Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2026-02-28 @ 7:10 PM
Study NCT ID:
NCT02119156
Status:
COMPLETED
Last Update Posted:
2020-01-31
First Post:
2014-04-17
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Belimumab Treatment Holiday and Treatment Re-start Study in Lupus Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008180', 'term': 'Lupus Erythematosus, Systemic'}], 'ancestors': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C511911', 'term': 'belimumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'GSKClinicalSupportHD@gsk.com', 'phone': '866-435-7343', 'title': 'GlaxoSmithKline', 'phoneExt': '1', 'organization': 'GlaxoSmithKline'}, 'certainAgreement': {'otherDetails': 'GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Study limitations include the small sample size and differences in Day 0 characteristics between Long-term Discontinuation and Treatment Control groups, which limits the ability to draw inferences.'}}, 'adverseEventsModule': {'timeFrame': 'Non-serious adverse events and serious adverse events (SAE) were collected up to 52 weeks for all treatment groups. For Treatment Control and Treatment Holiday Re-start, it also included 16 weeks follow up after the last dose of belimumab for participants who did not continue in Maintenance phase. For Maintenance phase, non-SAE and SAE were collected until Week 48 of subsequent years (Maintenance is Year 2, 3, 4) and includes 16 weeks follow up after last dose of belimumab.', 'description': 'Treatment holiday group had two phases holiday phase was Day 0 visit to Week 24/Treatment Re-start phase and Re-start phase started one day after Week 24 up to Week 52. Non-serious adverse events and SAEs were collected for ITT Population.', 'eventGroups': [{'id': 'EG000', 'title': 'Treatment Phase: Long-term Discontinuation Group', 'description': 'Participants in this group discontinued belimumab 10 mg/kg therapy for 52 weeks but remained on standard of care therapy. Participants from BEL114333 (NCT01597622), BEL112233 (NCT00724867) and BEL112626 (NCT00583362) were part of this group. Participants had been treated with belimumab for at least 6 months in one of these continuation studies but had withdrawn from belimumab therapy for no longer than 8 weeks prior to entry into this study.', 'otherNumAtRisk': 39, 'deathsNumAtRisk': 39, 'otherNumAffected': 30, 'seriousNumAtRisk': 39, 'deathsNumAffected': 0, 'seriousNumAffected': 6}, {'id': 'EG001', 'title': 'Treatment Phase: Treatment Control Group', 'description': 'Participants in this group continued to receive monthly belimumab 10 mg/kg therapy, in addition to standard of care SLE therapy for 52 weeks. Participants from BEL113750 (NCT01345253) and BEL114333 (NCT01597622) were part of this group. Participants had been treated with belimumab for at least 6 months in one of these continuation studies prior to entry into this study. Eligible participants on completion of 52-weeks entered Maintenance period and received belimumab 10 mg/kg every 4 weeks until Week 48 of subsequent years (Maintenance is Year 2, 3, 4).', 'otherNumAtRisk': 29, 'deathsNumAtRisk': 29, 'otherNumAffected': 18, 'seriousNumAtRisk': 29, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Treatment Phase: Treatment Holiday Group - Holiday Phase', 'description': 'Participants in the Treatment Holiday Group underwent a 24-week belimumab treatment holiday while remaining on standard of care SLE therapy, Holiday Phase was Day 0 visit to Week 24/Treatment Re-start phase. Participants from BEL113750 (NCT01345253) and BEL114333 (NCT01597622) were part of this group. Participants had been treated with belimumab for at least 6 months in one of these continuation studies prior to entry into this study. In the event of a severe flare, participants were allowed to enter Maintenance Phase and receive belimumab 10 mg/Kg every 4 weeks until Week 48 of subsequent years (Maintenance is Year 2, 3, 4).', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 7, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Treatment Phase: Treatment Holiday Group - Re-start Phase', 'description': 'Following Treatment holiday phase for 24 weeks, participants re-started belimumab therapy for 28 weeks while receiving standard of care SLE therapy for 52 weeks. Re-start Phase started one day after Week 24 up to Week 52. Participants from BEL113750 (NCT01345253) and BEL114333 (NCT01597622) were part of this group. Participants had been treated with belimumab for at least 6 months in one of these continuation studies prior to entry into this study. Eligible participants on completion of 52-weeks entered Maintenance period and received belimumab 10 mg/kg every 4 weeks until Week 48 of subsequent years (Maintenance is Year 2, 3, 4).', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 9, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG004', 'title': 'Maintenance Phase: Treatment Control', 'description': 'Participants from BEL113750 (NCT01345253) and BEL114333 (NCT01597622) were part of this group. Eligible participants on completion of 52-weeks entered Maintenance period and received belimumab 10 mg/kg every 4 weeks until Week 48 of subsequent years (Maintenance is Year 2, 3, 4).', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 4, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Maintenance Phase: Treatment Holiday', 'description': 'Participants from BEL113750 (NCT01345253) and BEL114333 (NCT01597622) were part of this group. Eligible participants on completion of 52-weeks entered Maintenance period and received belimumab 10 mg/kg every 4 weeks until Week 48 of subsequent years (Maintenance is Year 2, 3, 4).', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 8, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 16, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 16, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 5, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 7, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Upper respiratory tract infection bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Otitis externa bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Tinea versicolour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 10, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 8, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Bursitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Systemic lupus erythematosus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Dental caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Periodontal disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 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'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Head injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Limb injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Chillblains', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Benign neoplasm of skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Adrenal insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Drug eruption', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}], 'seriousEvents': [{'term': 'Diarrhoea infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pneumonia pseudomonal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Lupus nephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pericarditis lupus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Generalised oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Lumbar vertebral fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Skin laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Median Time to First SLE Flare Index (SFI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Long-term Discontinuation Group', 'description': 'Participants in this group discontinued belimumab 10 mg/kg therapy for 52 weeks but remained on standard of care therapy. Participants from BEL114333 (NCT01597622), BEL112233 (NCT00724867) and BEL112626 (NCT00583362) were part of this group. Participants had been treated with belimumab for at least 6 months in one of these continuation studies but had withdrawn from belimumab therapy for no longer than 8 weeks prior to entry into this study.'}, {'id': 'OG001', 'title': 'Treatment Control Group', 'description': 'Participants in this group continued to receive monthly belimumab 10 mg/kg therapy, in addition to standard of care SLE therapy for 52 weeks. Participants from BEL113750 (NCT01345253) and BEL114333 (NCT01597622) were part of this group. Participants had been treated with belimumab for at least 6 months in one of these continuation studies prior to entry into this study. Eligible participants on completion of 52-weeks entered Maintenance period and received belimumab 10 mg/kg every 4 weeks until Week 48 of subsequent years (Maintenance is Year 2, 3, 4).'}, {'id': 'OG002', 'title': 'Treatment Holiday Group - Holiday Phase', 'description': 'Participants in the Treatment Holiday Group underwent a 24-week belimumab treatment holiday while remaining on standard of care SLE therapy, Holiday Phase was Day 0 visit to Week 24/Treatment Re-start phase. Participants from BEL113750 (NCT01345253) and BEL114333 (NCT01597622) were part of this group. Participants had been treated with belimumab for at least 6 months in one of these continuation studies prior to entry into this study. In the event of a severe flare, participants were allowed to enter Maintenance Phase and receive belimumab 10 mg/Kg every 4 weeks until Week 48 of subsequent years (Maintenance is Year 2, 3, 4).'}, {'id': 'OG003', 'title': 'Treatment Holiday Group - Re-start Phase', 'description': 'Following Treatment holiday phase for 24 weeks, participants re-started belimumab therapy for 28 weeks while receiving standard of care SLE therapy for 52 weeks. Re-start Phase started one day after Week 24 up to Week 52. Participants from BEL113750 (NCT01345253) and BEL114333 (NCT01597622) were part of this group. Participants had been treated with belimumab for at least 6 months in one of these continuation studies prior to entry into this study. Eligible participants on completion of 52-weeks entered Maintenance period and received belimumab 10 mg/kg every 4 weeks until Week 48 of subsequent years (Maintenance is Year 2, 3, 4).'}], 'classes': [{'categories': [{'measurements': [{'value': '183.0', 'groupId': 'OG000', 'lowerLimit': '91.0', 'upperLimit': '370.0'}, {'value': 'NA', 'comment': 'NA indicates that "Due to low event rates of participants in treatment groups, the median time and/or interquartile range could not be estimated"', 'groupId': 'OG001', 'lowerLimit': '365.0', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'NA indicates that "Due to low event rates of participants in treatment groups, the median time and/or interquartile range could not be estimated"', 'groupId': 'OG002', 'lowerLimit': '30.0', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'NA indicates that "Due to low event rates of participants in treatment groups, the median time and/or interquartile range could not be estimated"', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 52 weeks', 'description': 'SFI Flare was defined as a mild/moderate or severe flare according to the modified Safety of Estrogen in Lupus National Assessment Systemic Lupus Erythematosus Disease Activity Index (SELENA SLEDAI) SLE Flare Index (modified excluded severe flares from the SELENA SLEDAI flare assessment that were triggered only by an increase in SELENA SLEDAI score to \\>12).Time to first SFI flare is defined as the number of days from Day 0 visit date to the date the participant has a flare (event date - Day 0 visit date + 1) in the 52 Week/Holiday phase; (event date - treatment re-start date + 1) in the Re-start Holiday phase. Day 0 visit date is defined as Day 0 from present study. Median time to first SFI flare is reported; estimated using the product-limit method.', 'unitOfMeasure': 'Days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population comprised of all participants who enrolled in the study, excluding screen failures.'}, {'type': 'SECONDARY', 'title': 'Rate of SLE Index Flare Per Subject Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Long-term Discontinuation Group', 'description': 'Participants in this group discontinued belimumab 10 mg/kg therapy for 52 weeks but remained on standard of care therapy. Participants from BEL114333 (NCT01597622), BEL112233 (NCT00724867) and BEL112626 (NCT00583362) were part of this group. Participants had been treated with belimumab for at least 6 months in one of these continuation studies but had withdrawn from belimumab therapy for no longer than 8 weeks prior to entry into this study.'}, {'id': 'OG001', 'title': 'Treatment Control Group', 'description': 'Participants in this group continued to receive monthly belimumab 10 mg/kg therapy, in addition to standard of care SLE therapy for 52 weeks. Participants from BEL113750 (NCT01345253) and BEL114333 (NCT01597622) were part of this group. Participants had been treated with belimumab for at least 6 months in one of these continuation studies prior to entry into this study. Eligible participants on completion of 52-weeks entered Maintenance period and received belimumab 10 mg/kg every 4 weeks until Week 48 of subsequent years (Maintenance is Year 2, 3, 4).'}, {'id': 'OG002', 'title': 'Treatment Holiday Group - Holiday Phase', 'description': 'Participants in the Treatment Holiday Group underwent a 24-week belimumab treatment holiday while remaining on standard of care SLE therapy, Holiday Phase was Day 0 visit to Week 24/Treatment Re-start phase. Participants from BEL113750 (NCT01345253) and BEL114333 (NCT01597622) were part of this group. Participants had been treated with belimumab for at least 6 months in one of these continuation studies prior to entry into this study. In the event of a severe flare, participants were allowed to enter Maintenance Phase and receive belimumab 10 mg/Kg every 4 weeks until Week 48 of subsequent years (Maintenance is Year 2, 3, 4).'}, {'id': 'OG003', 'title': 'Treatment Holiday Group - Re-start Phase', 'description': 'Following Treatment holiday phase for 24 weeks, participants re-started belimumab therapy for 28 weeks while receiving standard of care SLE therapy for 52 weeks. Re-start Phase started one day after Week 24 up to Week 52. Participants from BEL113750 (NCT01345253) and BEL114333 (NCT01597622) were part of this group. Participants had been treated with belimumab for at least 6 months in one of these continuation studies prior to entry into this study. Eligible participants on completion of 52-weeks entered Maintenance period and received belimumab 10 mg/kg every 4 weeks until Week 48 of subsequent years (Maintenance is Year 2, 3, 4).'