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Ignite Creation Date: 2025-12-25 @ 12:28 AM

Ignite Modification Date: 2025-12-25 @ 10:34 PM

Study NCT ID: NCT00724867

Status: COMPLETED

Last Update Posted: 2016-03-28

First Post: 2008-07-28

Is NOT Gene Therapy: False

Has Adverse Events: True

Brief Title: A Continuation Trial for Subjects With Lupus Who Completed Protocol HGS1006-C1056 in the United States

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Canada']}, 'conditionBrowseModule': {'meshes': [{'id': 'D008180', 'term': 'Lupus Erythematosus, Systemic'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}], 'ancestors': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C511911', 'term': 'belimumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '866-435-7343', 'title': 'GSK Response Center', '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}}, 'adverseEventsModule': {'timeFrame': 'On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (up to Week 440).', 'description': 'SAEs and non-serious AEs were collected in members of the MITT Population, comprised of all participants who received at least one dose of study medication.', 'eventGroups': [{'id': 'EG000', 'title': 'Belimumab 10 mg/kg IV', 'description': 'Belimumab 10 mg/kg IV every 28 days', 'otherNumAtRisk': 268, 'otherNumAffected': 266, 'seriousNumAtRisk': 268, 'seriousNumAffected': 112}], 'otherEvents': [{'term': 'Any event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 243}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Upper respiratory tract infection bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 77}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 76}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Urinary tract infection bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 69}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 62}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 59}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 56}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 52}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 42}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 38}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bronchitis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 36}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vulvovaginal mycotic infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 36}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 35}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 24}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 21}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 20}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 19}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Oral candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 17}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Tooth abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 15}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Any event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 217}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 106}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 63}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 55}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'SLE arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 43}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 41}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bursitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 36}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 35}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Joint swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 31}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Tendonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 27}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 26}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 25}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 24}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 22}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Fibromyalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 14}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Any event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 191}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 86}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 58}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 45}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 39}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 34}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 25}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dental caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 21}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Mouth ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 21}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 20}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Any event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 163}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 39}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 23}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Systemic lupus erythematosus rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 22}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 20}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 16}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 16}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Rash pruritic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 15}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Any event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 162}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 84}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 29}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 25}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 18}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 16}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Any event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 155}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 44}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ligament sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 27}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 25}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 24}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Muscle strain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 19}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 14}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 14}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Any event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 154}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 51}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 31}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Sinus congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 28}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 17}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Rhinitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 17}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 16}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pleuritic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 16}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Any event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 151}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 60}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 31}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Peripheral swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 31}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 30}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 30}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 18}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Any event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 107}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 57}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 42}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 30}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Any event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 89}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vitamin D deficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 34}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 17}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Any event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 86}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 25}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Any event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 85}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 44}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Any event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 79}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 18}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Any event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 56}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 20}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Any event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 53}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Seasonal allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 29}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Drug hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 17}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Any event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 37}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 16}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Sinusitis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 56}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra'}], 'seriousEvents': [{'term': 'Any event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 44}], 'organSystem': 'Infections and 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'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Meniscus injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Muscle rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumothorax traumatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Post procedural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Toxicity to various agents', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Wound dehiscence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Any event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 15}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Amnesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Intracranial aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Loss of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Metabolic encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Posterior reversible encephalopathy syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Any event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 13}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Intraductal proliferative breast lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Uterine leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Extranodal marginal zone B-cell lymphoma (MALT type)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': "Hodgkin's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Malignant melanoma in situ', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': "Non-Hodgkin's lymphoma", 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Non-small cell lung cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Oestrogen receptor positive breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ovarian cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Parathyroid tumour benign', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Thyroid adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Any event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 11}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pleurisy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Any event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 10}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Jugular vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lupus vasculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Malignant hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Peripheral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': "Raynaud's phenomenon", 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Subgaleal haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Any event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Electrolyte imbalance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypercalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Any event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 7}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypertensive heart disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Mitral valve disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Any event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 7}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dysthymic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Mental status changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Any event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 7}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lupus nephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Calculus ureteric', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypertonic bladder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Any event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Anaemia of chronic disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Any event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 5}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 4}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Any event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 4}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Uterovaginal prolapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 2}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cystocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Menorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Any event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 2}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Drug hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 2}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Any event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Drug eruption', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Systemic lupus erythematosus rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Any event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Spinocerebellar ataxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Any event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Thyroid mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Any event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Any event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Influenza A virus test positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Influenza B virus test positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Any event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abortion spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With the Indicated Type of Adverse Event (AEs) and Serious Adverse Event (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '268', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Belimumab 10 mg/kg IV', 'description': 'Participants, who had received belimumab 1milligram per kilogram (mg/kg) or 10 mg/kg or placebo in study HGS1006-C1056 , received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.'}], 'classes': [{'title': 'AE, Any time post baseline, n=268', 'categories': [{'measurements': [{'value': '267', 'groupId': 'OG000'}]}]}, {'title': 'AE, Year 0-1, n=268', 'categories': [{'measurements': [{'value': '260', 'groupId': 'OG000'}]}]}, {'title': 'AE, Year 1-2, n=259', 'categories': [{'measurements': [{'value': '235', 'groupId': 'OG000'}]}]}, {'title': 'AE, Year 2-3, n=244', 'categories': [{'measurements': [{'value': '206', 'groupId': 'OG000'}]}]}, {'title': 'AE, Year 3-4, n=219', 'categories': [{'measurements': [{'value': '184', 'groupId': 'OG000'}]}]}, {'title': 'AE, Year 4-5, n=202', 'categories': [{'measurements': [{'value': '167', 'groupId': 'OG000'}]}]}, {'title': 'AE, Year 5-6, n=192', 'categories': [{'measurements': [{'value': '145', 'groupId': 'OG000'}]}]}, {'title': 'AE, Year 6-7, n=130', 'categories': [{'measurements': [{'value': '87', 'groupId': 'OG000'}]}]}, {'title': 'AE, Year 7 plus, n=65', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}]}]}, {'title': 'SAE, Any time post baseline, n=268', 'categories': [{'measurements': [{'value': '112', 'groupId': 'OG000'}]}]}, {'title': 'SAE, Year 0-1, n=268', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}]}]}, {'title': 'SAE, Year 1-2, n=259', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}]}]}, {'title': 'SAE, Year 2-3, n=244', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}]}]}, {'title': 'SAE, Year 3-4, n=219', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}, {'title': 'SAE, Year 4-5, n=202', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}]}]}, {'title': 'SAE, Year 5-6, n=192', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': 'SAE, Year 6-7, n=130', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'SAE, Year 7 plus, n=65', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Week 440', 'description': 'An AE is defined as any untoward medical occurrence in a participant (par.) temporally associated with the use of a investigational product (IP), whether or not considered related to the IP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of an IP. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is an important medical event that jeopardizes the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, or is associated with liver injury and impaired liver function. Only those participants available at the specified time points (represented by n=X, in the category titles) were analyzed.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent to Treat (MIIT) Population: The MITT Population comprised of all the participants enrolled in the study who received at least one dose of IP.'}, {'type': 'PRIMARY', 'title': 'AE Rates by System Organ Class (SOC) During the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '268', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Belimumab 10 mg/kg IV', 'description': 'Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.'}], 'classes': [{'title': 'Infections and infestations', 'categories': [{'measurements': [{'value': '134.4', 'groupId': 'OG000'}]}]}, {'title': 'Musculoskeletal and connective tissue disorders', 'categories': [{'measurements': [{'value': '75.5', 'groupId': 'OG000'}]}]}, {'title': 'Gastrointestinal disorders', 'categories': [{'measurements': [{'value': '53.6', 'groupId': 'OG000'}]}]}, {'title': 'Injury, poisoning and procedural complications', 'categories': [{'measurements': [{'value': '32.3', 'groupId': 'OG000'}]}]}, {'title': 'Skin and subcutaneous tissue disorders', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}]}]}, {'title': 'Nervous system disorders', 'categories': [{'measurements': [{'value': '29.7', 'groupId': 'OG000'}]}]}, {'title': 'Respiratory, thoracic and mediastinal disorders', 'categories': [{'measurements': [{'value': '28.5', 'groupId': 'OG000'}]}]}, {'title': 'General disorders and administration sitecondition', 'categories': [{'measurements': [{'value': '27.9', 'groupId': 'OG000'}]}]}, {'title': 'Psychiatric disorders', 'categories': [{'measurements': [{'value': '12.4', 'groupId': 'OG000'}]}]}, {'title': 'Metabolism and nutrition disorders', 'categories': [{'measurements': [{'value': '10.1', 'groupId': 'OG000'}]}]}, {'title': 'Vascular disorders', 'categories': [{'measurements': [{'value': '9.1', 'groupId': 'OG000'}]}]}, {'title': 'Investigations', 'categories': [{'measurements': [{'value': '9.1', 'groupId': 'OG000'}]}]}, {'title': 'Eye disorders', 'categories': [{'measurements': [{'value': '8.2', 'groupId': 'OG000'}]}]}, {'title': 'Reproductive system and breast disorders', 'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000'}]}]}, {'title': 'Cardiac disorders', 'categories': [{'measurements': [{'value': '6.4', 'groupId': 'OG000'}]}]}, {'title': 'Immune system disorders', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Renal and urinary disorders', 'categories': [{'measurements': [{'value': '5.3', 'groupId': 'OG000'}]}]}, {'title': 'Neoplasms benign, malignant and unspecified', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Blood and lymphatic system disorders', 'categories': [{'measurements': [{'value': '4.4', 'groupId': 'OG000'}]}]}, {'title': 'Ear and labyrinth disorders', 'categories': [{'measurements': [{'value': '3.8', 'groupId': 'OG000'}]}]}, {'title': 'Hepatobiliary disorders', 'categories': [{'measurements': [{'value': '2.3', 'groupId': 'OG000'}]}]}, {'title': 'Endocrine disorders', 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000'}]}]}, {'title': 'Social circumstances', 'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000'}]}]}, {'title': 'Congenital, familial and genetic disorders', 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000'}]}]}, {'title': 'Pregnancy, puerperium and perinatal conditions', 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up Week 440', 'description': 'AE rates by SOC adjusting for participant-years on study drug anytime post Baseline are summarized, which included the follow up visits. Only treatment-emergent adverse events (AEs) are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. The event rate of an AE was calculated as the number of events per 100 participant years: Event Rate = 100\\* Number of Events / Participant Years. Participant years were calculated as sum across all participants (\\[last visit of interval day - first visit of interval day + 1\\]/365). Participant years excluded between study gaps if participant had not started extension study on date of last visit of parent study.', 'unitOfMeasure': 'Adverse events/100 participant-years', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT Population'}, {'type': 'PRIMARY', 'title': 'SAE Rates by System Organ Class (SOC) During the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '268', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Belimumab 10 mg/kg IV', 'description': 'Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.'}], 'classes': [{'title': 'Infections and infestations', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Gastrointestinal disorders', 'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000'}]}]}, {'title': 'Musculoskeletal and connective tissue disorders', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'General disorders and administration sitecondition', 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000'}]}]}, {'title': 'Nervous system disorders', 'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000'}]}]}, {'title': 'Injury, poisoning and procedural complications', 'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000'}]}]}, {'title': 'Vascular disorders', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Neoplasms benign, malignant and unspecified', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Respiratory, thoracic and mediastinal disorders', 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000'}]}]}, {'title': 'Cardiac disorders', 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000'}]}]}, {'title': 'Metabolism and nutrition disorders', 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000'}]}]}, {'title': 'Psychiatric disorders', 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000'}]}]}, {'title': 'Renal and urinary disorders', 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000'}]}]}, {'title': 'Hepatobiliary disorders', 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000'}]}]}, {'title': 'Blood and lymphatic system disorders', 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000'}]}]}, {'title': 'Reproductive system and breast disorders', 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000'}]}]}, {'title': 'Immune system disorders', 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000'}]}]}, {'title': 'Investigations', 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000'}]}]}, {'title': 'Skin and subcutaneous tissue disorders', 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000'}]}]}, {'title': 'Congenital, familial and genetic disorders', 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000'}]}]}, {'title': 'Endocrine disorders', 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000'}]}]}, {'title': 'Eye disorders', 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000'}]}]}, {'title': 'Pregnancy, puerperium and perinatal conditions', 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Week 440', 'description': 'SAE rates by SOC adjusting for participants-years on study drug anytime post Baseline are summarized, which included the follow up visits. Only treatment-emergent SAEs are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. The event rate of an SAE was calculated as the number of events per 100 participant years: Event Rate = 100\\* Number of Events / participants Years. participants years were calculated as = sum across all participants (\\[last visit of interval day - first visit of interval day + 1\\]/365). participants years excluded between study gaps if participant had not started extension study on date of last visit of parent study.', 'unitOfMeasure': 'Adverse events/100 participant-years', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT Population'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '268', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Belimumab 10 mg/kg IV', 'description': 'Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.'