #2', 'geoPoint': {'lat': 47.16667, 'lon': 27.6}}, {'zip': '03680', 'city': 'Kyiv', 'country': 'Ukraine', 'facility': 'National Scientific Center at Institute of Cardiology named after acad. M.D. Strazhesko', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}, {'zip': '04107', 'city': 'Kyiv', 'country': 'Ukraine', 'facility': 'Kyiv Regional Clinical Hospital', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}, {'zip': '65025', 'city': 'Odesa', 'country': 'Ukraine', 'facility': 'Odesa Regional Clinical Hospital', 'geoPoint': {'lat': 46.48572, 'lon': 30.74383}}, {'zip': '46002', 'city': 'Ternopil', 'country': 'Ukraine', 'facility': 'Communal Non-Profit Enterprise "Ternopil University Clinic" of Ternopil Regional Council', 'geoPoint': {'lat': 49.55404, 'lon': 25.59067}}, {'zip': '21018', 'city': 'Vinnytsia', 'country': 'Ukraine', 'facility': 'Vinnytsia Regional Clinical Hospital', 'geoPoint': {'lat': 49.2322, 'lon': 28.46871}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}