}], 'classes': [{'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000'}, {'value': '0.6', 'groupId': 'OG001'}, {'value': '1.0', 'groupId': 'OG002'}, {'value': '0.3', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 52 weeks', 'description': 'Rate per subject year of SFI flare was calculated as total number of flares divided by total subject years in interval. The total subject years for each participant was calculated as (Week 52/ Exit visit date minus Day 0 visit date + 1) for Long-term discontinuation and treatment control groups. For treatment holiday phase group the subject-years for each participant was calculated as (Week 24/Treatment Re-start/Exit visit date minus Day 0 Visit date + 1)/365.25. For re-start treatment holiday phase group the subject-years for each participant was calculated as (Week 52/Exit visit date minus Week 24/Treatment Re-start date + 1)/365.25. Day 0 visit date is defined as Day 0 from present study.', 'unitOfMeasure': 'Flares per Subject-year', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Median Time to First Severe SFI Flare', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Long-term Discontinuation Group', 'description': 'Participants in this group discontinued belimumab 10 mg/kg therapy for 52 weeks but remained on standard of care therapy. Participants from BEL114333 (NCT01597622), BEL112233 (NCT00724867) and BEL112626 (NCT00583362) were part of this group. Participants had been treated with belimumab for at least 6 months in one of these continuation studies but had withdrawn from belimumab therapy for no longer than 8 weeks prior to entry into this study.'}, {'id': 'OG001', 'title': 'Treatment Control Group', 'description': 'Participants in this group continued to receive monthly belimumab 10 mg/kg therapy, in addition to standard of care SLE therapy for 52 weeks. Participants from BEL113750 (NCT01345253) and BEL114333 (NCT01597622) were part of this group. Participants had been treated with belimumab for at least 6 months in one of these continuation studies prior to entry into this study. Eligible participants on completion of 52-weeks entered Maintenance period and received belimumab 10 mg/kg every 4 weeks until Week 48 of subsequent years (Maintenance is Year 2, 3, 4).'}, {'id': 'OG002', 'title': 'Treatment Holiday Group - Holiday Phase', 'description': 'Participants in the Treatment Holiday Group underwent a 24-week belimumab treatment holiday while remaining on standard of care SLE therapy, Holiday Phase was Day 0 visit to Week 24/Treatment Re-start phase. Participants from BEL113750 (NCT01345253) and BEL114333 (NCT01597622) were part of this group. Participants had been treated with belimumab for at least 6 months in one of these continuation studies prior to entry into this study. In the event of a severe flare, participants were allowed to enter Maintenance Phase and receive belimumab 10 mg/Kg every 4 weeks until Week 48 of subsequent years (Maintenance is Year 2, 3, 4).'}, {'id': 'OG003', 'title': 'Treatment Holiday Group - Re-start Phase', 'description': 'Following Treatment holiday phase for 24 weeks, participants re-started belimumab therapy for 28 weeks while receiving standard of care SLE therapy for 52 weeks. Re-start Phase started one day after Week 24 up to Week 52. Participants from BEL113750 (NCT01345253) and BEL114333 (NCT01597622) were part of this group. Participants had been treated with belimumab for at least 6 months in one of these continuation studies prior to entry into this study. Eligible participants on completion of 52-weeks entered Maintenance period and received belimumab 10 mg/kg every 4 weeks until Week 48 of subsequent years (Maintenance is Year 2, 3, 4).'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'NA indicates that "Due to low event rates of participants in treatment groups, the median time and/or interquartile range could not be estimated"', 'groupId': 'OG000', 'lowerLimit': '327.0', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'NA indicates that "Due to low event rates of participants in treatment groups, the median time and/or interquartile range could not be estimated"', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'NA indicates that "Due to low event rates of participants in treatment groups, the median time and/or interquartile range could not be estimated"', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'NA indicates that "Due to low event rates of participants in treatment groups, the median time and/or interquartile range could not be estimated"', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 52 weeks', 'description': 'The SLE Flare Index categorizes SLE flare as "mild or moderate" or "severe" based on a positive assessment for at least 1 of 5 variables as follows: Change in SELENA SLEDAI score from the most recent assessment to current; Change in signs or symptoms of disease activity; Change in prednisone dosage; Use of new medications for disease activity or hospitalization; Change in Physician\'s Global Assessment (PGA) score; Hospitalization for SLE activity is an additional category included only for a severe flare. Time to first severe flare is defined as (event date-Day 0 visit date) + 1 for Long-term discontinuation, treatment control groups and holiday phase group. For holiday phase group data censored at last flare assessment by treatment re-start date. Time to first severe flare is defined as (event date-treatment re-start date) + 1 for Re-start treatment holiday group. Median time to first severe SFI flare is reported; estimated using the product-limit method.', 'unitOfMeasure': 'Days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Evidence of Rebound', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Long-term Discontinuation Group', 'description': 'Participants in this group discontinued belimumab 10 mg/kg therapy for 52 weeks but remained on standard of care therapy. Participants from BEL114333 (NCT01597622), BEL112233 (NCT00724867) and BEL112626 (NCT00583362) were part of this group. Participants had been treated with belimumab for at least 6 months in one of these continuation studies but had withdrawn from belimumab therapy for no longer than 8 weeks prior to entry into this study.'}, {'id': 'OG001', 'title': 'Treatment Control Group', 'description': 'Participants in this group continued to receive monthly belimumab 10 mg/kg therapy, in addition to standard of care SLE therapy for 52 weeks. Participants from BEL113750 (NCT01345253) and BEL114333 (NCT01597622) were part of this group. Participants had been treated with belimumab for at least 6 months in one of these continuation studies prior to entry into this study. Eligible participants on completion of 52-weeks entered Maintenance period and received belimumab 10 mg/kg every 4 weeks until Week 48 of subsequent years (Maintenance is Year 2, 3, 4).'}, {'id': 'OG002', 'title': 'Treatment Holiday Group', 'description': 'Participants in the Treatment Holiday Group underwent a 24-week belimumab treatment holiday while remaining on standard of care SLE therapy, then re-started belimumab therapy for further 28 weeks while receiving standard of care SLE therapy. Participants from BEL113750 (NCT01345253) and BEL114333 (NCT01597622) were part of this group. Participants had been treated with belimumab for at least 6 months in one of these continuation studies prior to entry into this study. Eligible participants on completion of 52-weeks entered Maintenance period and received belimumab 10 mg/kg every 4 weeks until Week 48 of subsequent years (Maintenance is Year 2, 3, 4).'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 24 weeks', 'description': "Rebound is defined as SELENA SLEDAI score during the first 24 weeks that exceeds the Baseline SELENA SLEDAI score in the participant's respective original parent study. Baseline is defined as the Day 0 visit from the parent study. SELENA SLEDAI assessments consist of 24 individual weighted items in which signs and symptoms, laboratory tests, and physician's assessment for each of 9 organ systems are given a weighted score and summed if present (marked 'Yes') at the time of the visit or in the preceding 10 days. The maximum theoretical score is 105 (all 24 descriptors present simultaneously) with 0 indicating inactive disease (marked 'No'). Any time during the first 24 weeks of this study has been reported.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Confirmed True Positive Belimumab Anti-drug Antibodies (ADA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Long-term Discontinuation Group', 'description': 'Participants in this group discontinued belimumab 10 mg/kg therapy for 52 weeks but remained on standard of care therapy. Participants from BEL114333 (NCT01597622), BEL112233 (NCT00724867) and BEL112626 (NCT00583362) were part of this group. Participants had been treated with belimumab for at least 6 months in one of these continuation studies but had withdrawn from belimumab therapy for no longer than 8 weeks prior to entry into this study.'}, {'id': 'OG001', 'title': 'Treatment Control Group', 'description': 'Participants in this group continued to receive monthly belimumab 10 mg/kg therapy, in addition to standard of care SLE therapy for 52 weeks. Participants from BEL113750 (NCT01345253) and BEL114333 (NCT01597622) were part of this group. Participants had been treated with belimumab for at least 6 months in one of these continuation studies prior to entry into this study. Eligible participants on completion of 52-weeks entered Maintenance period and received belimumab 10 mg/kg every 4 weeks until Week 48 of subsequent years (Maintenance is Year 2, 3, 4).'}, {'id': 'OG002', 'title': 'Treatment Holiday Group - Holiday Phase', 'description': 'Participants in the Treatment Holiday Group underwent a 24-week belimumab treatment holiday while remaining on standard of care SLE therapy, Holiday Phase was Day 0 visit to Week 24/Treatment Re-start phase. Participants from BEL113750 (NCT01345253) and BEL114333 (NCT01597622) were part of this group. Participants had been treated with belimumab for at least 6 months in one of these continuation studies prior to entry into this study. In the event of a severe flare, participants were allowed to enter Maintenance Phase and receive belimumab 10 mg/Kg every 4 weeks until Week 48 of subsequent years (Maintenance is Year 2, 3, 4).'}, {'id': 'OG003', 'title': 'Treatment Holiday Group - Re-start Phase', 'description': 'Following Treatment holiday phase for 24 weeks, participants re-started belimumab therapy for 28 weeks while receiving standard of care SLE therapy for 52 weeks. Re-start Phase started one day after Week 24 up to Week 52. Participants from BEL113750 (NCT01345253) and BEL114333 (NCT01597622) were part of this group. Participants had been treated with belimumab for at least 6 months in one of these continuation studies prior to entry into this study. Eligible participants on completion of 52-weeks entered Maintenance period and received belimumab 10 mg/kg every 4 weeks until Week 48 of subsequent years (Maintenance is Year 2, 3, 4).'}], 'classes': [{'categories': [{'title': 'Negative', 'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}, {'title': 'Persistent positive', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Transient positive', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 52 weeks', 'description': 'Immunogenicity assay results were categorized as negative or positive. A persistent positive result was defined as a positive post-Day 0 visit immunogenic response that occurred for at least 2 consecutive assessments or a single result at the final assessment. A transient positive result was defined as a single post-Day 0 visit positive immunogenic response that did not occur at the final assessment. Any time post-Day 0 visit data are reported (or post-Week 24 for Treatment Holiday - Restart phase). Day 0 visit date is defined as Day 0 from present study.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population.'}, {'type': 'SECONDARY', 'title': 'Percentage Change From Baseline in Immunoglobulin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Long-term Discontinuation Group', 'description': 'Participants in this group discontinued belimumab 10 mg/kg therapy for 52 weeks but remained on standard of care therapy. Participants from BEL114333 (NCT01597622), BEL112233 (NCT00724867) and BEL112626 (NCT00583362) were part of this group. Participants had been treated with belimumab for at least 6 months in one of these continuation studies but had withdrawn from belimumab therapy for no longer than 8 weeks prior to entry into this study.'}, {'id': 'OG001', 'title': 'Treatment Control Group', 'description': 'Participants in this group continued to receive monthly belimumab 10 mg/kg therapy, in addition to standard of care SLE therapy for 52 weeks. Participants from BEL113750 (NCT01345253) and BEL114333 (NCT01597622) were part of this group. Participants had been treated with belimumab for at least 6 months in one of these continuation studies prior to entry into this study. Eligible participants on completion of 52-weeks entered Maintenance period and received belimumab 10 mg/kg every 4 weeks until Week 48 of subsequent years (Maintenance is Year 2, 3, 4).'}, {'id': 'OG002', 'title': 'Treatment Holiday Group - Holiday Phase', 'description': 'Participants in the Treatment Holiday Group underwent a 24-week belimumab treatment holiday while remaining on standard of care SLE therapy, Holiday Phase was Day 0 visit to Week 24/Treatment Re-start phase. Participants from BEL113750 (NCT01345253) and BEL114333 (NCT01597622) were part of this group. Participants had been treated with belimumab for at least 6 months in one of these continuation studies prior to entry into this study. In the event of a severe flare, participants were allowed to enter Maintenance Phase and receive belimumab 10 mg/Kg every 4 weeks until Week 48 of subsequent years (Maintenance is Year 2, 3, 4).'