}], 'classes': [{'title': 'APTT, Year 1, Week 4, n= 82', 'categories': [{'measurements': [{'value': '1.3', 'spread': '4.46', 'groupId': 'OG000'}]}]}, {'title': 'APTT, Year 1, Week 12, n= 79', 'categories': [{'measurements': [{'value': '1', 'spread': '4.56', 'groupId': 'OG000'}]}]}, {'title': 'APTT, Year 1, Week 24, n= 243', 'categories': [{'measurements': [{'value': '0.7', 'spread': '4.81', 'groupId': 'OG000'}]}]}, {'title': 'APTT, Year 1, Week 36, n= 71', 'categories': [{'measurements': [{'value': '1.4', 'spread': '4.83', 'groupId': 'OG000'}]}]}, {'title': 'APTT, Year 1, Week 48, n= 246', 'categories': [{'measurements': [{'value': '1.7', 'spread': '5.37', 'groupId': 'OG000'}]}]}, {'title': 'APTT, Year 2, Week 24, n= 231', 'categories': [{'measurements': [{'value': '2.7', 'spread': '5.88', 'groupId': 'OG000'}]}]}, {'title': 'APTT, Year 2, Week 48, n= 220', 'categories': [{'measurements': [{'value': '3.9', 'spread': '5.39', 'groupId': 'OG000'}]}]}, {'title': 'APTT, Year 3, Week 24, n= 206', 'categories': [{'measurements': [{'value': '4.5', 'spread': '4.92', 'groupId': 'OG000'}]}]}, {'title': 'APTT, Year 3, Week 48, n= 202', 'categories': [{'measurements': [{'value': '4', 'spread': '5.34', 'groupId': 'OG000'}]}]}, {'title': 'APTT, Year 4, Week 24, n= 201', 'categories': [{'measurements': [{'value': '4.2', 'spread': '6.51', 'groupId': 'OG000'}]}]}, {'title': 'APTT, Year 4, Week 48, n= 185', 'categories': [{'measurements': [{'value': '4.7', 'spread': '8.19', 'groupId': 'OG000'}]}]}, {'title': 'APTT, Year 5, Week 24, n= 174', 'categories': [{'measurements': [{'value': '4.7', 'spread': '7.03', 'groupId': 'OG000'}]}]}, {'title': 'APTT, Year 5, Week 48, n= 171', 'categories': [{'measurements': [{'value': '3.6', 'spread': '5.46', 'groupId': 'OG000'}]}]}, {'title': 'APTT, Year 6, Week 24, n= 160', 'categories': [{'measurements': [{'value': '4.3', 'spread': '6.37', 'groupId': 'OG000'}]}]}, {'title': 'APTT, Year 6, Week 48, n= 126', 'categories': [{'measurements': [{'value': '4.8', 'spread': '7.71', 'groupId': 'OG000'}]}]}, {'title': 'APTT, Year 7, Week 24, n= 118', 'categories': [{'measurements': [{'value': '4.4', 'spread': '4.77', 'groupId': 'OG000'}]}]}, {'title': 'APTT, Year 7, Week 48, n= 92', 'categories': [{'measurements': [{'value': '5', 'spread': '9.55', 'groupId': 'OG000'}]}]}, {'title': 'APTT, Year 8, Week 24, n= 59', 'categories': [{'measurements': [{'value': '4.7', 'spread': '5.02', 'groupId': 'OG000'}]}]}, {'title': 'APTT, Year 8, Week 48, n= 28', 'categories': [{'measurements': [{'value': '4.7', 'spread': '5.51', 'groupId': 'OG000'}]}]}, {'title': 'APTT, Year 9, Week 24, n= 2', 'categories': [{'measurements': [{'value': '8.5', 'spread': '13.44', 'groupId': 'OG000'}]}]}, {'title': 'APTT, Exit, n= 230', 'categories': [{'measurements': [{'value': '3.1', 'spread': '6.72', 'groupId': 'OG000'}]}]}, {'title': 'APTT, 8 Week, Follow-Up, n= 104', 'categories': [{'measurements': [{'value': '3.3', 'spread': '8.58', 'groupId': 'OG000'}]}]}, {'title': 'PT, Year 1, Week 4, n= 82', 'categories': [{'measurements': [{'value': '-0.05', 'spread': '1.463', 'groupId': 'OG000'}]}]}, {'title': 'PT, Year 1, Week 12, n= 79', 'categories': [{'measurements': [{'value': '-0.66', 'spread': '3.502', 'groupId': 'OG000'}]}]}, {'title': 'PT, Year 1, Week 24, n= 244', 'categories': [{'measurements': [{'value': '-0.04', 'spread': '3.239', 'groupId': 'OG000'}]}]}, {'title': 'PT, Year 1, Week 36, n= 71', 'categories': [{'measurements': [{'value': '-0.42', 'spread': '3.943', 'groupId': 'OG000'}]}]}, {'title': 'PT, Year 1, Week 48, n= 246', 'categories': [{'measurements': [{'value': '0.2', 'spread': '4.493', 'groupId': 'OG000'}]}]}, {'title': 'PT, Year 2, Week 24, n= 233', 'categories': [{'measurements': [{'value': '0.52', 'spread': '5.059', 'groupId': 'OG000'}]}]}, {'title': 'PT, Year 2, Week 48, n= 221', 'categories': [{'measurements': [{'value': '0.24', 'spread': '2.693', 'groupId': 'OG000'}]}]}, {'title': 'PT, Year 3, Week 24, n= 206', 'categories': [{'measurements': [{'value': '0.26', 'spread': '2.983', 'groupId': 'OG000'}]}]}, {'title': 'PT, Year 3, Week 48, n= 202', 'categories': [{'measurements': [{'value': '0.34', 'spread': '3.77', 'groupId': 'OG000'}]}]}, {'title': 'PT, Year 4, Week 24, n= 201', 'categories': [{'measurements': [{'value': '0.39', 'spread': '3.047', 'groupId': 'OG000'}]}]}, {'title': 'PT, Year 4, Week 48, n= 186', 'categories': [{'measurements': [{'value': '1.96', 'spread': '14.36', 'groupId': 'OG000'}]}]}, {'title': 'PT, Year 5, Week 24, n= 174', 'categories': [{'measurements': [{'value': '0.6', 'spread': '3.56', 'groupId': 'OG000'}]}]}, {'title': 'PT, Year 5, Week 48, n= 172', 'categories': [{'measurements': [{'value': '0.5', 'spread': '5.488', 'groupId': 'OG000'}]}]}, {'title': 'PT, Year 6, Week 24, n= 160', 'categories': [{'measurements': [{'value': '0.39', 'spread': '3.333', 'groupId': 'OG000'}]}]}, {'title': 'PT, Year 6, Week 48, n= 126', 'categories': [{'measurements': [{'value': '0.55', 'spread': '3.473', 'groupId': 'OG000'}]}]}, {'title': 'PT, Year 7, Week 24, n= 118', 'categories': [{'measurements': [{'value': '0.72', 'spread': '3.23', 'groupId': 'OG000'}]}]}, {'title': 'PT, Year 7, Week 48, n= 92', 'categories': [{'measurements': [{'value': '0.68', 'spread': '5.149', 'groupId': 'OG000'}]}]}, {'title': 'PT, Year 8, Week 24, n= 58', 'categories': [{'measurements': [{'value': '0.5', 'spread': '2.401', 'groupId': 'OG000'}]}]}, {'title': 'PT, Year 8, Week 48, n= 28', 'categories': [{'measurements': [{'value': '1.85', 'spread': '4.759', 'groupId': 'OG000'}]}]}, {'title': 'PT, Year 9, Week 24, n= 2', 'categories': [{'measurements': [{'value': '1.45', 'spread': '2.758', 'groupId': 'OG000'}]}]}, {'title': 'PT, Exit, n= 229', 'categories': [{'measurements': [{'value': '0.57', 'spread': '3.972', 'groupId': 'OG000'}]}]}, {'title': 'PT, 8 Week, Follow-Up, n= 103', 'categories': [{'measurements': [{'value': '0.33', 'spread': '2.202', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Week 440', 'description': 'Hematology parameters were assessed at Baseline (BL) (Day 0), Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in APTT and PT is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post- Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.', 'unitOfMeasure': 'Seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT Population'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '268', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Belimumab 10 mg/kg IV', 'description': 'Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.'}], 'classes': [{'title': 'Basophils, Year 1, Week 4, n= 257', 'categories': [{'measurements': [{'value': '0.001', 'spread': '0.0157', 'groupId': 'OG000'}]}]}, {'title': 'Basophils, Year 1, Week 12, n= 249', 'categories': [{'measurements': [{'value': '0.002', 'spread': '0.0173', 'groupId': 'OG000'}]}]}, {'title': 'Basophils, Year 1, Week 24, n= 249', 'categories': [{'measurements': [{'value': '0.003', 'spread': '0.0175', 'groupId': 'OG000'}]}]}, {'title': 'Basophils, Year 1, Week 36, n= 240', 'categories': [{'measurements': [{'value': '0.003', 'spread': '0.0172', 'groupId': 'OG000'}]}]}, {'title': 'Basophils, Year 1, Week 48, n= 254', 'categories': [{'measurements': [{'value': '0.001', 'spread': '0.016', 'groupId': 'OG000'}]}]}, {'title': 'Basophils, Year 2, Week 24, n= 250', 'categories': [{'measurements': [{'value': '0.002', 'spread': '0.0159', 'groupId': 'OG000'}]}]}, {'title': 'Basophils, Year 2, Week 48, n= 233', 'categories': [{'measurements': [{'value': '0.001', 'spread': '0.0157', 'groupId': 'OG000'}]}]}, {'title': 'Basophils, Year 3, Week 24, n= 219', 'categories': [{'measurements': [{'value': '0.004', 'spread': '0.0156', 'groupId': 'OG000'}]}]}, {'title': 'Basophils, Year 3, Week 48, n= 211', 'categories': [{'measurements': [{'value': '0.004', 'spread': '0.0179', 'groupId': 'OG000'}]}]}, {'title': 'Basophils, Year 4, Week 24, n= 210', 'categories': [{'measurements': [{'value': '0.004', 'spread': '0.0157', 'groupId': 'OG000'}]}]}, {'title': 'Basophils, Year 4, Week 48, n= 194', 'categories': [{'measurements': [{'value': '0.002', 'spread': '0.0159', 'groupId': 'OG000'}]}]}, {'title': 'Basophils, Year 5, Week 24, n= 188', 'categories': [{'measurements': [{'value': '0.003', 'spread': '0.0168', 'groupId': 'OG000'}]}]}, {'title': 'Basophils, Year 5, Week 48, n= 184', 'categories': [{'measurements': [{'value': '0.005', 'spread': '0.0226', 'groupId': 'OG000'}]}]}, {'title': 'Basophils, Year 6, Week 24, n= 176', 'categories': [{'measurements': [{'value': '0.003', 'spread': '0.0149', 'groupId': 'OG000'}]}]}, {'title': 'Basophils, Year 6, Week 48, n= 132', 'categories': [{'measurements': [{'value': '0.003', 'spread': '0.0178', 'groupId': 'OG000'}]}]}, {'title': 'Basophils, Year 7, Week 24, n= 122', 'categories': [{'measurements': [{'value': '0.005', 'spread': '0.0189', 'groupId': 'OG000'}]}]}, {'title': 'Basophils, Year 7, Week 48, n= 96', 'categories': [{'measurements': [{'value': '0.009', 'spread': '0.0188', 'groupId': 'OG000'}]}]}, {'title': 'Basophils, Year 8, Week 24, n= 60', 'categories': [{'measurements': [{'value': '0.002', 'spread': '0.0155', 'groupId': 'OG000'}]}]}, {'title': 'Basophils, Year 8, Week 48, n= 29', 'categories': [{'measurements': [{'value': '0.002', 'spread': '0.0147', 'groupId': 'OG000'}]}]}, {'title': 'Basophils, Year 9, Week 24, n= 2', 'categories': [{'measurements': [{'value': '0.02', 'spread': '0.0141', 'groupId': 'OG000'}]}]}, {'title': 'Basophils, Exit, n= 233', 'categories': [{'measurements': [{'value': '0.005', 'spread': '0.0183', 'groupId': 'OG000'}]}]}, {'title': 'Basophils, 8 Week, Follow-Up, n= 106', 'categories': [{'measurements': [{'value': '0.004', 'spread': '0.0186', 'groupId': 'OG000'}]}]}, {'title': 'Eosinophils, Year 1, Week 4, n= 257', 'categories': [{'measurements': [{'value': '-0.001', 'spread': '0.0893', 'groupId': 'OG000'}]}]}, {'title': 'Eosinophils, Year 1, Week 12, n= 249', 'categories': [{'measurements': [{'value': '0.005', 'spread': '0.1089', 'groupId': 'OG000'}]}]}, {'title': 'Eosinophils, Year 1, Week 24, n= 249', 'categories': [{'measurements': [{'value': '0.008', 'spread': '0.1281', 'groupId': 'OG000'}]}]}, {'title': 'Eosinophils, Year 1, Week 36, n= 240', 'categories': [{'measurements': [{'value': '0.004', 'spread': '0.1279', 'groupId': 'OG000'}]}]}, {'title': 'Eosinophils, Year 1, Week 48, n= 254', 'categories': [{'measurements': [{'value': '0.007', 'spread': '0.1216', 'groupId': 'OG000'}]}]}, {'title': 'Eosinophils, Year 2, Week 24, n= 250', 'categories': [{'measurements': [{'value': '0.006', 'spread': '0.1228', 'groupId': 'OG000'}]}]}, {'title': 'Eosinophils, Year 2, Week 48, n= 233', 'categories': [{'measurements': [{'value': '-0.009', 'spread': '0.1234', 'groupId': 'OG000'}]}]}, {'title': 'Eosinophils, Year 3, Week 24, n= 219', 'categories': [{'measurements': [{'value': '-0.002', 'spread': '0.1303', 'groupId': 'OG000'}]}]}, {'title': 'Eosinophils, Year 3, Week 48, n= 211', 'categories': [{'measurements': [{'value': '-0.023', 'spread': '0.1276', 'groupId': 'OG000'}]}]}, {'title': 'Eosinophils, Year 4, Week 24, n= 210', 'categories': [{'measurements': [{'value': '-0.034', 'spread': '0.125', 'groupId': 'OG000'}]}]}, {'title': 'Eosinophils, Year 4, Week 48, n= 194', 'categories': [{'measurements': [{'value': '-0.032', 'spread': '0.1407', 'groupId': 'OG000'}]}]}, {'title': 'Eosinophils, Year 5, Week 24, n= 188', 'categories': [{'measurements': [{'value': '-0.038', 'spread': '0.1281', 'groupId': 'OG000'}]}]}, {'title': 'Eosinophils, Year 5, Week 48, n= 184', 'categories': [{'measurements': [{'value': '-0.019', 'spread': '0.1547', 'groupId': 'OG000'}]}]}, {'title': 'Eosinophils, Year 6, Week 24, n= 176', 'categories': [{'measurements': [{'value': '-0.027', 'spread': '0.1169', 'groupId': 'OG000'}]}]}, {'title': 'Eosinophils, Year 6, Week 48, n= 132', 'categories': [{'measurements': [{'value': '-0.038', 'spread': '0.1227', 'groupId': 'OG000'}]}]}, {'title': 'Eosinophils, Year 7, Week 24, n= 122', 'categories': [{'measurements': [{'value': '-0.017', 'spread': '0.1269', 'groupId': 'OG000'}]}]}, {'title': 'Eosinophils, Year 7, Week 48, n= 96', 'categories': [{'measurements': [{'value': '-0.026', 'spread': '0.1401', 'groupId': 'OG000'}]}]}, {'title': 'Eosinophils, Year 8, Week 24, n= 60', 'categories': [{'measurements': [{'value': '-0.031', 'spread': '0.1425', 'groupId': 'OG000'}]}]}, {'title': 'Eosinophils, Year 8, Week 48, n= 29', 'categories': [{'measurements': [{'value': '-0.032', 'spread': '0.1121', 'groupId': 'OG000'}]}]}, {'title': 'Eosinophils, Year 9, Week 24, n= 2', 'categories': [{'measurements': [{'value': '-0.08', 'spread': '0.0141', 'groupId': 'OG000'}]}]}, {'title': 'Eosinophils, Exit, n= 233', 'categories': [{'measurements': [{'value': '-0.026', 'spread': '0.1295', 'groupId': 'OG000'}]}]}, {'title': 'Eosinophils, 8 Week, Follow-Up, n= 106', 'categories': [{'measurements': [{'value': '-0.022', 'spread': '0.1401', 'groupId': 'OG000'}]}]}, {'title': 'Leukocytes, Year 1, Week 4, n= 257', 'categories': [{'measurements': [{'value': '0.08', 'spread': '1.642', 'groupId': 'OG000'}]}]}, {'title': 'Leukocytes, Year 1, Week 12, n= 249', 'categories': [{'measurements': [{'value': '0.18', 'spread': '1.856', 'groupId': 'OG000'}]}]}, {'title': 'Leukocytes, Year 1, Week 24, n= 249', 'categories': [{'measurements': [{'value': '-0.02', 'spread': '1.884', 'groupId': 'OG000'}]}]}, {'title': 'Leukocytes, Year 1, Week 36, n= 240', 'categories': [{'measurements': [{'value': '0.04', 'spread': '2.092', 'groupId': 'OG000'}]}]}, {'title': 'Leukocytes, Year 1, Week 48, n= 254', 'categories': [{'measurements': [{'value': '-0.01', 'spread': '1.863', 'groupId': 'OG000'}]}]}, {'title': 'Leukocytes, Year 2, Week 24, n= 250', 'categories': [{'measurements': [{'value': '-0.19', 'spread': '2.087', 'groupId': 'OG000'}]}]}, {'title': 'Leukocytes, Year 2, Week 48, n= 233', 'categories': [{'measurements': [{'value': '-0.27', 'spread': '2.19', 'groupId': 'OG000'}]}]}, {'title': 'Leukocytes, Year 3, Week 24, n= 219', 'categories': [{'measurements': [{'value': '-0.33', 'spread': '1.959', 'groupId': 'OG000'}]}]}, {'title': 'Leukocytes, Year 3, Week 48, n= 211', 'categories': [{'measurements': [{'value': '-0.42', 'spread': '1.876', 'groupId': 'OG000'}]}]}, {'title': 'Leukocytes, Year 4, Week 24, n= 210', 'categories': [{'measurements': [{'value': '-0.29', 'spread': '2.205', 'groupId': 'OG000'}]}]}, {'title': 'Leukocytes, Year 4, Week 48, n= 194', 'categories': [{'measurements': [{'value': '-0.35', 'spread': '2.207', 'groupId': 'OG000'}]}]}, {'title': 'Leukocytes, Year 5, Week 24, n= 188', 'categories': [{'measurements': [{'value': '-0.4', 'spread': '2.112', 'groupId': 'OG000'}]}]}, {'title': 'Leukocytes, Year 5, Week 48, n= 184', 'categories': [{'measurements': [{'value': '-0.18', 'spread': '2.389', 'groupId': 'OG000'}]}]}, {'title': 'Leukocytes, Year 6, Week 24, n= 176', 'categories': [{'measurements': [{'value': '-0.4', 'spread': '2.161', 'groupId': 'OG000'}]}]}, {'title': 'Leukocytes, Year 6, Week 48, n= 132', 'categories': [{'measurements': [{'value': '-0.24', 'spread': '2.164', 'groupId': 'OG000'}]}]}, {'title': 'Leukocytes, Year 7, Week 24, n= 122', 'categories': [{'measurements': [{'value': '-0.22', 'spread': '2.149', 'groupId': 'OG000'}]}]}, {'title': 'Leukocytes, Year 7, Week 48, n= 96', 'categories': [{'measurements': [{'value': '0.05', 'spread': '2.388', 'groupId': 'OG000'}]}]}, {'title': 'Leukocytes, Year 8, Week 24, n= 60', 'categories': [{'measurements': [{'value': '0.17', 'spread': '2.297', 'groupId': 'OG000'}]}]}, {'title': 'Leukocytes, Year 8, Week 48, n= 29', 'categories': [{'measurements': [{'value': '-0.63', 'spread': '2.549', 'groupId': 'OG000'}]}]}, {'title': 'Leukocytes, Year 9, Week 24, n= 2', 'categories': [{'measurements': [{'value': '-3.7', 'spread': '1.273', 'groupId': 'OG000'}]}]}, {'title': 'Leukocytes, Exit, n= 233', 'categories': [{'measurements': [{'value': '0.09', 'spread': '2.969', 'groupId': 'OG000'}]}]}, {'title': 'Leukocytes, 8 Week, Follow-Up, n= 106', 'categories': [{'measurements': [{'value': '-0.11', 'spread': '2.613', 'groupId': 'OG000'}]}]}, {'title': 'Lymphocytes, Year 1, Week 4, n= 257', 'categories': [{'measurements': [{'value': '0.076', 'spread': '0.4223', 'groupId': 'OG000'}]}]}, {'title': 'Lymphocytes, Year 1, Week 12, n= 249', 'categories': [{'measurements': [{'value': '0.039', 'spread': '0.558', 'groupId': 'OG000'}]}]}, {'title': 'Lymphocytes, Year 1, Week 24, n= 249', 'categories': [{'measurements': [{'value': '0.002', 'spread': '0.5023', 'groupId': 'OG000'}]}]}, {'title': 'Lymphocytes, Year 1, Week 36, n= 240', 'categories': [{'measurements': [{'value': '0.059', 'spread': '0.5002', 'groupId': 'OG000'}]}]}, {'title': 'Lymphocytes, Year 1, Week 48, n= 254', 'categories': [{'measurements': [{'value': '-0.02', 'spread': '0.5129', 'groupId': 'OG000'}]}]}, {'title': 'Lymphocytes, Year 2, Week 24, n= 250', 'categories': [{'measurements': [{'value': '-0.073', 'spread': '0.5033', 'groupId': 'OG000'}]}]}, {'title': 'Lymphocytes, Year 2, Week 48, n= 233', 'categories': [{'measurements': [{'value': '-0.036', 'spread': '0.5299', 'groupId': 'OG000'}]}]}, {'title': 'Lymphocytes, Year 3, Week 24, n= 219', 'categories': [{'measurements': [{'value': '0.002', 'spread': '0.5621', 'groupId': 'OG000'}]}]}, {'title': 'Lymphocytes, Year 3, Week 48, n= 211', 'categories': [{'measurements': [{'value': '-0.028', 'spread': '0.572', 'groupId': 'OG000'}]}]}, {'title': 'Lymphocytes, Year 4, Week 24, n= 210', 'categories': [{'measurements': [{'value': '-0.036', 'spread': '0.5809', 'groupId': 'OG000'}]}]}, {'title': 'Lymphocytes, Year 4, Week 48, n= 194', 'categories': [{'measurements': [{'value': '-0.067', 'spread': '0.5678', 'groupId': 'OG000'}]}]}, {'title': 'Lymphocytes, Year 5, Week 24, n= 188', 'categories': [{'measurements': [{'value': '-0.07', 'spread': '0.5924', 'groupId': 'OG000'}]}]}, {'title': 'Lymphocytes, Year 5, Week 48, n= 184', 'categories': [{'measurements': [{'value': '-0.047', 'spread': '0.629', 'groupId': 'OG000'}]}]}, {'title': 'Lymphocytes, Year 6, Week 24, n= 176', 'categories': [{'measurements': [{'value': '-0.021', 'spread': '0.5876', 'groupId': 'OG000'}]}]}, {'title': 'Lymphocytes, Year 6, Week 48, n= 132', 'categories': [{'measurements': [{'value': '-0.008', 'spread': '0.5564', 'groupId': 'OG000'}]}]}, {'title': 'Lymphocytes, Year 7, Week 24, n= 122', 'categories': [{'measurements': [{'value': '0.011', 'spread': '0.6439', 'groupId': 'OG000'}]}]}, {'title': 'Lymphocytes, Year 7, Week 48, n= 96', 'categories': [{'measurements': [{'value': '0.143', 'spread': '0.6619', 'groupId': 'OG000'}]}]}, {'title': 'Lymphocytes, Year 8, Week 24, n= 60', 'categories': [{'measurements': [{'value': '0.126', 'spread': '0.6291', 'groupId': 'OG000'}]}]}, {'title': 'Lymphocytes, Year 8, Week 48, n= 29', 'categories': [{'measurements': [{'value': '0.059', 'spread': '0.8495', 'groupId': 'OG000'}]}]}, {'title': 'Lymphocytes, Year 9, Week 24, n= 2', 'categories': [{'measurements': [{'value': '0.765', 'spread': '1.4354', 'groupId': 'OG000'}]}]}, {'title': 'Lymphocytes, Exit, n= 233', 'categories': [{'measurements': [{'value': '-0.025', 'spread': '0.6129', 'groupId': 'OG000'}]}]}, {'title': 'Lymphocytes, 8 Week, Follow-Up, n= 106', 'categories': [{'measurements': [{'value': '0.029', 'spread': '0.6256', 'groupId': 'OG000'}]}]}, {'title': 'Monocytes, Year 1, Week 4, n= 257', 'categories': [{'measurements': [{'value': '0.028', 'spread': '0.1673', 'groupId': 'OG000'}]}]}, {'title': 'Monocytes, Year 1, Week 12, n= 249', 'categories': [{'measurements': [{'value': '0.036', 'spread': '0.1694', 'groupId': 'OG000'}]}]}, {'title': 'Monocytes, Year 1, Week 24, n= 249', 'categories': [{'measurements': [{'value': '0.024', 'spread': '0.1678', 'groupId': 'OG000'}]}]}, {'title': 'Monocytes, Year 1, Week 36, n= 240', 'categories': [{'measurements': [{'value': '0.054', 'spread': '0.1806', 'groupId': 'OG000'}]}]}, {'title': 'Monocytes, Year 1, Week 48, n= 254', 'categories': [{'measurements': [{'value': '0.044', 'spread': '0.1754', 'groupId': 'OG000'}]}]}, {'title': 'Monocytes, Year 2, Week 24, n= 250', 'categories': [{'measurements': [{'value': '0.053', 'spread': '0.1809', 'groupId': 'OG000'}]}]}, {'title': 'Monocytes, Year 2, Week 48, n= 233', 'categories': [{'measurements': [{'value': '0.052', 'spread': '0.1805', 'groupId': 'OG000'}]}]}, {'title': 'Monocytes, Year 3, Week 24, n= 219', 'categories': [{'measurements': [{'value': '0.059', 'spread': '0.1809', 'groupId': 'OG000'}]}]}, {'title': 'Monocytes, Year 3, Week 48, n= 211', 'categories': [{'measurements': [{'value': '0.071', 'spread': '0.1903', 'groupId': 'OG000'}]}]}, {'title': 'Monocytes, Year 4, Week 24, n= 210', 'categories': [{'measurements': [{'value': '0.065', 'spread': '0.1875', 'groupId': 'OG000'}]}]}, {'title': 'Monocytes, Year 4, Week 48, n= 194', 'categories': [{'measurements': [{'value': '0.084', 'spread': '0.1782', 'groupId': 'OG000'}]}]}, {'title': 'Monocytes, Year 5, Week 24, n= 188', 'categories': [{'measurements': [{'value': '0.095', 'spread': '0.1878', 'groupId': 'OG000'}]}]}, {'title': 'Monocytes, Year 5, Week 48, n= 184', 'categories': [{'measurements': [{'value': '0.086', 'spread': '0.1983', 'groupId': 'OG000'}]}]}, {'title': 'Monocytes, Year 6, Week 24, n= 176', 'categories': [{'measurements': [{'value': '0.072', 'spread': '0.1826', 'groupId': 'OG000'}]}]}, {'title': 'Monocytes, Year 6, Week 48, n= 132', 'categories': [{'measurements': [{'value': '0.049', 'spread': '0.1808', 'groupId': 'OG000'}]}]}, {'title': 'Monocytes, Year 7, Week 24, n= 122', 'categories': [{'measurements': [{'value': '0.098', 'spread': '0.1996', 'groupId': 'OG000'}]}]}, {'title': 'Monocytes, Year 7, Week 48, n= 96', 'categories': [{'measurements': [{'value': '0.097', 'spread': '0.2032', 'groupId': 'OG000'}]}]}, {'title': 'Monocytes, Year 8, Week 24, n= 60', 'categories': [{'measurements': [{'value': '0.101', 'spread': '0.1909', 'groupId': 'OG000'}]}]}, {'title': 'Monocytes, Year 8, Week 48, n= 29', 'categories': [{'measurements': [{'value': '0.024', 'spread': '0.2074', 'groupId': 'OG000'}]}]}, {'title': 'Monocytes, Year 9, Week 24, n= 2', 'categories': [{'measurements': [{'value': '0.03', 'spread': '0.3818', 'groupId': 'OG000'}]}]}, {'title': 'Monocytes, Exit, n= 233', 'categories': [{'measurements': [{'value': '0.075', 'spread': '0.1846', 'groupId': 'OG000'}]}]}, {'title': 'Monocytes, 8 Week, Follow-Up, n= 106', 'categories': [{'measurements': [{'value': '0.093', 'spread': '0.1958', 'groupId': 'OG000'}]}]}, {'title': 'Neutrophils, Year 1, Week 4, n= 257', 'categories': [{'measurements': [{'value': '-0.027', 'spread': '1.6734', 'groupId': 'OG000'}]}]}, {'title': 'Neutrophils, Year 1, Week 12, n= 249', 'categories': [{'measurements': [{'value': '0.1', 'spread': '1.7293', 'groupId': 'OG000'}]}]}, {'title': 'Neutrophils, Year 1, Week 24, n= 249', 'categories': [{'measurements': [{'value': '-0.059', 'spread': '1.8685', 'groupId': 'OG000'}]}]}, {'title': 'Neutrophils, Year 1, Week 36, n= 240', 'categories': [{'measurements': [{'value': '-0.086', 'spread': '2.1086', 'groupId': 'OG000'}]}]}, {'title': 'Neutrophils, Year 1, Week 48, n= 254', 'categories': [{'measurements': [{'value': '-0.037', 'spread': '1.7955', 'groupId': 'OG000'}]}]}, {'title': 'Neutrophils, Year 2, Week 24, n= 250', 'categories': [{'measurements': [{'value': '-0.176', 'spread': '2.0209', 'groupId': 'OG000'}]}]}, {'title': 'Neutrophils, Year 2, Week 48, n= 233', 'categories': [{'measurements': [{'value': '-0.283', 'spread': '2.1226', 'groupId': 'OG000'}]}]}, {'title': 'Neutrophils, Year 3, Week 24, n= 219', 'categories': [{'measurements': [{'value': '-0.397', 'spread': '1.8521', 'groupId': 'OG000'}]}]}, {'title': 'Neutrophils, Year 3, Week 48, n= 211', 'categories': [{'measurements': [{'value': '-0.443', 'spread': '1.763', 'groupId': 'OG000'}]}]}, {'title': 'Neutrophils, Year 4, Week 24, n= 210', 'categories': [{'measurements': [{'value': '-0.288', 'spread': '2.1214', 'groupId': 'OG000'}]}]}, {'title': 'Neutrophils, Year 4, Week 48, n= 194', 'categories': [{'measurements': [{'value': '-0.342', 'spread': '2.1425', 'groupId': 'OG000'}]}]}, {'title': 'Neutrophils, Year 5, Week 24, n= 188', 'categories': [{'measurements': [{'value': '-0.392', 'spread': '1.9654', 'groupId': 'OG000'}]}]}, {'title': 'Neutrophils, Year 5, Week 48, n= 184', 'categories': [{'measurements': [{'value': '-0.207', 'spread': '2.2312', 'groupId': 'OG000'}]}]}, {'title': 'Neutrophils, Year 6, Week 24, n= 176', 'categories': [{'measurements': [{'value': '-0.424', 'spread': '2.0787', 'groupId': 'OG000'}]}]}, {'title': 'Neutrophils, Year 6, Week 48, n= 132', 'categories': [{'measurements': [{'value': '-0.251', 'spread': '2.1415', 'groupId': 'OG000'}]}]}, {'title': 'Neutrophils, Year 7, Week 24, n= 122', 'categories': [{'measurements': [{'value': '-0.315', 'spread': '2.1382', 'groupId': 'OG000'}]}]}, {'title': 'Neutrophils, Year 7, Week 48, n= 96', 'categories': [{'measurements': [{'value': '-0.176', 'spread': '2.3755', 'groupId': 'OG000'}]}]}, {'title': 'Neutrophils, Year 8, Week 24, n= 60', 'categories': [{'measurements': [{'value': '-0.025', 'spread': '2.2303', 'groupId': 'OG000'}]}]}, {'title': 'Neutrophils, Year 8, Week 48, n= 29', 'categories': [{'measurements': [{'value': '-0.681', 'spread': '2.4214', 'groupId': 'OG000'}]}]}, {'title': 'Neutrophils, Year 9, Week 24, n= 2', 'categories': [{'measurements': [{'value': '-4.44', 'spread': '0.5798', 'groupId': 'OG000'}]}]}, {'title': 'Neutrophils, Exit, n= 233', 'categories': [{'measurements': [{'value': '0.058', 'spread': '2.9836', 'groupId': 'OG000'}]}]}, {'title': 'Neutrophils, 8 Week, Follow-Up, n= 106', 'categories': [{'measurements': [{'value': '-0.214', 'spread': '2.5793', 'groupId': 'OG000'}]}]}, {'title': 'Neutrophils segmented, Year 1, Week 4, n= 257', 'categories': [{'measurements': [{'value': '-0.028', 'spread': '1.6685', 'groupId': 'OG000'}]}]}, {'title': 'Neutrophils segmented, Year 1, Week 12, n= 249', 'categories': [{'measurements': [{'value': '0.098', 'spread': '1.7212', 'groupId': 'OG000'}]}]}, {'title': 'Neutrophils segmented, Year 1, Week 24, n= 249', 'categories': [{'measurements': [{'value': '-0.059', 'spread': '1.8683', 'groupId': 'OG000'}]}]}, {'title': 'Neutrophils segmented, Year 1, Week 36, n= 240', 'categories': [{'measurements': [{'value': '-0.086', 'spread': '2.1097', 'groupId': 'OG000'}]}]}, {'title': 'Neutrophils segmented, Year 1, Week 48, n= 254', 'categories': [{'measurements': [{'value': '-0.044', 'spread': '1.8014', 'groupId': 'OG000'}]}]}, {'title': 'Neutrophils segmented, Year 2, Week 24, n= 250', 'categories': [{'measurements': [{'value': '-0.177', 'spread': '2.0163', 'groupId': 'OG000'}]}]}, {'title': 'Neutrophils segmented, Year 2, Week 48, n= 233', 'categories': [{'measurements': [{'value': '-0.284', 'spread': '2.1204', 'groupId': 'OG000'}]}]}, {'title': 'Neutrophils segmented, Year 3, Week 24, n= 219', 'categories': [{'measurements': [{'value': '-0.397', 'spread': '1.8509', 'groupId': 'OG000'}]}]}, {'title': 'Neutrophils segmented, Year 3, Week 48, n= 211', 'categories': [{'measurements': [{'value': '-0.444', 'spread': '1.7607', 'groupId': 'OG000'}]}]}, {'title': 'Neutrophils segmented, Year 4, Week 24, n= 210', 'categories': [{'measurements': [{'value': '-0.286', 'spread': '2.1249', 'groupId': 'OG000'}]}]}, {'title': 'Neutrophils segmented, Year 4, Week 48, n= 194', 'categories': [{'measurements': [{'value': '-0.342', 'spread': '2.1464', 'groupId': 'OG000'}]}]}, {'title': 'Neutrophils segmented, Year 5, Week 24, n= 188', 'categories': [{'measurements': [{'value': '-0.39', 'spread': '1.9703', 'groupId': 'OG000'}]}]}, {'title': 'Neutrophils segmented, Year 5, Week 48, n= 184', 'categories': [{'measurements': [{'value': '-0.207', 'spread': '2.2273', 'groupId': 'OG000'}]}]}, {'title': 'Neutrophils segmented, Year 6, Week 24, n= 176', 'categories': [{'measurements': [{'value': '-0.422', 'spread': '2.0826', 'groupId': 'OG000'}]}]}, {'title': 'Neutrophils segmented, Year 6, Week 48, n= 132', 'categories': [{'measurements': [{'value': '-0.249', 'spread': '2.1432', 'groupId': 'OG000'}]}]}, {'title': 'Neutrophils segmented, Year 7, Week 24, n= 122', 'categories': [{'measurements': [{'value': '-0.313', 'spread': '2.1378', 'groupId': 'OG000'}]}]}, {'title': 'Neutrophils segmented, Year 7, Week 48, n= 96', 'categories': [{'measurements': [{'value': '-0.179', 'spread': '2.3698', 'groupId': 'OG000'}]}]}, {'title': 'Neutrophils segmented, Year 8, Week 24, n= 60', 'categories': [{'measurements': [{'value': '-0.025', 'spread': '2.2303', 'groupId': 'OG000'}]}]}, {'title': 'Neutrophils segmented, Year 8, Week 48, n= 29', 'categories': [{'measurements': [{'value': '-0.681', 'spread': '2.4214', 'groupId': 'OG000'}]}]}, {'title': 'Neutrophils segmented, Year 9, Week 24, n= 2', 'categories': [{'measurements': [{'value': '-4.44', 'spread': '0.5798', 'groupId': 'OG000'}]}]}, {'title': 'Neutrophils segmented, Exit, n= 233', 'categories': [{'measurements': [{'value': '0.046', 'spread': '2.8796', 'groupId': 'OG000'}]}]}, {'title': 'Neutrophils segmented, 8 Week, Follow-Up, n= 106', 'categories': [{'measurements': [{'value': '-0.215', 'spread': '2.5788', 'groupId': 'OG000'}]}]}, {'title': 'Platelets, Year 1, Week 4, n= 254', 'categories': [{'measurements': [{'value': '2.9', 'spread': '35.71', 'groupId': 'OG000'}]}]}, {'title': 'Platelets, Year 1, Week 12, n= 248', 'categories': [{'measurements': [{'value': '-1.1', 'spread': '42.04', 'groupId': 'OG000'}]}]}, {'title': 'Platelets, Year 1, Week 24, n= 247', 'categories': [{'measurements': [{'value': '-2', 'spread': '41.13', 'groupId': 'OG000'}]}]}, {'title': 'Platelets, Year 1, Week 36, n= 238', 'categories': [{'measurements': [{'value': '-5.9', 'spread': '46.11', 'groupId': 'OG000'}]}]}, {'title': 'Platelets, Year 1, Week 48, n= 252', 'categories': [{'measurements': [{'value': '-8.4', 'spread': '46.36', 'groupId': 'OG000'}]}]}, {'title': 'Platelets, Year 2, Week 24, n= 249', 'categories': [{'measurements': [{'value': '-17.5', 'spread': '56.18', 'groupId': 'OG000'}]}]}, {'title': 'Platelets, Year 2, Week 48, n= 233', 'categories': [{'measurements': [{'value': '-18.8', 'spread': '56.8', 'groupId': 'OG000'}]}]}, {'title': 'Platelets, Year 3, Week 24, n= 218', 'categories': [{'measurements': [{'value': '-17', 'spread': '56.86', 'groupId': 'OG000'}]}]}, {'title': 'Platelets, Year 3, Week 48, n= 210', 'categories': [{'measurements': [{'value': '-22.4', 'spread': '57.11', 'groupId': 'OG000'}]}]}, {'title': 'Platelets, Year 4, Week 24, n= 210', 'categories': [{'measurements': [{'value': '-14.6', 'spread': '64.11', 'groupId': 'OG000'}]}]}, {'title': 'Platelets, Year 4, Week 48, n= 193', 'categories': [{'measurements': [{'value': '-17', 'spread': '60.26', 'groupId': 'OG000'}]}]}, {'title': 'Platelets, Year 5, Week 24, n= 188', 'categories': [{'measurements': [{'value': '-19', 'spread': '65.99', 'groupId': 'OG000'}]}]}, {'title': 'Platelets, Year 5, Week 48, n= 184', 'categories': [{'measurements': [{'value': '-17.6', 'spread': '65.69', 'groupId': 'OG000'}]}]}, {'title': 'Platelets, Year 6, Week 24, n= 175', 'categories': [{'measurements': [{'value': '-18.9', 'spread': '62.88', 'groupId': 'OG000'}]}]}, {'title': 'Platelets, Year 6, Week 48, n= 132', 'categories': [{'measurements': [{'value': '-23.7', 'spread': '67.73', 'groupId': 'OG000'}]}]}, {'title': 'Platelets, Year 7, Week 24, n= 121', 'categories': [{'measurements': [{'value': '-14', 'spread': '77.75', 'groupId': 'OG000'}]}]}, {'title': 'Platelets, Year 7, Week 48, n= 96', 'categories': [{'measurements': [{'value': '-24.7', 'spread': '64.56', 'groupId': 'OG000'}]}]}, {'title': 'Platelets, Year 8, Week 24, n= 60', 'categories': [{'measurements': [{'value': '-30.5', 'spread': '65.89', 'groupId': 'OG000'}]}]}, {'title': 'Platelets, Year 8, Week 48, n= 29', 'categories': [{'measurements': [{'value': '-40.7', 'spread': '62.84', 'groupId': 'OG000'}]}]}, {'title': 'Platelets, Year 9, Week 24, n= 2', 'categories': [{'measurements': [{'value': '37', 'spread': '83.44', 'groupId': 'OG000'}]}]}, {'title': 'Platelets, Exit, n= 233', 'categories': [{'measurements': [{'value': '-9.4', 'spread': '59.82', 'groupId': 'OG000'}]}]}, {'title': 'Platelets, 8 Week, Follow-Up, n= 106', 'categories': [{'measurements': [{'value': '-8', 'spread': '70.29', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Week 440', 'description': 'Hematology parameters were assessed at Baseline (BL) (Day 0), Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in basophils, eosinophils, lymphocytes, monocytes, neutrophils, neutrophils segmented and platelets is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post- Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.', 'unitOfMeasure': 'Billion cells per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT Population'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Erythrocytes at the Indicated Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '268', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Belimumab 10 mg/kg IV', 'description': 'Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.'