}, {'id': 'OG003', 'title': 'Treatment Holiday Group - Re-start Phase', 'description': 'Following Treatment holiday phase for 24 weeks, participants re-started belimumab therapy for 28 weeks while receiving standard of care SLE therapy for 52 weeks. Re-start Phase started one day after Week 24 up to Week 52. Participants from BEL113750 (NCT01345253) and BEL114333 (NCT01597622) were part of this group. Participants had been treated with belimumab for at least 6 months in one of these continuation studies prior to entry into this study. Eligible participants on completion of 52-weeks entered Maintenance period and received belimumab 10 mg/kg every 4 weeks until Week 48 of subsequent years (Maintenance is Year 2, 3, 4).'}], 'classes': [{'title': 'IgA,Day 0,n=31,29, 12,0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-19.205', 'groupId': 'OG000', 'lowerLimit': '-38.406', 'upperLimit': '-7.229'}, {'value': '-25.909', 'groupId': 'OG001', 'lowerLimit': '-35.168', 'upperLimit': '-16.901'}, {'value': '-22.193', 'groupId': 'OG002', 'lowerLimit': '-33.468', 'upperLimit': '-14.278'}]}]}, {'title': 'IgA,Week 8,n=37,29, 11,0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-21.028', 'groupId': 'OG000', 'lowerLimit': '-41.897', 'upperLimit': '-11.066'}, {'value': '-31.455', 'groupId': 'OG001', 'lowerLimit': '-37.166', 'upperLimit': '-24.186'}, {'value': '-24.242', 'groupId': 'OG002', 'lowerLimit': '-36.981', 'upperLimit': '-14.213'}]}]}, {'title': 'IgA, Week 16,n=36,27, 11,0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-22.052', 'groupId': 'OG000', 'lowerLimit': '-39.715', 'upperLimit': '-8.880'}, {'value': '-31.016', 'groupId': 'OG001', 'lowerLimit': '-36.676', 'upperLimit': '-23.432'}, {'value': '-20.202', 'groupId': 'OG002', 'lowerLimit': '-38.381', 'upperLimit': '-4.975'}]}]}, {'title': 'IgA, Week 24,n=31,27, 11,0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-20.570', 'groupId': 'OG000', 'lowerLimit': '-34.101', 'upperLimit': '3.271'}, {'value': '-28.000', 'groupId': 'OG001', 'lowerLimit': '-34.097', 'upperLimit': '-21.033'}, {'value': '-21.711', 'groupId': 'OG002', 'lowerLimit': '-35.533', 'upperLimit': '5.240'}]}]}, {'title': 'IgA, Week 32,n=34,27,0,10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-11.243', 'groupId': 'OG000', 'lowerLimit': '-29.004', 'upperLimit': '3.004'}, {'value': '-29.703', 'groupId': 'OG001', 'lowerLimit': '-37.615', 'upperLimit': '-19.697'}, {'value': '-23.363', 'groupId': 'OG003', 'lowerLimit': '-39.164', 'upperLimit': '-1.875'}]}]}, {'title': 'IgA, Week 40,n=33,25,0,11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-10.769', 'groupId': 'OG000', 'lowerLimit': '-33.575', 'upperLimit': '2.715'}, {'value': '-30.617', 'groupId': 'OG001', 'lowerLimit': '-37.143', 'upperLimit': '-26.934'}, {'value': '-24.579', 'groupId': 'OG003', 'lowerLimit': '-33.891', 'upperLimit': '1.990'}]}]}, {'title': 'IgA, Week 48,n=33,27,0,10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-16.000', 'groupId': 'OG000', 'lowerLimit': '-27.848', 'upperLimit': '10.850'}, {'value': '-34.091', 'groupId': 'OG001', 'lowerLimit': '-37.867', 'upperLimit': '-19.767'}, {'value': '-33.936', 'groupId': 'OG003', 'lowerLimit': '-42.105', 'upperLimit': '6.883'}]}]}, {'title': 'IgA, Week 52,n=33,27,0,10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-14.859', 'groupId': 'OG000', 'lowerLimit': '-28.646', 'upperLimit': '9.346'}, {'value': '-30.698', 'groupId': 'OG001', 'lowerLimit': '-38.806', 'upperLimit': '-17.128'}, {'value': '-31.663', 'groupId': 'OG003', 'lowerLimit': '-40.102', 'upperLimit': '0.498'}]}]}, {'title': 'IgG,Day 0,n=39,29, 12,0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-13.939', 'groupId': 'OG000', 'lowerLimit': '-35.349', 'upperLimit': '3.571'}, {'value': '-29.524', 'groupId': 'OG001', 'lowerLimit': '-35.645', 'upperLimit': '-14.872'}, {'value': '-19.481', 'groupId': 'OG002', 'lowerLimit': '-33.330', 'upperLimit': '-9.757'}]}]}, {'title': 'IgG,Week 8,n=37,29, 11,0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-19.169', 'groupId': 'OG000', 'lowerLimit': '-37.209', 'upperLimit': '-0.877'}, {'value': '-29.048', 'groupId': 'OG001', 'lowerLimit': '-35.795', 'upperLimit': '-6.897'}, {'value': '-25.571', 'groupId': 'OG002', 'lowerLimit': '-31.788', 'upperLimit': '-16.234'}]}]}, {'title': 'IgG, Week 16,n=36,27, 11,0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-16.169', 'groupId': 'OG000', 'lowerLimit': '-37.881', 'upperLimit': '8.306'}, {'value': '-29.818', 'groupId': 'OG001', 'lowerLimit': '-35.714', 'upperLimit': '-5.172'}, {'value': '-21.642', 'groupId': 'OG002', 'lowerLimit': '-29.870', 'upperLimit': '-18.721'}]}]}, {'title': 'IgG, Week 24,n=31,27, 11,0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-17.982', 'groupId': 'OG000', 'lowerLimit': '-34.545', 'upperLimit': '0.662'}, {'value': '-26.241', 'groupId': 'OG001', 'lowerLimit': '-32.571', 'upperLimit': '-7.080'}, {'value': '-17.886', 'groupId': 'OG002', 'lowerLimit': '-26.623', 'upperLimit': '-8.955'}]}]}, {'title': 'IgG, Week 32,n=34,27,0,10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-9.798', 'groupId': 'OG000', 'lowerLimit': '-34.146', 'upperLimit': '3.653'}, {'value': '-23.288', 'groupId': 'OG001', 'lowerLimit': '-34.220', 'upperLimit': '-8.420'}, {'value': '-18.611', 'groupId': 'OG003', 'lowerLimit': '-24.725', 'upperLimit': '-9.459'}]}]}, {'title': 'IgG, Week 40,n=34,25,0,11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-6.955', 'groupId': 'OG000', 'lowerLimit': '-36.842', 'upperLimit': '4.878'}, {'value': '-25.532', 'groupId': 'OG001', 'lowerLimit': '-34.286', 'upperLimit': '-15.575'}, {'value': '-26.484', 'groupId': 'OG003', 'lowerLimit': '-27.473', 'upperLimit': '-16.418'}]}]}, {'title': 'IgG, Week 48,n=33,27,0,10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-14.063', 'groupId': 'OG000', 'lowerLimit': '-34.082', 'upperLimit': '2.222'}, {'value': '-25.133', 'groupId': 'OG001', 'lowerLimit': '-33.945', 'upperLimit': '-6.897'}, {'value': '-20.596', 'groupId': 'OG003', 'lowerLimit': '-29.870', 'upperLimit': '-8.209'}]}]}, {'title': 'IgG, Week 52,n=33,27,0,10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-11.258', 'groupId': 'OG000', 'lowerLimit': '-34.457', 'upperLimit': '9.756'}, {'value': '-23.596', 'groupId': 'OG001', 'lowerLimit': '-29.655', 'upperLimit': '-14.359'}, {'value': '-23.754', 'groupId': 'OG003', 'lowerLimit': '-25.974', 'upperLimit': '-18.543'}]}]}, {'title': 'IgM,Day 0,n=31,29, 12,0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-47.059', 'groupId': 'OG000', 'lowerLimit': '-67.333', 'upperLimit': '-26.761'}, {'value': '-53.608', 'groupId': 'OG001', 'lowerLimit': '-64.583', 'upperLimit': '-41.463'}, {'value': '-44.326', 'groupId': 'OG002', 'lowerLimit': '-63.895', 'upperLimit': '-25.516'}]}]}, {'title': 'IgM,Week 8,n=37,29, 11,0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-49.174', 'groupId': 'OG000', 'lowerLimit': '-65.672', 'upperLimit': '-34.868'}, {'value': '-53.659', 'groupId': 'OG001', 'lowerLimit': '-64.583', 'upperLimit': '-46.262'}, {'value': '-50.943', 'groupId': 'OG002', 'lowerLimit': '-70.621', 'upperLimit': '-31.325'}]}]}, {'title': 'IgM, Week 16,n=36,27, 11,0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-50.077', 'groupId': 'OG000', 'lowerLimit': '-61.922', 'upperLimit': '-30.099'}, {'value': '-54.945', 'groupId': 'OG001', 'lowerLimit': '-61.224', 'upperLimit': '-43.103'}, {'value': '-45.926', 'groupId': 'OG002', 'lowerLimit': '-70.690', 'upperLimit': '-19.277'}]}]}, {'title': 'IgM, Week 24,n=31,27, 11,0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-39.496', 'groupId': 'OG000', 'lowerLimit': '-53.153', 'upperLimit': '-36.184'}, {'value': '-50.909', 'groupId': 'OG001', 'lowerLimit': '-62.963', 'upperLimit': '-34.483'}, {'value': '-45.161', 'groupId': 'OG002', 'lowerLimit': '-65.517', 'upperLimit': '-8.511'}]}]}, {'title': 'IgM, Week 32,n=34,27,0,10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-34.887', 'groupId': 'OG000', 'lowerLimit': '-48.936', 'upperLimit': '-18.000'}, {'value': '-52.577', 'groupId': 'OG001', 'lowerLimit': '-66.667', 'upperLimit': '-31.250'}, {'value': '-46.548', 'groupId': 'OG003', 'lowerLimit': '-56.863', 'upperLimit': '-12.766'}]}]}, {'title': 'IgM, Week 40,n=34,25,0,11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-37.870', 'groupId': 'OG000', 'lowerLimit': '-46.847', 'upperLimit': '-20.667'}, {'value': '-52.381', 'groupId': 'OG001', 'lowerLimit': '-65.556', 'upperLimit': '-41.304'}, {'value': '-48.889', 'groupId': 'OG003', 'lowerLimit': '-67.241', 'upperLimit': '-10.638'}]}]}, {'title': 'IgM, Week 48,n=33,27,0,10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-31.707', 'groupId': 'OG000', 'lowerLimit': '-54.667', 'upperLimit': '-11.765'}, {'value': '-53.636', 'groupId': 'OG001', 'lowerLimit': '-63.333', 'upperLimit': '-40.625'}, {'value': '-48.268', 'groupId': 'OG003', 'lowerLimit': '-58.824', 'upperLimit': '-14.458'}]}]}, {'title': 'IgM, Week 52,n=33,27,0,10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-30.921', 'groupId': 'OG000', 'lowerLimit': '-53.750', 'upperLimit': '-4.348'}, {'value': '-51.648', 'groupId': 'OG001', 'lowerLimit': '-67.532', 'upperLimit': '-46.429'}, {'value': '-57.966', 'groupId': 'OG003', 'lowerLimit': '-72.414', 'upperLimit': '-30.120'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (Day 0 from parent studies); Day 0 and 8, 16, 24, 32, 40, 48 and 52 weeks', 'description': 'Serum samples were collected at indicated time-points for analysis of immunoglobulins: Immunoglobulin G (IgG), Immunoglobulin A (IgA), and Immunoglobulin M (IgM). Baseline is defined as the Day 0 visit from parent studies. Percentage change from Baseline is equal to 100\\* (value at specified visit minus Baseline value) divided by Baseline value.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).'}, {'type': 'SECONDARY', 'title': 'Percentage Change From Baseline in Autoantibody:Anti-double Stranded Deoxyribonucleic Acid (dsDNA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Long-term Discontinuation Group', 'description': 'Participants in this group discontinued belimumab 10 mg/kg therapy for 52 weeks but remained on standard of care therapy. Participants from BEL114333 (NCT01597622), BEL112233 (NCT00724867) and BEL112626 (NCT00583362) were part of this group. Participants had been treated with belimumab for at least 6 months in one of these continuation studies but had withdrawn from belimumab therapy for no longer than 8 weeks prior to entry into this study.'}, {'id': 'OG001', 'title': 'Treatment Control Group', 'description': 'Participants in this group continued to receive monthly belimumab 10 mg/kg therapy, in addition to standard of care SLE therapy for 52 weeks. Participants from BEL113750 (NCT01345253) and BEL114333 (NCT01597622) were part of this group. Participants had been treated with belimumab for at least 6 months in one of these continuation studies prior to entry into this study. Eligible participants on completion of 52-weeks entered Maintenance period and received belimumab 10 mg/kg every 4 weeks until Week 48 of subsequent years (Maintenance is Year 2, 3, 4).'}, {'id': 'OG002', 'title': 'Treatment Holiday Group - Holiday Phase', 'description': 'Participants in the Treatment Holiday Group underwent a 24-week belimumab treatment holiday while remaining on standard of care SLE therapy, Holiday Phase was Day 0 visit to Week 24/Treatment Re-start phase. Participants from BEL113750 (NCT01345253) and BEL114333 (NCT01597622) were part of this group. Participants had been treated with belimumab for at least 6 months in one of these continuation studies prior to entry into this study. In the event of a severe flare, participants were allowed to enter Maintenance Phase and receive belimumab 10 mg/Kg every 4 weeks until Week 48 of subsequent years (Maintenance is Year 2, 3, 4).'}, {'id': 'OG003', 'title': 'Treatment Holiday Group - Re-start Phase', 'description': 'Following Treatment holiday phase for 24 weeks, participants re-started belimumab therapy for 28 weeks while receiving standard of care SLE therapy for 52 weeks. Re-start Phase started one day after Week 24 up to Week 52. Participants from BEL113750 (NCT01345253) and BEL114333 (NCT01597622) were part of this group. Participants had been treated with belimumab for at least 6 months in one of these continuation studies prior to entry into this study. Eligible participants on completion of 52-weeks entered Maintenance period and received belimumab 10 mg/kg every 4 weeks until Week 48 of subsequent years (Maintenance is Year 2, 3, 4).'}], 'classes': [{'title': 'Day 0,n=39,29,12, 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-82.8', 'groupId': 'OG000', 'lowerLimit': '-90.3', 'upperLimit': '-38.5'}, {'value': '-69.4', 'groupId': 'OG001', 'lowerLimit': '-88.7', 'upperLimit': '-46.2'}, {'value': '-81.3', 'groupId': 'OG002', 'lowerLimit': '-84.9', 'upperLimit': '-52.0'}]}]}, {'title': 'Week 4,n=39,29,12, 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-82.8', 'groupId': 'OG000', 'lowerLimit': '-92.2', 'upperLimit': '-46.1'}, {'value': '-65.9', 'groupId': 'OG001', 'lowerLimit': '-89.0', 'upperLimit': '-53.8'}, {'value': '-83.2', 'groupId': 'OG002', 'lowerLimit': '-90.0', 'upperLimit': '-51.6'}]}]}, {'title': 'Week 8,n=37,29, 11,0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-74.3', 'groupId': 'OG000', 'lowerLimit': '-89.5', 'upperLimit': '-33.7'}, {'value': '-70.3', 'groupId': 'OG001', 'lowerLimit': '-89.5', 'upperLimit': '-47.5'}, {'value': '-81.6', 'groupId': 'OG002', 'lowerLimit': '-87.7', 'upperLimit': '-54.5'}]}]}, {'title': 'Week 12,n=38,29, 11,0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-77.3', 'groupId': 'OG000', 'lowerLimit': '-89.1', 'upperLimit': '-28.2'}, {'value': '-68.9', 'groupId': 'OG001', 'lowerLimit': '-90.1', 'upperLimit': '-50.0'}, {'value': '-85.0', 'groupId': 'OG002', 'lowerLimit': '-88.6', 'upperLimit': '-53.0'}]}]}, {'title': 'Week 16,n=36,27, 11,0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-78.4', 'groupId': 'OG000', 'lowerLimit': '-89.7', 'upperLimit': '-33.9'}, {'value': '-72.8', 'groupId': 'OG001', 'lowerLimit': '-91.2', 'upperLimit': '-34.1'}, {'value': '-79.7', 'groupId': 'OG002', 'lowerLimit': '-86.4', 'upperLimit': '-64.1'}]}]}, {'title': 'Week 20,n=34,27, 11,0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-82.8', 'groupId': 'OG000', 'lowerLimit': '-90.3', 'upperLimit': '-33.7'}, {'value': '-70.3', 'groupId': 'OG001', 'lowerLimit': '-91.9', 'upperLimit': '-50.0'}, {'value': '-79.9', 'groupId': 'OG002', 'lowerLimit': '-88.3', 'upperLimit': '-55.2'}]}]}, {'title': 'Week 24,n=31,27, 11,0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-82.8', 'groupId': 'OG000', 'lowerLimit': '-92.6', 'upperLimit': '-41.2'}, {'value': '-71.8', 'groupId': 'OG001', 'lowerLimit': '-91.9', 'upperLimit': '-38.5'}, {'value': '-75.0', 'groupId': 'OG002', 'lowerLimit': '-87.4', 'upperLimit': '-54.5'}]}]}, {'title': 'Week 28,n=35,27,0,10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-69.8', 'groupId': 'OG000', 'lowerLimit': '-88.9', 'upperLimit': '-28.1'}, {'value': '-72.3', 'groupId': 'OG001', 'lowerLimit': '-91.9', 'upperLimit': '-46.2'}, {'value': '-79.9', 'groupId': 'OG003', 'lowerLimit': '-88.3', 'upperLimit': '-56.8'}]}]}, {'title': 'Week 32,n=34,27,0,11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-77.9', 'groupId': 'OG000', 'lowerLimit': '-90.0', 'upperLimit': '-33.3'}, {'value': '-71.4', 'groupId': 'OG001', 'lowerLimit': '-89.5', 'upperLimit': '-50.0'}, {'value': '-79.6', 'groupId': 'OG003', 'lowerLimit': '-91.3', 'upperLimit': '-57.1'}]}]}, {'title': 'Week 36,n=34,27,0,11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-75.1', 'groupId': 'OG000', 'lowerLimit': '-88.4', 'upperLimit': '-13.5'}, {'value': '-71.0', 'groupId': 'OG001', 'lowerLimit': '-92.9', 'upperLimit': '-50.0'}, {'value': '-80.8', 'groupId': 'OG003', 'lowerLimit': '-90.8', 'upperLimit': '-62.9'}]}]}, {'title': 'Week 40,n=34,25,0,11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-73.6', 'groupId': 'OG000', 'lowerLimit': '-91.2', 'upperLimit': '-4.8'}, {'value': '-87.4', 'groupId': 'OG001', 'lowerLimit': '-93.7', 'upperLimit': '-70.2'}, {'value': '-79.9', 'groupId': 'OG003', 'lowerLimit': '-90.1', 'upperLimit': '-53.2'}]}]}, {'title': 'Week 44,n=34,27,0,10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-62.0', 'groupId': 'OG000', 'lowerLimit': '-90.3', 'upperLimit': '-21.4'}, {'value': '-77.7', 'groupId': 'OG001', 'lowerLimit': '-94.0', 'upperLimit': '-52.3'}, {'value': '-82.5', 'groupId': 'OG003', 'lowerLimit': '-91.1', 'upperLimit': '-50.0'}]}]}, {'title': 'Week 48,n=33,27,0,10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-71.8', 'groupId': 'OG000', 'lowerLimit': '-90.3', 'upperLimit': '-21.4'}, {'value': '-76.6', 'groupId': 'OG001', 'lowerLimit': '-92.8', 'upperLimit': '-50.0'}, {'value': '-80.6', 'groupId': 'OG003', 'lowerLimit': '-86.4', 'upperLimit': '-63.3'}]}]}, {'title': 'Week 52,n=33,27,0,10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-65.3', 'groupId': 'OG000', 'lowerLimit': '-91.7', 'upperLimit': '-15.9'}, {'value': '-78.3', 'groupId': 'OG001', 'lowerLimit': '-91.5', 'upperLimit': '-38.5'}, {'value': '-79.5', 'groupId': 'OG003', 'lowerLimit': '-91.1', 'upperLimit': '-64.3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (Day 0 from parent studies); Day 0 and 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 weeks', 'description': 'Blood samples were collected at indicated time-points for analysis of autoantibodies like dsDNA. Baseline is defined as the Day 0 visit from parent studies. Percentage change from Baseline is equal to 100\\* (Value at specified visit minus Baseline value) divided by Baseline value.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).'}, {'type': 'SECONDARY', 'title': 'Percentage Change From Baseline in Autoantibody: Antinuclear Antibody (ANA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Long-term Discontinuation Group', 'description': 'Participants in this group discontinued belimumab 10 mg/kg therapy for 52 weeks but remained on standard of care therapy. Participants from BEL114333 (NCT01597622), BEL112233 (NCT00724867) and BEL112626 (NCT00583362) were part of this group. Participants had been treated with belimumab for at least 6 months in one of these continuation studies but had withdrawn from belimumab therapy for no longer than 8 weeks prior to entry into this study.'}, {'id': 'OG001', 'title': 'Treatment Control Group', 'description': 'Participants in this group continued to receive monthly belimumab 10 mg/kg therapy, in addition to standard of care SLE therapy for 52 weeks. Participants from BEL113750 (NCT01345253) and BEL114333 (NCT01597622) were part of this group. Participants had been treated with belimumab for at least 6 months in one of these continuation studies prior to entry into this study. Eligible participants on completion of 52-weeks entered Maintenance period and received belimumab 10 mg/kg every 4 weeks until Week 48 of subsequent years (Maintenance is Year 2, 3, 4).'}, {'id': 'OG002', 'title': 'Treatment Holiday Group - Holiday Phase', 'description': 'Participants in the Treatment Holiday Group underwent a 24-week belimumab treatment holiday while remaining on standard of care SLE therapy, Holiday Phase was Day 0 visit to Week 24/Treatment Re-start phase. Participants from BEL113750 (NCT01345253) and BEL114333 (NCT01597622) were part of this group. Participants had been treated with belimumab for at least 6 months in one of these continuation studies prior to entry into this study. In the event of a severe flare, participants were allowed to enter Maintenance Phase and receive belimumab 10 mg/Kg every 4 weeks until Week 48 of subsequent years (Maintenance is Year 2, 3, 4).'}, {'id': 'OG003', 'title': 'Treatment Holiday Group - Re-start Phase', 'description': 'Following Treatment holiday phase for 24 weeks, participants re-started belimumab therapy for 28 weeks while receiving standard of care SLE therapy for 52 weeks. Re-start Phase started one day after Week 24 up to Week 52. Participants from BEL113750 (NCT01345253) and BEL114333 (NCT01597622) were part of this group. Participants had been treated with belimumab for at least 6 months in one of these continuation studies prior to entry into this study. Eligible participants on completion of 52-weeks entered Maintenance period and received belimumab 10 mg/kg every 4 weeks until Week 48 of subsequent years (Maintenance is Year 2, 3, 4).'}], 'classes': [{'title': 'Day 0,n=21,27, 10,0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-15.044', 'groupId': 'OG000', 'lowerLimit': '-29.716', 'upperLimit': '4.193'}, {'value': '-24.938', 'groupId': 'OG001', 'lowerLimit': '-58.221', 'upperLimit': '0.000'}, {'value': '-32.336', 'groupId': 'OG002', 'lowerLimit': '-47.741', 'upperLimit': '-26.843'}]}]}, {'title': 'Week 24,n=20,26, 10,0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5.723', 'groupId': 'OG000', 'lowerLimit': '-9.113', 'upperLimit': '24.347'}, {'value': '-27.434', 'groupId': 'OG001', 'lowerLimit': '-62.747', 'upperLimit': '0.000'}, {'value': '-29.771', 'groupId': 'OG002', 'lowerLimit': '-44.978', 'upperLimit': '-13.643'}]}]}, {'title': 'Week 52,n=19,26,0,9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-16.455', 'groupId': 'OG000', 'lowerLimit': '-56.522', 'upperLimit': '21.800'}, {'value': '-45.961', 'groupId': 'OG001', 'lowerLimit': '-66.917', 'upperLimit': '-11.765'}, {'value': '-35.539', 'groupId': 'OG003', 'lowerLimit': '-43.928', 'upperLimit': '-20.586'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (Day 0 from parent studies); Day 0 and 24 and 52 weeks', 'description': 'Blood samples were collected at indicated time-points for analysis of autoantibodies like ANA. Only participants who had an ANA value measured in INDEX at the parent studies Baseline were included in this analysis. Baseline is defined as the Day 0 visit from parent studies. Percentage change from Baseline is equal to 100\\* (Value at specified visit minus Baseline value) divided by Baseline value.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).'}, {'type': 'SECONDARY', 'title': 'Percentage Change From Baseline in Complement Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Long-term Discontinuation Group', 'description': 'Participants in this group discontinued belimumab 10 mg/kg therapy for 52 weeks but remained on standard of care therapy. Participants from BEL114333 (NCT01597622), BEL112233 (NCT00724867) and BEL112626 (NCT00583362) were part of this group. Participants had been treated with belimumab for at least 6 months in one of these continuation studies but had withdrawn from belimumab therapy for no longer than 8 weeks prior to entry into this study.'}, {'id': 'OG001', 'title': 'Treatment Control Group', 'description': 'Participants in this group continued to receive monthly belimumab 10 mg/kg therapy, in addition to standard of care SLE therapy for 52 weeks. Participants from BEL113750 (NCT01345253) and BEL114333 (NCT01597622) were part of this group. Participants had been treated with belimumab for at least 6 months in one of these continuation studies prior to entry into this study. Eligible participants on completion of 52-weeks entered Maintenance period and received belimumab 10 mg/kg every 4 weeks until Week 48 of subsequent years (Maintenance is Year 2, 3, 4).'}, {'id': 'OG002', 'title': 'Treatment Holiday Group - Holiday Phase', 'description': 'Participants in the Treatment Holiday Group underwent a 24-week belimumab treatment holiday while remaining on standard of care SLE therapy, Holiday Phase was Day 0 visit to Week 24/Treatment Re-start phase. Participants from BEL113750 (NCT01345253) and BEL114333 (NCT01597622) were part of this group. Participants had been treated with belimumab for at least 6 months in one of these continuation studies prior to entry into this study. In the event of a severe flare, participants were allowed to enter Maintenance Phase and receive belimumab 10 mg/Kg every 4 weeks until Week 48 of subsequent years (Maintenance is Year 2, 3, 4).'}, {'id': 'OG003', 'title': 'Treatment Holiday Group - Re-start Phase', 'description': 'Following Treatment holiday phase for 24 weeks, participants re-started belimumab therapy for 28 weeks while receiving standard of care SLE therapy for 52 weeks. Re-start Phase started one day after Week 24 up to Week 52. Participants from BEL113750 (NCT01345253) and BEL114333 (NCT01597622) were part of this group. Participants had been treated with belimumab for at least 6 months in one of these continuation studies prior to entry into this study. Eligible participants on completion of 52-weeks entered Maintenance period and received belimumab 10 mg/kg every 4 weeks until Week 48 of subsequent years (Maintenance is Year 2, 3, 4).'}], 'classes': [{'title': 'C3, Day 0,n=39,27,12, 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '10.3', 'groupId': 'OG000', 'lowerLimit': '-4.5', 'upperLimit': '42.9'}, {'value': '7.2', 'groupId': 'OG001', 'lowerLimit': '-6.8', 'upperLimit': '35.8'}, {'value': '32.1', 'groupId': 'OG002', 'lowerLimit': '23.7', 'upperLimit': '61.5'}]}]}, {'title': 'C3, Week 4,n=39,29,12, 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '15.4', 'groupId': 'OG000', 'lowerLimit': '-2.2', 'upperLimit': '42.0'}, {'value': '16.0', 'groupId': 'OG001', 'lowerLimit': '-7.3', 'upperLimit': '27.5'}, {'value': '14.8', 'groupId': 'OG002', 'lowerLimit': '-6.8', 'upperLimit': '46.1'}]}]}, {'title': 'C3,Week 8,n=37,29, 11,0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '13.6', 'groupId': 'OG000', 'lowerLimit': '4.3', 'upperLimit': '38.3'}, {'value': '19.8', 'groupId': 'OG001', 'lowerLimit': '-1.0', 'upperLimit': '40.6'}, {'value': '31.4', 'groupId': 'OG002', 'lowerLimit': '17.2', 'upperLimit': '60.9'}]}]}, {'title': 'C3,Week 12,n=38,29, 11,0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '10.9', 'groupId': 'OG000', 'lowerLimit': '-6.3', 'upperLimit': '50.0'}, {'value': '14.1', 'groupId': 'OG001', 'lowerLimit': '5.2', 'upperLimit': '39.1'}, {'value': '30.4', 'groupId': 'OG002', 'lowerLimit': '24.7', 'upperLimit': '75.0'}]}]}, {'title': 'C3,Week 16,n=36,27, 11,0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '15.2', 'groupId': 'OG000', 'lowerLimit': '-0.6', 'upperLimit': '59.1'}, {'value': '20.5', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '46.7'}, {'value': '32.2', 'groupId': 'OG002', 'lowerLimit': '20.0', 'upperLimit': '62.5'}]}]}, {'title': 'C3,Week 20,n=34,27, 11,0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '15.4', 'groupId': 'OG000', 'lowerLimit': '-4.7', 'upperLimit': '40.3'}, {'value': '13.6', 'groupId': 'OG001', 'lowerLimit': '-4.3', 'upperLimit': '26.6'}, {'value': '30.0', 'groupId': 'OG002', 'lowerLimit': '18.3', 'upperLimit': '70.3'}]}]}, {'title': 'C3,Week 24,n=31,27, 11,0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '17.3', 'groupId': 'OG000', 'lowerLimit': '-7.0', 'upperLimit': '41.0'}, {'value': '19.8', 'groupId': 'OG001', 'lowerLimit': '-1.3', 'upperLimit': '58.9'}, {'value': '44.2', 'groupId': 'OG002', 'lowerLimit': '5.7', 'upperLimit': '53.2'}]}]}, {'title': 'C3,Week 28,n=35,27,0,10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '15.8', 'groupId': 'OG000', 'lowerLimit': '-10.0', 'upperLimit': '36.4'}, {'value': '15.4', 'groupId': 'OG001', 'lowerLimit': '7.8', 'upperLimit': '42.2'}, {'value': '31.3', 'groupId': 'OG003', 'lowerLimit': '12.6', 'upperLimit': '57.7'}]}]}, {'title': 'C3,Week 32,n=34,27,0,11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '13.8', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '53.7'}, {'value': '21.6', 'groupId': 'OG001', 'lowerLimit': '6.7', 'upperLimit': '50.7'}, {'value': '31.6', 'groupId': 'OG003', 'lowerLimit': '16.0', 'upperLimit': '69.2'}]}]}, {'title': 'C3,Week 36,n=34,27,0,11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '9.4', 'groupId': 'OG000', 'lowerLimit': '-2.9', 'upperLimit': '44.8'}, {'value': '17.0', 'groupId': 'OG001', 'lowerLimit': '-8.1', 'upperLimit': '35.1'}, {'value': '26.0', 'groupId': 'OG003', 'lowerLimit': '11.7', 'upperLimit': '67.3'}]}]}, {'title': 'C3,Week 40,n=34,25,0,11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '12.8', 'groupId': 'OG000', 'lowerLimit': '-2.5', 'upperLimit': '28.3'}, {'value': '17.3', 'groupId': 'OG001', 'lowerLimit': '3.1', 'upperLimit': '39.7'}, {'value': '41.8', 'groupId': 'OG003', 'lowerLimit': '12.8', 'upperLimit': '62.5'}]}]}, {'title': 'C3,Week 44,n=34,27,0,10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '14.1', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '29.7'}, {'value': '22.7', 'groupId': 'OG001', 'lowerLimit': '-6.3', 'upperLimit': '51.6'}, {'value': '38.9', 'groupId': 'OG003', 'lowerLimit': '23.0', 'upperLimit': '75.0'}]}]}, {'title': 'C3,Week 48,n=33,27,0,10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '15.4', 'groupId': 'OG000', 'lowerLimit': '-5.1', 'upperLimit': '35.0'}, {'value': '15.9', 'groupId': 'OG001', 'lowerLimit': '-4.5', 'upperLimit': '41.5'}, {'value': '30.4', 'groupId': 'OG003', 'lowerLimit': '13.8', 'upperLimit': '82.7'}]}]}, {'title': 'C3,Week 52,n=33,27,0,10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000', 