}], 'classes': [{'title': 'Erythrocytes, Year 1, Week 4, n= 257', 'categories': [{'measurements': [{'value': '0', 'spread': '0.243', 'groupId': 'OG000'}]}]}, {'title': 'Erythrocytes, Year 1, Week 12, n= 249', 'categories': [{'measurements': [{'value': '0.01', 'spread': '0.284', 'groupId': 'OG000'}]}]}, {'title': 'Erythrocytes, Year 1, Week 24, n= 250', 'categories': [{'measurements': [{'value': '0.04', 'spread': '0.291', 'groupId': 'OG000'}]}]}, {'title': 'Erythrocytes, Year 1, Week 36, n= 240', 'categories': [{'measurements': [{'value': '0.03', 'spread': '0.309', 'groupId': 'OG000'}]}]}, {'title': 'Erythrocytes, Year 1, Week 48, n= 254', 'categories': [{'measurements': [{'value': '0.06', 'spread': '0.337', 'groupId': 'OG000'}]}]}, {'title': 'Erythrocytes, Year 2, Week 24, n= 249', 'categories': [{'measurements': [{'value': '0.06', 'spread': '0.341', 'groupId': 'OG000'}]}]}, {'title': 'Erythrocytes, Year 2, Week 48, n= 233', 'categories': [{'measurements': [{'value': '0.04', 'spread': '0.338', 'groupId': 'OG000'}]}]}, {'title': 'Erythrocytes, Year 3, Week 24, n= 219', 'categories': [{'measurements': [{'value': '0.06', 'spread': '0.361', 'groupId': 'OG000'}]}]}, {'title': 'Erythrocytes, Year 3, Week 48, n= 211', 'categories': [{'measurements': [{'value': '0.04', 'spread': '0.362', 'groupId': 'OG000'}]}]}, {'title': 'Erythrocytes, Year 4, Week 24, n= 210', 'categories': [{'measurements': [{'value': '0.03', 'spread': '0.37', 'groupId': 'OG000'}]}]}, {'title': 'Erythrocytes, Year 4, Week 48, n= 194', 'categories': [{'measurements': [{'value': '0.07', 'spread': '0.376', 'groupId': 'OG000'}]}]}, {'title': 'Erythrocytes, Year 5, Week 24, n= 189', 'categories': [{'measurements': [{'value': '0.08', 'spread': '0.395', 'groupId': 'OG000'}]}]}, {'title': 'Erythrocytes, Year 5, Week 48, n= 184', 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.412', 'groupId': 'OG000'}]}]}, {'title': 'Erythrocytes, Year 6, Week 24, n= 176', 'categories': [{'measurements': [{'value': '0.13', 'spread': '0.405', 'groupId': 'OG000'}]}]}, {'title': 'Erythrocytes, Year 6, Week 48, n= 132', 'categories': [{'measurements': [{'value': '0.19', 'spread': '0.393', 'groupId': 'OG000'}]}]}, {'title': 'Erythrocytes, Year 7, Week 24, n= 122', 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.438', 'groupId': 'OG000'}]}]}, {'title': 'Erythrocytes, Year 7, Week 48, n= 96', 'categories': [{'measurements': [{'value': '0.19', 'spread': '0.441', 'groupId': 'OG000'}]}]}, {'title': 'Erythrocytes, Year 8, Week 24, n= 60', 'categories': [{'measurements': [{'value': '0.25', 'spread': '0.404', 'groupId': 'OG000'}]}]}, {'title': 'Erythrocytes, Year 8, Week 48, n= 29', 'categories': [{'measurements': [{'value': '0.39', 'spread': '0.403', 'groupId': 'OG000'}]}]}, {'title': 'Erythrocytes, Year 9, Week 24, n= 2', 'categories': [{'measurements': [{'value': '0.1', 'spread': '0', 'groupId': 'OG000'}]}]}, {'title': 'Erythrocytes, Exit, n= 233', 'categories': [{'measurements': [{'value': '0.26', 'spread': '0.398', 'groupId': 'OG000'}]}]}, {'title': 'Erythrocytes, 8 Week, Follow-Up, n= 106', 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.415', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Week 440', 'description': 'Hematology parameters were assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in erythrocytes is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post- Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.', 'unitOfMeasure': 'Trillions cells per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT Population'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Hematocrit at the Indicated Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '268', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Belimumab 10 mg/kg IV', 'description': 'Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.'}], 'classes': [{'title': 'Hematocrit, Year 1, Week 4, n= 257', 'categories': [{'measurements': [{'value': '0.16', 'spread': '2.247', 'groupId': 'OG000'}]}]}, {'title': 'Hematocrit, Year 1, Week 12, n= 249', 'categories': [{'measurements': [{'value': '0.11', 'spread': '2.62', 'groupId': 'OG000'}]}]}, {'title': 'Hematocrit, Year 1, Week 24, n= 250', 'categories': [{'measurements': [{'value': '0.31', 'spread': '2.683', 'groupId': 'OG000'}]}]}, {'title': 'Hematocrit, Year 1, Week 36, n= 240', 'categories': [{'measurements': [{'value': '0.2', 'spread': '2.836', 'groupId': 'OG000'}]}]}, {'title': 'Hematocrit, Year 1, Week 48, n= 254', 'categories': [{'measurements': [{'value': '0.73', 'spread': '3.087', 'groupId': 'OG000'}]}]}, {'title': 'Hematocrit, Year 2, Week 24, n= 249', 'categories': [{'measurements': [{'value': '0.81', 'spread': '3.321', 'groupId': 'OG000'}]}]}, {'title': 'Hematocrit, Year 2, Week 48, n= 233', 'categories': [{'measurements': [{'value': '1.09', 'spread': '3.433', 'groupId': 'OG000'}]}]}, {'title': 'Hematocrit, Year 3, Week 24, n= 219', 'categories': [{'measurements': [{'value': '1.4', 'spread': '3.604', 'groupId': 'OG000'}]}]}, {'title': 'Hematocrit, Year 3, Week 48, n= 211', 'categories': [{'measurements': [{'value': '1.53', 'spread': '3.545', 'groupId': 'OG000'}]}]}, {'title': 'Hematocrit, Year 4, Week 24, n= 210', 'categories': [{'measurements': [{'value': '1.39', 'spread': '3.448', 'groupId': 'OG000'}]}]}, {'title': 'Hematocrit, Year 4, Week 48, n= 194', 'categories': [{'measurements': [{'value': '1.67', 'spread': '3.414', 'groupId': 'OG000'}]}]}, {'title': 'Hematocrit, Year 5, Week 24, n= 189', 'categories': [{'measurements': [{'value': '1.78', 'spread': '3.596', 'groupId': 'OG000'}]}]}, {'title': 'Hematocrit, Year 5, Week 48, n= 184', 'categories': [{'measurements': [{'value': '1.98', 'spread': '3.943', 'groupId': 'OG000'}]}]}, {'title': 'Hematocrit, Year 6, Week 24, n= 176', 'categories': [{'measurements': [{'value': '2.16', 'spread': '3.94', 'groupId': 'OG000'}]}]}, {'title': 'Hematocrit, Year 6, Week 48, n= 132', 'categories': [{'measurements': [{'value': '2.49', 'spread': '3.561', 'groupId': 'OG000'}]}]}, {'title': 'Hematocrit, Year 7, Week 24, n= 122', 'categories': [{'measurements': [{'value': '2.34', 'spread': '4.166', 'groupId': 'OG000'}]}]}, {'title': 'Hematocrit, Year 7, Week 48, n= 96', 'categories': [{'measurements': [{'value': '1.86', 'spread': '4.108', 'groupId': 'OG000'}]}]}, {'title': 'Hematocrit, Year 8, Week 24, n= 60', 'categories': [{'measurements': [{'value': '2.68', 'spread': '3.807', 'groupId': 'OG000'}]}]}, {'title': 'Hematocrit, Year 8, Week 48, n= 29', 'categories': [{'measurements': [{'value': '3.49', 'spread': '3.554', 'groupId': 'OG000'}]}]}, {'title': 'Hematocrit, Year 9, Week 24, n= 2', 'categories': [{'measurements': [{'value': '0.7', 'spread': '0.99', 'groupId': 'OG000'}]}]}, {'title': 'Hematocrit, Exit, n= 233', 'categories': [{'measurements': [{'value': '3.25', 'spread': '3.613', 'groupId': 'OG000'}]}]}, {'title': 'Hematocrit, 8 Week, Follow-Up, n= 106', 'categories': [{'measurements': [{'value': '3.04', 'spread': '3.478', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Week 440', 'description': 'Hematology parameters were assessed at Baseline (BL) (Day 0), Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in hematocrit is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post- Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.', 'unitOfMeasure': 'Percentage', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT Population'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Hemoglobin at the Indicated Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '268', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Belimumab 10 mg/kg IV', 'description': 'Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.'}], 'classes': [{'title': 'Hemoglobin, Year 1, Week 4, n= 257', 'categories': [{'measurements': [{'value': '0', 'spread': '7.03', 'groupId': 'OG000'}]}]}, {'title': 'Hemoglobin, Year 1, Week 12, n= 249', 'categories': [{'measurements': [{'value': '0.3', 'spread': '8.17', 'groupId': 'OG000'}]}]}, {'title': 'Hemoglobin, Year 1, Week 24, n= 250', 'categories': [{'measurements': [{'value': '0.5', 'spread': '8.81', 'groupId': 'OG000'}]}]}, {'title': 'Hemoglobin, Year 1, Week 36, n= 240', 'categories': [{'measurements': [{'value': '0.5', 'spread': '9.51', 'groupId': 'OG000'}]}]}, {'title': 'Hemoglobin, Year 1, Week 48, n= 254', 'categories': [{'measurements': [{'value': '2.1', 'spread': '10.2', 'groupId': 'OG000'}]}]}, {'title': 'Hemoglobin, Year 2, Week 24, n= 250', 'categories': [{'measurements': [{'value': '2.5', 'spread': '11.07', 'groupId': 'OG000'}]}]}, {'title': 'Hemoglobin, Year 2, Week 48, n= 233', 'categories': [{'measurements': [{'value': '2.4', 'spread': '11.76', 'groupId': 'OG000'}]}]}, {'title': 'Hemoglobin, Year 3, Week 24, n= 219', 'categories': [{'measurements': [{'value': '3.7', 'spread': '11.93', 'groupId': 'OG000'}]}]}, {'title': 'Hemoglobin, Year 3, Week 48, n= 211', 'categories': [{'measurements': [{'value': '3.9', 'spread': '11.86', 'groupId': 'OG000'}]}]}, {'title': 'Hemoglobin, Year 4, Week 24, n= 210', 'categories': [{'measurements': [{'value': '2.5', 'spread': '11.91', 'groupId': 'OG000'}]}]}, {'title': 'Hemoglobin, Year 4, Week 48, n= 194', 'categories': [{'measurements': [{'value': '3.2', 'spread': '11.82', 'groupId': 'OG000'}]}]}, {'title': 'Hemoglobin, Year 5, Week 24, n= 189', 'categories': [{'measurements': [{'value': '3.7', 'spread': '12.44', 'groupId': 'OG000'}]}]}, {'title': 'Hemoglobin, Year 5, Week 48, n= 184', 'categories': [{'measurements': [{'value': '3.7', 'spread': '13.71', 'groupId': 'OG000'}]}]}, {'title': 'Hemoglobin, Year 6, Week 24, n= 176', 'categories': [{'measurements': [{'value': '3.7', 'spread': '13.6', 'groupId': 'OG000'}]}]}, {'title': 'Hemoglobin, Year 6, Week 48, n= 132', 'categories': [{'measurements': [{'value': '4.2', 'spread': '13.13', 'groupId': 'OG000'}]}]}, {'title': 'Hemoglobin, Year 7, Week 24, n= 122', 'categories': [{'measurements': [{'value': '3.3', 'spread': '14.73', 'groupId': 'OG000'}]}]}, {'title': 'Hemoglobin, Year 7, Week 48, n= 96', 'categories': [{'measurements': [{'value': '2.6', 'spread': '14.98', 'groupId': 'OG000'}]}]}, {'title': 'Hemoglobin, Year 8, Week 24, n= 60', 'categories': [{'measurements': [{'value': '5.2', 'spread': '12.78', 'groupId': 'OG000'}]}]}, {'title': 'Hemoglobin, Year 8, Week 48, n= 29', 'categories': [{'measurements': [{'value': '8.4', 'spread': '12.98', 'groupId': 'OG000'}]}]}, {'title': 'Hemoglobin, Year 9, Week 24, n= 2', 'categories': [{'measurements': [{'value': '-3', 'spread': '2.83', 'groupId': 'OG000'}]}]}, {'title': 'Hemoglobin, Exit, n= 233', 'categories': [{'measurements': [{'value': '7.2', 'spread': '12.46', 'groupId': 'OG000'}]}]}, {'title': 'Hemoglobin, 8 Week, Follow-Up, n= 106', 'categories': [{'measurements': [{'value': '6.5', 'spread': '11.93', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Week 440', 'description': 'Hematology parameters were assessed at Baseline (BL) (Day 0), Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in hemoglobin is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post- Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.', 'unitOfMeasure': 'Grams per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT Population'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Albumin and Protein at the Indicated Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '268', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Belimumab 10 mg/kg IV', 'description': 'Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.'}], 'classes': [{'title': 'Albumin, Year 1, Week 4, n= 251', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '2.17', 'groupId': 'OG000'}]}]}, {'title': 'Albumin, Year 1, Week 12, n= 248', 'categories': [{'measurements': [{'value': '0.1', 'spread': '2.53', 'groupId': 'OG000'}]}]}, {'title': 'Albumin, Year 1, Week 24, n= 246', 'categories': [{'measurements': [{'value': '0.3', 'spread': '2.47', 'groupId': 'OG000'}]}]}, {'title': 'Albumin, Year 1, Week 36, n= 238', 'categories': [{'measurements': [{'value': '0.4', 'spread': '2.69', 'groupId': 'OG000'}]}]}, {'title': 'Albumin, Year 1, Week 48, n= 250', 'categories': [{'measurements': [{'value': '1.1', 'spread': '2.88', 'groupId': 'OG000'}]}]}, {'title': 'Albumin, Year 2, Week 24, n= 248', 'categories': [{'measurements': [{'value': '1.1', 'spread': '3.18', 'groupId': 'OG000'}]}]}, {'title': 'Albumin, Year 2, Week 48, n= 233', 'categories': [{'measurements': [{'value': '1.2', 'spread': '3.25', 'groupId': 'OG000'}]}]}, {'title': 'Albumin, Year 3, Week 24, n= 218', 'categories': [{'measurements': [{'value': '1.3', 'spread': '3.41', 'groupId': 'OG000'}]}]}, {'title': 'Albumin, Year 3, Week 48, n= 209', 'categories': [{'measurements': [{'value': '1.4', 'spread': '3.65', 'groupId': 'OG000'}]}]}, {'title': 'Albumin, Year 4, Week 24, n= 207', 'categories': [{'measurements': [{'value': '1.3', 'spread': '3.6', 'groupId': 'OG000'}]}]}, {'title': 'Albumin, Year 4, Week 48, n= 194', 'categories': [{'measurements': [{'value': '1.5', 'spread': '3.5', 'groupId': 'OG000'}]}]}, {'title': 'Albumin, Year 5, Week 24, n= 184', 'categories': [{'measurements': [{'value': '1.7', 'spread': '3.76', 'groupId': 'OG000'}]}]}, {'title': 'Albumin, Year 5, Week 48, n= 178', 'categories': [{'measurements': [{'value': '2', 'spread': '3.69', 'groupId': 'OG000'}]}]}, {'title': 'Albumin, Year 6, Week 24, n= 175', 'categories': [{'measurements': [{'value': '1.8', 'spread': '4.05', 'groupId': 'OG000'}]}]}, {'title': 'Albumin, Year 6, Week 48, n= 134', 'categories': [{'measurements': [{'value': '1.8', 'spread': '4.09', 'groupId': 'OG000'}]}]}, {'title': 'Albumin, Year 7, Week 24, n= 123', 'categories': [{'measurements': [{'value': '1.4', 'spread': '4.14', 'groupId': 'OG000'}]}]}, {'title': 'Albumin, Year 7, Week 48, n= 97', 'categories': [{'measurements': [{'value': '1.6', 'spread': '4.19', 'groupId': 'OG000'}]}]}, {'title': 'Albumin, Year 8, Week 24, n= 60', 'categories': [{'measurements': [{'value': '2', 'spread': '4.4', 'groupId': 'OG000'}]}]}, {'title': 'Albumin, Year 8, Week 48, n= 28', 'categories': [{'measurements': [{'value': '2.9', 'spread': '3.92', 'groupId': 'OG000'}]}]}, {'title': 'Albumin, Year 9, Week 24, n= 2', 'categories': [{'measurements': [{'value': '1', 'spread': '0', 'groupId': 'OG000'}]}]}, {'title': 'Albumin, Exit, n= 235', 'categories': [{'measurements': [{'value': '2.2', 'spread': '3.59', 'groupId': 'OG000'}]}]}, {'title': 'Albumin, 8 Week, Follow-Up, n= 107', 'categories': [{'measurements': [{'value': '1.8', 'spread': '3.77', 'groupId': 'OG000'}]}]}, {'title': 'Protein, Year 1, Week 4, n= 251', 'categories': [{'measurements': [{'value': '-1.3', 'spread': '3.73', 'groupId': 'OG000'}]}]}, {'title': 'Protein, Year 1, Week 12, n= 248', 'categories': [{'measurements': [{'value': '-1.9', 'spread': '4.41', 'groupId': 'OG000'}]}]}, {'title': 'Protein, Year 1, Week 24, n= 246', 'categories': [{'measurements': [{'value': '-2.1', 'spread': '4.31', 'groupId': 'OG000'}]}]}, {'title': 'Protein, Year 1, Week 36, n= 238', 'categories': [{'measurements': [{'value': '-2.6', 'spread': '4.59', 'groupId': 'OG000'}]}]}, {'title': 'Protein, Year 1, Week 48, n= 250', 'categories': [{'measurements': [{'value': '-1.8', 'spread': '4.91', 'groupId': 'OG000'}]}]}, {'title': 'Protein, Year 2, Week 24, n= 248', 'categories': [{'measurements': [{'value': '-2.2', 'spread': '4.9', 'groupId': 'OG000'}]}]}, {'title': 'Protein, Year 2, Week 48, n= 233', 'categories': [{'measurements': [{'value': '-2.6', 'spread': '5.08', 'groupId': 'OG000'}]}]}, {'title': 'Protein, Year 3, Week 24, n= 218', 'categories': [{'measurements': [{'value': '-2.6', 'spread': '5', 'groupId': 'OG000'}]}]}, {'title': 'Protein, Year 3, Week 48, n= 209', 'categories': [{'measurements': [{'value': '-3', 'spread': '5.36', 'groupId': 'OG000'}]}]}, {'title': 'Protein, Year 4, Week 24, n= 207', 'categories': [{'measurements': [{'value': '-3.4', 'spread': '5.3', 'groupId': 'OG000'}]}]}, {'title': 'Protein, Year 4, Week 48, n= 194', 'categories': [{'measurements': [{'value': '-3.6', 'spread': '5.22', 'groupId': 'OG000'}]}]}, {'title': 'Protein, Year 5, Week 24, n= 184', 'categories': [{'measurements': [{'value': '-3.4', 'spread': '5.44', 'groupId': 'OG000'}]}]}, {'title': 'Protein, Year 5, Week 48, n= 178', 'categories': [{'measurements': [{'value': '-3.4', 'spread': '5.16', 'groupId': 'OG000'}]}]}, {'title': 'Protein, Year 6, Week 24, n= 175', 'categories': [{'measurements': [{'value': '-4', 'spread': '5.55', 'groupId': 'OG000'}]}]}, {'title': 'Protein, Year 6, Week 48, n= 134', 'categories': [{'measurements': [{'value': '-3.5', 'spread': '5.81', 'groupId': 'OG000'}]}]}, {'title': 'Protein, Year 7, Week 24, n= 123', 'categories': [{'measurements': [{'value': '-4.3', 'spread': '5.56', 'groupId': 'OG000'}]}]}, {'title': 'Protein, Year 7, Week 48, n= 97', 'categories': [{'measurements': [{'value': '-4.3', 'spread': '5.87', 'groupId': 'OG000'}]}]}, {'title': 'Protein, Year 8, Week 24, n= 60', 'categories': [{'measurements': [{'value': '-4.1', 'spread': '5.78', 'groupId': 'OG000'}]}]}, {'title': 'Protein, Year 8, Week 48, n= 28', 'categories': [{'measurements': [{'value': '-3', 'spread': '5.18', 'groupId': 'OG000'}]}]}, {'title': 'Protein, Year 9, Week 24, n= 2', 'categories': [{'measurements': [{'value': '-1.5', 'spread': '2.12', 'groupId': 'OG000'}]}]}, {'title': 'Protein, Exit, n= 235', 'categories': [{'measurements': [{'value': '-2.6', 'spread': '5.53', 'groupId': 'OG000'}]}]}, {'title': 'Protein, 8 Week, Follow-Up, n= 107', 'categories': [{'measurements': [{'value': '-3.1', 'spread': '6.19', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Week 440', 'description': 'Clinical chemistry parameters were assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in albumin and protein is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post- Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.', 'unitOfMeasure': 'Grams per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT Population'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '268', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Belimumab 10 mg/kg IV', 'description': 'Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.'}], 'classes': [{'title': 'Blood urea nitrogen, Year 1, Week 4, n= 251', 'categories': [{'measurements': [{'value': '0.026', 'spread': '1.4283', 'groupId': 'OG000'}]}]}, {'title': 'Blood urea nitrogen, Year 1, Week 12, n= 248', 'categories': [{'measurements': [{'value': '-0.1695', 'spread': '1.4782', 'groupId': 'OG000'}]}]}, {'title': 'Blood urea nitrogen, Year 1, Week 24, n= 246', 'categories': [{'measurements': [{'value': '-0.1612', 'spread': '1.9011', 'groupId': 'OG000'}]}]}, {'title': 'Blood urea nitrogen, Year 1, Week 36, n= 238', 'categories': [{'measurements': [{'value': '-0.1732', 'spread': '1.5648', 'groupId': 'OG000'}]}]}, {'title': 'Blood urea nitrogen, Year 1, Week 48, n= 250', 'categories': [{'measurements': [{'value': '-0.1013', 'spread': '1.5557', 'groupId': 'OG000'}]}]}, {'title': 'Blood urea nitrogen, Year 2, Week 24, n= 248', 'categories': [{'measurements': [{'value': '-0.1873', 'spread': '1.6796', 'groupId': 'OG000'}]}]}, {'title': 'Blood urea nitrogen, Year 2, Week 48, n= 233', 'categories': [{'measurements': [{'value': '-0.0134', 'spread': '1.7024', 'groupId': 'OG000'}]}]}, {'title': 'Blood urea nitrogen, Year 3, Week 24, n= 218', 'categories': [{'measurements': [{'value': '-0.0552', 'spread': '1.7117', 'groupId': 'OG000'}]}]}, {'title': 'Blood urea nitrogen, Year 3, Week 48, n= 209', 'categories': [{'measurements': [{'value': '-0.0472', 'spread': '1.6693', 'groupId': 'OG000'}]}]}, {'title': 'Blood urea nitrogen, Year 4, Week 24, n= 207', 'categories': [{'measurements': [{'value': '-0.09', 'spread': '1.6775', 'groupId': 'OG000'}]}]}, {'title': 'Blood urea nitrogen, Year 4, Week 48, n= 194', 'categories': [{'measurements': [{'value': '-0.1162', 'spread': '1.721', 'groupId': 'OG000'}]}]}, {'title': 'Blood urea nitrogen, Year 5, Week 24, n= 184', 'categories': [{'measurements': [{'value': '-0.0331', 'spread': '1.6526', 'groupId': 'OG000'}]}]}, {'title': 'Blood urea nitrogen, Year 5, Week 48, n= 178', 'categories': [{'measurements': [{'value': '0.0176', 'spread': '1.7712', 'groupId': 'OG000'}]}]}, {'title': 'Blood urea nitrogen, Year 6, Week 24, n= 175', 'categories': [{'measurements': [{'value': '-0.0029', 'spread': '1.6054', 'groupId': 'OG000'}]}]}, {'title': 'Blood urea nitrogen, Year 6, Week 48, n= 134', 'categories': [{'measurements': [{'value': '-0.0858', 'spread': '1.6972', 'groupId': 'OG000'}]}]}, {'title': 'Blood urea nitrogen, Year 7, Week 24, n= 123', 'categories': [{'measurements': [{'value': '0.0246', 'spread': '1.6668', 'groupId': 'OG000'}]}]}, {'title': 'Blood urea nitrogen, Year 7, Week 48, n= 97', 'categories': [{'measurements': [{'value': '-0.008', 'spread': '1.6683', 'groupId': 'OG000'}]}]}, {'title': 'Blood urea nitrogen, Year 8, Week 24, n= 60', 'categories': [{'measurements': [{'value': '-0.1152', 'spread': '1.5362', 'groupId': 'OG000'}]}]}, {'title': 'Blood urea nitrogen, Year 8, Week 48, n= 28', 'categories': [{'measurements': [{'value': '-0.1603', 'spread': '1.5417', 'groupId': 'OG000'}]}]}, {'title': 'Blood urea nitrogen, Year 9, Week 24, n= 2', 'categories': [{'measurements': [{'value': '-0.1805', 'spread': '1.06', 'groupId': 'OG000'}]}]}, {'title': 'Blood urea nitrogen, Exit, n= 235', 'categories': [{'measurements': [{'value': '0.0501', 'spread': '1.7369', 'groupId': 'OG000'}]}]}, {'title': 'Blood urea nitrogen, 8 Week, Follow-Up, n= 107', 'categories': [{'measurements': [{'value': '0.3248', 'spread': '2.2109', 'groupId': 'OG000'}]}]}, {'title': 'Glucose, Year 1, Week 4, n= 251', 'categories': [{'measurements': [{'value': '0.1088', 'spread': '1.1734', 'groupId': 'OG000'}]}]}, {'title': 'Glucose, Year 1, Week 12, n= 248', 'categories': [{'measurements': [{'value': '0.2006', 'spread': '1.1712', 'groupId': 'OG000'}]}]}, {'title': 'Glucose, Year 1, Week 24, n= 246', 'categories': [{'measurements': [{'value': '0.0881', 'spread': '1.2279', 'groupId': 'OG000'}]}]}, {'title': 'Glucose, Year 1, Week 36, n= 238', 'categories': [{'measurements': [{'value': '0.2158', 'spread': '1.2519', 'groupId': 'OG000'}]}]}, {'title': 'Glucose, Year 1, Week 48, n= 250', 'categories': [{'measurements': [{'value': '0.1482', 'spread': '1.5029', 'groupId': 'OG000'}]}]}, {'title': 'Glucose, Year 2, Week 24, n= 248', 'categories': [{'measurements': [{'value': '0.1146', 'spread': '1.3072', 'groupId': 'OG000'}]}]}, {'title': 'Glucose, Year 2, Week 48, n= 233', 'categories': [{'measurements': [{'value': '0.323', 'spread': '1.5426', 'groupId': 'OG000'}]}]}, {'title': 'Glucose, Year 3, Week 24, n= 218', 'categories': [{'measurements': [{'value': '0.1927', 'spread': '1.4319', 'groupId': 'OG000'}]}]}, {'title': 'Glucose, Year 3, Week 48, n= 209', 'categories': [{'measurements': [{'value': '0.1719', 'spread': '1.4829', 'groupId': 'OG000'}]}]}, {'title': 'Glucose, Year 4, Week 24, n= 207', 'categories': [{'measurements': [{'value': '0.2737', 'spread': '1.6169', 'groupId': 'OG000'}]}]}, {'title': 'Glucose, Year 4, Week 48, n= 194', 'categories': [{'measurements': [{'value': '0.2523', 'spread': '2.1698', 'groupId': 'OG000'}]}]}, {'title': 'Glucose, Year 5, Week 24, n= 184', 'categories': [{'measurements': [{'value': '0.2579', 'spread': '1.4792', 'groupId': 'OG000'}]}]}, {'title': 'Glucose, Year 5, Week 48, n= 178', 'categories': [{'measurements': [{'value': '0.2964', 'spread': '1.7205', 'groupId': 'OG000'}]}]}, {'title': 'Glucose, Year 6, Week 24, n= 175', 'categories': [{'measurements': [{'value': '0.2903', 'spread': '1.7746', 'groupId': 'OG000'}]}]}, {'title': 'Glucose, Year 6, Week 48, n= 134', 'categories': [{'measurements': [{'value': '0.3897', 'spread': '1.7503', 'groupId': 'OG000'}]}]}, {'title': 'Glucose, Year 7, Week 24, n= 123', 'categories': [{'measurements': [{'value': '0.297', 'spread': '2.257', 'groupId': 'OG000'}]}]}, {'title': 'Glucose, Year 7, Week 48, n= 97', 'categories': [{'measurements': [{'value': '0.5098', 'spread': '1.8839', 'groupId': 'OG000'}]}]}, {'title': 'Glucose, Year 8, Week 24, n= 60', 'categories': [{'measurements': [{'value': '0.449', 'spread': '1.9609', 'groupId': 'OG000'}]}]}, {'title': 'Glucose, Year 8, Week 48, n= 28', 'categories': [{'measurements': [{'value': '0.7571', 'spread': '2.2408', 'groupId': 'OG000'}]}]}, {'title': 'Glucose, Year 9, Week 24, n= 2', 'categories': [{'measurements': [{'value': '0.8845', 'spread': '0.4094', 'groupId': 'OG000'}]}]}, {'title': 'Glucose, Exit, n= 235', 'categories': [{'measurements': [{'value': '0.2986', 'spread': '1.3871', 'groupId': 'OG000'}]}]}, {'title': 'Glucose, 8 Week, Follow-Up, n= 107', 'categories': [{'measurements': [{'value': '0.3354', 'spread': '1.4114', 'groupId': 'OG000'}]}]}, {'title': 'Calcium, Year 1, Week 4, n= 242', 'categories': [{'measurements': [{'value': '0.0071', 'spread': '0.0888', 'groupId': 'OG000'}]}]}, {'title': 'Calcium, Year 1, Week 12, n= 247', 'categories': [{'measurements': [{'value': '-0.0043', 'spread': '0.0872', 'groupId': 'OG000'}]}]}, {'title': 'Calcium, Year 1, Week 24, n= 244', 'categories': [{'measurements': [{'value': '-0.0023', 'spread': '0.0889', 'groupId': 'OG000'}]}]}, {'title': 'Calcium, Year 1, Week 36, n= 235', 'categories': [{'measurements': [{'value': '-0.0156', 'spread': '0.0884', 'groupId': 'OG000'}]}]}, {'title': 'Calcium, Year 1, Week 48, n= 250', 'categories': [{'measurements': [{'value': '0.0007', 'spread': '0.0896', 'groupId': 'OG000'}]}]}, {'title': 'Calcium, Year 2, Week 24, n= 246', 'categories': [{'measurements': [{'value': '-0.0017', 'spread': '0.0946', 'groupId': 'OG000'}]}]}, {'title': 'Calcium, Year 2, Week 48, n= 231', 'categories': [{'measurements': [{'value': '-0.0019', 'spread': '0.0922', 'groupId': 'OG000'}]}]}, {'title': 'Calcium, Year 3, Week 24, n= 214', 'categories': [{'measurements': [{'value': '-0.0009', 'spread': '0.09', 'groupId': 'OG000'}]}]}, {'title': 'Calcium, Year 3, Week 48, n= 205', 'categories': [{'measurements': [{'value': '-0.0109', 'spread': '0.1004', 'groupId': 'OG000'}]}]}, {'title': 'Calcium, Year 4, Week 24, n= 204', 'categories': [{'measurements': [{'value': '-0.0115', 'spread': '0.095', 'groupId': 'OG000'}]}]}, {'title': 'Calcium, Year 4, Week 48, n= 191', 'categories': [{'measurements': [{'value': '-0.0072', 'spread': '0.0889', 'groupId': 'OG000'}]}]}, {'title': 'Calcium, Year 5, Week 24, n= 184', 'categories': [{'measurements': [{'value': '-0.0181', 'spread': '0.0986', 'groupId': 'OG000'}]}]}, {'title': 'Calcium, Year 5, Week 48, n= 176', 'categories': [{'measurements': [{'value': '-0.0011', 'spread': '0.0912', 'groupId': 'OG000'}]}]}, {'title': 'Calcium, Year 6, Week 24, n= 172', 'categories': [{'measurements': [{'value': '-0.0107', 'spread': '0.0977', 'groupId': 'OG000'}]}]}, {'title': 'Calcium, Year 6, Week 48, n= 134', 'categories': [{'measurements': [{'value': '0.0007', 