'lowerLimit': '-9.1', 'upperLimit': '25.9'}, {'value': '21.9', 'groupId': 'OG001', 'lowerLimit': '3.5', 'upperLimit': '32.8'}, {'value': '36.5', 'groupId': 'OG003', 'lowerLimit': '7.1', 'upperLimit': '77.3'}]}]}, {'title': 'C4, Day 0,n=39,27,12, 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '36.4', 'groupId': 'OG000', 'lowerLimit': '-6.3', 'upperLimit': '100.0'}, {'value': '27.8', 'groupId': 'OG001', 'lowerLimit': '11.1', 'upperLimit': '128.6'}, {'value': '70.8', 'groupId': 'OG002', 'lowerLimit': '25.2', 'upperLimit': '154.2'}]}]}, {'title': 'C4, Week 4,n=39,29,12, 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '31.6', 'groupId': 'OG000', 'lowerLimit': '10.0', 'upperLimit': '100.0'}, {'value': '47.4', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '87.5'}, {'value': '39.7', 'groupId': 'OG002', 'lowerLimit': '6.7', 'upperLimit': '110.4'}]}]}, {'title': 'C4,Week 8,n=37,29, 11,0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '37.5', 'groupId': 'OG000', 'lowerLimit': '2.6', 'upperLimit': '83.3'}, {'value': '71.4', 'groupId': 'OG001', 'lowerLimit': '11.8', 'upperLimit': '105.6'}, {'value': '58.3', 'groupId': 'OG002', 'lowerLimit': '33.3', 'upperLimit': '183.3'}]}]}, {'title': 'C4,Week 12,n=38,29, 11,0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '27.6', 'groupId': 'OG000', 'lowerLimit': '4.5', 'upperLimit': '122.2'}, {'value': '68.4', 'groupId': 'OG001', 'lowerLimit': '12.0', 'upperLimit': '121.4'}, {'value': '64.3', 'groupId': 'OG002', 'lowerLimit': '16.7', 'upperLimit': '200.0'}]}]}, {'title': 'C4,Week 16,n=36,27, 11,0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '35.4', 'groupId': 'OG000', 'lowerLimit': '13.1', 'upperLimit': '158.3'}, {'value': '50.0', 'groupId': 'OG001', 'lowerLimit': '17.4', 'upperLimit': '114.3'}, {'value': '41.7', 'groupId': 'OG002', 'lowerLimit': '25.0', 'upperLimit': '150.0'}]}]}, {'title': 'C4,Week 20,n=34,27, 11,0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '32.6', 'groupId': 'OG000', 'lowerLimit': '4.2', 'upperLimit': '114.3'}, {'value': '64.3', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '109.1'}, {'value': '58.3', 'groupId': 'OG002', 'lowerLimit': '17.6', 'upperLimit': '166.7'}]}]}, {'title': 'C4,Week 24,n=31,27, 11,0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '34.8', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '128.6'}, {'value': '57.1', 'groupId': 'OG001', 'lowerLimit': '15.8', 'upperLimit': '125.0'}, {'value': '66.7', 'groupId': 'OG002', 'lowerLimit': '26.3', 'upperLimit': '83.3'}]}]}, {'title': 'C4,Week 28,n=35,27,0,10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '31.3', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '100.0'}, {'value': '66.7', 'groupId': 'OG001', 'lowerLimit': '8.0', 'upperLimit': '100.0'}, {'value': '50.6', 'groupId': 'OG003', 'lowerLimit': '8.3', 'upperLimit': '166.7'}]}]}, {'title': 'C4,Week 32,n=34,27,0,11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '27.6', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '106.7'}, {'value': '92.9', 'groupId': 'OG001', 'lowerLimit': '21.7', 'upperLimit': '128.6'}, {'value': '58.3', 'groupId': 'OG003', 'lowerLimit': '21.1', 'upperLimit': '175.0'}]}]}, {'title': 'C4,Week 36,n=34,27,0,11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '29.2', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '100.0'}, {'value': '50.0', 'groupId': 'OG001', 'lowerLimit': '11.1', 'upperLimit': '116.7'}, {'value': '58.3', 'groupId': 'OG003', 'lowerLimit': '25.0', 'upperLimit': '183.3'}]}]}, {'title': 'C4,Week 40,n=34,25,0,11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '32.1', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '73.3'}, {'value': '73.3', 'groupId': 'OG001', 'lowerLimit': '29.4', 'upperLimit': '112.5'}, {'value': '58.3', 'groupId': 'OG003', 'lowerLimit': '21.1', 'upperLimit': '116.7'}]}]}, {'title': 'C4,Week 44,n=34,27,0,10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '20.5', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '68.8'}, {'value': '57.1', 'groupId': 'OG001', 'lowerLimit': '12.0', 'upperLimit': '116.7'}, {'value': '60.7', 'groupId': 'OG003', 'lowerLimit': '36.8', 'upperLimit': '150.0'}]}]}, {'title': 'C4,Week 48,n=33,27,0,10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '31.3', 'groupId': 'OG000', 'lowerLimit': '-5.9', 'upperLimit': '60.0'}, {'value': '64.3', 'groupId': 'OG001', 'lowerLimit': '15.8', 'upperLimit': '114.3'}, {'value': '34.5', 'groupId': 'OG003', 'lowerLimit': '10.5', 'upperLimit': '100.0'}]}]}, {'title': 'C4,Week 52,n=33,27,0,10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '17.6', 'groupId': 'OG000', 'lowerLimit': '-5.9', 'upperLimit': '62.5'}, {'value': '63.2', 'groupId': 'OG001', 'lowerLimit': '-4.0', 'upperLimit': '126.7'}, {'value': '58.3', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '133.3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (Day 0 from parent studies); Day 0 and 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 weeks', 'description': 'Blood samples were collected at indicated time-points for analysis of complement levels like complement 3 (C3) and complement 4 (C4). Baseline is defined as the Day 0 visit from parent studies. Percentage change from Baseline is equal to 100\\* (Value at specified visit minus Baseline value) divided by Baseline value.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).'}, {'type': 'SECONDARY', 'title': 'Percentage Change From Baseline in B Cell Subsets', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Long-term Discontinuation Group', 'description': 'Participants in this group discontinued belimumab 10 mg/kg therapy for 52 weeks but remained on standard of care therapy. Participants from BEL114333 (NCT01597622), BEL112233 (NCT00724867) and BEL112626 (NCT00583362) were part of this group. Participants had been treated with belimumab for at least 6 months in one of these continuation studies but had withdrawn from belimumab therapy for no longer than 8 weeks prior to entry into this study.'}, {'id': 'OG001', 'title': 'Treatment Control Group', 'description': 'Participants in this group continued to receive monthly belimumab 10 mg/kg therapy, in addition to standard of care SLE therapy for 52 weeks. Participants from BEL113750 (NCT01345253) and BEL114333 (NCT01597622) were part of this group. Participants had been treated with belimumab for at least 6 months in one of these continuation studies prior to entry into this study. Eligible participants on completion of 52-weeks entered Maintenance period and received belimumab 10 mg/kg every 4 weeks until Week 48 of subsequent years (Maintenance is Year 2, 3, 4).'}, {'id': 'OG002', 'title': 'Treatment Holiday Group - Holiday Phase', 'description': 'Participants in the Treatment Holiday Group underwent a 24-week belimumab treatment holiday while remaining on standard of care SLE therapy, Holiday Phase was Day 0 visit to Week 24/Treatment Re-start phase. Participants from BEL113750 (NCT01345253) and BEL114333 (NCT01597622) were part of this group. Participants had been treated with belimumab for at least 6 months in one of these continuation studies prior to entry into this study. In the event of a severe flare, participants were allowed to enter Maintenance Phase and receive belimumab 10 mg/Kg every 4 weeks until Week 48 of subsequent years (Maintenance is Year 2, 3, 4).'}, {'id': 'OG003', 'title': 'Treatment Holiday Group - Re-start Phase', 'description': 'Following Treatment holiday phase for 24 weeks, participants re-started belimumab therapy for 28 weeks while receiving standard of care SLE therapy for 52 weeks. Re-start Phase started one day after Week 24 up to Week 52. Participants from BEL113750 (NCT01345253) and BEL114333 (NCT01597622) were part of this group. Participants had been treated with belimumab for at least 6 months in one of these continuation studies prior to entry into this study. Eligible participants on completion of 52-weeks entered Maintenance period and received belimumab 10 mg/kg every 4 weeks until Week 48 of subsequent years (Maintenance is Year 2, 3, 4).'}], 'classes': [{'title': 'Memory CD19+CD20+CD27+, Day 0,n=16,2,8,0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-69.0', 'groupId': 'OG000', 'lowerLimit': '-80.9', 'upperLimit': '-58.9'}, {'value': '-76.1', 'groupId': 'OG001', 'lowerLimit': '-80.0', 'upperLimit': '-72.2'}, {'value': '-43.2', 'groupId': 'OG002', 'lowerLimit': '-55.0', 'upperLimit': '68.3'}]}]}, {'title': 'Memory CD19+CD20+CD27+, Week 8,n=15,2,5,0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-73.7', 'groupId': 'OG000', 'lowerLimit': '-85.0', 'upperLimit': '-60.0'}, {'value': '-78.9', 'groupId': 'OG001', 'lowerLimit': '-80.0', 'upperLimit': '-77.8'}, {'value': '-50.0', 'groupId': 'OG002', 'lowerLimit': '-71.4', 'upperLimit': '50.0'}]}]}, {'title': 'Memory CD19+CD20+CD27+,Week16,n=14,2,6,0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-83.4', 'groupId': 'OG000', 'lowerLimit': '-93.2', 'upperLimit': '-66.7'}, {'value': '-69.2', 'groupId': 'OG001', 'lowerLimit': '-80.0', 'upperLimit': '-58.3'}, {'value': '-60.7', 'groupId': 'OG002', 'lowerLimit': '-80.0', 'upperLimit': '0.0'}]}]}, {'title': 'Memory CD19+CD20+CD27+,Week24,n=13,2,6,0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '2', 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{'title': 'CD20+,Week24,n=13,2,6,0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-52.0', 'groupId': 'OG000', 'lowerLimit': '-90.9', 'upperLimit': '26.3'}, {'value': '-87.7', 'groupId': 'OG001', 'lowerLimit': '-93.7', 'upperLimit': '-81.6'}, {'value': '-53.4', 'groupId': 'OG002', 'lowerLimit': '-71.3', 'upperLimit': '31.9'}]}]}, {'title': 'CD20+,Week32,n=12,2,0,7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-49.0', 'groupId': 'OG000', 'lowerLimit': '-74.1', 'upperLimit': '62.4'}, {'value': '-87.4', 'groupId': 'OG001', 'lowerLimit': '-95.4', 'upperLimit': '-79.3'}, {'value': '-66.2', 'groupId': 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'upperLimit': '-85.1'}, {'value': '-71.8', 'groupId': 'OG003', 'lowerLimit': '-92.7', 'upperLimit': '19.4'}]}]}, {'title': 'Activated CD19+CD20+CD69+,Day0, n=11,1,8,0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-99.8', 'groupId': 'OG000', 'lowerLimit': '-100.0', 'upperLimit': '-91.7'}, {'value': '-86.1', 'groupId': 'OG001', 'lowerLimit': '-86.1', 'upperLimit': '-86.1'}, {'value': '-65.1', 'groupId': 'OG002', 'lowerLimit': '-93.6', 'upperLimit': '-2.1'}]}]}, {'title': 'Activated CD19+CD20+CD69+, Week8, n=10,1,7,0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-99.6', 'groupId': 'OG000', 'lowerLimit': '-100.0', 'upperLimit': '-98.2'}, {'value': '-97.1', 'groupId': 'OG001', 'lowerLimit': '-97.1', 'upperLimit': '-97.1'}, {'value': '-76.3', 'groupId': 'OG002', 'lowerLimit': '-100.0', 'upperLimit': '2141.7'}]}]}, {'title': 'Activated CD19+CD20+CD69+, Week16, n=9,1,7,0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-98.9', 'groupId': 'OG000', 'lowerLimit': '-99.4', 'upperLimit': '-98.3'}, {'value': '-93.4', 'groupId': 'OG001', 'lowerLimit': '-93.4', 'upperLimit': '-93.4'}, {'value': '-72.3', 'groupId': 'OG002', 'lowerLimit': '-98.9', 'upperLimit': '-22.9'}]}]}, {'title': 'Activated CD19+CD20+CD69+,Week24, n=9,1,7,0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-99.7', 'groupId': 'OG000', 'lowerLimit': '-100.0', 'upperLimit': '-95.3'}, {'value': '-94.2', 'groupId': 'OG001', 'lowerLimit': '-94.2', 'upperLimit': '-94.2'}, {'value': '-50.9', 'groupId': 'OG002', 'lowerLimit': '-95.6', 'upperLimit': '80.0'}]}]}, {'title': 'Activated CD19+CD20+CD69+,Week32, n=9,1,0,7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-98.0', 'groupId': 'OG000', 'lowerLimit': '-99.8', 'upperLimit': '-97.4'}, {'value': '-86.9', 'groupId': 'OG001', 'lowerLimit': '-86.9', 'upperLimit': '-86.9'}, {'value': '-54.5', 'groupId': 'OG003', 'lowerLimit': '-74.1', 'upperLimit': '975.0'}]}]}, {'title': 'Activated CD19+CD20+CD69+, Week40, n=9,1,0,7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-98.1', 'groupId': 'OG000', 'lowerLimit': '-99.8', 'upperLimit': '-96.7'}, {'value': '-100.0', 'groupId': 'OG001', 'lowerLimit': '-100.0', 'upperLimit': '-100.0'}, {'value': '-47.5', 'groupId': 'OG003', 'lowerLimit': '-100.0', 'upperLimit': '-24.6'}]}]}, {'title': 'Activated CD19+CD20+CD69+, Week52, n=9,1,0,6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-96.9', 'groupId': 'OG000', 'lowerLimit': '-99.3', 'upperLimit': '-93.6'}, {'value': '-100.0', 'groupId': 'OG001', 'lowerLimit': '-100.0', 'upperLimit': '-100.0'}, {'value': '-27.4', 'groupId': 'OG003', 'lowerLimit': '-57.5', 'upperLimit': '50.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (Day 0 from parent studies); Day 0 and 8, 16, 24, 32, 40 and 52 weeks', 'description': 'Blood samples were collected at indicated time-points for analysis of Activated B cells subsets like Activated CD19+CD20+CD69+, cluster of differentiation 20+ (CD20+), Memory CD19+CD20+CD27+, Naive CD19+CD20+CD27-, Plasma CD19+CD20-CD138+, Plasmacytoid CD19+CD20+CD138+, and SLE Subset CD19+CD38b+CD27b+Lymph. Baseline is defined as the Day 0 visit from parent studies. Percentage change from Baseline is equal to 100\\* (Value at specified visit minus Baseline value) divided by Baseline value.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).'}, {'type': 'SECONDARY', 'title': 'Percentage Change From 24 Week in B Cell Subsets: Treatment Holiday Group (Re-start Phase)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Holiday Group - Re-start Phase', 'description': 'Following Treatment holiday phase for 24 weeks, participants re-started belimumab therapy for 28 weeks while receiving standard of care SLE therapy for 52 weeks. Re-start Phase started one day after Week 24 up to Week 52. Participants from BEL113750 (NCT01345253) and BEL114333 (NCT01597622) were part of this group. Participants had been treated with belimumab for at least 6 months in one of these continuation studies prior to entry into this study. Eligible participants on completion of 52-weeks entered Maintenance period and received belimumab 10 mg/kg every 4 weeks until Week 48 of subsequent years (Maintenance is Year 2, 3, 4).'