'spread': '0.0925', 'groupId': 'OG000'}]}]}, {'title': 'Calcium, Year 7, Week 24, n= 121', 'categories': [{'measurements': [{'value': '0.0014', 'spread': '0.0873', 'groupId': 'OG000'}]}]}, {'title': 'Calcium, Year 7, Week 48, n= 97', 'categories': [{'measurements': [{'value': '0.0063', 'spread': '0.0964', 'groupId': 'OG000'}]}]}, {'title': 'Calcium, Year 8, Week 24, n= 60', 'categories': [{'measurements': [{'value': '-0.0123', 'spread': '0.0788', 'groupId': 'OG000'}]}]}, {'title': 'Calcium, Year 8, Week 48, n= 28', 'categories': [{'measurements': [{'value': '0.0021', 'spread': '0.0935', 'groupId': 'OG000'}]}]}, {'title': 'Calcium, Year 9, Week 24, n= 2', 'categories': [{'measurements': [{'value': '-0.005', 'spread': '0.0354', 'groupId': 'OG000'}]}]}, {'title': 'Calcium, Exit, n= 235', 'categories': [{'measurements': [{'value': '0.0151', 'spread': '0.0923', 'groupId': 'OG000'}]}]}, {'title': 'Calcium, 8 Week, Follow-Up, n= 107', 'categories': [{'measurements': [{'value': '0.0046', 'spread': '0.1029', 'groupId': 'OG000'}]}]}, {'title': 'Carbon dioxide, Year 1, Week 4, n= 243', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '2.72', 'groupId': 'OG000'}]}]}, {'title': 'Carbon dioxide, Year 1, Week 12, n= 245', 'categories': [{'measurements': [{'value': '-0.4', 'spread': '2.62', 'groupId': 'OG000'}]}]}, {'title': 'Carbon dioxide, Year 1, Week 24, n= 244', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '2.51', 'groupId': 'OG000'}]}]}, {'title': 'Carbon dioxide, Year 1, Week 36, n= 234', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '2.67', 'groupId': 'OG000'}]}]}, {'title': 'Carbon dioxide, Year 1, Week 48, n= 250', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '2.64', 'groupId': 'OG000'}]}]}, {'title': 'Carbon dioxide, Year 2, Week 24, n= 246', 'categories': [{'measurements': [{'value': '0', 'spread': '2.58', 'groupId': 'OG000'}]}]}, {'title': 'Carbon dioxide, Year 2, Week 48, n= 231', 'categories': [{'measurements': [{'value': '-0.5', 'spread': '2.78', 'groupId': 'OG000'}]}]}, {'title': 'Carbon dioxide, Year 3, Week 24, n= 215', 'categories': [{'measurements': [{'value': '-0.5', 'spread': '2.75', 'groupId': 'OG000'}]}]}, {'title': 'Carbon dioxide, Year 3, Week 48, n= 205', 'categories': [{'measurements': [{'value': '-0.9', 'spread': '2.82', 'groupId': 'OG000'}]}]}, {'title': 'Carbon dioxide, Year 4, Week 24, n= 204', 'categories': [{'measurements': [{'value': '-0.6', 'spread': '2.7', 'groupId': 'OG000'}]}]}, {'title': 'Carbon dioxide, Year 4, Week 48, n= 191', 'categories': [{'measurements': [{'value': '-0.6', 'spread': '2.79', 'groupId': 'OG000'}]}]}, {'title': 'Carbon dioxide, Year 5, Week 24, n= 184', 'categories': [{'measurements': [{'value': '-0.9', 'spread': '2.68', 'groupId': 'OG000'}]}]}, {'title': 'Carbon dioxide, Year 5, Week 48, n= 176', 'categories': [{'measurements': [{'value': '-0.7', 'spread': '2.73', 'groupId': 'OG000'}]}]}, {'title': 'Carbon dioxide, Year 6, Week 24, n= 172', 'categories': [{'measurements': [{'value': '-0.8', 'spread': '2.62', 'groupId': 'OG000'}]}]}, {'title': 'Carbon dioxide, Year 6, Week 48, n= 134', 'categories': [{'measurements': [{'value': '-0.7', 'spread': '3.23', 'groupId': 'OG000'}]}]}, {'title': 'Carbon dioxide, Year 7, Week 24, n= 121', 'categories': [{'measurements': [{'value': '-0.7', 'spread': '2.84', 'groupId': 'OG000'}]}]}, {'title': 'Carbon dioxide, Year 7, Week 48, n= 97', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '3.14', 'groupId': 'OG000'}]}]}, {'title': 'Carbon dioxide, Year 8, Week 24, n= 60', 'categories': [{'measurements': [{'value': '-0.5', 'spread': '3.17', 'groupId': 'OG000'}]}]}, {'title': 'Carbon dioxide, Year 8, Week 48, n= 28', 'categories': [{'measurements': [{'value': '-0.7', 'spread': '2.87', 'groupId': 'OG000'}]}]}, {'title': 'Carbon dioxide, Year 9, Week 24, n= 2', 'categories': [{'measurements': [{'value': '-1', 'spread': '1.41', 'groupId': 'OG000'}]}]}, {'title': 'Carbon dioxide, Exit, n= 235', 'categories': [{'measurements': [{'value': '0.1', 'spread': '2.74', 'groupId': 'OG000'}]}]}, {'title': 'Carbon dioxide, 8 Week, Follow-Up, n= 107', 'categories': [{'measurements': [{'value': '0', 'spread': '2.55', 'groupId': 'OG000'}]}]}, {'title': 'Chloride, Year 1, Week 4, n= 251', 'categories': [{'measurements': [{'value': '0.2', 'spread': '2.8', 'groupId': 'OG000'}]}]}, {'title': 'Chloride, Year 1, Week 12, n= 248', 'categories': [{'measurements': [{'value': '0.1', 'spread': '2.53', 'groupId': 'OG000'}]}]}, {'title': 'Chloride, Year 1, Week 24, n= 246', 'categories': [{'measurements': [{'value': '0.3', 'spread': '2.31', 'groupId': 'OG000'}]}]}, {'title': 'Chloride, Year 1, Week 36, n= 238', 'categories': [{'measurements': [{'value': '0.5', 'spread': '2.43', 'groupId': 'OG000'}]}]}, {'title': 'Chloride, Year 1, Week 48, n= 250', 'categories': [{'measurements': [{'value': '0', 'spread': '2.53', 'groupId': 'OG000'}]}]}, {'title': 'Chloride, Year 2, Week 24, n= 248', 'categories': [{'measurements': [{'value': '0.1', 'spread': '2.6', 'groupId': 'OG000'}]}]}, {'title': 'Chloride, Year 2, Week 48, n= 233', 'categories': [{'measurements': [{'value': '0.1', 'spread': '3.03', 'groupId': 'OG000'}]}]}, {'title': 'Chloride, Year 3, Week 24, n= 218', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '3.01', 'groupId': 'OG000'}]}]}, {'title': 'Chloride, Year 3, Week 48, n= 209', 'categories': [{'measurements': [{'value': '0.1', 'spread': '3.06', 'groupId': 'OG000'}]}]}, {'title': 'Chloride, Year 4, Week 24, n= 207', 'categories': [{'measurements': [{'value': '-0.4', 'spread': '3.28', 'groupId': 'OG000'}]}]}, {'title': 'Chloride, Year 4, Week 48, n= 194', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '2.83', 'groupId': 'OG000'}]}]}, {'title': 'Chloride, Year 5, Week 24, n= 184', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '3.06', 'groupId': 'OG000'}]}]}, {'title': 'Chloride, Year 5, Week 48, n= 178', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '3.02', 'groupId': 'OG000'}]}]}, {'title': 'Chloride, Year 6, Week 24, n= 175', 'categories': [{'measurements': [{'value': '0', 'spread': '3.11', 'groupId': 'OG000'}]}]}, {'title': 'Chloride, Year 6, Week 48, n= 134', 'categories': [{'measurements': [{'value': '0.3', 'spread': '2.89', 'groupId': 'OG000'}]}]}, {'title': 'Chloride, Year 7, Week 24, n= 123', 'categories': [{'measurements': [{'value': '0.4', 'spread': '3.1', 'groupId': 'OG000'}]}]}, {'title': 'Chloride, Year 7, Week 48, n= 97', 'categories': [{'measurements': [{'value': '0.5', 'spread': '3.28', 'groupId': 'OG000'}]}]}, {'title': 'Chloride, Year 8, Week 24, n= 60', 'categories': [{'measurements': [{'value': '0.5', 'spread': '3.21', 'groupId': 'OG000'}]}]}, {'title': 'Chloride, Year 8, Week 48, n= 28', 'categories': [{'measurements': [{'value': '1.1', 'spread': '2.49', 'groupId': 'OG000'}]}]}, {'title': 'Chloride, Year 9, Week 24, n= 2', 'categories': [{'measurements': [{'value': '1.5', 'spread': '2.12', 'groupId': 'OG000'}]}]}, {'title': 'Chloride, Exit, n= 235', 'categories': [{'measurements': [{'value': '-0.5', 'spread': '2.96', 'groupId': 'OG000'}]}]}, {'title': 'Chloride, 8 Week, Follow-Up, n= 107', 'categories': [{'measurements': [{'value': '0.1', 'spread': '2.65', 'groupId': 'OG000'}]}]}, {'title': 'Magnesium, Year 1, Week 4, n= 251', 'categories': [{'measurements': [{'value': '0.002', 'spread': '0.0673', 'groupId': 'OG000'}]}]}, {'title': 'Magnesium, Year 1, Week 12, n= 248', 'categories': [{'measurements': [{'value': '-0.005', 'spread': '0.0625', 'groupId': 'OG000'}]}]}, {'title': 'Magnesium, Year 1, Week 24, n= 246', 'categories': [{'measurements': [{'value': '0.004', 'spread': '0.0599', 'groupId': 'OG000'}]}]}, {'title': 'Magnesium, Year 1, Week 36, n= 238', 'categories': [{'measurements': [{'value': '0.001', 'spread': '0.066', 'groupId': 'OG000'}]}]}, {'title': 'Magnesium, Year 1, Week 48, n= 250', 'categories': [{'measurements': [{'value': '0.001', 'spread': '0.0677', 'groupId': 'OG000'}]}]}, {'title': 'Magnesium, Year 2, Week 24, n= 248', 'categories': [{'measurements': [{'value': '0.003', 'spread': '0.0709', 'groupId': 'OG000'}]}]}, {'title': 'Magnesium, Year 2, Week 48, n= 233', 'categories': [{'measurements': [{'value': '0.003', 'spread': '0.0699', 'groupId': 'OG000'}]}]}, {'title': 'Magnesium, Year 3, Week 24, n= 218', 'categories': [{'measurements': [{'value': '0.007', 'spread': '0.0719', 'groupId': 'OG000'}]}]}, {'title': 'Magnesium, Year 3, Week 48, n= 209', 'categories': [{'measurements': [{'value': '0.011', 'spread': '0.0681', 'groupId': 'OG000'}]}]}, {'title': 'Magnesium, Year 4, Week 24, n= 207', 'categories': [{'measurements': [{'value': '0.009', 'spread': '0.0682', 'groupId': 'OG000'}]}]}, {'title': 'Magnesium, Year 4, Week 48, n= 194', 'categories': [{'measurements': [{'value': '0.012', 'spread': '0.0692', 'groupId': 'OG000'}]}]}, {'title': 'Magnesium, Year 5, Week 24, n= 184', 'categories': [{'measurements': [{'value': '0.017', 'spread': '0.062', 'groupId': 'OG000'}]}]}, {'title': 'Magnesium, Year 5, Week 48, n= 178', 'categories': [{'measurements': [{'value': '0.014', 'spread': '0.0622', 'groupId': 'OG000'}]}]}, {'title': 'Magnesium, Year 6, Week 24, n= 175', 'categories': [{'measurements': [{'value': '0.017', 'spread': '0.067', 'groupId': 'OG000'}]}]}, {'title': 'Magnesium, Year 6, Week 48, n= 134', 'categories': [{'measurements': [{'value': '0.003', 'spread': '0.0664', 'groupId': 'OG000'}]}]}, {'title': 'Magnesium, Year 7, Week 24, n= 123', 'categories': [{'measurements': [{'value': '0.004', 'spread': '0.0691', 'groupId': 'OG000'}]}]}, {'title': 'Magnesium, Year 7, Week 48, n= 97', 'categories': [{'measurements': [{'value': '0.001', 'spread': '0.0681', 'groupId': 'OG000'}]}]}, {'title': 'Magnesium, Year 8, Week 24, n= 60', 'categories': [{'measurements': [{'value': '-0.006', 'spread': '0.0644', 'groupId': 'OG000'}]}]}, {'title': 'Magnesium, Year 8, Week 48, n= 28', 'categories': [{'measurements': [{'value': '0.016', 'spread': '0.0599', 'groupId': 'OG000'}]}]}, {'title': 'Magnesium, Year 9, Week 24, n= 2', 'categories': [{'measurements': [{'value': '0.02', 'spread': '0.0283', 'groupId': 'OG000'}]}]}, {'title': 'Magnesium, Exit, n= 235', 'categories': [{'measurements': [{'value': '0.03', 'spread': '0.0676', 'groupId': 'OG000'}]}]}, {'title': 'Magnesium, 8 Week, Follow-Up, n= 107', 'categories': [{'measurements': [{'value': '0.028', 'spread': '0.0728', 'groupId': 'OG000'}]}]}, {'title': 'Phosphate, Year 1, Week 4, n= 251', 'categories': [{'measurements': [{'value': '0.0165', 'spread': '0.1857', 'groupId': 'OG000'}]}]}, {'title': 'Phosphate, Year 1, Week 12, n= 248', 'categories': [{'measurements': [{'value': '-0.0065', 'spread': '0.1851', 'groupId': 'OG000'}]}]}, {'title': 'Phosphate, Year 1, Week 24, n= 246', 'categories': [{'measurements': [{'value': '0.0106', 'spread': '0.2027', 'groupId': 'OG000'}]}]}, {'title': 'Phosphate, Year 1, Week 36, n= 238', 'categories': [{'measurements': [{'value': '-0.0039', 'spread': '0.1825', 'groupId': 'OG000'}]}]}, {'title': 'Phosphate, Year 1, Week 48, n= 250', 'categories': [{'measurements': [{'value': '0.0019', 'spread': '0.1926', 'groupId': 'OG000'}]}]}, {'title': 'Phosphate, Year 2, Week 24, n= 248', 'categories': [{'measurements': [{'value': '-0.0133', 'spread': '0.2219', 'groupId': 'OG000'}]}]}, {'title': 'Phosphate, Year 2, Week 48, n= 233', 'categories': [{'measurements': [{'value': '0.0099', 'spread': '0.1968', 'groupId': 'OG000'}]}]}, {'title': 'Phosphate, Year 3, Week 24, n= 218', 'categories': [{'measurements': [{'value': '0.0033', 'spread': '0.2129', 'groupId': 'OG000'}]}]}, {'title': 'Phosphate, Year 3, Week 48, n= 209', 'categories': [{'measurements': [{'value': '0.0017', 'spread': '0.221', 'groupId': 'OG000'}]}]}, {'title': 'Phosphate, Year 4, Week 24, n= 207', 'categories': [{'measurements': [{'value': '-0.0022', 'spread': '0.2145', 'groupId': 'OG000'}]}]}, {'title': 'Phosphate, Year 4, Week 48, n= 194', 'categories': [{'measurements': [{'value': '-0.0102', 'spread': '0.1765', 'groupId': 'OG000'}]}]}, {'title': 'Phosphate, Year 5, Week 24, n= 184', 'categories': [{'measurements': [{'value': '-0.015', 'spread': '0.1899', 'groupId': 'OG000'}]}]}, {'title': 'Phosphate, Year 5, Week 48, n= 178', 'categories': [{'measurements': [{'value': '-0.0035', 'spread': '0.1892', 'groupId': 'OG000'}]}]}, {'title': 'Phosphate, Year 6, Week 24, n= 175', 'categories': [{'measurements': [{'value': '-0.004', 'spread': '0.2153', 'groupId': 'OG000'}]}]}, {'title': 'Phosphate, Year 6, Week 48, n= 134', 'categories': [{'measurements': [{'value': '-0.0139', 'spread': '0.2097', 'groupId': 'OG000'}]}]}, {'title': 'Phosphate, Year 7, Week 24, n= 123', 'categories': [{'measurements': [{'value': '0.0296', 'spread': '0.1962', 'groupId': 'OG000'}]}]}, {'title': 'Phosphate, Year 7, Week 48, n= 97', 'categories': [{'measurements': [{'value': '0.031', 'spread': '0.1875', 'groupId': 'OG000'}]}]}, {'title': 'Phosphate, Year 8, Week 24, n= 60', 'categories': [{'measurements': [{'value': '-0.0223', 'spread': '0.2186', 'groupId': 'OG000'}]}]}, {'title': 'Phosphate, Year 8, Week 48, n= 28', 'categories': [{'measurements': [{'value': '-0.0054', 'spread': '0.2093', 'groupId': 'OG000'}]}]}, {'title': 'Phosphate, Year 9, Week 24, n= 2', 'categories': [{'measurements': [{'value': '0.1467', 'spread': '0.1893', 'groupId': 'OG000'}]}]}, {'title': 'Phosphate, Exit, n= 235', 'categories': [{'measurements': [{'value': '0.0161', 'spread': '0.2151', 'groupId': 'OG000'}]}]}, {'title': 'Phosphate, 8 Week, Follow-Up, n= 107', 'categories': [{'measurements': [{'value': '0.0438', 'spread': '0.2131', 'groupId': 'OG000'}]}]}, {'title': 'Potassium, Year 1, Week 4, n= 242', 'categories': [{'measurements': [{'value': '0.07', 'spread': '0.407', 'groupId': 'OG000'}]}]}, {'title': 'Potassium, Year 1, Week 12, n= 245', 'categories': [{'measurements': [{'value': '0.02', 'spread': '0.412', 'groupId': 'OG000'}]}]}, {'title': 'Potassium, Year 1, Week 24, n= 244', 'categories': [{'measurements': [{'value': '0.02', 'spread': '0.409', 'groupId': 'OG000'}]}]}, {'title': 'Potassium, Year 1, Week 36, n= 234', 'categories': [{'measurements': [{'value': '0.03', 'spread': '0.427', 'groupId': 'OG000'}]}]}, {'title': 'Potassium, Year 1, Week 48, n= 250', 'categories': [{'measurements': [{'value': '-0.04', 'spread': '0.413', 'groupId': 'OG000'}]}]}, {'title': 'Potassium, Year 2, Week 24, n= 246', 'categories': [{'measurements': [{'value': '0.01', 'spread': '0.42', 'groupId': 'OG000'}]}]}, {'title': 'Potassium, Year 2, Week 48, n= 231', 'categories': [{'measurements': [{'value': '0.02', 'spread': '0.426', 'groupId': 'OG000'}]}]}, {'title': 'Potassium, Year 3, Week 24, n= 215', 'categories': [{'measurements': [{'value': '0.01', 'spread': '0.418', 'groupId': 'OG000'}]}]}, {'title': 'Potassium, Year 3, Week 48, n= 205', 'categories': [{'measurements': [{'value': '0.01', 'spread': '0.466', 'groupId': 'OG000'}]}]}, {'title': 'Potassium, Year 4, Week 24, n= 204', 'categories': [{'measurements': [{'value': '-0.02', 'spread': '0.409', 'groupId': 'OG000'}]}]}, {'title': 'Potassium, Year 4, Week 48, n= 191', 'categories': [{'measurements': [{'value': '0.04', 'spread': '0.417', 'groupId': 'OG000'}]}]}, {'title': 'Potassium, Year 5, Week 24, n= 184', 'categories': [{'measurements': [{'value': '0', 'spread': '0.406', 'groupId': 'OG000'}]}]}, {'title': 'Potassium, Year 5, Week 48, n= 176', 'categories': [{'measurements': [{'value': '0.06', 'spread': '0.427', 'groupId': 'OG000'}]}]}, {'title': 'Potassium, Year 6, Week 24, n= 172', 'categories': [{'measurements': [{'value': '-0.03', 'spread': '0.431', 'groupId': 'OG000'}]}]}, {'title': 'Potassium, Year 6, Week 48, n= 134', 'categories': [{'measurements': [{'value': '0.06', 'spread': '0.438', 'groupId': 'OG000'}]}]}, {'title': 'Potassium, Year 7, Week 24, n= 121', 'categories': [{'measurements': [{'value': '0.04', 'spread': '0.379', 'groupId': 'OG000'}]}]}, {'title': 'Potassium, Year 7, Week 48, n= 97', 'categories': [{'measurements': [{'value': '0.06', 'spread': '0.387', 'groupId': 'OG000'}]}]}, {'title': 'Potassium, Year 8, Week 24, n= 60', 'categories': [{'measurements': [{'value': '0', 'spread': '0.354', 'groupId': 'OG000'}]}]}, {'title': 'Potassium, Year 8, Week 48, n= 28', 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.401', 'groupId': 'OG000'}]}]}, {'title': 'Potassium, Year 9, Week 24, n= 2', 'categories': [{'measurements': [{'value': '0.05', 'spread': '0.212', 'groupId': 'OG000'}]}]}, {'title': 'Potassium, Exit, n= 235', 'categories': [{'measurements': [{'value': '0.11', 'spread': '0.431', 'groupId': 'OG000'}]}]}, {'title': 'Potassium, 8 Week, Follow-Up, n= 107', 'categories': [{'measurements': [{'value': '0.07', 'spread': '0.493', 'groupId': 'OG000'}]}]}, {'title': 'Sodium, Year 1, Week 4, n= 251', 'categories': [{'measurements': [{'value': '0.4', 'spread': '2.67', 'groupId': 'OG000'}]}]}, {'title': 'Sodium, Year 1, Week 12, n= 248', 'categories': [{'measurements': [{'value': '0', 'spread': '2.67', 'groupId': 'OG000'}]}]}, {'title': 'Sodium, Year 1, Week 24, n= 246', 'categories': [{'measurements': [{'value': '0.3', 'spread': '2.02', 'groupId': 'OG000'}]}]}, {'title': 'Sodium, Year 1, Week 36, n= 238', 'categories': [{'measurements': [{'value': '0.3', 'spread': '2.46', 'groupId': 'OG000'}]}]}, {'title': 'Sodium, Year 1, Week 48, n= 250', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '2.06', 'groupId': 'OG000'}]}]}, {'title': 'Sodium, Year 2, Week 24, n= 248', 'categories': [{'measurements': [{'value': '0', 'spread': '2.19', 'groupId': 'OG000'}]}]}, {'title': 'Sodium, Year 2, Week 48, n= 233', 'categories': [{'measurements': [{'value': '0', 'spread': '2.58', 'groupId': 'OG000'}]}]}, {'title': 'Sodium, Year 3, Week 24, n= 218', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '2.18', 'groupId': 'OG000'}]}]}, {'title': 'Sodium, Year 3, Week 48, n= 209', 'categories': [{'measurements': [{'value': '0.4', 'spread': '2.44', 'groupId': 'OG000'}]}]}, {'title': 'Sodium, Year 4, Week 24, n= 207', 'categories': [{'measurements': [{'value': '0.2', 'spread': '2.54', 'groupId': 'OG000'}]}]}, {'title': 'Sodium, Year 4, Week 48, n= 194', 'categories': [{'measurements': [{'value': '0.1', 'spread': '2.36', 'groupId': 'OG000'}]}]}, {'title': 'Sodium, Year 5, Week 24, n= 184', 'categories': [{'measurements': [{'value': '0.1', 'spread': '2.19', 'groupId': 'OG000'}]}]}, {'title': 'Sodium, Year 5, Week 48, n= 178', 'categories': [{'measurements': [{'value': '0', 'spread': '2.37', 'groupId': 'OG000'}]}]}, {'title': 'Sodium, Year 6, Week 24, n= 175', 'categories': [{'measurements': [{'value': '0.1', 'spread': '2.33', 'groupId': 'OG000'}]}]}, {'title': 'Sodium, Year 6, Week 48, n= 134', 'categories': [{'measurements': [{'value': '0.3', 'spread': '2.72', 'groupId': 'OG000'}]}]}, {'title': 'Sodium, Year 7, Week 24, n= 123', 'categories': [{'measurements': [{'value': '0.3', 'spread': '2.97', 'groupId': 'OG000'}]}]}, {'title': 'Sodium, Year 7, Week 48, n= 97', 'categories': [{'measurements': [{'value': '0.3', 'spread': '2.49', 'groupId': 'OG000'}]}]}, {'title': 'Sodium, Year 8, Week 24, n= 60', 'categories': [{'measurements': [{'value': '0.2', 'spread': '2.32', 'groupId': 'OG000'}]}]}, {'title': 'Sodium, Year 8, Week 48, n= 28', 'categories': [{'measurements': [{'value': '0.4', 'spread': '1.95', 'groupId': 'OG000'}]}]}, {'title': 'Sodium, Year 9, Week 24, n= 2', 'categories': [{'measurements': [{'value': '-1', 'spread': '1.41', 'groupId': 'OG000'}]}]}, {'title': 'Sodium, Exit, n= 235', 'categories': [{'measurements': [{'value': '0.1', 'spread': '2.32', 'groupId': 'OG000'}]}]}, {'title': 'Sodium, 8 Week, Follow-Up, n= 107', 'categories': [{'measurements': [{'value': '0.8', 'spread': '2.33', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Week 440', 'description': 'Clinical chemistry parameters were assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in blood urea nitrogen, glucose, calcium, carbon dioxide, chloride, magnesium, phosphate, potassium and sodium is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post- Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.', 'unitOfMeasure': 'Millimoles per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT Population'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '268', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Belimumab 10 mg/kg IV', 'description': 'Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.'}], 'classes': [{'title': 'Creatinine, Year 1, Week 4, n= 250', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '4.69', 'groupId': 'OG000'}]}]}, {'title': 'Creatinine, Year 1, Week 12, n= 248', 'categories': [{'measurements': [{'value': '-0.5', 'spread': '4.86', 'groupId': 'OG000'}]}]}, {'title': 'Creatinine, Year 1, Week 24, n= 246', 'categories': [{'measurements': [{'value': '-0.6', 'spread': '5.31', 'groupId': 'OG000'}]}]}, {'title': 'Creatinine, Year 1, Week 36, n= 237', 'categories': [{'measurements': [{'value': '-0.4', 'spread': '5.07', 'groupId': 'OG000'}]}]}, {'title': 'Creatinine, Year 1, Week 48, n= 250', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '5.29', 'groupId': 'OG000'}]}]}, {'title': 'Creatinine, Year 2, Week 24, n= 248', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '5.76', 'groupId': 'OG000'}]}]}, {'title': 'Creatinine, Year 2, Week 48, n= 233', 'categories': [{'measurements': [{'value': '0.3', 'spread': '4.78', 'groupId': 'OG000'}]}]}, {'title': 'Creatinine, Year 3, Week 24, n= 218', 'categories': [{'measurements': [{'value': '0.8', 'spread': '5.63', 'groupId': 'OG000'}]}]}, {'title': 'Creatinine, Year 3, Week 48, n= 209', 'categories': [{'measurements': [{'value': '0.9', 'spread': '5.61', 'groupId': 'OG000'}]}]}, {'title': 'Creatinine, Year 4, Week 24, n= 207', 'categories': [{'measurements': [{'value': '1.2', 'spread': '5.86', 'groupId': 'OG000'}]}]}, {'title': 'Creatinine, Year 4, Week 48, n= 194', 'categories': [{'measurements': [{'value': '0.9', 'spread': '6.05', 'groupId': 'OG000'}]}]}, {'title': 'Creatinine, Year 5, Week 24, n= 184', 'categories': [{'measurements': [{'value': '1', 'spread': '5.52', 'groupId': 'OG000'}]}]}, {'title': 'Creatinine, Year 5, Week 48, n= 178', 'categories': [{'measurements': [{'value': '1.2', 'spread': '6.49', 'groupId': 'OG000'}]}]}, {'title': 'Creatinine, Year 6, Week 24, n= 175', 'categories': [{'measurements': [{'value': '1.2', 'spread': '5.79', 'groupId': 'OG000'}]}]}, {'title': 'Creatinine, Year 6, Week 48, n= 134', 'categories': [{'measurements': [{'value': '1', 'spread': '6.38', 'groupId': 'OG000'}]}]}, {'title': 'Creatinine, Year 7, Week 24, n= 123', 'categories': [{'measurements': [{'value': '1.1', 'spread': '5.75', 'groupId': 'OG000'}]}]}, {'title': 'Creatinine, Year 7, Week 48, n= 97', 'categories': [{'measurements': [{'value': '0.7', 'spread': '5.42', 'groupId': 'OG000'}]}]}, {'title': 'Creatinine, Year 8, Week 24, n= 60', 'categories': [{'measurements': [{'value': '0.8', 'spread': '5.09', 'groupId': 'OG000'}]}]}, {'title': 'Creatinine, Year 8, Week 48, n= 28', 'categories': [{'measurements': [{'value': '0.4', 'spread': '5.28', 'groupId': 'OG000'}]}]}, {'title': 'Creatinine, Year 9, Week 24, n= 2', 'categories': [{'measurements': [{'value': '-0.5', 'spread': '0.71', 'groupId': 'OG000'}]}]}, {'title': 'Creatinine, Exit, n= 235', 'categories': [{'measurements': [{'value': '1.1', 'spread': '5.57', 'groupId': 'OG000'}]}]}, {'title': 'Creatinine, 8 Week, Follow-Up, n= 107', 'categories': [{'measurements': [{'value': '1.3', 'spread': '5.99', 'groupId': 'OG000'}]}]}, {'title': 'Urate, Year 1, Week 4, n= 251', 'categories': [{'measurements': [{'value': '-1.653', 'spread': '46.0197', 'groupId': 'OG000'}]}]}, {'title': 'Urate, Year 1, Week 12, n= 248', 'categories': [{'measurements': [{'value': '-5.5803', 'spread': '52.2256', 'groupId': 'OG000'}]}]}, {'title': 'Urate, Year 1, Week 24, n= 246', 'categories': [{'measurements': [{'value': '-11.6488', 'spread': '55.2277', 'groupId': 'OG000'}]}]}, {'title': 'Urate, Year 1, Week 36, n= 238', 'categories': [{'measurements': [{'value': '-9.984', 'spread': '57.2999', 'groupId': 'OG000'}]}]}, {'title': 'Urate, Year 1, Week 48, n= 250', 'categories': [{'measurements': [{'value': '-4.108', 'spread': '58.0533', 'groupId': 'OG000'}]}]}, {'title': 'Urate, Year 2, Week 24, n= 248', 'categories': [{'measurements': [{'value': '-6.4785', 'spread': '57.0915', 'groupId': 'OG000'}]}]}, {'title': 'Urate, Year 2, Week 48, n= 233', 'categories': [{'measurements': [{'value': '-4.6501', 'spread': '60.3008', 'groupId': 'OG000'}]}]}, {'title': 'Urate, Year 3, Week 24, n= 218', 'categories': [{'measurements': [{'value': '1.6919', 'spread': '63.7367', 'groupId': 'OG000'}]}]}, {'title': 'Urate, Year 3, Week 48, n= 209', 'categories': [{'measurements': [{'value': '-4.5543', 'spread': '66.183', 'groupId': 'OG000'}]}]}, {'title': 'Urate, Year 4, Week 24, n= 207', 'categories': [{'measurements': [{'value': '-4.8112', 'spread': '60.2771', 'groupId': 'OG000'}]}]}, {'title': 'Urate, Year 4, Week 48, n= 194', 'categories': [{'measurements': [{'value': '-2.0736', 'spread': '60.7226', 'groupId': 'OG000'}]}]}, {'title': 'Urate, Year 5, Week 24, n= 184', 'categories': [{'measurements': [{'value': '-5.296', 'spread': '65.2308', 'groupId': 'OG000'}]}]}, {'title': 'Urate, Year 5, Week 48, n= 178', 'categories': [{'measurements': [{'value': '-5.7908', 'spread': '65.6118', 'groupId': 'OG000'}]}]}, {'title': 'Urate, Year 6, Week 24, n= 175', 'categories': [{'measurements': [{'value': '-2.084', 'spread': '73.3489', 'groupId': 'OG000'}]}]}, {'title': 'Urate, Year 6, Week 48, n= 134', 'categories': [{'measurements': [{'value': '-8.7672', 'spread': '74.9078', 'groupId': 'OG000'}]}]}, {'title': 'Urate, Year 7, Week 24, n= 123', 'categories': [{'measurements': [{'value': '-2.0775', 'spread': '72.282', 'groupId': 'OG000'}]}]}, {'title': 'Urate, Year 7, Week 48, n= 97', 'categories': [{'measurements': [{'value': '-0.1021', 'spread': '60.8139', 'groupId': 'OG000'}]}]}, {'title': 'Urate, Year 8, Week 24, n= 60', 'categories': [{'measurements': [{'value': '2.0387', 'spread': '66.4246', 'groupId': 'OG000'}]}]}, {'title': 'Urate, Year 8, Week 48, n= 28', 'categories': [{'measurements': [{'value': '1.1266', 'spread': '62.7192', 'groupId': 'OG000'}]}]}, {'title': 'Urate, Year 9, Week 24, n= 2', 'categories': [{'measurements': [{'value': '-1.782', 'spread': '16.402', 'groupId': 'OG000'}]}]}, {'title': 'Urate, Exit, n= 235', 'categories': [{'measurements': [{'value': '-7.3728', 'spread': '71.4811', 'groupId': 'OG000'}]}]}, {'title': 'Urate, 8 Week, Follow-Up, n= 107', 'categories': [{'measurements': [{'value': '-6.6934', 'spread': '84.8414', 'groupId': 'OG000'}]}]}, {'title': 'Bilirubin, Year 1, Week 4, n= 251', 'categories': [{'measurements': [{'value': '0.008', 'spread': '2.0889', 'groupId': 'OG000'}]}]}, {'title': 'Bilirubin, Year 1, Week 12, n= 248', 'categories': [{'measurements': [{'value': '0.165', 'spread': '2.4872', 'groupId': 'OG000'}]}]}, {'title': 'Bilirubin, Year 1, Week 24, n= 246', 'categories': [{'measurements': [{'value': '0.075', 'spread': '2.2546', 'groupId': 'OG000'}]}]}, {'title': 'Bilirubin, Year 1, Week 36, n= 238', 'categories': [{'measurements': [{'value': '0.124', 'spread': '2.4316', 'groupId': 'OG000'}]}]}, {'title': 'Bilirubin, Year 1, Week 48, n= 250', 'categories': [{'measurements': [{'value': '0.231', 'spread': '2.3675', 'groupId': 'OG000'}]}]}, {'title': 'Bilirubin, Year 2, Week 24, n= 248', 'categories': [{'measurements': [{'value': '0.359', 'spread': '2.7306', 'groupId': 'OG000'}]}]}, {'title': 'Bilirubin, Year 2, Week 48, n= 233', 'categories': [{'measurements': [{'value': '0.307', 'spread': '3.0385', 'groupId': 'OG000'}]}]}, {'title': 'Bilirubin, Year 3, Week 24, n= 218', 'categories': [{'measurements': [{'value': '0.249', 'spread': '2.8298', 'groupId': 'OG000'}]}]}, {'title': 'Bilirubin, Year 3, Week 48, n= 209', 'categories': [{'measurements': [{'value': '-0.115', 'spread': '2.548', 'groupId': 'OG000'}]}]}, {'title': 'Bilirubin, Year 4, Week 24, n= 207', 'categories': [{'measurements': [{'value': '-0.276', 'spread': '2.6718', 'groupId': 'OG000'}]}]}, {'title': 'Bilirubin, Year 4, Week 48, n= 194', 'categories': [{'measurements': [{'value': '-0.156', 'spread': '2.823', 'groupId': 'OG000'}]}]}, {'title': 'Bilirubin, Year 5, Week 24, n= 184', 'categories': [{'measurements': [{'value': '-0.147', 'spread': '2.8668', 'groupId': 'OG000'}]}]}, {'title': 'Bilirubin, Year 5, Week 48, n= 178', 'categories': [{'measurements': [{'value': '0.13', 'spread': '2.7449', 'groupId': 'OG000'}]}]}, {'title': 'Bilirubin, Year 6, Week 24, n= 175', 'categories': [{'measurements': [{'value': '-0.067', 'spread': '2.7954', 'groupId': 'OG000'}]}]}, {'title': 'Bilirubin, Year 6, Week 48, n= 134', 'categories': [{'measurements': [{'value': '0.268', 'spread': '2.6834', 'groupId': 'OG000'}]}]}, {'title': 'Bilirubin, Year 7, Week 24, n= 123', 'categories': [{'measurements': [{'value': '-0.071', 'spread': '2.7018', 'groupId': 'OG000'}]}]}, {'title': 'Bilirubin, Year 7, Week 48, n= 97', 'categories': [{'measurements': [{'value': '0.285', 'spread': '2.85', 'groupId': 'OG000'}]}]}, {'title': 'Bilirubin, Year 8, Week 24, n= 60', 'categories': [{'measurements': [{'value': '0.529', 'spread': '2.8249', 'groupId': 'OG000'}]}]}, {'title': 'Bilirubin, Year 8, Week 48, n= 28', 'categories': [{'measurements': [{'value': '0.175', 'spread': '2.4435', 'groupId': 'OG000'}]}]}, {'title': 'Bilirubin, Year 9, Week 24, n= 2', 'categories': [{'measurements': [{'value': '-0.45', 'spread': '1.4142', 'groupId': 'OG000'}]}]}, {'title': 'Bilirubin, Exit, n= 235', 'categories': [{'measurements': [{'value': '0.403', 'spread': '2.8268', 'groupId': 'OG000'}]}]}, {'title': 'Bilirubin, 8 Week, Follow-Up, n= 107', 'categories': [{'measurements': [{'value': '-0.191', 'spread': '3.2759', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Week 440', 'description': 'Clinical chemistry parameters were assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in urate, creatinine and bilirubin is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post- Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.', 'unitOfMeasure': 'Micromoles per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT Population'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Creatinine Clearance at the Indicated Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '268', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Belimumab 10 mg/kg IV', 'description': 'Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.'