}], 'classes': [{'title': 'Memory CD19+CD20+CD27+, Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '40.5', 'upperLimit': '250.0'}]}]}, {'title': 'Memory CD19+CD20+CD27+, Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '83.3', 'groupId': 'OG000', 'lowerLimit': '48.3', 'upperLimit': '366.7'}]}]}, {'title': 'Memory CD19+CD20+CD27+,Week52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000', 'lowerLimit': '12.4', 'upperLimit': '233.3'}]}]}, {'title': 'Naive CD19+CD20+CD27-,Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-19.0', 'groupId': 'OG000', 'lowerLimit': '-58.8', 'upperLimit': '31.1'}]}]}, {'title': 'Naive CD19+CD20+CD27-,Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-12.5', 'groupId': 'OG000', 'lowerLimit': '-61.8', 'upperLimit': '7.7'}]}]}, {'title': 'Naive CD19+CD20+CD27-,Week52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-35.6', 'groupId': 'OG000', 'lowerLimit': '-84.8', 'upperLimit': '-7.9'}]}]}, {'title': 'Plasma CD19+CD20-CD138+,Week32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-16.3', 'groupId': 'OG000', 'lowerLimit': '-71.4', 'upperLimit': '237.8'}]}]}, {'title': 'Plasma CD19+CD20-CD138+, Week40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-59.8', 'groupId': 'OG000', 'lowerLimit': '-73.7', 'upperLimit': '18.5'}]}]}, {'title': 'Plasma CD19+CD20-CD138+,Week52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-48.0', 'groupId': 'OG000', 'lowerLimit': '-92.4', 'upperLimit': '188.9'}]}]}, {'title': 'Plasmacytoid CD19+CD20+CD138+,Week32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-35.7', 'groupId': 'OG000', 'lowerLimit': '-69.3', 'upperLimit': '133.5'}]}]}, {'title': 'Plasmacytoid CD19+CD20+CD138+,Week40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-64.3', 'groupId': 'OG000', 'lowerLimit': '-89.4', 'upperLimit': '-56.9'}]}]}, {'title': 'Plasmacytoid CD19+CD20+CD138+,Week52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-55.0', 'groupId': 'OG000', 'lowerLimit': '-72.7', 'upperLimit': '-52.1'}]}]}, {'title': 'SLE SubsetCD19+CD38b+CD27b+Lymph,Week32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-55.4', 'groupId': 'OG000', 'lowerLimit': '-71.6', 'upperLimit': '-27.2'}]}]}, {'title': 'SLE SubsetCD19+CD38b+CD27b+Lymph,Week40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-56.9', 'groupId': 'OG000', 'lowerLimit': '-75.3', 'upperLimit': '-0.7'}]}]}, {'title': 'SLE SubsetCD19+CD38b+CD27b+Lymph,Week52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-67.2', 'groupId': 'OG000', 'lowerLimit': '-79.7', 'upperLimit': '-41.0'}]}]}, {'title': 'CD20+, Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.3', 'groupId': 'OG000', 'lowerLimit': '-45.2', 'upperLimit': '29.7'}]}]}, {'title': 'CD20+, Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000', 'lowerLimit': '-51.4', 'upperLimit': '17.4'}]}]}, {'title': 'CD20+, Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-20.0', 'groupId': 'OG000', 'lowerLimit': '-78.9', 'upperLimit': '30.8'}]}]}, {'title': 'Activated CD19+CD20+CD69+,Week32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-28.8', 'groupId': 'OG000', 'lowerLimit': '-75.8', 'upperLimit': '64.7'}]}]}, {'title': 'Activated CD19+CD20+CD69+,Week40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-23.8', 'groupId': 'OG000', 'lowerLimit': '-88.1', 'upperLimit': '191.2'}]}]}, {'title': 'Activated CD19+CD20+CD69+,Week52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-66.7', 'groupId': 'OG000', 'lowerLimit': '-89.0', 'upperLimit': '87.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Week 24, 32, 40 and 52 weeks', 'description': 'Blood samples were collected at indicated time-points for analysis of Activated B cells subsets like Activated CD19+CD20+CD69+, CD20+, Memory CD19+CD20+CD27+, Naive CD19+CD20+CD27-, Plasma CD19+CD20-CD138+, Plasmacytoid CD19+CD20+CD138+, and SLE Subset CD19+CD38b+CD27b+Lymph. Percentage change from Week 24 of present study was calculated as 100\\*(value at specified visit - Week 24 value) divided by week 24 value. The data below is only reported for the Treatment Holiday Group (Re-start phase). Participants in this group restarted belimumab therapy one day after Week 24, hence the Baseline for this outcome measure was Week 24 visit. No other groups were measured for this outcome.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Participants in this group restarted belimumab therapy one day after Week 24, hence the Baseline for this outcome measure was Week 24 visit. The data below is only reported for the Treatment Holiday Group and no other groups were measured.'}, {'type': 'SECONDARY', 'title': 'SELENA SLEDAI Scores Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Long-term Discontinuation', 'description': 'Participants in this group discontinued belimumab 10 mg/kg therapy for 52 weeks but remained on standard of care therapy. Participants from BEL114333 (NCT01597622), BEL112233 (NCT00724867) and BEL112626 (NCT00583362) were part of this group. Participants had been treated with belimumab for at least 6 months in one of these continuation studies but had withdrawn from belimumab therapy for no longer than 8 weeks prior to entry into this study.'}, {'id': 'OG001', 'title': 'Treatment Control Group', 'description': 'Participants in this group continued to receive monthly belimumab 10 mg/kg therapy, in addition to standard of care SLE therapy for 52 weeks. Participants from BEL113750 (NCT01345253) and BEL114333 (NCT01597622) were part of this group. Participants had been treated with belimumab for at least 6 months in one of these continuation studies prior to entry into this study. Eligible participants on completion of 52-weeks entered Maintenance period and received belimumab 10 mg/kg every 4 weeks until Week 48 of subsequent years (Maintenance is Year 2, 3, 4).'}, {'id': 'OG002', 'title': 'Treatment Holiday Group - Holiday Phase', 'description': 'Participants in the Treatment Holiday Group underwent a 24-week belimumab treatment holiday while remaining on standard of care SLE therapy, Holiday Phase was Day 0 visit to Week 24/Treatment Re-start phase. Participants from BEL113750 (NCT01345253) and BEL114333 (NCT01597622) were part of this group. Participants had been treated with belimumab for at least 6 months in one of these continuation studies prior to entry into this study. In the event of a severe flare, participants were allowed to enter Maintenance Phase and receive belimumab 10 mg/Kg every 4 weeks until Week 48 of subsequent years (Maintenance is Year 2, 3, 4).'}, {'id': 'OG003', 'title': 'Treatment Holiday Group - Re-start Phase', 'description': 'Following Treatment holiday phase for 24 weeks, participants re-started belimumab therapy for 28 weeks while receiving standard of care SLE therapy for 52 weeks. Re-start Phase started one day after Week 24 up to Week 52. Participants from BEL113750 (NCT01345253) and BEL114333 (NCT01597622) were part of this group. Participants had been treated with belimumab for at least 6 months in one of these continuation studies prior to entry into this study. Eligible participants on completion of 52-weeks entered Maintenance period and received belimumab 10 mg/kg every 4 weeks until Week 48 of subsequent years (Maintenance is Year 2, 3, 4).'}], 'classes': [{'title': 'Day 0,n=39,29,12, 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-6.2', 'spread': '4.12', 'groupId': 'OG000'}, {'value': '-6.9', 'spread': '3.62', 'groupId': 'OG001'}, {'value': '-6.3', 'spread': '4.31', 'groupId': 'OG002'}]}]}, {'title': 'Week 4,n=39,29,12, 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-5.9', 'spread': '5.07', 'groupId': 'OG000'}, {'value': '-6.6', 'spread': '3.44', 'groupId': 'OG001'}, {'value': '-6.1', 'spread': '4.01', 'groupId': 'OG002'}]}]}, {'title': 'Week 8,n=38,29, 11,0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-6.4', 'spread': '4.18', 'groupId': 'OG000'}, {'value': '-7.0', 'spread': '3.73', 'groupId': 'OG001'}, {'value': '-5.9', 'spread': '4.16', 'groupId': 'OG002'}]}]}, {'title': 'Week 12,n=38,29, 11,0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-6.1', 'spread': '4.28', 'groupId': 'OG000'}, {'value': '-7.0', 'spread': '3.75', 'groupId': 'OG001'}, {'value': '-6.3', 'spread': '3.95', 'groupId': 'OG002'}]}]}, {'title': 'Week 16,n=36,27, 11,0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-6.4', 'spread': '5.21', 'groupId': 'OG000'}, {'value': '-6.8', 'spread': '4.05', 'groupId': 'OG001'}, {'value': '-6.1', 'spread': '3.96', 'groupId': 'OG002'}]}]}, {'title': 'Week 20,n=36,27, 11,0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-6.9', 'spread': '4.17', 'groupId': 'OG000'}, {'value': '-6.9', 'spread': '3.23', 'groupId': 'OG001'}, {'value': '-6.1', 'spread': '3.96', 'groupId': 'OG002'}]}]}, {'title': 'Week 24,n=36,27, 11,0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-6.4', 'spread': '4.45', 'groupId': 'OG000'}, {'value': '-6.7', 'spread': '3.45', 'groupId': 'OG001'}, {'value': '-5.4', 'spread': '4.01', 'groupId': 'OG002'}]}]}, {'title': 'Week 28,n=35,27,0,10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-5.8', 'spread': '4.22', 'groupId': 'OG000'}, {'value': '-7.0', 'spread': '3.32', 'groupId': 'OG001'}, {'value': '-5.5', 'spread': '5.36', 'groupId': 'OG003'}]}]}, {'title': 'Week 32,n=34,27,0,11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-5.7', 'spread': '4.59', 'groupId': 'OG000'}, {'value': '-7.1', 'spread': '3.38', 'groupId': 'OG001'}, {'value': '-6.1', 'spread': '4.01', 'groupId': 'OG003'}]}]}, {'title': 'Week 36,n=34,27,0,11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-5.0', 'spread': '4.42', 'groupId': 'OG000'}, {'value': '-6.7', 'spread': '3.59', 'groupId': 'OG001'}, {'value': '-5.9', 'spread': '4.01', 'groupId': 'OG003'}]}]}, {'title': 'Week 40,n=34,27,0,11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-5.2', 'spread': '4.30', 'groupId': 'OG000'}, {'value': '-7.2', 'spread': '3.37', 'groupId': 'OG001'}, {'value': '-6.6', 'spread': '4.30', 'groupId': 'OG003'}]}]}, {'title': 'Week 44,n=34,27,0,11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-5.8', 'spread': '4.15', 'groupId': 'OG000'}, {'value': '-7.3', 'spread': '3.49', 'groupId': 'OG001'}, {'value': '-6.3', 'spread': '4.65', 'groupId': 'OG003'}]}]}, {'title': 'Week 48,n=33,27,0,11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-5.7', 'spread': '4.30', 'groupId': 'OG000'}, {'value': '-7.3', 'spread': '3.28', 'groupId': 'OG001'}, {'value': '-6.1', 'spread': '3.91', 'groupId': 'OG003'}]}]}, {'title': 'Week 52,n=33,27,0,11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-5.0', 'spread': '4.39', 'groupId': 'OG000'}, {'value': '-6.9', 'spread': '3.69', 'groupId': 'OG001'}, {'value': '-5.5', 'spread': '4.08', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 0 from parent studies); Day 0 and 4, 8, 12, 16, 20, 24, 28, 32,36, 40, 44, 48 and 52 weeks', 'description': "SELENA SLEDAI assessments consist of 24 individual weighted items in which signs and symptoms, laboratory tests, and physician's assessment for each of 9 organ systems are given a weighted score and summed if present (marked 'Yes') at the time of the visit or in the preceding 10 days. The maximum theoretical score is 105 (all 24 descriptors present simultaneously) with 0 indicating inactive disease (marked 'No'). Data are reported at the specified time-points from Day 0 (of present study) up to Week 52. Baseline is defined as the Day 0 from parent studies. Change from Baseline is equal to (Value at specified visit minus Baseline value).", 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).'}, {'type': 'SECONDARY', 'title': 'Number of Days of Daily Prednisone Dose >=7.5 mg/Day and/or Increased by 25 Percent From Day 0 of This Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Long-term Discontinuation Group', 'description': 'Participants in this group discontinued belimumab 10 mg/kg therapy for 52 weeks but remained on standard of care therapy. Participants from BEL114333 (NCT01597622), BEL112233 (NCT00724867) and BEL112626 (NCT00583362) were part of this group. Participants had been treated with belimumab for at least 6 months in one of these continuation studies but had withdrawn from belimumab therapy for no longer than 8 weeks prior to entry into this study.'}, {'id': 'OG001', 'title': 'Treatment Control Group', 'description': 'Participants in this group continued to receive monthly belimumab 10 mg/kg therapy, in addition to standard of care SLE therapy for 52 weeks. Participants from BEL113750 (NCT01345253) and BEL114333 (NCT01597622) were part of this group. Participants had been treated with belimumab for at least 6 months in one of these continuation studies prior to entry into this study. Eligible participants on completion of 52-weeks entered Maintenance period and received belimumab 10 mg/kg every 4 weeks until Week 48 of subsequent years (Maintenance is Year 2, 3, 4).'}, {'id': 'OG002', 'title': 'Treatment Holiday Group', 'description': 'Participants in the Treatment Holiday Group underwent a 24-week belimumab treatment holiday while remaining on standard of care SLE therapy, then re-started belimumab therapy for further 28 weeks while receiving standard of care SLE therapy. Participants from BEL113750 (NCT01345253) and BEL114333 (NCT01597622) were part of this group. Participants had been treated with belimumab for at least 6 months in one of these continuation studies prior to entry into this study. Eligible participants on completion of 52-weeks entered Maintenance period and received belimumab 10 mg/kg every 4 weeks until Week 48 of subsequent years (Maintenance is Year 2, 3, 4).'}], 'classes': [{'title': 'Day 0 to Week 24, n=11, 12, 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '143.0', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '173'}, {'value': '170.0', 'groupId': 'OG001', 'lowerLimit': '67', 'upperLimit': '175'}, {'value': '168.0', 'groupId': 'OG002', 'lowerLimit': '61', 'upperLimit': '170'}]}]}, {'title': 'Day 0 to Week 52, n=13, 12, 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '278.0', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '369'}, {'value': '364.0', 'groupId': 'OG001', 'lowerLimit': '145', 'upperLimit': '392'}, {'value': '364.0', 'groupId': 'OG002', 'lowerLimit': '250', 'upperLimit': '366'}]}]}, {'title': 'Week 24 to Week 52, n=10, 9, 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '167.5', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '201'}, {'value': '196.0', 'groupId': 'OG001', 'lowerLimit': '189', 'upperLimit': '217'}, {'value': '196.0', 'groupId': 'OG002', 'lowerLimit': '194', 'upperLimit': '196'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 0 to Week 24; Week 24 to Week 52; Day 0 to Week 52', 'description': 'All corticosteroids are converted to a prednisone equivalent average daily dose (mg/day). The average daily dose at Day 0 was used to assess the relative change in daily dose on a given day. The average daily dose at Day 0 was calculated as sum of the daily dose across all days from the Screening visit date up to and including Day 0 visit date divided by the number of days in the time period. Data reported are the median number of days on which the specified criteria was met for Day 0 to Week 24, Week 24 to Week 52, Day 0 to Week 52. For treatment holiday group, Day 0 to Week 24 corresponds to holiday phase, Week 24 to Week 52 corresponds to treatment Re-start phase.', 'unitOfMeasure': 'Days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Only those participants who met specified criteria (\\>=7.5 mg/day and/or increased by 25%) within specified time period were analyzed (represented by n= X in the category titles).'}, {'type': 'SECONDARY', 'title': 'Number of Days of Daily Prednisone Dose <=7.5 mg/Day and/or Decreased by 25 Percent From Day 0 of This Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Long-term Discontinuation Group', 'description': 'Participants in this group discontinued belimumab 10 mg/kg therapy for 52 weeks but remained on standard of care therapy. Participants from BEL114333 (NCT01597622), BEL112233 (NCT00724867) and BEL112626 (NCT00583362) were part of this group. Participants had been treated with belimumab for at least 6 months in one of these continuation studies but had withdrawn from belimumab therapy for no longer than 8 weeks prior to entry into this study.'}, {'id': 'OG001', 'title': 'Treatment Control Group', 'description': 'Participants in this group continued to receive monthly belimumab 10 mg/kg therapy, in addition to standard of care SLE therapy for 52 weeks. Participants from BEL113750 (NCT01345253) and BEL114333 (NCT01597622) were part of this group. Participants had been treated with belimumab for at least 6 months in one of these continuation studies prior to entry into this study. Eligible participants on completion of 52-weeks entered Maintenance period and received belimumab 10 mg/kg every 4 weeks until Week 48 of subsequent years (Maintenance is Year 2, 3, 4).'}, {'id': 'OG002', 'title': 'Treatment Holiday Group', 'description': 'Participants in the Treatment Holiday Group underwent a 24-week belimumab treatment holiday while remaining on standard of care SLE therapy, then re-started belimumab therapy for further 28 weeks while receiving standard of care SLE therapy. Participants from BEL113750 (NCT01345253) and BEL114333 (NCT01597622) were part of this group. Participants had been treated with belimumab for at least 6 months in one of these continuation studies prior to entry into this study. Eligible participants on completion of 52-weeks entered Maintenance period and received belimumab 10 mg/kg every 4 weeks until Week 48 of subsequent years (Maintenance is Year 2, 3, 4).'}], 'classes': [{'title': 'Day 0 to Week 24, n=23,19, 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '168.0', 'groupId': 'OG000', 'lowerLimit': '23', 'upperLimit': '181'}, {'value': '168.0', 'groupId': 'OG001', 'lowerLimit': '26', 'upperLimit': '175'}, {'value': '166.0', 'groupId': 'OG002', 'lowerLimit': '49', 'upperLimit': '170'}]}]}, {'title': 'Day 0 to Week 52, n=25,19, 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '362.0', 'groupId': 'OG000', 'lowerLimit': '23', 'upperLimit': '385'}, {'value': '364.0', 'groupId': 'OG001', 'lowerLimit': '91', 'upperLimit': '391'}, {'value': '364.0', 'groupId': 'OG002', 'lowerLimit': '49', 'upperLimit': '370'}]}]}, {'title': 'Week 24 to Week 52, n=24,18, 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '195.0', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '208'}, {'value': '196.0', 'groupId': 'OG001', 'lowerLimit': '189', 'upperLimit': '225'}, {'value': '200.0', 'groupId': 'OG002', 'lowerLimit': '189', 'upperLimit': '203'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 0 to Week 24; Week 24 to Week 52; Day 0 to Week 52', 'description': 'All corticosteroids are converted to a prednisone equivalent average daily dose (mg/day). The average daily dose at Day 0 was used to assess the relative change in daily dose on a given day. The average daily dose at Day 0 was calculated as sum of the daily dose across all days from the Screening visit date up to and including Day 0 visit date divided by the number of days in the time period. Data reported are the median number of days on which the specified criteria was met for Day 0 to Week 24, Week 24 to Week 52, Day 0 to Week 52. For treatment holiday group, Day 0 to Week 24 corresponds to holiday phase, Week 24 to Week 52 corresponds to treatment Re-start phase.', 'unitOfMeasure': 'Days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Only those participants who met specified criteria (\\<=7.5 mg/day and/or decreased by 25%) within specified time period were analyzed (represented by n= X in the category titles).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Long-term Discontinuation Group', 'description': 'Participants in this group discontinued belimumab 10 mg/kg therapy for 52 weeks but remained on standard of care therapy. Participants from BEL114333 (NCT01597622), BEL112233 (NCT00724867) and BEL112626 (NCT00583362) were part of this group. Participants had been treated with belimumab for at least 6 months in one of these continuation studies but had withdrawn from belimumab therapy for no longer than 8 weeks prior to entry into this study.'}, {'id': 'FG001', 'title': 'Treatment Control Group', 'description': 'Participants in this group continued to receive monthly belimumab 10 mg/kg therapy, in addition to standard of care SLE therapy for 52 weeks. Participants from BEL113750 (NCT01345253) and BEL114333 (NCT01597622) were part of this group. Participants had been treated with belimumab for at least 6 months in one of these continuation studies prior to entry into this study. Eligible participants on completion of 52-weeks entered Maintenance period and received belimumab 10 mg/kg every 4 weeks until Week 48 of subsequent years (Maintenance is Year 2, 3, 4).'}, {'id': 'FG002', 'title': 'Treatment Holiday Group', 'description': 'Participants in the Treatment Holiday Group underwent a 24-week belimumab treatment holiday while remaining on standard of care SLE therapy, then re-started belimumab therapy for further 28 weeks while receiving standard of care SLE therapy. Participants from BEL113750 (NCT01345253) and BEL114333 (NCT01597622) were part of this group. Participants had been treated with belimumab for at least 6 months in one of these continuation studies prior to entry into this study. Eligible participants on completion of 52-weeks entered Maintenance period and received belimumab 10 mg/kg every 4 weeks until Week 48 of subsequent years (Maintenance is Year 2, 3, 4).'}], 'periods': [{'title': 'Treatment Phase (Up to 52 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '29'}, {'groupId': 'FG002', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '27'}, {'groupId': 'FG002', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Study Terminated By Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Maintenance (Up to 48 Weeks of Year 2-4)', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Long-term discontinuation participants were not allowed in Maintenance period', 'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'Eligible participants of Treatment control and holiday group on completion of 52-weeks were included', 'groupId': 'FG001', 'numSubjects': '16'}, {'comment': 'Eligible participants of Treatment control and holiday group on completion of 52-weeks were included', 'groupId': 'FG002', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Study Terminated By Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '7'}]}]}], 'recruitmentDetails': 'This was multi-center study to evaluate temporary discontinuation of belimumab 10 milligram(mg)/kilogram(kg) for 24 weeks followed by reintroduction of belimumab 10 mg/kg Intravenous (IV) for 28 weeks, in participants with low Systemic Lupus Erythematosus (SLE) disease activity receiving belimumab plus standard of care.', 'preAssignmentDetails': 'A total of 80 participants were enrolled for this study. Participants were enrolled across 20 sites in China, Japan, Korea and the United States.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '80', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Long-term Discontinuation Group', 'description': 'Participants in this group discontinued belimumab 10 mg/kg therapy for 52 weeks but remained on standard of care therapy. Participants from BEL114333 (NCT01597622), BEL112233 (NCT00724867) and BEL112626 (NCT00583362) were part of this group. Participants had been treated with belimumab for at least 6 months in one of these continuation studies but had withdrawn from belimumab therapy for no longer than 8 weeks prior to entry into this study.'}, {'id': 'BG001', 'title': 'Treatment Control Group', 'description': 'Participants in this group continued to receive monthly belimumab 10 mg/kg therapy, in addition to standard of care SLE therapy for 52 weeks. Participants from BEL113750 (NCT01345253) and BEL114333 (NCT01597622) were part of this group. Participants had been treated with belimumab for at least 6 months in one of these continuation studies prior to entry into this study. Eligible participants on completion of 52-weeks entered Maintenance period and received belimumab 10 mg/kg every 4 weeks until Week 48 of subsequent years (Maintenance is Year 2, 3, 4).'}, {'id': 'BG002', 'title': 'Treatment Holiday Group', 'description': 'Participants in the Treatment Holiday Group underwent a 24-week belimumab treatment holiday while remaining on standard of care SLE therapy, then re-started belimumab therapy for further 28 weeks while receiving standard of care SLE therapy. Participants from BEL113750 (NCT01345253) and BEL114333 (NCT01597622) were part of this group. Participants had been treated with belimumab for at least 6 months in one of these continuation studies prior to entry into this study. Eligible participants on completion of 52-weeks entered Maintenance period and received belimumab 10 mg/kg every 4 weeks until Week 48 of subsequent years (Maintenance is Year 2, 3, 4).'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '38.9', 'spread': '12.01', 'groupId': 'BG000'}, {'value': '40.6', 'spread': '9.76', 'groupId': 'BG001'}, {'value': '38.1', 'spread': '8.04', 'groupId': 'BG002'}, {'value': '39.4', 'spread': '10.63', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '71', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White/Caucasian/European Heritage', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}]}, {'title': 'Asian: Central/South Asian Heritage', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'Asian: East Asian Heritage', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '54', 'groupId': 'BG003'}]}]}, {'title': 'Asian: Japanese Heritage', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}]}, {'title': 'African American/African Heritage', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-01-30', 'size': 838795, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-11-22T00:19', 'hasProtocol': False}, {'date': '2017-09-12', 'size': 1565509, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-11-29T00:41', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'nctId': 'NCT03125486', 'statusForNctId': 'NO_LONGER_AVAILABLE', 'hasExpandedAccess': True}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2018-12-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-21', 'studyFirstSubmitDate': '2014-04-17', 'resultsFirstSubmitDate': '2019-12-13', 'studyFirstSubmitQcDate': '2014-04-17', 'lastUpdatePostDateStruct': {'date': '2020-01-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-01-21', 'studyFirstPostDateStruct': {'date': '2014-04-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Median Time to First SLE Flare Index (SFI)', 'timeFrame': 'Up to 52 weeks', 'description': 'SFI Flare was defined as a mild/moderate or severe flare according to the modified Safety of Estrogen in Lupus National Assessment Systemic Lupus Erythematosus Disease Activity Index (SELENA SLEDAI) SLE Flare Index (modified excluded severe flares from the SELENA SLEDAI flare assessment that were triggered only by an increase in SELENA SLEDAI score to \\>12).Time to first SFI flare is defined as the number of days from Day 0 visit date to the date the participant has a flare (event date - Day 0 visit date + 1) in the 52 Week/Holiday phase; (event date - treatment re-start date + 1) in the Re-start Holiday phase. Day 0 visit date is defined as Day 0 from present study. Median time to first SFI flare is reported; estimated using the product-limit method.'}], 'secondaryOutcomes': [{'measure': 'Rate of SLE Index Flare Per Subject Year', 'timeFrame': 'Up to 52 weeks', 'description': 'Rate per subject year of SFI flare was calculated as total number of flares divided by total subject years in interval. The total subject years for each participant was calculated as (Week 52/ Exit visit date minus Day 0 visit date + 1) for Long-term discontinuation and treatment control groups. For treatment holiday phase group the subject-years for each participant was calculated as (Week 24/Treatment Re-start/Exit visit date minus Day 0 Visit date + 1)/365.25. For re-start treatment holiday phase group the subject-years for each participant was calculated as (Week 52/Exit visit date minus Week 24/Treatment Re-start date + 1)/365.25. Day 0 visit date is defined as Day 0 from present study.'}, {'measure': 'Median Time to First Severe SFI Flare', 'timeFrame': 'Up to 52 weeks', 'description': 'The SLE Flare Index categorizes SLE flare as "mild or moderate" or "severe" based on a positive assessment for at least 1 of 5 variables as follows: Change in SELENA SLEDAI score from the most recent assessment to current; Change in signs or symptoms of disease activity; Change in prednisone dosage; Use of new medications for disease activity or hospitalization; Change in Physician\'s Global Assessment (PGA) score; Hospitalization for SLE activity is an additional category included only for a severe flare. Time to first severe flare is defined as (event date-Day 0 visit date) + 1 for Long-term discontinuation, treatment control groups and holiday phase group. For holiday phase group data censored at last flare assessment by treatment re-start date. Time to first severe flare is defined as (event date-treatment re-start date) + 1 for Re-start treatment holiday group. Median time to first severe SFI flare is reported; estimated using the product-limit method.'