}], 'classes': [{'title': 'Creatinine clearance, Year 1, Week 4, n= 251', 'categories': [{'measurements': [{'value': '-0.022', 'spread': '0.2312', 'groupId': 'OG000'}]}]}, {'title': 'Creatinine clearance, Year 1, Week 12, n= 248', 'categories': [{'measurements': [{'value': '0.01', 'spread': '0.2455', 'groupId': 'OG000'}]}]}, {'title': 'Creatinine clearance, Year 1, Week 24, n= 246', 'categories': [{'measurements': [{'value': '0.028', 'spread': '0.2831', 'groupId': 'OG000'}]}]}, {'title': 'Creatinine clearance, Year 1, Week 36, n= 238', 'categories': [{'measurements': [{'value': '0.034', 'spread': '0.3083', 'groupId': 'OG000'}]}]}, {'title': 'Creatinine clearance, Year 1, Week 48, n= 250', 'categories': [{'measurements': [{'value': '0.017', 'spread': '0.306', 'groupId': 'OG000'}]}]}, {'title': 'Creatinine clearance, Year 2, Week 24, n= 248', 'categories': [{'measurements': [{'value': '0.047', 'spread': '0.3145', 'groupId': 'OG000'}]}]}, {'title': 'Creatinine clearance, Year 2, Week 48, n= 233', 'categories': [{'measurements': [{'value': '0.04', 'spread': '0.3498', 'groupId': 'OG000'}]}]}, {'title': 'Creatinine clearance, Year 3, Week 24, n= 218', 'categories': [{'measurements': [{'value': '0.093', 'spread': '0.38', 'groupId': 'OG000'}]}]}, {'title': 'Creatinine clearance, Year 3, Week 48, n= 209', 'categories': [{'measurements': [{'value': '0.093', 'spread': '0.3784', 'groupId': 'OG000'}]}]}, {'title': 'Creatinine clearance, Year 4, Week 24, n= 207', 'categories': [{'measurements': [{'value': '0.13', 'spread': '0.3981', 'groupId': 'OG000'}]}]}, {'title': 'Creatinine clearance, Year 4, Week 48, n= 194', 'categories': [{'measurements': [{'value': '0.084', 'spread': '0.3628', 'groupId': 'OG000'}]}]}, {'title': 'Creatinine clearance, Year 5, Week 24, n= 184', 'categories': [{'measurements': [{'value': '0.087', 'spread': '0.3724', 'groupId': 'OG000'}]}]}, {'title': 'Creatinine clearance, Year 5, Week 48, n= 178', 'categories': [{'measurements': [{'value': '0.04', 'spread': '0.3652', 'groupId': 'OG000'}]}]}, {'title': 'Creatinine clearance, Year 6, Week 24, n= 175', 'categories': [{'measurements': [{'value': '0.035', 'spread': '0.3971', 'groupId': 'OG000'}]}]}, {'title': 'Creatinine clearance, Year 6, Week 48, n= 134', 'categories': [{'measurements': [{'value': '0.039', 'spread': '0.3985', 'groupId': 'OG000'}]}]}, {'title': 'Creatinine clearance, Year 7, Week 24, n= 123', 'categories': [{'measurements': [{'value': '-0.007', 'spread': '0.4482', 'groupId': 'OG000'}]}]}, {'title': 'Creatinine clearance, Year 7, Week 48, n= 97', 'categories': [{'measurements': [{'value': '0.005', 'spread': '0.4424', 'groupId': 'OG000'}]}]}, {'title': 'Creatinine clearance, Year 8, Week 24, n= 60', 'categories': [{'measurements': [{'value': '-0.018', 'spread': '0.4682', 'groupId': 'OG000'}]}]}, {'title': 'Creatinine clearance, Year 8, Week 48, n= 28', 'categories': [{'measurements': [{'value': '-0.042', 'spread': '0.2808', 'groupId': 'OG000'}]}]}, {'title': 'Creatinine clearance, Year 9, Week 24, n= 2', 'categories': [{'measurements': [{'value': '-0.083', 'spread': '0.165', 'groupId': 'OG000'}]}]}, {'title': 'Creatinine clearance, Exit, n= 235', 'categories': [{'measurements': [{'value': '0.011', 'spread': '0.3986', 'groupId': 'OG000'}]}]}, {'title': 'Creatinine clearance, 8 Week, Follow-Up, n= 106', 'categories': [{'measurements': [{'value': '0.036', 'spread': '0.3467', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Week 440', 'description': 'Clinical chemistry parameters were assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in creatinine clearance is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post- Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.', 'unitOfMeasure': 'Milliliters per second', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT Population'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in BUN/Creatinine at the Indicated Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '268', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Belimumab 10 mg/kg IV', 'description': 'Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.'}], 'classes': [{'title': 'BUN/creatinine, Year 1, Week 4, n= 251', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '4.69', 'groupId': 'OG000'}]}]}, {'title': 'BUN/creatinine, Year 1, Week 12, n= 248', 'categories': [{'measurements': [{'value': '-0.5', 'spread': '4.86', 'groupId': 'OG000'}]}]}, {'title': 'BUN/creatinine, Year 1, Week 24, n= 246', 'categories': [{'measurements': [{'value': '-0.6', 'spread': '5.31', 'groupId': 'OG000'}]}]}, {'title': 'BUN/creatinine, Year 1, Week 36, n= 238', 'categories': [{'measurements': [{'value': '-0.4', 'spread': '5.07', 'groupId': 'OG000'}]}]}, {'title': 'BUN/creatinine, Year 1, Week 48, n= 250', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '5.29', 'groupId': 'OG000'}]}]}, {'title': 'BUN/creatinine, Year 2, Week 24, n= 248', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '5.76', 'groupId': 'OG000'}]}]}, {'title': 'BUN/creatinine, Year 2, Week 48, n= 233', 'categories': [{'measurements': [{'value': '0.3', 'spread': '4.78', 'groupId': 'OG000'}]}]}, {'title': 'BUN/creatinine, Year 3, Week 24, n= 218', 'categories': [{'measurements': [{'value': '0.8', 'spread': '5.63', 'groupId': 'OG000'}]}]}, {'title': 'BUN/creatinine, Year 3, Week 48, n= 209', 'categories': [{'measurements': [{'value': '0.9', 'spread': '5.61', 'groupId': 'OG000'}]}]}, {'title': 'BUN/creatinine, Year 4, Week 24, n= 207', 'categories': [{'measurements': [{'value': '1.2', 'spread': '5.86', 'groupId': 'OG000'}]}]}, {'title': 'BUN/creatinine, Year 4, Week 48, n= 194', 'categories': [{'measurements': [{'value': '0.9', 'spread': '6.05', 'groupId': 'OG000'}]}]}, {'title': 'BUN/creatinine, Year 5, Week 24, n= 184', 'categories': [{'measurements': [{'value': '1', 'spread': '5.52', 'groupId': 'OG000'}]}]}, {'title': 'BUN/creatinine, Year 5, Week 48, n= 178', 'categories': [{'measurements': [{'value': '1.2', 'spread': '6.49', 'groupId': 'OG000'}]}]}, {'title': 'BUN/creatinine, Year 6, Week 24, n= 175', 'categories': [{'measurements': [{'value': '1.2', 'spread': '5.79', 'groupId': 'OG000'}]}]}, {'title': 'BUN/creatinine, Year 6, Week 48, n= 134', 'categories': [{'measurements': [{'value': '1', 'spread': '6.38', 'groupId': 'OG000'}]}]}, {'title': 'BUN/creatinine, Year 7, Week 24, n= 123', 'categories': [{'measurements': [{'value': '1.1', 'spread': '5.75', 'groupId': 'OG000'}]}]}, {'title': 'BUN/creatinine, Year 7, Week 48, n= 97', 'categories': [{'measurements': [{'value': '0.7', 'spread': '5.42', 'groupId': 'OG000'}]}]}, {'title': 'BUN/creatinine, Year 8, Week 24, n= 60', 'categories': [{'measurements': [{'value': '0.8', 'spread': '5.09', 'groupId': 'OG000'}]}]}, {'title': 'BUN/creatinine, Year 8, Week 48, n= 28', 'categories': [{'measurements': [{'value': '0.4', 'spread': '5.28', 'groupId': 'OG000'}]}]}, {'title': 'BUN/creatinine, Year 9, Week 24, n= 2', 'categories': [{'measurements': [{'value': '-0.5', 'spread': '0.71', 'groupId': 'OG000'}]}]}, {'title': 'BUN/creatinine, Exit, n= 235', 'categories': [{'measurements': [{'value': '1.1', 'spread': '5.57', 'groupId': 'OG000'}]}]}, {'title': 'BUN/creatinine, 8 Week, Follow-Up, n= 107', 'categories': [{'measurements': [{'value': '1.3', 'spread': '5.99', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Week 440', 'description': 'Clinical chemistry parameters were assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in BUN/creatinine is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post- Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT Population'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '268', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Belimumab 10 mg/kg IV', 'description': 'Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.'}], 'classes': [{'title': 'Alanine aminotransferase, Year 1, Week 4, n= 251', 'categories': [{'measurements': [{'value': '0.5', 'spread': '14.89', 'groupId': 'OG000'}]}]}, {'title': 'Alanine aminotransferase, Year 1, Week 12, n= 248', 'categories': [{'measurements': [{'value': '-0.5', 'spread': '11.01', 'groupId': 'OG000'}]}]}, {'title': 'Alanine aminotransferase, Year 1, Week 24, n= 246', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '12.27', 'groupId': 'OG000'}]}]}, {'title': 'Alanine aminotransferase, Year 1, Week 36, n= 238', 'categories': [{'measurements': [{'value': '0.3', 'spread': '14.12', 'groupId': 'OG000'}]}]}, {'title': 'Alanine aminotransferase, Year 1, Week 48, n= 250', 'categories': [{'measurements': [{'value': '0.4', 'spread': '14.64', 'groupId': 'OG000'}]}]}, {'title': 'Alanine aminotransferase, Year 2, Week 24, n= 248', 'categories': [{'measurements': [{'value': '0.8', 'spread': '12.33', 'groupId': 'OG000'}]}]}, {'title': 'Alanine aminotransferase, Year 2, Week 48, n= 233', 'categories': [{'measurements': [{'value': '1.7', 'spread': '16.67', 'groupId': 'OG000'}]}]}, {'title': 'Alanine aminotransferase, Year 3, Week 24, n= 218', 'categories': [{'measurements': [{'value': '0.9', 'spread': '12.32', 'groupId': 'OG000'}]}]}, {'title': 'Alanine aminotransferase, Year 3, Week 48, n= 209', 'categories': [{'measurements': [{'value': '0.4', 'spread': '14.93', 'groupId': 'OG000'}]}]}, {'title': 'Alanine aminotransferase, Year 4, Week 24, n= 207', 'categories': [{'measurements': [{'value': '1.7', 'spread': '17.02', 'groupId': 'OG000'}]}]}, {'title': 'Alanine aminotransferase, Year 4, Week 48, n= 194', 'categories': [{'measurements': [{'value': '2.4', 'spread': '24.4', 'groupId': 'OG000'}]}]}, {'title': 'Alanine aminotransferase, Year 5, Week 24, n= 184', 'categories': [{'measurements': [{'value': '1.8', 'spread': '15.79', 'groupId': 'OG000'}]}]}, {'title': 'Alanine aminotransferase, Year 5, Week 48, n= 178', 'categories': [{'measurements': [{'value': '0.3', 'spread': '17.15', 'groupId': 'OG000'}]}]}, {'title': 'Alanine aminotransferase, Year 6, Week 24, n= 175', 'categories': [{'measurements': [{'value': '1', 'spread': '20.87', 'groupId': 'OG000'}]}]}, {'title': 'Alanine aminotransferase, Year 6, Week 48, n= 134', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '13.25', 'groupId': 'OG000'}]}]}, {'title': 'Alanine aminotransferase, Year 7, Week 24, n= 123', 'categories': [{'measurements': [{'value': '-2.8', 'spread': '13.96', 'groupId': 'OG000'}]}]}, {'title': 'Alanine aminotransferase, Year 7, Week 48, n= 97', 'categories': [{'measurements': [{'value': '-2.8', 'spread': '15.06', 'groupId': 'OG000'}]}]}, {'title': 'Alanine aminotransferase, Year 8, Week 24, n= 60', 'categories': [{'measurements': [{'value': '-5.1', 'spread': '12.06', 'groupId': 'OG000'}]}]}, {'title': 'Alanine aminotransferase, Year 8, Week 48, n= 28', 'categories': [{'measurements': [{'value': '-0.6', 'spread': '11.39', 'groupId': 'OG000'}]}]}, {'title': 'Alanine aminotransferase, Year 9, Week 24, n= 2', 'categories': [{'measurements': [{'value': '5', 'spread': '4.24', 'groupId': 'OG000'}]}]}, {'title': 'Alanine aminotransferase, Exit, n= 235', 'categories': [{'measurements': [{'value': '-1.2', 'spread': '13.77', 'groupId': 'OG000'}]}]}, {'title': 'Alanine aminotransferase, 8 Week, Follow-Up, n= 10', 'categories': [{'measurements': [{'value': '0.1', 'spread': '14.46', 'groupId': 'OG000'}]}]}, {'title': 'Alkaline phosphatase, Year 1, Week 4, n= 251', 'categories': [{'measurements': [{'value': '-0.8', 'spread': '13.82', 'groupId': 'OG000'}]}]}, {'title': 'Alkaline phosphatase, Year 1, Week 12, n= 248', 'categories': [{'measurements': [{'value': '0.4', 'spread': '17.41', 'groupId': 'OG000'}]}]}, {'title': 'Alkaline phosphatase, Year 1, Week 24, n= 246', 'categories': [{'measurements': [{'value': '0.3', 'spread': '16.72', 'groupId': 'OG000'}]}]}, {'title': 'Alkaline phosphatase, Year 1, Week 36, n= 238', 'categories': [{'measurements': [{'value': '1.2', 'spread': '16.2', 'groupId': 'OG000'}]}]}, {'title': 'Alkaline phosphatase, Year 1, Week 48, n= 250', 'categories': [{'measurements': [{'value': '3.3', 'spread': '19.97', 'groupId': 'OG000'}]}]}, {'title': 'Alkaline phosphatase, Year 2, Week 24, n= 248', 'categories': [{'measurements': [{'value': '4.9', 'spread': '21.17', 'groupId': 'OG000'}]}]}, {'title': 'Alkaline phosphatase, Year 2, Week 48, n= 233', 'categories': [{'measurements': [{'value': '5.8', 'spread': '21.25', 'groupId': 'OG000'}]}]}, {'title': 'Alkaline phosphatase, Year 3, Week 24, n= 218', 'categories': [{'measurements': [{'value': '5.4', 'spread': '20.61', 'groupId': 'OG000'}]}]}, {'title': 'Alkaline phosphatase, Year 3, Week 48, n= 209', 'categories': [{'measurements': [{'value': '3.1', 'spread': '21.89', 'groupId': 'OG000'}]}]}, {'title': 'Alkaline phosphatase, Year 4, Week 24, n= 207', 'categories': [{'measurements': [{'value': '6.5', 'spread': '29.67', 'groupId': 'OG000'}]}]}, {'title': 'Alkaline phosphatase, Year 4, Week 48, n= 194', 'categories': [{'measurements': [{'value': '6.2', 'spread': '33.31', 'groupId': 'OG000'}]}]}, {'title': 'Alkaline phosphatase, Year 5, Week 24, n= 184', 'categories': [{'measurements': [{'value': '7.8', 'spread': '24.75', 'groupId': 'OG000'}]}]}, {'title': 'Alkaline phosphatase, Year 5, Week 48, n= 178', 'categories': [{'measurements': [{'value': '6.7', 'spread': '26.55', 'groupId': 'OG000'}]}]}, {'title': 'Alkaline phosphatase, Year 6, Week 24, n= 175', 'categories': [{'measurements': [{'value': '7.5', 'spread': '33.87', 'groupId': 'OG000'}]}]}, {'title': 'Alkaline phosphatase, Year 6, Week 48, n= 134', 'categories': [{'measurements': [{'value': '6.6', 'spread': '26.36', 'groupId': 'OG000'}]}]}, {'title': 'Alkaline phosphatase, Year 7, Week 24, n= 123', 'categories': [{'measurements': [{'value': '5.5', 'spread': '25', 'groupId': 'OG000'}]}]}, {'title': 'Alkaline phosphatase, Year 7, Week 48, n= 97', 'categories': [{'measurements': [{'value': '5.2', 'spread': '24.83', 'groupId': 'OG000'}]}]}, {'title': 'Alkaline phosphatase, Year 8, Week 24, n= 60', 'categories': [{'measurements': [{'value': '2.3', 'spread': '29.63', 'groupId': 'OG000'}]}]}, {'title': 'Alkaline phosphatase, Year 8, Week 48, n= 28', 'categories': [{'measurements': [{'value': '0.3', 'spread': '38.97', 'groupId': 'OG000'}]}]}, {'title': 'Alkaline phosphatase, Year 9, Week 24, n= 2', 'categories': [{'measurements': [{'value': '19.5', 'spread': '24.75', 'groupId': 'OG000'}]}]}, {'title': 'Alkaline phosphatase, Exit, n= 235', 'categories': [{'measurements': [{'value': '4.6', 'spread': '23.59', 'groupId': 'OG000'}]}]}, {'title': 'Alkaline phosphatase, 8 Week, Follow-Up, n= 107', 'categories': [{'measurements': [{'value': '2.8', 'spread': '26.98', 'groupId': 'OG000'}]}]}, {'title': 'Aspartate aminotransferase ,Year 1, Week 4, n= 242', 'categories': [{'measurements': [{'value': '0.3', 'spread': '11.18', 'groupId': 'OG000'}]}]}, {'title': 'Aspartate aminotransferase ,Year 1,Week 12, n= 245', 'categories': [{'measurements': [{'value': '-0.6', 'spread': '9.37', 'groupId': 'OG000'}]}]}, {'title': 'Aspartate aminotransferase ,Year 1,Week 24, n= 244', 'categories': [{'measurements': [{'value': '-0.8', 'spread': '8.14', 'groupId': 'OG000'}]}]}, {'title': 'Aspartate aminotransferase,Year 1,Week 36,n=234', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '11.29', 'groupId': 'OG000'}]}]}, {'title': 'Aspartate aminotransferase ,Year 1,Week 48, n= 250', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '10.67', 'groupId': 'OG000'}]}]}, {'title': 'Aspartate aminotransferase , Year 2, Week 24,n=246', 'categories': [{'measurements': [{'value': '0.4', 'spread': '10.97', 'groupId': 'OG000'}]}]}, {'title': 'Aspartate aminotransferase , Year 2, Week 48,n=231', 'categories': [{'measurements': [{'value': '1', 'spread': '12.24', 'groupId': 'OG000'}]}]}, {'title': 'Aspartate aminotransferase , Year 3,Week 24,n=215', 'categories': [{'measurements': [{'value': '0.2', 'spread': '9.49', 'groupId': 'OG000'}]}]}, {'title': 'Aspartate aminotransferase ,Year 3,Week 48, n= 205', 'categories': [{'measurements': [{'value': '0.1', 'spread': '14.63', 'groupId': 'OG000'}]}]}, {'title': 'Aspartate aminotransferase , Year 4,Week 24, n=204', 'categories': [{'measurements': [{'value': '1.3', 'spread': '14.74', 'groupId': 'OG000'}]}]}, {'title': 'Aspartate aminotransferase , Year 4, Week 48,n=191', 'categories': [{'measurements': [{'value': '3.7', 'spread': '32.99', 'groupId': 'OG000'}]}]}, {'title': 'Aspartate aminotransferase , Year 5,Week 24, n=184', 'categories': [{'measurements': [{'value': '1.7', 'spread': '16.27', 'groupId': 'OG000'}]}]}, {'title': 'Aspartate aminotransferase , Year 5,Week 48, n=176', 'categories': [{'measurements': [{'value': '0.6', 'spread': '15.15', 'groupId': 'OG000'}]}]}, {'title': 'Aspartate aminotransferase , Year 6,Week 24,n= 172', 'categories': [{'measurements': [{'value': '2.4', 'spread': '22.03', 'groupId': 'OG000'}]}]}, {'title': 'Aspartate aminotransferase , Year 6,Week 48, n=134', 'categories': [{'measurements': [{'value': '1', 'spread': '13.55', 'groupId': 'OG000'}]}]}, {'title': 'Aspartate aminotransferase , Year 7,Week 24,n=121', 'categories': [{'measurements': [{'value': '-0.6', 'spread': '13.14', 'groupId': 'OG000'}]}]}, {'title': 'Aspartate aminotransferase , Year 7, Week 48, n=97', 'categories': [{'measurements': [{'value': '-1.1', 'spread': '14.1', 'groupId': 'OG000'}]}]}, {'title': 'Aspartate aminotransferase , Year 8, Week 24,n=60', 'categories': [{'measurements': [{'value': '-2.7', 'spread': '9.66', 'groupId': 'OG000'}]}]}, {'title': 'Aspartate aminotransferase , Year 8, Week 48, n=28', 'categories': [{'measurements': [{'value': '0.1', 'spread': '8.02', 'groupId': 'OG000'}]}]}, {'title': 'Aspartate aminotransferase , Year 9, Week 24, n= 2', 'categories': [{'measurements': [{'value': '5', 'spread': '4.24', 'groupId': 'OG000'}]}]}, {'title': 'Aspartate aminotransferase , Exit, n= 235', 'categories': [{'measurements': [{'value': '-0.4', 'spread': '15.07', 'groupId': 'OG000'}]}]}, {'title': 'Aspartate aminotransferase,8 Week,Follow-Up, n=107', 'categories': [{'measurements': [{'value': '-0.7', 'spread': '12.45', 'groupId': 'OG000'}]}]}, {'title': 'Gamma glutamyl transferase, Year 1, Week 4, n= 251', 'categories': [{'measurements': [{'value': '0.5', 'spread': '22.54', 'groupId': 'OG000'}]}]}, {'title': 'Gamma glutamyl transferase, Year 1,Week 12, n= 248', 'categories': [{'measurements': [{'value': '0.5', 'spread': '21.44', 'groupId': 'OG000'}]}]}, {'title': 'Gamma glutamyl transferase, Year 1,Week 24, n= 246', 'categories': [{'measurements': [{'value': '-1.3', 'spread': '20.21', 'groupId': 'OG000'}]}]}, {'title': 'Gamma glutamyl transferase, Year 1, Week 36, n=238', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '18.64', 'groupId': 'OG000'}]}]}, {'title': 'Gamma glutamyl transferase, Year 1, Week 48, n=250', 'categories': [{'measurements': [{'value': '2.2', 'spread': '39.98', 'groupId': 'OG000'}]}]}, {'title': 'Gamma glutamyl transferase, Year 2,Week 24, n= 248', 'categories': [{'measurements': [{'value': '1.2', 'spread': '27.97', 'groupId': 'OG000'}]}]}, {'title': 'Gamma glutamyl transferase, Year 2, Week 48,n= 233', 'categories': [{'measurements': [{'value': '1.9', 'spread': '28.88', 'groupId': 'OG000'}]}]}, {'title': 'Gamma glutamyl transferase, Year 3, Week 24, n=218', 'categories': [{'measurements': [{'value': '1.8', 'spread': '20.1', 'groupId': 'OG000'}]}]}, {'title': 'Gamma glutamyl transferase, Year 3, Week 48, n=209', 'categories': [{'measurements': [{'value': '-2.4', 'spread': '31.27', 'groupId': 'OG000'}]}]}, {'title': 'Gamma glutamyl transferase, Year 4, Week 24, n=207', 'categories': [{'measurements': [{'value': '2.5', 'spread': '45.58', 'groupId': 'OG000'}]}]}, {'title': 'Gamma glutamyl transferase, Year 4, Week 48, n=194', 'categories': [{'measurements': [{'value': '1.5', 'spread': '47.03', 'groupId': 'OG000'}]}]}, {'title': 'Gamma glutamyl transferase, Year 5,Week 24, n= 184', 'categories': [{'measurements': [{'value': '-0.4', 'spread': '32.51', 'groupId': 'OG000'}]}]}, {'title': 'Gamma glutamyl transferase, Year 5, Week 48, n=178', 'categories': [{'measurements': [{'value': '0.6', 'spread': '40.11', 'groupId': 'OG000'}]}]}, {'title': 'Gamma glutamyl transferase, Year 6, Week 24, n=175', 'categories': [{'measurements': [{'value': '-3.3', 'spread': '40.3', 'groupId': 'OG000'}]}]}, {'title': 'Gamma glutamyl transferase, Year 6, Week 48, n=134', 'categories': [{'measurements': [{'value': '-4.4', 'spread': '37.08', 'groupId': 'OG000'}]}]}, {'title': 'Gamma glutamyl transferase, Year 7, Week 24, n=123', 'categories': [{'measurements': [{'value': '-7.2', 'spread': '38.88', 'groupId': 'OG000'}]}]}, {'title': 'Gamma glutamyl transferase, Year 7, Week 48, n= 97', 'categories': [{'measurements': [{'value': '-8.8', 'spread': '36.19', 'groupId': 'OG000'}]}]}, {'title': 'Gamma glutamyl transferase, Year 8, Week 24, n= 60', 'categories': [{'measurements': [{'value': '-12.9', 'spread': '35.44', 'groupId': 'OG000'}]}]}, {'title': 'Gamma glutamyl transferase, Year 8, Week 48, n= 28', 'categories': [{'measurements': [{'value': '-6.9', 'spread': '31.02', 'groupId': 'OG000'}]}]}, {'title': 'Gamma glutamyl transferase, Year 9, Week 24, n= 2', 'categories': [{'measurements': [{'value': '2.5', 'spread': '3.54', 'groupId': 'OG000'}]}]}, {'title': 'Gamma glutamyl transferase, Exit, n= 235', 'categories': [{'measurements': [{'value': '-2.2', 'spread': '35.29', 'groupId': 'OG000'}]}]}, {'title': 'Gamma glutamyl transferase, 8 Week,Follow-Up,n=107', 'categories': [{'measurements': [{'value': '2.1', 'spread': '35.9', 'groupId': 'OG000'}]}]}, {'title': 'Lactate dehydrogenase , Year 1, Week 4, n= 242', 'categories': [{'measurements': [{'value': '0.2', 'spread': '26.46', 'groupId': 'OG000'}]}]}, {'title': 'Lactate dehydrogenase , Year 1, Week 12, n= 245', 'categories': [{'measurements': [{'value': '-2.4', 'spread': '29.56', 'groupId': 'OG000'}]}]}, {'title': 'Lactate dehydrogenase , Year 1, Week 24, n= 244', 'categories': [{'measurements': [{'value': '-2.2', 'spread': '37.57', 'groupId': 'OG000'}]}]}, {'title': 'Lactate dehydrogenase , Year 1, Week 36, n= 234', 'categories': [{'measurements': [{'value': '-2.8', 'spread': '34.88', 'groupId': 'OG000'}]}]}, {'title': 'Lactate dehydrogenase , Year 1, Week 48, n= 250', 'categories': [{'measurements': [{'value': '-4.3', 'spread': '35.5', 'groupId': 'OG000'}]}]}, {'title': 'Lactate dehydrogenase , Year 2, Week 24, n= 246', 'categories': [{'measurements': [{'value': '-4.8', 'spread': '36.29', 'groupId': 'OG000'}]}]}, {'title': 'Lactate dehydrogenase , Year 2, Week 48, n= 231', 'categories': [{'measurements': [{'value': '-5.4', 'spread': '40.42', 'groupId': 'OG000'}]}]}, {'title': 'Lactate dehydrogenase , Year 3, Week 24, n= 215', 'categories': [{'measurements': [{'value': '-8.1', 'spread': '40.13', 'groupId': 'OG000'}]}]}, {'title': 'Lactate dehydrogenase , Year 3, Week 48, n= 205', 'categories': [{'measurements': [{'value': '-9.2', 'spread': '47.95', 'groupId': 'OG000'}]}]}, {'title': 'Lactate dehydrogenase , Year 4, Week 24, n= 204', 'categories': [{'measurements': [{'value': '-7.7', 'spread': '45.12', 'groupId': 'OG000'}]}]}, {'title': 'Lactate dehydrogenase , Year 4, Week 48, n= 191', 'categories': [{'measurements': [{'value': '-4.7', 'spread': '53.17', 'groupId': 'OG000'}]}]}, {'title': 'Lactate dehydrogenase , Year 5, Week 24, n= 184', 'categories': [{'measurements': [{'value': '-5.5', 'spread': '48.34', 'groupId': 'OG000'}]}]}, {'title': 'Lactate dehydrogenase , Year 5, Week 48, n= 176', 'categories': [{'measurements': [{'value': '-10.3', 'spread': '49.81', 'groupId': 'OG000'}]}]}, {'title': 'Lactate dehydrogenase , Year 6, Week 24, n= 172', 'categories': [{'measurements': [{'value': '-2.7', 'spread': '72.28', 'groupId': 'OG000'}]}]}, {'title': 'Lactate dehydrogenase , Year 6, Week 48, n= 134', 'categories': [{'measurements': [{'value': '-5.3', 'spread': '55.64', 'groupId': 'OG000'}]}]}, {'title': 'Lactate dehydrogenase , Year 7, Week 24, n= 121', 'categories': [{'measurements': [{'value': '-7.9', 'spread': '53.17', 'groupId': 'OG000'}]}]}, {'title': 'Lactate dehydrogenase , Year 7, Week 48, n= 97', 'categories': [{'measurements': [{'value': '-9.5', 'spread': '57.15', 'groupId': 'OG000'}]}]}, {'title': 'Lactate dehydrogenase , Year 8, Week 24, n= 60', 'categories': [{'measurements': [{'value': '-11.2', 'spread': '58.81', 'groupId': 'OG000'}]}]}, {'title': 'Lactate dehydrogenase , Year 8, Week 48, n= 28', 'categories': [{'measurements': [{'value': '-5.5', 'spread': '81.78', 'groupId': 'OG000'}]}]}, {'title': 'Lactate dehydrogenase , Year 9, Week 24, n= 2', 'categories': [{'measurements': [{'value': '-9.5', 'spread': '0.71', 'groupId': 'OG000'}]}]}, {'title': 'Lactate dehydrogenase , Exit, n= 235', 'categories': [{'measurements': [{'value': '-6.5', 'spread': '56.73', 'groupId': 'OG000'}]}]}, {'title': 'Lactate dehydrogenase , 8 Week, Follow-Up, n= 107', 'categories': [{'measurements': [{'value': '-3.4', 'spread': '52.66', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Week 432', 'description': 'Clinical chemistry parameters were assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 432 weeks and at exit visit. Change from Baseline in alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, gamma glutamyl transferase and lactate dehydrogenase is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post- Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.', 'unitOfMeasure': 'Units per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT Population'}, {'type': 'PRIMARY', 'title': 'Number of Participants With the Indicated Immunogenic Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '268', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Belimumab 10 mg/kg IV', 'description': 'Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.'