}, {'measure': 'Number of Participants With Evidence of Rebound', 'timeFrame': 'Up to 24 weeks', 'description': "Rebound is defined as SELENA SLEDAI score during the first 24 weeks that exceeds the Baseline SELENA SLEDAI score in the participant's respective original parent study. Baseline is defined as the Day 0 visit from the parent study. SELENA SLEDAI assessments consist of 24 individual weighted items in which signs and symptoms, laboratory tests, and physician's assessment for each of 9 organ systems are given a weighted score and summed if present (marked 'Yes') at the time of the visit or in the preceding 10 days. The maximum theoretical score is 105 (all 24 descriptors present simultaneously) with 0 indicating inactive disease (marked 'No'). Any time during the first 24 weeks of this study has been reported."}, {'measure': 'Number of Participants With Confirmed True Positive Belimumab Anti-drug Antibodies (ADA)', 'timeFrame': 'Up to 52 weeks', 'description': 'Immunogenicity assay results were categorized as negative or positive. A persistent positive result was defined as a positive post-Day 0 visit immunogenic response that occurred for at least 2 consecutive assessments or a single result at the final assessment. A transient positive result was defined as a single post-Day 0 visit positive immunogenic response that did not occur at the final assessment. Any time post-Day 0 visit data are reported (or post-Week 24 for Treatment Holiday - Restart phase). Day 0 visit date is defined as Day 0 from present study.'}, {'measure': 'Percentage Change From Baseline in Immunoglobulin', 'timeFrame': 'Baseline (Day 0 from parent studies); Day 0 and 8, 16, 24, 32, 40, 48 and 52 weeks', 'description': 'Serum samples were collected at indicated time-points for analysis of immunoglobulins: Immunoglobulin G (IgG), Immunoglobulin A (IgA), and Immunoglobulin M (IgM). Baseline is defined as the Day 0 visit from parent studies. Percentage change from Baseline is equal to 100\\* (value at specified visit minus Baseline value) divided by Baseline value.'}, {'measure': 'Percentage Change From Baseline in Autoantibody:Anti-double Stranded Deoxyribonucleic Acid (dsDNA)', 'timeFrame': 'Baseline (Day 0 from parent studies); Day 0 and 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 weeks', 'description': 'Blood samples were collected at indicated time-points for analysis of autoantibodies like dsDNA. Baseline is defined as the Day 0 visit from parent studies. Percentage change from Baseline is equal to 100\\* (Value at specified visit minus Baseline value) divided by Baseline value.'}, {'measure': 'Percentage Change From Baseline in Autoantibody: Antinuclear Antibody (ANA)', 'timeFrame': 'Baseline (Day 0 from parent studies); Day 0 and 24 and 52 weeks', 'description': 'Blood samples were collected at indicated time-points for analysis of autoantibodies like ANA. Only participants who had an ANA value measured in INDEX at the parent studies Baseline were included in this analysis. Baseline is defined as the Day 0 visit from parent studies. Percentage change from Baseline is equal to 100\\* (Value at specified visit minus Baseline value) divided by Baseline value.'}, {'measure': 'Percentage Change From Baseline in Complement Levels', 'timeFrame': 'Baseline (Day 0 from parent studies); Day 0 and 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 weeks', 'description': 'Blood samples were collected at indicated time-points for analysis of complement levels like complement 3 (C3) and complement 4 (C4). Baseline is defined as the Day 0 visit from parent studies. Percentage change from Baseline is equal to 100\\* (Value at specified visit minus Baseline value) divided by Baseline value.'}, {'measure': 'Percentage Change From Baseline in B Cell Subsets', 'timeFrame': 'Baseline (Day 0 from parent studies); Day 0 and 8, 16, 24, 32, 40 and 52 weeks', 'description': 'Blood samples were collected at indicated time-points for analysis of Activated B cells subsets like Activated CD19+CD20+CD69+, cluster of differentiation 20+ (CD20+), Memory CD19+CD20+CD27+, Naive CD19+CD20+CD27-, Plasma CD19+CD20-CD138+, Plasmacytoid CD19+CD20+CD138+, and SLE Subset CD19+CD38b+CD27b+Lymph. Baseline is defined as the Day 0 visit from parent studies. Percentage change from Baseline is equal to 100\\* (Value at specified visit minus Baseline value) divided by Baseline value.'}, {'measure': 'Percentage Change From 24 Week in B Cell Subsets: Treatment Holiday Group (Re-start Phase)', 'timeFrame': 'Week 24, 32, 40 and 52 weeks', 'description': 'Blood samples were collected at indicated time-points for analysis of Activated B cells subsets like Activated CD19+CD20+CD69+, CD20+, Memory CD19+CD20+CD27+, Naive CD19+CD20+CD27-, Plasma CD19+CD20-CD138+, Plasmacytoid CD19+CD20+CD138+, and SLE Subset CD19+CD38b+CD27b+Lymph. Percentage change from Week 24 of present study was calculated as 100\\*(value at specified visit - Week 24 value) divided by week 24 value. The data below is only reported for the Treatment Holiday Group (Re-start phase). Participants in this group restarted belimumab therapy one day after Week 24, hence the Baseline for this outcome measure was Week 24 visit. No other groups were measured for this outcome.'}, {'measure': 'SELENA SLEDAI Scores Change From Baseline', 'timeFrame': 'Baseline (Day 0 from parent studies); Day 0 and 4, 8, 12, 16, 20, 24, 28, 32,36, 40, 44, 48 and 52 weeks', 'description': "SELENA SLEDAI assessments consist of 24 individual weighted items in which signs and symptoms, laboratory tests, and physician's assessment for each of 9 organ systems are given a weighted score and summed if present (marked 'Yes') at the time of the visit or in the preceding 10 days. The maximum theoretical score is 105 (all 24 descriptors present simultaneously) with 0 indicating inactive disease (marked 'No'). Data are reported at the specified time-points from Day 0 (of present study) up to Week 52. Baseline is defined as the Day 0 from parent studies. Change from Baseline is equal to (Value at specified visit minus Baseline value)."}, {'measure': 'Number of Days of Daily Prednisone Dose >=7.5 mg/Day and/or Increased by 25 Percent From Day 0 of This Study', 'timeFrame': 'Day 0 to Week 24; Week 24 to Week 52; Day 0 to Week 52', 'description': 'All corticosteroids are converted to a prednisone equivalent average daily dose (mg/day). The average daily dose at Day 0 was used to assess the relative change in daily dose on a given day. The average daily dose at Day 0 was calculated as sum of the daily dose across all days from the Screening visit date up to and including Day 0 visit date divided by the number of days in the time period. Data reported are the median number of days on which the specified criteria was met for Day 0 to Week 24, Week 24 to Week 52, Day 0 to Week 52. For treatment holiday group, Day 0 to Week 24 corresponds to holiday phase, Week 24 to Week 52 corresponds to treatment Re-start phase.'}, {'measure': 'Number of Days of Daily Prednisone Dose <=7.5 mg/Day and/or Decreased by 25 Percent From Day 0 of This Study', 'timeFrame': 'Day 0 to Week 24; Week 24 to Week 52; Day 0 to Week 52', 'description': 'All corticosteroids are converted to a prednisone equivalent average daily dose (mg/day). The average daily dose at Day 0 was used to assess the relative change in daily dose on a given day. The average daily dose at Day 0 was calculated as sum of the daily dose across all days from the Screening visit date up to and including Day 0 visit date divided by the number of days in the time period. Data reported are the median number of days on which the specified criteria was met for Day 0 to Week 24, Week 24 to Week 52, Day 0 to Week 52. For treatment holiday group, Day 0 to Week 24 corresponds to holiday phase, Week 24 to Week 52 corresponds to treatment Re-start phase.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['treatment holiday', 'PGA', 'belimumab', 'Lymphostat-B', 'rebound', 'SELENA SLEDAI', 'Systemic Lupus Erythematosus', 'immunogenicity'], 'conditions': ['Systemic Lupus Erythematosus']}, 'referencesModule': {'references': [{'pmid': '35172878', 'type': 'DERIVED', 'citation': 'Bae SC, Bass DL, Chu M, Curtis P, Dimelow R, Harvey L, Ji B, Kurrasch R, Muzaffar S, Punwaney R, Roth DA, Song YW, Xie W, Zhang F. The effect of 24-week belimumab treatment withdrawal followed by treatment restart in patients with SLE: an open-label, non-randomised 52-week study. Arthritis Res Ther. 2022 Feb 16;24(1):46. doi: 10.1186/s13075-022-02723-y.'}]}, 'descriptionModule': {'briefSummary': 'This study will assess the effect of a 24-week withdrawal followed by a 28-week reintroduction of belimumab 10 mg/kg plus standard of care medications in subjects with stable low systemic lupus erythematosus (SLE) disease activity. Rebound phenomenon will be assessed for subjects who have permanently withdrawn from further belimumab treatment.', 'detailedDescription': 'This study will assess the effect of a 24-week withdrawal of belimumab followed by a 28-week reintroduction of belimumab 10 mg/kg plus standard of care medications on immunogenicity, markers of biological activity, efficacy, and safety in subjects with stable low systemic lupus erythematosus (SLE) disease activity. Additionally, this study will assess rebound phenomenon in subjects with any disease level of SLE who have permanently withdrawn from further belimumab treatment'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Received a minimun of 6 months therapy with with belimumab 10 mg/kg in their current SLE belimumab continuation study.\n* Be 18 years of age at the Day 0 visit.\n* Non-prenant, non-lactating females willing to comply with specific birth control requirements as set forth in the protocol.\n* Able to provide written informed consent to participate.\n* Subjects who wish to enroll in the control group and the group taking a 6 month belimumab treatment holiday will need a SELENA SLEDAI score of 3 or less after the minimum of 6 months belimumab therapy, as well as having C3 and C4 complement levels at or above the lower limit of the central laboratory reference range, and are on a stable SLE treatment regimen during the 30 day screening period prior to Day 0.\n* Subjects who wish to enroll in the long-term discontinuation group have voluntarily withdrawn from their continuation studies.\n\nExclusion Criteria:\n\n* Subjects who have developed clinical evidence of significant, unstable or uncontrolled, acute or chronic diseases not due to SLE, or experienced an adverse event (AE) in their belimumab continuation study that could, in the opinion of the principle investigator, put the subject at undue risk.\n* Subjects who have developed any other medical diseases, laboratory abnormalities, or conditions that, in the opinion of the principle investigator, makes the subject unsuitable for the study.'}, 'identificationModule': {'nctId': 'NCT02119156', 'briefTitle': 'Belimumab Treatment Holiday and Treatment Re-start Study in Lupus Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'An Open-label, Non-randomized, 52-Week Study to Evaluate Treatment Holidays and Rebound Phenomenon After Treatment With Belimumab 10 mg/kg in Systemic Lupus Erythematosus Subjects', 'orgStudyIdInfo': {'id': '116027'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Holiday Group', 'description': 'Subjects in the Treatment Holiday Group will undergo a 6 month belimumab treatment holiday while remaining on standard of care SLE therapy, then re-start belimumab therapy for 6 months while receiving standard of care SLE therapy.', 'interventionNames': ['Drug: Belimumab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'Subjects in the Control Group will continue to receive monthly belimumab therapy, in addition to standard of care SLE therapy for 52 weeks.', 'interventionNames': ['Drug: Belimumab']}, {'type': 'NO_INTERVENTION', 'label': 'Long-Term Discontinuation Group', 'description': 'Subjects in the Long-Term Discontinuation Group have elected to discontinue further belimumab therapy and will remain on standard of care SLE therapy as directed by the investigator, and agree to return for monthly visits for 52 weeks.'}], 'interventions': [{'name': 'Belimumab', 'type': 'DRUG', 'description': 'Monthly intravenous infusions dosed as 10 mg/kg body weight', 'armGroupLabels': ['Control Group', 'Treatment Holiday Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '11030', 'city': 'Manhasset', 'state': 'New York', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 40.79788, 'lon': -73.69957}}, {'zip': '75246', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '230001', 'city': 'Hefei', 'state': 'Anhui', 'country': 'China', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}, {'zip': '215006', 'city': 'Suzhou', 'state': 'Jiangsu', 'country': 'China', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 31.30408, 'lon': 120.59538}}, {'zip': '310009', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'zip': '100032', 'city': 'Beijing', 'country': 'China', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100044', 'city': 'Beijing', 'country': 'China', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '275-8580', 'city': 'Chiba', 'country': 'Japan', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.6, 'lon': 140.11667}}, {'zip': '791-0295', 'city': 'Ehime', 'country': 'Japan', 'facility': 'GSK Investigational Site'}, {'zip': '060-8604', 'city': 'Hokkaido', 'country': 'Japan', 'facility': 'GSK Investigational Site'}, {'zip': '980-8574', 'city': 'Miyagi', 'country': 'Japan', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 26.62566, 'lon': 128.18236}}, {'zip': '857-1195', 'city': 'Nagasaki', 'country': 'Japan', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 32.75, 'lon': 129.88333}}, {'zip': '104-8560', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '162-8655', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '700-721', 'city': 'Daegu', 'country': 'South Korea', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'zip': '110-744', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '133-792', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '443-721', 'city': 'Suwon, Kyonggi-do', 'country': 'South Korea', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}