}], 'classes': [{'title': 'Negative, Year 0-1, n=267', 'categories': [{'measurements': [{'value': '262', 'groupId': 'OG000'}]}]}, {'title': 'Negative, Year 1-2, n=255', 'categories': [{'measurements': [{'value': '251', 'groupId': 'OG000'}]}]}, {'title': 'Negative, Year 2-3, n=240', 'categories': [{'measurements': [{'value': '239', 'groupId': 'OG000'}]}]}, {'title': 'Negative, Year 3-4, n=214', 'categories': [{'measurements': [{'value': '213', 'groupId': 'OG000'}]}]}, {'title': 'Negative, Year 4-5, n=195', 'categories': [{'measurements': [{'value': '195', 'groupId': 'OG000'}]}]}, {'title': 'Negative, Year 5-6, n=185', 'categories': [{'measurements': [{'value': '185', 'groupId': 'OG000'}]}]}, {'title': 'Negative, Year 6-7, n=125', 'categories': [{'measurements': [{'value': '125', 'groupId': 'OG000'}]}]}, {'title': 'Negative, Year 7 plus, n=63', 'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}]}]}, {'title': 'Transient positive, Year 0-1, n=267', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Transient positive, Year 1-2, n=255', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Transient positive, Year 2-3, n=240', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Transient positive, Year 3-4, n=214', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Transient positive, Year 4-5, n=195', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Transient positive, Year 5-6, n=185', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Transient positive, Year 6-7, n=125', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Transient positive, Year 7 plus, n=63', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Persistent positive, Year 0-1, n=267', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Persistent positive, Year 1-2, n=255', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Persistent positive, Year 2-3, n=240', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Persistent positive, Year 3-4, n=214', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Persistent positive, Year 4-5, n=195', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Persistent positive, Year 5-6, n=185', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Persistent positive, Year 6-7, n=125', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Persistent positive, Year 7 plus, n=63', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Unknown, Year 0-1, n=267', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Unknown, Year 1-2, n=255', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Unknown, Year 2-3, n=240', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Unknown, Year 3-4, n=214', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Unknown, Year 4-5, n=195', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Unknown, Year 5-6, n=185', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Unknown, Year 6-7, n=125', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Unknown, Year 7 plus, n=63', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Week 440', 'description': 'Immunogenic response was assessed by binding confirmatory assay at Baseline (BL) (Day 0), at Week 24 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Number of participants with the indicated immunogenic response are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Results of binding confirmatory assay were categorized as negative, persistent positive (defined as a positive immunogenic response that occurs at least 2 consecutive assessments or a single result at the final assessment) or transient positive (defined as a single positive immunogenic response that does not occur at the final assessment). Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT Population'}, {'type': 'PRIMARY', 'title': 'Systolic Blood Pressure and Diastolic Blood Pressure at Indicated Time Points.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '268', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Belimumab 10 mg/kg IV', 'description': 'Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.'}], 'classes': [{'title': 'DBP, Baseline, n= 268', 'categories': [{'measurements': [{'value': '74.3', 'spread': '9.92', 'groupId': 'OG000'}]}]}, {'title': 'DBP, Year 1 , Week 24, n= 255', 'categories': [{'measurements': [{'value': '74.5', 'spread': '9.96', 'groupId': 'OG000'}]}]}, {'title': 'DBP, Year 1 , Week 48, n= 255', 'categories': [{'measurements': [{'value': '73.5', 'spread': '9.92', 'groupId': 'OG000'}]}]}, {'title': 'DBP, Year 2 , Week 24, n= 251', 'categories': [{'measurements': [{'value': '74.5', 'spread': '11.01', 'groupId': 'OG000'}]}]}, {'title': 'DBP, Year 2 , Week 48, n= 236', 'categories': [{'measurements': [{'value': '73.5', 'spread': '10.17', 'groupId': 'OG000'}]}]}, {'title': 'DBP, Year 3 , Week 24, n= 223', 'categories': [{'measurements': [{'value': '73.6', 'spread': '10.32', 'groupId': 'OG000'}]}]}, {'title': 'DBP, Year 3 , Week 48, n= 214', 'categories': [{'measurements': [{'value': '73.4', 'spread': '10.12', 'groupId': 'OG000'}]}]}, {'title': 'DBP, Year 4 , Week 24, n= 214', 'categories': [{'measurements': [{'value': '74.4', 'spread': '9.56', 'groupId': 'OG000'}]}]}, {'title': 'DBP, Year 4 , Week 48, n= 199', 'categories': [{'measurements': [{'value': '75.2', 'spread': '10.52', 'groupId': 'OG000'}]}]}, {'title': 'DBP, Year 5 , Week 24, n= 187', 'categories': [{'measurements': [{'value': '74.3', 'spread': '9.89', 'groupId': 'OG000'}]}]}, {'title': 'DBP, Year 5 , Week 48, n= 185', 'categories': [{'measurements': [{'value': '73.4', 'spread': '10.15', 'groupId': 'OG000'}]}]}, {'title': 'DBP, Year 6 , Week 24, n= 178', 'categories': [{'measurements': [{'value': '74.1', 'spread': '10.25', 'groupId': 'OG000'}]}]}, {'title': 'DBP, Year 6 , Week 48, n= 138', 'categories': [{'measurements': [{'value': '73.9', 'spread': '10.78', 'groupId': 'OG000'}]}]}, {'title': 'DBP, Year 7 , Week 24, n= 124', 'categories': [{'measurements': [{'value': '75.2', 'spread': '9.5', 'groupId': 'OG000'}]}]}, {'title': 'DBP, Year 7 , Week 48, n= 98', 'categories': [{'measurements': [{'value': '73.1', 'spread': '9.94', 'groupId': 'OG000'}]}]}, {'title': 'DBP, Year 8 , Week 24, n= 60', 'categories': [{'measurements': [{'value': '73.4', 'spread': '9.79', 'groupId': 'OG000'}]}]}, {'title': 'DBP, Year 8 , Week 48, n= 29', 'categories': [{'measurements': [{'value': '73.6', 'spread': '8.27', 'groupId': 'OG000'}]}]}, {'title': 'DBP, Year 9 , Week 24, n= 2', 'categories': [{'measurements': [{'value': '90', 'spread': '12.73', 'groupId': 'OG000'}]}]}, {'title': 'DBP, Exit, n= 233', 'categories': [{'measurements': [{'value': '75.2', 'spread': '9.77', 'groupId': 'OG000'}]}]}, {'title': 'SBP, Baseline, n= 268', 'categories': [{'measurements': [{'value': '119.7', 'spread': '15.75', 'groupId': 'OG000'}]}]}, {'title': 'SBP, Year 1 , Week 24, n= 255', 'categories': [{'measurements': [{'value': '120', 'spread': '16.14', 'groupId': 'OG000'}]}]}, {'title': 'SBP, Year 1 , Week 48, n= 255', 'categories': [{'measurements': [{'value': '120.2', 'spread': '14.66', 'groupId': 'OG000'}]}]}, {'title': 'SBP, Year 2 , Week 24, n= 251', 'categories': [{'measurements': [{'value': '120.1', 'spread': '16.49', 'groupId': 'OG000'}]}]}, {'title': 'SBP, Year 2 , Week 48, n= 236', 'categories': [{'measurements': [{'value': '119.1', 'spread': '15.22', 'groupId': 'OG000'}]}]}, {'title': 'SBP, Year 3 , Week 24, n= 223', 'categories': [{'measurements': [{'value': '120.7', 'spread': '16.23', 'groupId': 'OG000'}]}]}, {'title': 'SBP, Year 3 , Week 48, n= 214', 'categories': [{'measurements': [{'value': '120.2', 'spread': '14.44', 'groupId': 'OG000'}]}]}, {'title': 'SBP, Year 4 , Week 24, n= 214', 'categories': [{'measurements': [{'value': '121.4', 'spread': '14.61', 'groupId': 'OG000'}]}]}, {'title': 'SBP, Year 4 , Week 48, n= 199', 'categories': [{'measurements': [{'value': '121.4', 'spread': '15.03', 'groupId': 'OG000'}]}]}, {'title': 'SBP, Year 5 , Week 24, n= 187', 'categories': [{'measurements': [{'value': '120.7', 'spread': '14.92', 'groupId': 'OG000'}]}]}, {'title': 'SBP, Year 5 , Week 48, n= 185', 'categories': [{'measurements': [{'value': '119.9', 'spread': '15.29', 'groupId': 'OG000'}]}]}, {'title': 'SBP, Year 6 , Week 24, n= 178', 'categories': [{'measurements': [{'value': '121.5', 'spread': '15.29', 'groupId': 'OG000'}]}]}, {'title': 'SBP, Year 6 , Week 48, n= 138', 'categories': [{'measurements': [{'value': '121.7', 'spread': '15.86', 'groupId': 'OG000'}]}]}, {'title': 'SBP, Year 7 , Week 24, n= 124', 'categories': [{'measurements': [{'value': '121.6', 'spread': '14.73', 'groupId': 'OG000'}]}]}, {'title': 'SBP, Year 7 , Week 48, n= 98', 'categories': [{'measurements': [{'value': '120.6', 'spread': '14.19', 'groupId': 'OG000'}]}]}, {'title': 'SBP, Year 8 , Week 24, n= 60', 'categories': [{'measurements': [{'value': '120.5', 'spread': '14.65', 'groupId': 'OG000'}]}]}, {'title': 'SBP, Year 8 , Week 48, n= 29', 'categories': [{'measurements': [{'value': '118.2', 'spread': '11.73', 'groupId': 'OG000'}]}]}, {'title': 'SBP, Year 9 , Week 24, n= 2', 'categories': [{'measurements': [{'value': '115.5', 'spread': '6.36', 'groupId': 'OG000'}]}]}, {'title': 'SBP, Exit, n= 233', 'categories': [{'measurements': [{'value': '123.3', 'spread': '15.53', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Week 432', 'description': 'Systolic blood pressure (SBP) and diastolic blood pressure (DBP) was measured at Baseline (BL) (Day 0), at Week 24 and 48 in first year, at Week 24 and 48 in subsequent years up to 432 weeks and at exit visit. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.', 'unitOfMeasure': 'Millimeters of mercury', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT Population'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With at Least 25% Increase From Baseline in Creatinine at Indicated Time Points.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '177', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Belimumab 10 mg/kg IV (Placebo)', 'description': 'Participants, who had received placebo in study HGS1006-C1056, received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. The dosing was continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.'}, {'id': 'OG001', 'title': 'Belimumab 10 mg/kg IV (Belimumab)', 'description': 'Participants, who had received belimumab 1mg/kg or 10 mg/kg in study HGS1006-C1056, received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. The dosing was continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.'}], 'classes': [{'title': 'Year 0-1, n= 91, 177', 'categories': [{'measurements': [{'value': '7.7', 'groupId': 'OG000'}, {'value': '23.2', 'groupId': 'OG001'}]}]}, {'title': 'Year 1-2, n= 79, 177', 'categories': [{'measurements': [{'value': '3.8', 'groupId': 'OG000'}, {'value': '20.3', 'groupId': 'OG001'}]}]}, {'title': 'Year 2-3, n= 75, 168', 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000'}, {'value': '8.3', 'groupId': 'OG001'}]}]}, {'title': 'Year 3-4, n= 68, 150', 'categories': [{'measurements': [{'value': '4.4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Year 4-5, n= 61, 139', 'categories': [{'measurements': [{'value': '4.9', 'groupId': 'OG000'}, {'value': '9.4', 'groupId': 'OG001'}]}]}, {'title': 'Year 5-6, n= 59, 132', 'categories': [{'measurements': [{'value': '5.1', 'groupId': 'OG000'}, {'value': '9.1', 'groupId': 'OG001'}]}]}, {'title': 'Year 6-7, n= 12, 118', 'categories': [{'measurements': [{'value': '8.3', 'groupId': 'OG000'}, {'value': '11.9', 'groupId': 'OG001'}]}]}, {'title': 'Year 7+, n= 0, 65', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '10.8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Week 440', 'description': 'Serum creatinine was assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Percentage of participants with at least 25% increase from baseline in creatinine are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT Population'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With at Least 25% Reduction From Baseline in Creatinine at Indicated Time Points. Amongst Subjects With Abnormal (>124 Umol/L) Creatinine at Baseline by Year Interval.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '177', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Belimumab 10 mg/kg IV (Placebo)', 'description': 'Participants, who had received placebo in study HGS1006-C1056, received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. The dosing was continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.'}, {'id': 'OG001', 'title': 'Belimumab 10 mg/kg IV (Belimumab)', 'description': 'Participants, who had received belimumab 1mg/kg or 10 mg/kg in study HGS1006-C1056, received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. The dosing was continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.'}], 'classes': [{'title': 'Year 0-1, n= 6, 3', 'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000'}, {'value': '33.3', 'groupId': 'OG001'}]}]}, {'title': 'Year 1-2, n= 5, 3', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Year 2-3, n= 3, 3', 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Year 3-4, n= 2, 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}]}, {'title': 'Year 4-5, n= 2, 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}]}, {'title': 'Year 5-6, n= 2, 2', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Year 6-7, n= 1, 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Year 7+, n= 0, 0', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Week 440', 'description': 'Serum creatinine was assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Percentage of participants with at least 25% reduction from baseline in creatinine are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT Population. Only those subjects with abnormal (\\>124 umol/L) creatinine at baseline by year interval.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Serum Immunoglobulins Below the Lower Limit of Normal at Indicated Time Points.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '268', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Belimumab 10 mg/kg IV', 'description': 'Participants, who had received belimumab 1milligram per kilogram (mg/kg) or 10 mg/kg or placebo in study HGS1006-C1056 , received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.'}], 'classes': [{'title': 'Baseline, n=268', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Year 1, Week 24, n= 252', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'Year 1, Week 48, n= 255', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': 'Year 2, Week 48, n= 237', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}, {'title': 'Year 3, Week 48, n= 224', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': 'Year 4, Week 48, n= 208', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}]}]}, {'title': 'Year 5, Week 48, n= 190', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}, {'title': 'Year 6, Week 48, n= 150', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}, {'title': 'Year 7, Week 48, n= 112', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}, {'title': 'Year 8, Week 48, n= 59', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Exit, n= 235', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}]}]}, {'title': '8 Week Follow-Up, n= 106', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Week 392', 'description': 'Serum immunoglobulin G (IgG) was collected at Baseline (BL) (Day 0), at Week 24 and Week 48 in first year, at Week 48 in subsequent years up to 8 years and at follow-up (up to 8 weeks post last infusion). Number of participants with serum immunoglobulins below the lower limit of normal (LLN) (\\<0.5 nanograms per milliliter \\[ng/mL\\]) are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT Population'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving SRI Response at Indicated Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '268', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Belimumab 10 mg/kg IV', 'description': 'Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.'}], 'classes': [{'title': 'Year 1 , Week 24, n= 229', 'categories': [{'measurements': [{'value': '41.9', 'groupId': 'OG000'}]}]}, {'title': 'Year 1 , Week 48, n= 225', 'categories': [{'measurements': [{'value': '45.3', 'groupId': 'OG000'}]}]}, {'title': 'Year 2 , Week 24, n= 227', 'categories': [{'measurements': [{'value': '49.3', 'groupId': 'OG000'}]}]}, {'title': 'Year 2 , Week 48, n= 204', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}]}]}, {'title': 'Year 3 , Week 24, n= 211', 'categories': [{'measurements': [{'value': '51.2', 'groupId': 'OG000'}]}]}, {'title': 'Year 3 , Week 48, n= 185', 'categories': [{'measurements': [{'value': '58.4', 'groupId': 'OG000'}]}]}, {'title': 'Year 4 , Week 24, n= 188', 'categories': [{'measurements': [{'value': '56.9', 'groupId': 'OG000'}]}]}, {'title': 'Year 4 , Week 48, n= 174', 'categories': [{'measurements': [{'value': '64.9', 'groupId': 'OG000'}]}]}, {'title': 'Year 5 , Week 24, n= 168', 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}]}]}, {'title': 'Year 5 , Week 48, n= 157', 'categories': [{'measurements': [{'value': '62.4', 'groupId': 'OG000'}]}]}, {'title': 'Year 6 , Week 24, n= 164', 'categories': [{'measurements': [{'value': '69.5', 'groupId': 'OG000'}]}]}, {'title': 'Year 6 , Week 48, n= 123', 'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}]}]}, {'title': 'Year 7 , Week 24, n= 119', 'categories': [{'measurements': [{'value': '75.6', 'groupId': 'OG000'}]}]}, {'title': 'Year 7 , Week 48, n= 93', 'categories': [{'measurements': [{'value': '78.5', 'groupId': 'OG000'}]}]}, {'title': 'Year 8 , Week 24, n= 63', 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}]}]}, {'title': 'Year 8 , Week 48, n= 29', 'categories': [{'measurements': [{'value': '65.5', 'groupId': 'OG000'}]}]}, {'title': 'Year 9 , Week 24, n= 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Week 440', 'description': 'The percentage of participants achieving a SLE Responder Index (SRI) response at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion) are summarized. The BL is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Response is defined as:\\>=4 point reduction from the BL in the safety of estrogen in lupus national assessment (SELENA) SLE disease activity index (SLEDAI) score and no worsening (increase of \\<0.30 points from the BL) in Physicians Global Assessment (PGA), and no new British Isles Lupus Assessment Group (BILAG) A organ domain score or 2 new BILAG B organ domain scores compared with the BL. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'MIIT Population'}, {'type': 'SECONDARY', 'title': 'Observed Anti-double Stranded DNA Levels at Indicated Time Points.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Belimumab 10 mg/kg IV', 'description': 'Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.'}], 'classes': [{'title': 'Baseline, n= 135', 'categories': [{'measurements': [{'value': '193', 'groupId': 'OG000', 'lowerLimit': '34', 'upperLimit': '201'}]}]}, {'title': 'Year 1, Week 24, n= 128', 'categories': [{'measurements': [{'value': '127.5', 'groupId': 'OG000', 'lowerLimit': '29', 'upperLimit': '201'}]}]}, {'title': 'Year 1, Week 48, n= 130', 'categories': [{'measurements': [{'value': '123', 'groupId': 'OG000', 'lowerLimit': '29', 'upperLimit': '201'}]}]}, {'title': 'Year 2, Week 24, n= 126', 'categories': [{'measurements': [{'value': '93.5', 'groupId': 'OG000', 'lowerLimit': '29', 'upperLimit': '349'}]}]}, {'title': 'Year 2, Week 48, n= 128', 'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '2505'}]}]}, {'title': 'Year 3, Week 24, n= 120', 'categories': [{'measurements': [{'value': '82.5', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '1545'}]}]}, {'title': 'Year 3, Week 48, n= 116', 'categories': [{'measurements': [{'value': '86.5', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '556'}]}]}, {'title': 'Year 4, Week 24, n= 112', 'categories': [{'measurements': [{'value': '87.5', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '2305'}]}]}, {'title': 'Year 4, Week 48, n= 100', 'categories': [{'measurements': [{'value': '76.5', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '1873'}]}]}, {'title': 'Year 5, Week 24, n= 98', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '1188'}]}]}, {'title': 'Year 5, Week 48, n= 96', 'categories': [{'measurements': [{'value': '47.5', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '1765'}]}]}, {'title': 'Year 6, Week 24, n= 87', 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '1863'}]}]}, {'title': 'Year 6, Week 48, n= 66', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '1018'}]}]}, {'title': 'Year 7, Week 24, n= 63', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '2648'}]}]}, {'title': 'Year 7, Week 48, n= 48', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '736'}]}]}, {'title': 'Year 8, Week 24, n= 35', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '521'}]}]}, {'title': 'Year 8, Week 48, n= 16', 'categories': [{'measurements': [{'value': '50.5', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '439'}]}]}, {'title': 'Year 9, Week 24, n= 1', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000', 'lowerLimit': '45', 'upperLimit': '45'}]}]}, {'title': 'Exit, n= 120', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '1608'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to Week 432', 'description': 'Anti-double stranded deoxyribonucleic acid (anti-dsDNA) levels were assessed at Baseline (BL) (Day 0), at Week 24 and 48 in first year, at Week 24 and 48 in subsequent years up to 432 weeks in participants who were positive at baseline (anti-dsDNA \\>=30 International Units/milliliter \\[IU/mL\\]). Observed anti-dsDNA levels are summarized. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.', 'unitOfMeasure': 'International units per milliliter', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT Population'}, {'type': 'SECONDARY', 'title': 'Median Percent Change From Baseline in Anti-double Stranded DNA at Indicated Time Points.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Belimumab 10 mg/kg IV', 'description': 'Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.'}], 'classes': [{'title': 'Year 1, Week 24, n= 128', 'categories': [{'measurements': [{'value': '-9.77', 'groupId': 'OG000', 'lowerLimit': '-75.6', 'upperLimit': '54.6'}]}]}, {'title': 'Year 1, Week 48, n= 130', 'categories': [{'measurements': [{'value': '-15.58', 'groupId': 'OG000', 'lowerLimit': '-84.2', 'upperLimit': '183.1'}]}]}, {'title': 'Year 2, Week 24, n= 126', 'categories': [{'measurements': [{'value': '-27.5', 'groupId': 'OG000', 'lowerLimit': '-84.7', 'upperLimit': '181.7'}]}]}, {'title': 'Year 2, Week 48, n= 128', 'categories': [{'measurements': [{'value': '-30.12', 'groupId': 'OG000', 'lowerLimit': '-90.6', 'upperLimit': '1253.6'}]}]}, {'title': 'Year 3, Week 24, n= 120', 'categories': [{'measurements': [{'value': '-34.22', 'groupId': 'OG000', 'lowerLimit': '-90.6', 'upperLimit': '668.7'}]}]}, {'title': 'Year 3, Week 48, n= 116', 'categories': [{'measurements': [{'value': '-34.92', 'groupId': 'OG000', 'lowerLimit': '-90.6', 'upperLimit': '176.6'}]}]}, {'title': 'Year 4, Week 24, n= 112', 'categories': [{'measurements': [{'value': '-38.58', 'groupId': 'OG000', 'lowerLimit': '-90.6', 'upperLimit': '1046.8'}]}]}, {'title': 'Year 4, Week 48, n= 100', 'categories': [{'measurements': [{'value': '-54.46', 'groupId': 'OG000', 'lowerLimit': '-96', 'upperLimit': '831.8'}]}]}, {'title': 'Year 5, Week 24, n= 98', 'categories': [{'measurements': [{'value': '-54.39', 'groupId': 'OG000', 'lowerLimit': '-96.5', 'upperLimit': '491'}]}]}, {'title': 'Year 5, Week 48, n= 96', 'categories': [{'measurements': [{'value': '-64.43', 'groupId': 'OG000', 'lowerLimit': '-97.5', 'upperLimit': '778.1'}]}]}, {'title': 'Year 6, Week 24, n= 87', 'categories': [{'measurements': [{'value': '-64.04', 'groupId': 'OG000', 'lowerLimit': '-97.5', 'upperLimit': '826.9'}]}]}, {'title': 'Year 6, Week 48, n= 66', 'categories': [{'measurements': [{'value': '-64.91', 'groupId': 'OG000', 'lowerLimit': '-97.5', 'upperLimit': '406.5'}]}]}, {'title': 'Year 7, Week 24, n= 63', 'categories': [{'measurements': [{'value': '-74.74', 'groupId': 'OG000', 'lowerLimit': '-97.5', 'upperLimit': '1217.4'}]}]}, {'title': 'Year 7, Week 48, n= 48', 'categories': [{'measurements': [{'value': '-78.15', 'groupId': 'OG000', 'lowerLimit': '-97.5', 'upperLimit': '557.1'}]}]}, {'title': 'Year 8, Week 24, n= 35', 'categories': [{'measurements': [{'value': '-79.1', 'groupId': 'OG000', 'lowerLimit': '-97.5', 'upperLimit': '365.2'}]}]}, {'title': 'Year 8, Week 48, n= 16', 'categories': [{'measurements': [{'value': '-72.38', 'groupId': 'OG000', 'lowerLimit': '-97.5', 'upperLimit': '292'}]}]}, {'title': 'Year 9, Week 24, n= 1', 'categories': [{'measurements': [{'value': '-77.6', 'groupId': 'OG000', 'lowerLimit': '-77.6', 'upperLimit': '-77.6'}]}]}, {'title': 'Exit, n= 120', 'categories': [{'measurements': [{'value': '-66.67', 'groupId': 'OG000', 'lowerLimit': '-97.5', 'upperLimit': '700'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to Week 432', 'description': 'Anti-dsDNA levels were assessed at Baseline (BL) (Day 0), 24 and 48 in first year, at Week 24 and 48 in subsequent years up to 432 weeks and at exit visit in participants who were positive at baseline (anti-dsDNA ≥30 IU/mL). Median percent change from Baseline in anti-dsDNA levels are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Percent change from Baseline is calculated as: 100 x (\\[Post-Dose Visit Value - Baseline\\] / Baseline). Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.', 'unitOfMeasure': 'Percentage change', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT Population'}, {'type': 'SECONDARY', 'title': 'Observed Complement C3 and C4 Levels at Indicated Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Belimumab 10 mg/kg IV', 'description': 'Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.'}], 'classes': [{'title': 'C3, Baseline, n= 86', 'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000', 'lowerLimit': '40', 'upperLimit': '89'}]}]}, {'title': 'C3, Year 1, Week 24, n= 83', 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000', 'lowerLimit': '43', 'upperLimit': '160'}]}]}, {'title': 'C3, Year 1, Week 48, n= 83', 'categories': [{'measurements': [{'value': '86', 'groupId': 'OG000', 'lowerLimit': '38', 'upperLimit': '144'}]}]}, {'title': 'C3, Year 2, Week 24, n= 81', 'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000', 'lowerLimit': '46', 'upperLimit': '157'}]}]}, {'title': 'C3, Year 2, Week 48, n= 80', 'categories': [{'measurements': [{'value': '88.5', 'groupId': 'OG000', 'lowerLimit': '36', 'upperLimit': '137'}]}]}, {'title': 'C3, Year 3, Week 24, n= 74', 'categories': [{'measurements': [{'value': '90.5', 'groupId': 'OG000', 'lowerLimit': '55', 'upperLimit': '133'}]}]}, {'title': 'C3, Year 3, Week 48, n= 73', 'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000', 'lowerLimit': '51', 'upperLimit': '139'}]}]}, {'title': 'C3, Year 4, Week 24, n= 72', 'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000', 'lowerLimit': '47', 'upperLimit': '150'}]}]}, {'title': 'C3, Year 4, Week 48, n= 66', 'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000', 'lowerLimit': '58', 'upperLimit': '137'}]}]}, {'title': 'C3, Year 5, Week 24, n= 63', 'categories': [{'measurements': [{'value': '99', 'groupId': 'OG000', 'lowerLimit': '64', 'upperLimit': '193'}]}]}, {'title': 'C3, Year 5, Week 48, n= 61', 'categories': [{'measurements': [{'value': '97', 'groupId': 'OG000', 'lowerLimit': '56', 'upperLimit': '172'}]}]}, {'title': 'C3, Year 6, Week 24, n= 55', 'categories': [{'measurements': [{'value': '99', 'groupId': 'OG000', 'lowerLimit': '54', 'upperLimit': '161'}]}]}, {'title': 'C3, Year 6, Week 48, n= 37', 'categories': [{'measurements': [{'value': '103', 'groupId': 'OG000', 'lowerLimit': '47', 'upperLimit': '158'}]}]}, {'title': 'C3, Year 7, Week 24, n= 41', 'categories': [{'measurements': [{'value': '103', 'groupId': 'OG000', 'lowerLimit': '50', 'upperLimit': '147'}]}]}, {'title': 'C3, Year 7, Week 48, n= 32', 'categories': [{'measurements': [{'value': '110', 'groupId': 'OG000', 'lowerLimit': '51', 'upperLimit': '173'}]}]}, {'title': 'C3, Year 8, Week 24, n= 20', 'categories': [{'measurements': [{'value': '110.5', 'groupId': 'OG000', 'lowerLimit': '76', 'upperLimit': '177'}]}]}, {'title': 'C3, Year 8, Week 48, n= 9', 'categories': [{'measurements': [{'value': '104', 'groupId': 'OG000', 'lowerLimit': '79', 'upperLimit': '158'}]}]}, {'title': 'C3, Exit, n= 74', 'categories': [{'measurements': [{'value': '103', 'groupId': 'OG000', 'lowerLimit': '56', 'upperLimit': '173'}]}]}, {'title': 'C4, Baseline, n=98', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '15'}]}]}, {'title': 'C4, Year 1, Week 24, n=95', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '25'}]}]}, {'title': 'C4, Year 1, Week 48, n=93', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '28'}]}]}, {'title': 'C4, Year 2, Week 24, n=93', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '29'}]}]}, {'title': 'C4, Year 2, Week 48, n=94', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '37'}]}]}, {'title': 'C4, Year 3, Week 24, n=84', 'categories': [{'measurements': [{'value': '15.5', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '31'}]}]}, {'title': 'C4, Year 3, Week 48, n=83', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '35'}]}]}, {'title': 'C4, Year 4, Week 24, n=81', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '38'}]}]}, {'title': 'C4, Year 4, Week 48, n=71', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '26'}]}]}, {'title': 'C4, Year 5, Week 24, n=70', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '40'}]}]}, {'title': 'C4, Year 5, Week 48, n=70', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '39'}]}]}, {'title': 'C4, Year 6, Week 24, n=62', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '36'}]}]}, {'title': 'C4, Year 6, Week 48, n=45', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '29'}]}]}, {'title': 'C4, Year 7, Week 24, n=49', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000', 'lowerLimit': '6', 'upperLimit': '34'}]}]}, {'title': 'C4, Year 7, Week 48, n=35', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000', 'lowerLimit': '6', 'upperLimit': '34'}]}]}, {'title': 'C4, Year 8, Week 24, n=24', 'categories': [{'measurements': [{'value': '20.5', 'groupId': 'OG000', 'lowerLimit': '10', 'upperLimit': '35'}]}]}, {'title': 'C4, Year 8, Week 48, n=12', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000', 'lowerLimit': '7', 'upperLimit': '36'}]}]}, {'title': 'C4, Year 9, Week 24, n=1', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000', 'lowerLimit': '22', 'upperLimit': '22'}]}]}, {'title': 'C4, Exit, n=85', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '41'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to Week 440', 'description': 'Complement C3 and C4 levels were assessed at Baseline (BL) (Day 0), at Week 24 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at exit visit in participants with low complements at Baseline (C3 \\<90 milligram per deciliter (mg/dL) and C4 \\<16 mg/dL). Observed complement C3 and C4 levels are summarized. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.', 'unitOfMeasure': 'Milligrams per deciliter', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT Population'}, {'type': 'SECONDARY', 'title': 'Median Percent Change From Baseline in Complement C3 and C4 Levels at Indicated Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Belimumab 10 mg/kg IV', 'description': 'Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.'}], 'classes': [{'title': 'C3, Year 1, Week 24, n= 83', 'categories': [{'measurements': [{'value': '10.91', 'groupId': 'OG000', 'lowerLimit': '-33', 'upperLimit': '281'}]}]}, {'title': 'C3, Year 1, Week 48, n= 83', 'categories': [{'measurements': [{'value': '17.86', 'groupId': 'OG000', 'lowerLimit': '-45.3', 'upperLimit': '104.8'}]}]}, {'title': 'C3, Year 2, Week 24, n= 81', 'categories': [{'measurements': [{'value': '18.64', 'groupId': 'OG000', 'lowerLimit': '-23.3', 'upperLimit': '192.9'}]}]}, {'title': 'C3, Year 2, Week 48, n= 80', 'categories': [{'measurements': [{'value': '16.71', 'groupId': 'OG000', 'lowerLimit': '-37.9', 'upperLimit': '163.3'}]}]}, {'title': 'C3, Year 3, Week 24, n= 74', 'categories': [{'measurements': [{'value': '24.26', 'groupId': 'OG000', 'lowerLimit': '-17.3', 'upperLimit': '161.2'}]}]}, {'title': 'C3, Year 3, Week 48, n= 73', 'categories': [{'measurements': [{'value': '22.73', 'groupId': 'OG000', 'lowerLimit': '-34.6', 'upperLimit': '163.3'}]}]}, {'title': 'C3, Year 4, Week 24, n= 72', 'categories': [{'measurements': [{'value': '32.43', 'groupId': 'OG000', 'lowerLimit': '-32.9', 'upperLimit': '206.1'}]}]}, {'title': 'C3, Year 4, Week 48, n= 66', 'categories': [{'measurements': [{'value': '30.63', 'groupId': 'OG000', 'lowerLimit': '-27.5', 'upperLimit': '177.6'}]}]}, {'title': 'C3, Year 5, Week 24, n= 63', 'categories': [{'measurements': [{'value': '33.93', 'groupId': 'OG000', 'lowerLimit': '-24.7', 'upperLimit': '175.7'}]}]}, {'title': 'C3, Year 5, Week 48, n= 61', 'categories': [{'measurements': [{'value': '34.29', 'groupId': 'OG000', 'lowerLimit': '-17.9', 'upperLimit': '173.5'}]}]}, {'title': 'C3, Year 6, Week 24, n= 55', 'categories': [{'measurements': [{'value': '35.71', 'groupId': 'OG000', 'lowerLimit': '-18', 'upperLimit': '159.7'}]}]}, {'title': 'C3, Year 6, Week 48, n= 37', 'categories': [{'measurements': [{'value': '34.57', 'groupId': 'OG000', 'lowerLimit': '-32.9', 'upperLimit': '166.7'}]}]}, {'title': 'C3, Year 7, Week 24, n= 41', 'categories': [{'measurements': [{'value': '36.11', 'groupId': 'OG000', 'lowerLimit': '-34.2', 'upperLimit': '137.1'}]}]}, {'title': 'C3, Year 7, Week 48, n= 32', 'categories': [{'measurements': [{'value': '42.04', 'groupId': 'OG000', 'lowerLimit': '-36.3', 'upperLimit': '179'}]}]}, {'title': 'C3, Year 8, Week 24, n= 20', 'categories': [{'measurements': [{'value': '36.97', 'groupId': 'OG000', 'lowerLimit': '7.7', 'upperLimit': '185.5'}]}]}, {'title': 'C3, Year 8, Week 48, n= 9', 'categories': [{'measurements': [{'value': '30.16', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '163.3'}]}]}, {'title': 'C3, Exit, n= 74', 'categories': [{'measurements': [{'value': '39.05', 'groupId': 'OG000', 'lowerLimit': '-25.6', 'upperLimit': '195.2'}]}]}, {'title': 'C4, Year 1, Week 24, n=95', 'categories': [{'measurements': [{'value': '30.77', 'groupId': 'OG000', 'lowerLimit': '-53.3', 'upperLimit': '275'}]}]}, {'title': 'C4, Year 1, Week 48, n=93', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000', 'lowerLimit': '-40', 'upperLimit': '200'}]}]}, {'title': 'C4, Year 2, Week 24, n=93', 'categories': [{'measurements': [{'value': '42.86', 'groupId': 'OG000', 'lowerLimit': '-57.1', 'upperLimit': '350'}]}]}, {'title': 'C4, Year 2, Week 48, n=94', 'categories': [{'measurements': [{'value': '47.73', 'groupId': 'OG000', 'lowerLimit': '-33.3', 'upperLimit': '270'}]}]}, {'title': 'C4, Year 3, Week 24, n=84', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000', 'lowerLimit': '-20', 'upperLimit': '266.7'}]}]}, {'title': 'C4, Year 3, Week 48, n=83', 'categories': [{'measurements': [{'value': '46.15', 'groupId': 'OG000', 'lowerLimit': '-40', 'upperLimit': '250'}]}]}, {'title': 'C4, Year 4, Week 24, n=81', 'categories': [{'measurements': [{'value': '57.14', 'groupId': 'OG000', 'lowerLimit': '-70', 'upperLimit': '450'}]}]}, {'title': 'C4, Year 4, Week 48, n=71', 'categories': [{'measurements': [{'value': '58.33', 'groupId': 'OG000', 'lowerLimit': '-42.9', 'upperLimit': '433.3'}]}]}, {'title': 'C4, Year 5, Week 24, n=70', 'categories': [{'measurements': [{'value': '70.33', 'groupId': 'OG000', 'lowerLimit': '-30', 'upperLimit': '500'}]}]}, {'title': 'C4, Year 5, Week 48, n=70', 'categories': [{'measurements': [{'value': '65.15', 'groupId': 'OG000', 'lowerLimit': '-40', 'upperLimit': '566.7'}]}]}, {'title': 'C4, Year 6, Week 24, n=62', 'categories': [{'measurements': [{'value': '71.36', 'groupId': 'OG000', 'lowerLimit': '-10', 'upperLimit': '800'}]}]}, {'title': 'C4, Year 6, Week 48, n=45', 'categories': [{'measurements': [{'value': '57.14', 'groupId': 'OG000', 'lowerLimit': '-40', 'upperLimit': '600'}]}]}, {'title': 'C4, Year 7, Week 24, n=49', 'categories': [{'measurements': [{'value': '63.64', 'groupId': 'OG000', 'lowerLimit': '-40', 'upperLimit': '700'}]}]}, {'title': 'C4, Year 7, Week 48, n=35', 'categories': [{'measurements': [{'value': '62.5', 'groupId': 'OG000', 'lowerLimit': '-14.3', 'upperLimit': '900'}]}]}, {'title': 'C4, Year 8, Week 24, n=24', 'categories': [{'measurements': [{'value': '78.97', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '900'}]}]}, {'title': 'C4, Year 8, Week 48, n=12', 'categories': [{'measurements': [{'value': '69.74', 'groupId': 'OG000', 'lowerLimit': '-30', 'upperLimit': '1100'}]}]}, {'title': 'C4, Year 9, Week 24, n=1', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '100', 'upperLimit': '100'}]}]}, {'title': 'C4, Exit, n=85', 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000', 'lowerLimit': '-53.8', 'upperLimit': '1066.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to Week 432', 'description': 'Complement C3 and C4 levels were assessed at Baseline (BL) (Day 0), 24 and 48 in first year, at Week 24 and 48 in subsequent years up to 432 weeks and at exit visit in participants with low complements at Baseline (C3 \\<90 milligrams per decilitre (mg/dL) and C4 \\<16 mg/dL). Median percent change from Baseline in complement C3 and C4 levels are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Percent change from Baseline is calculated as: 100 x (\\[Post-Dose Visit Value - Baseline\\] / Baseline). Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.', 'unitOfMeasure': 'Percent Change', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT Population'}, {'type': 'SECONDARY', 'title': 'Percent of Participants With Daily Prednisone Dose Reduction at Indicated Time Points.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Belimumab 10 mg/kg IV', 'description': 'Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.'}], 'classes': [{'title': 'Year 1, Week 24, n= 80', 'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000'}]}]}, {'title': 'Year 1, Week 48, n= 81', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}, {'title': 'Year 2, Week 24, n= 78', 'categories': [{'measurements': [{'value': '38.5', 'groupId': 'OG000'}]}]}, {'title': 'Year 2, Week 48, n= 76', 'categories': [{'measurements': [{'value': '40.8', 'groupId': 'OG000'}]}]}, {'title': 'Year 3, Week 24, n= 64', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}]}]}, {'title': 'Year 3, Week 48, n= 63', 'categories': [{'measurements': [{'value': '41.3', 'groupId': 'OG000'}]}]}, {'title': 'Year 4, Week 24, n= 65', 'categories': [{'measurements': [{'value': '43.1', 'groupId': 'OG000'}]}]}, {'title': 'Year 4, Week 48, n= 62', 'categories': [{'measurements': [{'value': '37.1', 'groupId': 'OG000'}]}]}, {'title': 'Year 5, Week 24, n= 57', 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}]}]}, {'title': 'Year 5, Week 48, n= 57', 'categories': [{'measurements': [{'value': '38.6', 'groupId': 'OG000'}]}]}, {'title': 'Year 6, Week 24, n= 55', 'categories': [{'measurements': [{'value': '34.5', 'groupId': 'OG000'}]}]}, {'title': 'Year 6, Week 48, n= 47', 'categories': [{'measurements': [{'value': '42.6', 'groupId': 'OG000'}]}]}, {'title': 'Year 7, Week 24, n= 42', 'categories': [{'measurements': [{'value': '38.1', 'groupId': 'OG000'}]}]}, {'title': 'Year 7, Week 48, n= 38', 'categories': [{'measurements': [{'value': '39.5', 'groupId': 'OG000'}]}]}, {'title': 'Year 8, Week 24, n= 24', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}]}]}, {'title': 'Year 8, Week 48, n= 12', 'categories': [{'measurements': [{'value': '58.3', 'groupId': 'OG000'}]}]}, {'title': 'Year 9, Week 24, n= 2', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Week 432', 'description': 'Trends for reduction in prednisone use in participants receiving belimumab were observed up to 432 weeks. Percentage of participants with daily prednisone dose reduced to \\<=7.5 mg/day from \\>7.5 mg/kg at the Baseline are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT Population'}, {'type': 'SECONDARY', 'title': 'Percent of Participants With >= 50% Reduction in Proteinuria at Indicated Time Points.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Belimumab 10 mg/kg IV', 'description': 'Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.'}], 'classes': [{'title': 'Year 1, Week 24, n=34', 'categories': [{'measurements': [{'value': '41.2', 'groupId': 'OG000'}]}]}, {'title': 'Year 1, Week 48, n=33', 'categories': [{'measurements': [{'value': '63.6', 'groupId': 'OG000'}]}]}, {'title': 'Year 2, Week 24, n=33', 'categories': [{'measurements': [{'value': '60.6', 'groupId': 'OG000'}]}]}, {'title': 'Year 2, Week 48, n=30', 'categories': [{'measurements': [{'value': '53.3', 'groupId': 'OG000'}]}]}, {'title': 'Year 3, Week 24, n=31', 'categories': [{'measurements': [{'value': '74.2', 'groupId': 'OG000'}]}]}, {'title': 'Year 3, Week 48, n=28', 'categories': [{'measurements': [{'value': '67.9', 'groupId': 'OG000'}]}]}, {'title': 'Year 4, Week 24, n=25', 'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000'}]}]}, {'title': 'Year 4, Week 48, n=23', 'categories': [{'measurements': [{'value': '73.9', 'groupId': 'OG000'}]}]}, {'title': 'Year 5, Week 24, n=23', 'categories': [{'measurements': [{'value': '73.9', 'groupId': 'OG000'}]}]}, {'title': 'Year 5, Week 48, n=22', 'categories': [{'measurements': [{'value': '86.4', 'groupId': 'OG000'}]}]}, {'title': 'Year 6, Week 24, n=22', 'categories': [{'measurements': [{'value': '77.3', 'groupId': 'OG000'}]}]}, {'title': 'Year 6, Week 48, n=17', 'categories': [{'measurements': [{'value': '76.5', 'groupId': 'OG000'}]}]}, {'title': 'Year 7, Week 24, n=14', 'categories': [{'measurements': [{'value': '78.6', 'groupId': 'OG000'}]}]}, {'title': 'Year 7, Week 48, n=7', 'categories': [{'measurements': [{'value': '71.4', 'groupId': 'OG000'}]}]}, {'title': 'Year 8, Week 24, n=4', 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}]}]}, {'title': 'Year 8, Week 48, n=1', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Year 9, Week 24, n=28', 'categories': [{'measurements': [{'value': '64.3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Week 432', 'description': 'Proteinuria is defined as the presence of an excess of serum proteins in the urine. Trends for reduction in proteinuria in participants receiving belimumab were assessed up to 432 weeks and at Exit visit. Percentage of participants with \\>= 50% reduction in proteinuria among participants with Baseline proteinuria \\>0.5 g/24 hour (hr) are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT Population'}, {'type': 'SECONDARY', 'title': 'Observed B-cell Levels at Indicated Time Points.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '268', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Belimumab 10 mg/kg IV', 'description': 'Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.'}], 'classes': [{'title': 'CD20+, Baseline, n= 262', 'categories': [{'measurements': [{'value': '112.5', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '807'}]}]}, {'title': 'CD20+, Yr 1, Wk 24, n= 251', 'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '433'}]}]}, {'title': 'CD20+, Yr 1, Wk 48, n= 242', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '407'}]}]}, {'title': 'CD20+, Yr 2, Wk 24, n= 238', 'categories': [{'measurements': [{'value': '37.5', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '278'}]}]}, {'title': 'CD20+, Yr 2, Wk 48, n= 224', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '1528'}]}]}, {'title': 'CD20+, Yr 3, Wk 24, n= 212', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '293'}]}]}, {'title': 'CD20+, Yr 3, Wk 48, n= 202', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '500'}]}]}, {'title': 'CD20+, Yr 4, Wk 24, n= 196', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '355'}]}]}, {'title': 'CD20+, Yr 4, Wk 48, n= 181', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '238'}]}]}, {'title': 'CD20+, Yr 5, Wk 24, n= 172', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '141'}]}]}, {'title': 'CD20+, Yr 5, Wk 48, n= 166', 'categories': [{'measurements': [{'value': '18.5', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '248'}]}]}, {'title': 'CD20+, Yr 6, Wk 24, n= 159', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '397'}]}]}, {'title': 'CD20+, Yr 6, Wk 48, n= 114', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '113'}]}]}, {'title': 'CD20+, Yr 7, Wk 24, n= 111', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '158'}]}]}, {'title': 'CD20+, Yr 7, Wk 48, n= 87', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '120'}]}]}, {'title': 'CD20+, Yr 8, Wk 24, n= 54', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '91'}]}]}, {'title': 'CD20+, Yr 8, Wk 48, n= 28', 'categories': [{'measurements': [{'value': '15.5', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '57'}]}]}, {'title': 'CD20+, Yr 9, Wk 24, n= 2', 'categories': [{'measurements': [{'value': '7.5', 'groupId': 'OG000', 'lowerLimit': '7', 'upperLimit': '8'}]}]}, {'title': 'CD20+, Exit, n= 207', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '364'}]}]}, {'title': 'CD19+/27BRIGHT/38BRIGHT SLE, Baseline, n= 262', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '600'}]}]}, {'title': 'CD19+/27BRIGHT/38BRIGHT SLE, Yr 1, Wk 24, n= 251', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '452'}]}]}, {'title': 'CD19+/27BRIGHT/38BRIGHT SLE, Yr 1, Wk 48, n= 247', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '177'}]}]}, {'title': 'CD19+/27BRIGHT/38BRIGHT SLE, Yr 2, Wk 24, n= 246', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '204'}]}]}, {'title': 'CD19+/27BRIGHT/38BRIGHT SLE, Yr 2, Wk 48, n= 233', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '345'}]}]}, {'title': 'CD19+/27BRIGHT/38BRIGHT SLE, Yr 3, Wk 24, n= 218', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '216'}]}]}, {'title': 'CD19+/27BRIGHT/38BRIGHT SLE, Yr 3, Wk 48, n= 212', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '331'}]}]}, {'title': 'CD19+/27BRIGHT/38BRIGHT SLE, Yr 4, Wk 24, n= 211', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '407'}]}]}, {'title': 'CD19+/27BRIGHT/38BRIGHT SLE, Yr 4, Wk 48, n= 194', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '442'}]}]}, {'title': 'CD19+/27BRIGHT/38BRIGHT SLE, Yr 5, Wk 24, n= 189', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '414'}]}]}, {'title': 'CD19+/27BRIGHT/38BRIGHT SLE, Yr 5, Wk 48, n= 181', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '591'}]}]}, {'title': 'CD19+/27BRIGHT/38BRIGHT SLE, Yr 6, Wk 24, n= 174', 'categories': [{'measurements': [{'value': '10.5', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '443'}]}]}, {'title': 'CD19+/27BRIGHT/38BRIGHT SLE, Yr 6, Wk 48, n= 133', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '248'}]}]}, {'title': 'CD19+/27BRIGHT/38BRIGHT SLE, Yr 7, Wk 24, n= 122', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '381'}]}]}, {'title': 'CD19+/27BRIGHT/38BRIGHT SLE, Yr 7, Wk 48, n= 97', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '156'}]}]}, {'title': 'CD19+/27BRIGHT/38BRIGHT SLE, Yr 8, Wk 24, n= 60', 'categories': [{'measurements': [{'value': '6.5', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '755'}]}]}, {'title': 'CD19+/27BRIGHT/38BRIGHT SLE, Yr 8, Wk 48, n= 29', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '39'}]}]}, {'title': 'CD19+/27BRIGHT/38BRIGHT SLE, Yr 9, Wk 24, n= 2', 'categories': [{'measurements': [{'value': '17.5', 'groupId': 'OG000', 'lowerLimit': '6', 'upperLimit': '29'}]}]}, {'title': 'CD19+/27BRIGHT/38BRIGHT SLE, Exit, n= 232', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '555'}]}]}, {'title': 'CD19+20-27hi+ SLPC, Baseline, n= 258', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '585'}]}]}, {'title': 'CD19+20-27hi+ SLPC, Yr 1, Wk 24, n= 247', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '443'}]}]}, {'title': 'CD19+20-27hi+ SLPC, Yr 1, Wk 48, n= 244', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '145'}]}]}, {'title': 'CD19+20-27hi+ SLPC, Yr 2, Wk 24, n= 244', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '289'}]}]}, {'title': 'CD19+20-27hi+ SLPC, Yr 2, Wk 48, n= 233', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '316'}]}]}, {'title': 'CD19+20-27hi+ SLPC, Yr 3, Wk 24, n= 218', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '210'}]}]}, {'title': 'CD19+20-27hi+ SLPC, Yr 3, Wk 48, n= 211', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '324'}]}]}, {'title': 'CD19+20-27hi+ SLPC, Yr 4, Wk 24, n= 210', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '364'}]}]}, {'title': 'CD19+20-27hi+ SLPC, Yr 4, Wk 48, n= 193', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '452'}]}]}, {'title': 'CD19+20-27hi+ SLPC, Yr 5, Wk 24, n= 188', 'categories': [{'measurements': [{'value': '10.5', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '377'}]}]}, {'title': 'CD19+20-27hi+ SLPC, Yr 5, Wk 48, n= 181', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '597'}]}]}, {'title': 'CD19+20-27hi+ SLPC, Yr 6, Wk 24, n= 174', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '400'}]}]}, {'title': 'CD19+20-27hi+ SLPC, Yr 6, Wk 48, n= 133', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '227'}]}]}, {'title': 'CD19+20-27hi+ SLPC, Yr 7, Wk 24, n= 122', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '328'}]}]}, {'title': 'CD19+20-27hi+ SLPC, Yr 7, Wk 48, n= 97', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '156'}]}]}, {'title': 'CD19+20-27hi+ SLPC, Yr 8, Wk 24, n= 60', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '754'}]}]}, {'title': 'CD19+20-27hi+ SLPC, Yr 8, Wk 48, n= 29', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '42'}]}]}, {'title': 'CD19+20-27hi+ SLPC, Yr 9, Wk 24, n= 2', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '28'}]}]}, {'title': 'CD19+20-27hi+ SLPC, Exit, n= 233', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '603'}]}]}, {'title': 'CD20+/138+ plasmacytoid, Baseline, n= 261', 'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '4274'}]}]}, {'title': 'CD20+/138+ plasmacytoid, Yr 1, Wk 24, n= 251', 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '1613'}]}]}, {'title': 'CD20+/138+ plasmacytoid, Yr 1, Wk 48, n= 247', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '962'}]}]}, {'title': 'CD20+/138+ plasmacytoid, Yr 2, Wk 24, n= 246', 'categories': [{'measurements': [{'value': '32.5', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '221'}]}]}, {'title': 'CD20+/138+ plasmacytoid, Yr 2, Wk 48, n= 233', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '249'}]}]}, {'title': 'CD20+/138+ plasmacytoid, Yr 3, Wk 24, n= 218', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '322'}]}]}, {'title': 'CD20+/138+ plasmacytoid, Yr 3, Wk 48, n= 212', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '220'}]}]}, {'title': 'CD20+/138+ plasmacytoid, Yr 4, Wk 24, n= 211', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '128'}]}]}, {'title': 'CD20+/138+ plasmacytoid, Yr 4, Wk 48, n= 194', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '246'}]}]}, {'title': 'CD20+/138+ plasmacytoid, Yr 5, Wk 24, n= 189', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '136'}]}]}, {'title': 'CD20+/138+ plasmacytoid, Yr 5, Wk 48, n= 181', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '102'}]}]}, {'title': 'CD20+/138+ plasmacytoid, Yr 6, Wk 24, n= 174', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '38'}]}]}, {'title': 'CD20+/138+ plasmacytoid, Yr 6, Wk 48, n= 133', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '25'}]}]}, {'title': 'CD20+/138+ plasmacytoid, Yr 7, Wk 24, n= 122', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '70'}]}]}, {'title': 'CD20+/138+ plasmacytoid, Yr 7, Wk 48, n= 97', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '23'}]}]}, {'title': 'CD20+/138+ plasmacytoid, Yr 8, Wk 24, n= 60', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '18'}]}]}, {'title': 'CD20+/138+ plasmacytoid, Yr 8, Wk 48, n= 29', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '16'}]}]}, {'title': 'CD20+/138+ plasmacytoid, Yr 9, Wk 24, n= 2', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '2'}]}]}, {'title': 'CD20+/138+ plasmacytoid, Exit, n= 232', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '231'}]}]}, {'title': 'CD20+/27+Memory, Baseline, n= 262', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '177'}]}]}, {'title': 'CD20+/27+Memory, Yr 1, Wk 24, n= 251', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '279'}]}]}, {'title': 'CD20+/27+Memory, Yr 1, Wk 48, n= 242', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '275'}]}]}, {'title': 'CD20+/27+Memory, Yr 2, Wk 24, n= 238', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '181'}]}]}, {'title': 'CD20+/27+Memory, Yr 2, Wk 48, n= 224', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '686'}]}]}, {'title': 'CD20+/27+Memory, Yr 3, Wk 24, n= 212', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '88'}]}]}, {'title': 'CD20+/27+Memory, Yr 3, Wk 48, n= 202', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '342'}]}]}, {'title': 'CD20+/27+Memory, Yr 4, Wk 24, n= 196', 'categories': [{'measurements': [{'value': '10.5', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '276'}]}]}, {'title': 'CD20+/27+Memory, Yr 4, Wk 48, n= 181', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '196'}]}]}, {'title': 'CD20+/27+Memory, Yr 5, Wk 24, n= 172', 'categories': [{'measurements': [{'value': '8.5', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '76'}]}]}, {'title': 'CD20+/27+Memory, Yr 5, Wk 48, n= 166', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '166'}]}]}, {'title': 'CD20+/27+Memory, Yr 6,Wk 24,n=158', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '73'}]}]}, {'title': 'CD20+/27+Memory, Yr 6, Wk 48, n= 114', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '46'}]}]}, {'title': 'CD20+/27+Memory, Yr 7, Wk 24, n= 111', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '91'}]}]}, {'title': 'CD20+/27+Memory, Yr 7, Wk 48, n= 87', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '81'}]}]}, {'title': 'CD20+/27+Memory, Yr 8, Wk 24, n= 54', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '34'}]}]}, {'title': 'CD20+/27+Memory, Yr 8, Wk 48, n= 28', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '32'}]}]}, {'title': 'CD20+/27+Memory, Yr 9, Wk 24, n= 2', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '3'}]}]}, {'title': 'CD20+/27+Memory, Exit, n= 207', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '167'}]}]}, {'title': 'CD20+/27-naive, Baseline, n= 262', 'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '717'}]}]}, {'title': 'CD20+/27-naive, Yr 1, Wk 24, n= 251', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '371'}]}]}, {'title': 'CD20+/27-naive, Yr 1, Wk 48, n= 242', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '209'}]}]}, {'title': 'CD20+/27-naive, Yr 2, Wk 24, n= 238', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '176'}]}]}, {'title': 'CD20+/27-naive, Yr 2, Wk 48, n= 224', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '826'}]}]}, {'title': 'CD20+/27-naive, Yr 3, Wk 24, n= 212', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '243'}]}]}, {'title': 'CD20+/27-naive, Yr 3, Wk 48, n= 202', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '163'}]}]}, {'title': 'CD20+/27-naive, Yr 4, Wk 24, n= 196', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '140'}]}]}, {'title': 'CD20+/27-naive, Yr 4, Wk 48, n= 181', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '152'}]}]}, {'title': 'CD20+/27-naive, Yr 5, Wk 24, n= 172', 'categories': [{'measurements': [{'value': '12.5', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '127'}]}]}, {'title': 'CD20+/27-naive, Yr 5, Wk 48, n= 166', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '176'}]}]}, {'title': 'CD20+/27-naive, Yr 6, Wk 24, n= 159', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '67'}]}]}, {'title': 'CD20+/27-naive, Yr 6, Wk 48, n= 114', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '68'}]}]}, {'title': 'CD20+/27-naive, Yr 7, Wk 24, n= 111', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '69'}]}]}, {'title': 'CD20+/27-naive, Yr 7, Wk 48, n= 87', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '59'}]}]}, {'title': 'CD20+/27-naive, Yr 8, Wk 24, n= 54', 'categories': [{'measurements': [{'value': '11.5', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '62'}]}]}, {'title': 'CD20+/27-naive, Yr 8, Wk 48, n= 28', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '54'}]}]}, {'title': 'CD20+/27-naive, Yr 9, Wk 24, n= 2', 'categories': [{'measurements': [{'value': '5.5', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '7'}]}]}, {'title': 'CD20+/27-naive, Exit, n= 207', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '313'}]}]}, {'title': 'CD20+/69+activated, Baseline, n= 257', 'categories': [{'measurements': [{'value': '190', 'groupId': 'OG000', 'lowerLimit': '11', 'upperLimit': '2492'}]}]}, {'title': 'CD20+/69+activated, Yr 1, Wk 24, n= 247', 'categories': [{'measurements': [{'value': '131', 'groupId': 'OG000', 'lowerLimit': '7', 'upperLimit': '1503'}]}]}, {'title': 'CD20+/69+activated, Yr 1, Wk 48, n= 244', 'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '561'}]}]}, {'title': 'CD20+/69+activated, Yr 2, Wk 24, n= 244', 'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '916'}]}]}, {'title': 'CD20+/69+activated, Yr 2, Wk 48, n= 233', 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '472'}]}]}, {'title': 'CD20+/69+activated, Yr 3, Wk 24, n= 218', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '242'}]}]}, {'title': 'CD20+/69+activated, Yr 3, Wk 48, n= 211', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '233'}]}]}, {'title': 'CD20+/69+activated, Yr 4, Wk 24, n= 210', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '687'}]}]}, {'title': 'CD20+/69+activated, Yr 4, Wk 48, n= 193', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '288'}]}]}, {'title': 'CD20+/69+activated, Yr 5, Wk 24, n= 188', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '147'}]}]}, {'title': 'CD20+/69+activated, Yr 5, Wk 48, n= 181', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '61'}]}]}, {'title': 'CD20+/69+activated, Yr 6, Wk 24, n= 174', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '40'}]}]}, {'title': 'CD20+/69+activated, Yr 6, Wk 48, n= 133', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '56'}]}]}, {'title': 'CD20+/69+activated, Yr 7, Wk 24, n= 122', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '43'}]}]}, {'title': 'CD20+/69+activated, Yr 7, Wk 48, n= 97', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '29'}]}]}, {'title': 'CD20+/69+activated, Yr 8, Wk 24, n= 60', 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '21'}]}]}, {'title': 'CD20+/69+activated, Yr 8, Wk 48, n= 29', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '10'}]}]}, {'title': 'CD20+/69+activated, Yr 9, Wk 24, n= 2', 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '1'}]}]}, {'title': 'CD20+/69+activated, Exit, n= 233', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '457'}]}]}, {'title': 'CD20-/138+plasma cells, Baseline, n= 261', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '870'}]}]}, {'title': 'CD20-/138+plasma cells, Yr 1, Wk 24, n= 251', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '393'}]}]}, {'title': 'CD20-/138+plasma cells, Yr 1, Wk 48, n= 247', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '255'}]}]}, {'title': 'CD20-/138+plasma cells, Yr 2, Wk 24, n= 246', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '446'}]}]}, {'title': 'CD20-/138+plasma cells, Yr 2, Wk 48, n= 233', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '1513'}]}]}, {'title': 'CD20-/138+plasma cells, Yr 3, Wk 24, n= 218', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '312'}]}]}, {'title': 'CD20-/138+plasma cells, Yr 3, Wk 48, n= 212', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '225'}]}]}, {'title': 'CD20-/138+plasma cells, Yr 4, Wk 24, n= 211', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '337'}]}]}, {'title': 'CD20-/138+plasma cells, Yr 4, Wk 48, n= 194', 'categories': [{'measurements': [{'value': '7.5', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '214'}]}]}, {'title': 'CD20-/138+plasma cells, Yr 5, Wk 24, n= 189', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '135'}]}]}, {'title': 'CD20-/138+plasma cells, Yr 5, Wk 48, n= 181', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '75'}]}]}, {'title': 'CD20-/138+plasma cells, Yr 6, Wk 24, n= 174', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '50'}]}]}, {'title': 'CD20-/138+plasma cells, Yr 6, Wk 48, n= 133', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '64'}]}]}, {'title': 'CD20-/138+plasma cells, Yr 7, Wk 24, n= 122', 'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '84'}]}]}, {'title': 'CD20-/138+plasma cells, Yr 7, Wk 48, n= 97', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '47'}]}]}, {'title': 'CD20-/138+plasma cells, Yr 8, Wk 24, n= 60', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '75'}]}]}, {'title': 'CD20-/138+plasma cells, Yr 8, Wk 48, n= 29', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '28'}]}]}, {'title': 'CD20-/138+plasma cells, Yr 9, Wk 24, n= 2', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '14'}]}]}, {'title': 'CD20-/138+plasma cells, Exit, n= 232', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '221'}]}]}, {'title': 'Total CD19+ B-cells (CD19+), Baseline, n= 265', 'categories': [{'measurements': [{'value': '114', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '815'}]}]}, {'title': 'Total CD19+ B-cells (CD19+), Yr 1, Wk 24, n= 253', 'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '437'}]}]}, {'title': 'Total CD19+ B-cells (CD19+), Yr 1, Wk 48, n= 254', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '411'}]}]}, {'title': 'Total CD19+ B-cells (CD19+), Yr 2, Wk 24, n= 247', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '281'}]}]}, {'title': 'Total CD19+ B-cells (CD19+), Yr 2, Wk 48, n= 234', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '1559'}]}]}, {'title': 'Total CD19+ B-cells (CD19+), Yr 3, Wk 24, n= 220', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '296'}]}]}, {'title': 'Total CD19+ B-cells (CD19+), Yr 3, Wk 48, n= 212', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '510'}]}]}, {'title': 'Total CD19+ B-cells (CD19+), Yr 4, Wk 24, n= 211', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '359'}]}]}, {'title': 'Total CD19+ B-cells (CD19+), Yr 4, Wk 48, n= 195', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '245'}]}]}, {'title': 'Total CD19+ B-cells (CD19+), Yr 5, Wk 24, n= 190', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '144'}]}]}, {'title': 'Total CD19+ B-cells (CD19+), Yr 5, Wk 48, n= 182', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '301'}]}]}, {'title': 'Total CD19+ B-cells (CD19+), Yr 6, Wk 24, n= 175', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '117'}]}]}, {'title': 'Total CD19+ B-cells (CD19+), Yr 6, Wk 48, n= 132', 'categories': [{'measurements': [{'value': '17.5', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '114'}]}]}, {'title': 'Total CD19+ B-cells (CD19+), Yr 7, Wk 24, n= 122', 'categories': [{'measurements': [{'value': '18.5', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '160'}]}]}, {'title': 'Total CD19+ B-cells (CD19+), Yr 7, Wk 48, n= 97', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '121'}]}]}, {'title': 'Total CD19+ B-cells (CD19+), Yr 8, Wk 24, n= 60', 'categories': [{'measurements': [{'value': '16.5', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '92'}]}]}, {'title': 'Total CD19+ B-cells (CD19+), Yr 8, Wk 48, n= 29', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '58'}]}]}, {'title': 'Total CD19+ B-cells (CD19+), Yr 9, Wk 24, n= 2', 'categories': [{'measurements': [{'value': '7.5', 'groupId': 'OG000', 'lowerLimit': '7', 'upperLimit': '8'}]}]}, {'title': 'Total CD19+ B-cells (CD19+), Exit, n= 234', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '368'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to Week 432', 'description': 'B-cell levels were assessed at Baseline (BL) (Day 0), Week (Wk) 24 and 48 in first year, at Week 24 and 48 in subsequent years up to 432 weeks and at exit visit. Observed absolute B cell subsets (CD20+), CD19+/27BRIGHT/38BRIGHT SLE subset, CD19+20-27hi+ short-lived plasma cells (SLPC), CD20+/138+ plasmacytoid, CD20+/27+ memory, CD20+/27- naïve, CD20+/69+activated, CD20-/138+ plasma cells, Total CD19+ B-cells (CD19+) levels are summarized. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.', 'unitOfMeasure': 'Cell count', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT Population'}, {'type': 'SECONDARY', 'title': 'Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '268', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Belimumab 10 mg/kg IV', 'description': 'Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.'}], 'classes': [{'title': 'CD20+, Yr 1, Wk 24, n= 245', 'categories': [{'measurements': [{'value': '-31.82', 'groupId': 'OG000', 'lowerLimit': '-91.9', 'upperLimit': '394.1'}]}]}, {'title': 'CD20+, Yr 1, Wk 48, n= 237', 'categories': [{'measurements': [{'value': '-51.61', 'groupId': 'OG000', 'lowerLimit': '-94.7', 'upperLimit': '216.7'}]}]}, {'title': 'CD20+, Yr 2, Wk 24, n= 233', 'categories': [{'measurements': [{'value': '-61.76', 'groupId': 'OG000', 'lowerLimit': '-95.4', 'upperLimit': '250'}]}]}, {'title': 'CD20+, Yr 2, Wk 48, n= 218', 'categories': [{'measurements': [{'value': '-66.21', 'groupId': 'OG000', 'lowerLimit': '-96.3', 'upperLimit': '1616.9'}]}]}, {'title': 'CD20+, Yr 3, Wk 24, n= 206', 'categories': [{'measurements': [{'value': '-69.68', 'groupId': 'OG000', 'lowerLimit': '-96.2', 'upperLimit': '250'}]}]}, {'title': 'CD20+, Yr 3, Wk 48, n= 196', 'categories': [{'measurements': [{'value': '-72.77', 'groupId': 'OG000', 'lowerLimit': '-97.3', 'upperLimit': '270.6'}]}]}, {'title': 'CD20+, Yr 4, Wk 24, n= 191', 'categories': [{'measurements': [{'value': '-75.16', 'groupId': 'OG000', 'lowerLimit': '-96.8', 'upperLimit': '82.4'}]}]}, {'title': 'CD20+, Yr 4, Wk 48, n= 175', 'categories': [{'measurements': [{'value': '-78.33', 'groupId': 'OG000', 'lowerLimit': '-97.6', 'upperLimit': '561.1'}]}]}, {'title': 'CD20+, Yr 5, Wk 24, n= 166', 'categories': [{'measurements': [{'value': '-80.26', 'groupId': 'OG000', 'lowerLimit': '-97.6', 'upperLimit': '156.3'}]}]}, {'title': 'CD20+, Yr 5, Wk 48, n= 161', 'categories': [{'measurements': [{'value': '-81.06', 'groupId': 'OG000', 'lowerLimit': '-98.1', 'upperLimit': '93.8'}]}]}, {'title': 'CD20+, Yr 6, Wk 24, n= 154', 'categories': [{'measurements': [{'value': '-81.87', 'groupId': 'OG000', 'lowerLimit': '-98.1', 'upperLimit': '2381.3'}]}]}, {'title': 'CD20+, Yr 6, Wk 48, n= 109', 'categories': [{'measurements': [{'value': '-82.94', 'groupId': 'OG000', 'lowerLimit': '-96.7', 'upperLimit': '102.9'}]}]}, {'title': 'CD20+, Yr 7, Wk 24, n= 107', 'categories': [{'measurements': [{'value': '-83.22', 'groupId': 'OG000', 'lowerLimit': '-97.6', 'upperLimit': '188.9'}]}]}, {'title': 'CD20+, Yr 7, Wk 48, n= 82', 'categories': [{'measurements': [{'value': '-80.96', 'groupId': 'OG000', 'lowerLimit': '-97.3', 'upperLimit': '172.2'}]}]}, {'title': 'CD20+, Yr 8, Wk 24, n= 52', 'categories': [{'measurements': [{'value': '-78.94', 'groupId': 'OG000', 'lowerLimit': '-96.9', 'upperLimit': '244.4'}]}]}, {'title': 'CD20+, Yr 8, Wk 48, n= 27', 'categories': [{'measurements': [{'value': '-85.29', 'groupId': 'OG000', 'lowerLimit': '-95.5', 'upperLimit': '105.9'}]}]}, {'title': 'CD20+, Yr 9, Wk 24, n= 2', 'categories': [{'measurements': [{'value': '-63.65', 'groupId': 'OG000', 'lowerLimit': '-84.4', 'upperLimit': '-42.9'}]}]}, {'title': 'CD20+, Exit, n= 203', 'categories': [{'measurements': [{'value': '-80.6', 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[{'measurements': [{'value': '-44.44', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '11100'}]}]}, {'title': 'CD19+/27BRIGHT/38BRIGHT SLE, Yr 6, Wk 48, n= 126', 'categories': [{'measurements': [{'value': '-50', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '24700'}]}]}, {'title': 'CD19+/27BRIGHT/38BRIGHT SLE, Yr 7, Wk 24, n= 117', 'categories': [{'measurements': [{'value': '-50', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '29300'}]}]}, {'title': 'CD19+/27BRIGHT/38BRIGHT SLE, Yr 7, Wk 48, n= 92', 'categories': [{'measurements': [{'value': '-70.76', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '2100'}]}]}, {'title': 'CD19+/27BRIGHT/38BRIGHT SLE, Yr 8, Wk 24, n= 57', 'categories': [{'measurements': [{'value': '-71.43', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '1787.5'}]}]}, {'title': 'CD19+/27BRIGHT/38BRIGHT SLE, Yr 8, Wk 48, n= 28', 'categories': [{'measurements': [{'value': '-85', 'groupId': 'OG000', 'lowerLimit': '-100', 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'-30', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '4385.7'}]}]}, {'title': 'CD19+20-27hi+ SLPC, Yr 3, Wk 24, n= 207', 'categories': [{'measurements': [{'value': '-37.5', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '1300'}]}]}, {'title': 'CD19+20-27hi+ SLPC, Yr 3, Wk 48, n= 199', 'categories': [{'measurements': [{'value': '-40.54', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '6600'}]}]}, {'title': 'CD19+20-27hi+ SLPC, Yr 4, Wk 24, n= 199', 'categories': [{'measurements': [{'value': '-29.41', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '1900'}]}]}, {'title': 'CD19+20-27hi+ SLPC, Yr 4, Wk 48, n= 184', 'categories': [{'measurements': [{'value': '-29.29', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '1250'}]}]}, {'title': 'CD19+20-27hi+ SLPC, Yr 5, Wk 24, n= 178', 'categories': [{'measurements': [{'value': '-44.6', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '1400'}]}]}, {'title': 'CD19+20-27hi+ SLPC, Yr 5, Wk 48, n= 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plasmacytoid, Yr 5, Wk 24, n= 181', 'categories': [{'measurements': [{'value': '-96.25', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '33.3'}]}]}, {'title': 'CD20+/138+ plasmacytoid, Yr 5, Wk 48, n= 174', 'categories': [{'measurements': [{'value': '-96.75', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '-21.2'}]}]}, {'title': 'CD20+/138+ plasmacytoid, Yr 6, Wk 24, n= 167', 'categories': [{'measurements': [{'value': '-96.53', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '-9.1'}]}]}, {'title': 'CD20+/138+ plasmacytoid, Yr 6, Wk 48, n= 126', 'categories': [{'measurements': [{'value': '-97.96', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '-36.4'}]}]}, {'title': 'CD20+/138+ plasmacytoid, Yr 7, Wk 24, n= 117', 'categories': [{'measurements': [{'value': '-98', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '-33.3'}]}]}, {'title': 'CD20+/138+ plasmacytoid, Yr 7, Wk 48, n= 91', 'categories': [{'measurements': [{'value': '-98.46', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '-40'}]}]}, {'title': 'CD20+/138+ plasmacytoid, Yr 8, Wk 24, n= 57', 'categories': [{'measurements': [{'value': '-98.64', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '-70'}]}]}, {'title': 'CD20+/138+ plasmacytoid, Yr 8, Wk 48, n= 28', 'categories': [{'measurements': [{'value': '-98.68', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '-92.9'}]}]}, {'title': 'CD20+/138+ plasmacytoid, Yr 9, Wk 24, n= 2', 'categories': [{'measurements': [{'value': '-96.15', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '-92.3'}]}]}, {'title': 'CD20+/138+ plasmacytoid, Exit, n= 225', 'categories': [{'measurements': [{'value': '-96.83', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '610.7'}]}]}, {'title': 'CD20+/27+Memory, Yr 1, Wk 24, n= 244', 'categories': [{'measurements': [{'value': '87.65', 'groupId': 'OG000', 'lowerLimit': '-97.1', 'upperLimit': '1420'}]}]}, {'title': 'CD20+/27+Memory, Yr 1, Wk 48, n= 237', 'categories': [{'measurements': [{'value': '42.86', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '800'}]}]}, {'title': 'CD20+/27+Memory, Yr 2, Wk 24, n= 233', 'categories': [{'measurements': [{'value': '11.11', 'groupId': 'OG000', 'lowerLimit': '-88.9', 'upperLimit': '700'}]}]}, {'title': 'CD20+/27+Memory, Yr 2, Wk 48, n= 217', 'categories': [{'measurements': [{'value': '-7.69', 'groupId': 'OG000', 'lowerLimit': '-84.6', 'upperLimit': '5616.7'}]}]}, {'title': 'CD20+/27+Memory, Yr 3, Wk 24, n= 205', 'categories': [{'measurements': [{'value': '-23.26', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '900'}]}]}, {'title': 'CD20+/27+Memory, Yr 3, Wk 48, n= 196', 'categories': [{'measurements': [{'value': '-35.29', 'groupId': 'OG000', 'lowerLimit': '-97.1', 'upperLimit': '3000'}]}]}, {'title': 'CD20+/27+Memory, Yr 4, Wk 24, n= 191', 'categories': [{'measurements': [{'value': '-40', 'groupId': 'OG000', 'lowerLimit': '-92.6', 'upperLimit': '1400'}]}]}, {'title': 'CD20+/27+Memory, Yr 4, Wk 48, n= 175', 'categories': [{'measurements': [{'value': '-50', 'groupId': 'OG000', 'lowerLimit': '-92.3', 'upperLimit': '3166.7'}]}]}, {'title': 'CD20+/27+Memory, Yr 5, Wk 24, n= 166', 'categories': [{'measurements': [{'value': '-50', 'groupId': 'OG000', 'lowerLimit': '-97.7', 'upperLimit': '500'}]}]}, {'title': 'CD20+/27+Memory, Yr 5, Wk 48, n= 160', 'categories': [{'measurements': [{'value': '-58.87', 'groupId': 'OG000', 'lowerLimit': '-96', 'upperLimit': '800'}]}]}, {'title': 'CD20+/27+Memory, Yr 6, Wk 24, n= 153', 'categories': [{'measurements': [{'value': '-57.89', 'groupId': 'OG000', 'lowerLimit': '-96.2', 'upperLimit': '533.3'}]}]}, {'title': 'CD20+/27+Memory, Yr 6, Wk 48, n= 108', 'categories': [{'measurements': [{'value': '-63.4', 'groupId': 'OG000', 'lowerLimit': '-92.9', 'upperLimit': '400'}]}]}, {'title': 'CD20+/27+Memory, Yr 7, Wk 24, n= 106', 'categories': [{'measurements': [{'value': '-67.18', 'groupId': 'OG000', 'lowerLimit': '-96.2', 'upperLimit': '500'}]}]}, {'title': 'CD20+/27+Memory, Yr 7, Wk 48, n= 81', 'categories': [{'measurements': [{'value': '-71.43', 'groupId': 'OG000', 'lowerLimit': '-92.3', 'upperLimit': '400'}]}]}, {'title': 'CD20+/27+Memory, Yr 8, Wk 24, n= 52', 'categories': [{'measurements': [{'value': '-67.03', 'groupId': 'OG000', 'lowerLimit': '-96', 'upperLimit': '200'}]}]}, {'title': 'CD20+/27+Memory, Yr 8, Wk 48, n= 27', 'categories': [{'measurements': [{'value': '-64.71', 'groupId': 'OG000', 'lowerLimit': '-88.8', 'upperLimit': '600'}]}]}, {'title': 'CD20+/27+Memory, Yr 9, Wk 24, n= 2', 'categories': [{'measurements': [{'value': '-75.96', 'groupId': 'OG000', 'lowerLimit': '-76.9', 'upperLimit': '-75'}]}]}, {'title': 'CD20+/27+Memory, Exit, n= 202', 'categories': [{'measurements': [{'value': '-61.41', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '1000'}]}]}, {'title': 'CD20+/27-naive, Yr 1, Wk 24, n= 245', 'categories': [{'measurements': [{'value': '-55.56', 'groupId': 'OG000', 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'-81.93', 'groupId': 'OG000', 'lowerLimit': '-98.8', 'upperLimit': '100'}]}]}, {'title': 'CD20+/27-naive, Yr 4, Wk 48, n= 175', 'categories': [{'measurements': [{'value': '-84.21', 'groupId': 'OG000', 'lowerLimit': '-98.8', 'upperLimit': '100'}]}]}, {'title': 'CD20+/27-naive, Yr 5, Wk 24, n= 166', 'categories': [{'measurements': [{'value': '-86.09', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '66.7'}]}]}, {'title': 'CD20+/27-naive, Yr 5, Wk 48, n= 161', 'categories': [{'measurements': [{'value': '-87.5', 'groupId': 'OG000', 'lowerLimit': '-99.2', 'upperLimit': '57.7'}]}]}, {'title': 'CD20+/27-naive, Yr 6, Wk 24, n= 154', 'categories': [{'measurements': [{'value': '-86.88', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '233.3'}]}]}, {'title': 'CD20+/27-naive, Yr 6, Wk 48, n= 109', 'categories': [{'measurements': [{'value': '-86.93', 'groupId': 'OG000', 'lowerLimit': '-97.7', 'upperLimit': '100'}]}]}, {'title': 'CD20+/27-naive, Yr 7, Wk 24, n= 107', 'categories': [{'measurements': [{'value': '-87.39', 'groupId': 'OG000', 'lowerLimit': '-98.4', 'upperLimit': '300'}]}]}, {'title': 'CD20+/27-naive, Yr 7, Wk 48, n= 82', 'categories': [{'measurements': [{'value': '-84.78', 'groupId': 'OG000', 'lowerLimit': '-98', 'upperLimit': '300'}]}]}, {'title': 'CD20+/27-naive, Yr 8, Wk 24, n= 52', 'categories': [{'measurements': [{'value': '-83.7', 'groupId': 'OG000', 'lowerLimit': '-97.9', 'upperLimit': '510'}]}]}, {'title': 'CD20+/27-naive, Yr 8, Wk 48, n= 27', 'categories': [{'measurements': [{'value': '-88.15', 'groupId': 'OG000', 'lowerLimit': '-96.5', 'upperLimit': '86.7'}]}]}, {'title': 'CD20+/27-naive, Yr 9, Wk 24, n= 2', 'categories': [{'measurements': [{'value': '-61.93', 'groupId': 'OG000', 'lowerLimit': '-87.5', 'upperLimit': '-36.4'}]}]}, {'title': 'CD20+/27-naive, Exit, n= 203', 'categories': [{'measurements': [{'value': '-86.42', 'groupId': 'OG000', 'lowerLimit': '-99', 'upperLimit': '433.3'}]}]}, {'title': 'CD20+/69+activated, Yr 1, Wk 24, n= 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'325.7'}]}]}, {'title': 'CD20+/69+activated, Yr 4, Wk 24, n= 201', 'categories': [{'measurements': [{'value': '-93.14', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '89.3'}]}]}, {'title': 'CD20+/69+activated, Yr 4, Wk 48, n= 185', 'categories': [{'measurements': [{'value': '-94.85', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '263.6'}]}]}, {'title': 'CD20+/69+activated, Yr 5, Wk 24, n= 180', 'categories': [{'measurements': [{'value': '-96.99', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '13.4'}]}]}, {'title': 'CD20+/69+activated, Yr 5, Wk 48, n= 172', 'categories': [{'measurements': [{'value': '-98.04', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '14.3'}]}]}, {'title': 'CD20+/69+activated, Yr 6, Wk 24, n= 165', 'categories': [{'measurements': [{'value': '-98.04', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '-16.7'}]}]}, {'title': 'CD20+/69+activated, Yr 6, Wk 48, n= 125', 'categories': [{'measurements': [{'value': '-98.76', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '20'}]}]}, {'title': 'CD20+/69+activated, Yr 7, Wk 24, n= 116', 'categories': [{'measurements': [{'value': '-98.85', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '-24.1'}]}]}, {'title': 'CD20+/69+activated, Yr 7, Wk 48, n=89', 'categories': [{'measurements': [{'value': '-99.22', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '-76'}]}]}, {'title': 'CD20+/69+activated, Yr 8, Wk 24, n= 56', 'categories': [{'measurements': [{'value': '-99.33', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '-83.7'}]}]}, {'title': 'CD20+/69+activated, Yr 8, Wk 48, n= 28', 'categories': [{'measurements': [{'value': '-99.71', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '-95.8'}]}]}, {'title': 'CD20+/69+activated, Yr 9, Wk 24, n= 2', 'categories': [{'measurements': [{'value': '-97.92', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '-95.8'}]}]}, {'title': 'CD20+/69+activated, Exit, n= 226', 'categories': [{'measurements': [{'value': '-98.99', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '453.1'}]}]}, {'title': 'CD20-/138+plasma cells, Yr 1, Wk 24, n= 244', 'categories': [{'measurements': [{'value': '-37.2', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '3400'}]}]}, {'title': 'CD20-/138+plasma cells, Yr 1, Wk 48, n= 241', 'categories': [{'measurements': [{'value': '-50', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '4700'}]}]}, {'title': 'CD20-/138+plasma cells, Yr 2, Wk 24, n= 240', 'categories': [{'measurements': [{'value': '-47.83', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '1200'}]}]}, {'title': 'CD20-/138+plasma cells, Yr 2, Wk 48, n= 226', 'categories': [{'measurements': [{'value': '-53.92', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '5500'}]}]}, {'title': 'CD20-/138+plasma cells, Yr 3, Wk 24, n= 212', 'categories': [{'measurements': [{'value': '-64.82', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '1000'}]}]}, {'title': 'CD20-/138+plasma cells, Yr 3, Wk 48, n= 205', 'categories': [{'measurements': [{'value': '-71.43', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '2566.7'}]}]}, {'title': 'CD20-/138+plasma cells, Yr 4, Wk 24, n= 205', 'categories': [{'measurements': [{'value': '-73.76', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '910'}]}]}, {'title': 'CD20-/138+plasma cells, Yr 4, Wk 48, n= 187', 'categories': [{'measurements': [{'value': '-81.58', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '586.4'}]}]}, {'title': 'CD20-/138+plasma cells, Yr 5, Wk 24, n= 182', 'categories': [{'measurements': [{'value': '-86.46', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '133.3'}]}]}, {'title': 'CD20-/138+plasma cells, Yr 5, Wk 48, n= 175', 'categories': [{'measurements': [{'value': '-88.89', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '300'}]}]}, {'title': 'CD20-/138+plasma cells, Yr 6, Wk 24, n= 168', 'categories': [{'measurements': [{'value': '-91.3', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '900'}]}]}, {'title': 'CD20-/138+plasma cells, Yr 6, Wk 48, n= 127', 'categories': [{'measurements': [{'value': '-90.91', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '2100'}]}]}, {'title': 'CD20-/138+plasma cells, Yr 7, Wk 24, n= 118', 'categories': [{'measurements': [{'value': '-92.31', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '1700'}]}]}, {'title': 'CD20-/138+plasma cells, Yr 7, Wk 48, n= 92', 'categories': [{'measurements': [{'value': '-93.83', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '200'}]}]}, {'title': 'CD20-/138+plasma cells, Yr 8, Wk 24, n= 57', 'categories': [{'measurements': [{'value': '-93.39', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '-11.1'}]}]}, {'title': 'CD20-/138+plasma cells, Yr 8, Wk 48, n= 28', 'categories': [{'measurements': [{'value': '-97.56', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '-75'}]}]}, {'title': 'CD20-/138+plasma cells, Yr 9, Wk 24, n= 2', 'categories': [{'measurements': [{'value': '-80.78', 'groupId': 'OG000', 'lowerLimit': '-90.1', 'upperLimit': '-71.4'}]}]}, {'title': 'CD20-/138+plasma cells, Exit, n= 226', 'categories': [{'measurements': [{'value': '-88.58', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '1600'}]}]}, {'title': 'Total CD19+ B-cells (CD19+), Yr 1, Wk 24, n= 250', 'categories': [{'measurements': [{'value': '-32.56', 'groupId': 'OG000', 'lowerLimit': '-91.7', 'upperLimit': '400'}]}]}, {'title': 'Total CD19+ B-cells (CD19+), Yr 1, Wk 48, n= 251', 'categories': [{'measurements': [{'value': '-51.61', 'groupId': 'OG000', 'lowerLimit': '-94.6', 'upperLimit': '214.3'}]}]}, {'title': 'Total CD19+ B-cells (CD19+), Yr 2, Wk 24, n= 244', 'categories': [{'measurements': [{'value': '-61.71', 'groupId': 'OG000', 'lowerLimit': '-95.5', 'upperLimit': '244.4'}]}]}, {'title': 'Total CD19+ B-cells (CD19+), Yr 2, Wk 48, n= 231', 'categories': [{'measurements': [{'value': '-66.67', 'groupId': 'OG000', 'lowerLimit': '-96', 'upperLimit': '1576.3'}]}]}, {'title': 'Total CD19+ B-cells (CD19+), Yr 3, Wk 24, n= 217', 'categories': [{'measurements': [{'value': '-70.21', 'groupId': 'OG000', 'lowerLimit': '-96.3', 'upperLimit': '153.3'}]}]}, {'title': 'Total CD19+ B-cells (CD19+), Yr 3, Wk 48, n= 209', 'categories': [{'measurements': [{'value': '-74.24', 'groupId': 'OG000', 'lowerLimit': '-97.3', 'upperLimit': '276.5'}]}]}, {'title': 'Total CD19+ B-cells (CD19+), Yr 4, Wk 24, n= 209', 'categories': [{'measurements': [{'value': '-75.61', 'groupId': 'OG000', 'lowerLimit': '-97.8', 'upperLimit': '82.4'}]}]}, {'title': 'Total CD19+ B-cells (CD19+), Yr 4, Wk 48, n= 192', 'categories': [{'measurements': [{'value': '-78.54', 'groupId': 'OG000', 'lowerLimit': '-97.8', 'upperLimit': '528.2'}]}]}, {'title': 'Total CD19+ B-cells (CD19+), Yr 5, Wk 24, n= 187', 'categories': [{'measurements': [{'value': '-80.56', 'groupId': 'OG000', 'lowerLimit': '-97.8', 'upperLimit': '141.2'}]}]}, {'title': 'Total CD19+ B-cells (CD19+), Yr 5, Wk 48, n= 179', 'categories': [{'measurements': [{'value': '-81.14', 'groupId': 'OG000', 'lowerLimit': '-98.1', 'upperLimit': '100'}]}]}, {'title': 'Total CD19+ B-cells (CD19+), Yr 6, Wk 24, n= 172', 'categories': [{'measurements': [{'value': '-81.85', 'groupId': 'OG000', 'lowerLimit': '-98.1', 'upperLimit': '75'}]}]}, {'title': 'Total CD19+ B-cells (CD19+), Yr 6, Wk 48, n= 130', 'categories': [{'measurements': [{'value': '-82.34', 'groupId': 'OG000', 'lowerLimit': '-98.5', 'upperLimit': '79.5'}]}]}, {'title': 'Total CD19+ B-cells (CD19+), Yr 7, Wk 24, n= 120', 'categories': [{'measurements': [{'value': '-82.73', 'groupId': 'OG000', 'lowerLimit': '-97.6', 'upperLimit': '125'}]}]}, {'title': 'Total CD19+ B-cells (CD19+), Yr 7, Wk 48, n= 95', 'categories': [{'measurements': [{'value': '-80.95', 'groupId': 'OG000', 'lowerLimit': '-97.8', 'upperLimit': '172.2'}]}]}, {'title': 'Total CD19+ B-cells (CD19+), Yr 8, Wk 24, n= 59', 'categories': [{'measurements': [{'value': '-79.87', 'groupId': 'OG000', 'lowerLimit': '-96.9', 'upperLimit': '250'}]}]}, {'title': 'Total CD19+ B-cells (CD19+), Yr 8, Wk 48, n= 28', 'categories': [{'measurements': [{'value': '-84.79', 'groupId': 'OG000', 'lowerLimit': '-95.6', 'upperLimit': '94.4'}]}]}, {'title': 'Total CD19+ B-cells (CD19+), Yr 9, Wk 24, n= 2', 'categories': [{'measurements': [{'value': '-66.04', 'groupId': 'OG000', 'lowerLimit': '-85.4', 'upperLimit': '-46.7'}]}]}, {'title': 'Total CD19+ B-cells (CD19+), Exit, n= 232', 'categories': [{'measurements': [{'value': '-80.81', 'groupId': 'OG000', 'lowerLimit': '-98.2', 'upperLimit': '178.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to Week 432', 'description': 'B-cell levels were assessed at Baseline (BL) (Day 0), Week (Wk) 24 and 48 in first year, at Week 24 and 48 in subsequent years up to 432 weeks and at exit visit. Median percent change from Baseline in absolute B cell subsets (CD20+), CD19+/27BRIGHT/38BRIGHT SLE subset, CD19+20-27hi+ short-lived plasma cells (SLPC), CD20+/138+ plasmacytoid, CD20+/27+ memory, CD20+/27- naïve, CD20+/69+activated, CD20-/138+ plasma cells, Total CD19+ B-cells (CD19+) levels are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Percent change from Baseline is calculated as: 100 x (\\[Post-Dose Visit Value - Baseline\\] / Baseline). Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.', 'unitOfMeasure': 'Percentage change', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT Population'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Worsening in SLICC/ACR Damage Index at Indicated Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '268', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Belimumab 10 mg/kg IV', 'description': 'Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.'}], 'classes': [{'title': 'Year 1, Week 48, n=263', 'categories': [{'measurements': [{'value': '5.7', 'groupId': 'OG000'}]}]}, {'title': 'Year 2, Week 48, n=256', 'categories': [{'measurements': [{'value': '12.1', 'groupId': 'OG000'}]}]}, {'title': 'Year 3, Week 48, n=239', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}, {'title': 'Year 4, Week 48, n=212', 'categories': [{'measurements': [{'value': '20.8', 'groupId': 'OG000'}]}]}, {'title': 'Year 5, Week 48, n=195', 'categories': [{'measurements': [{'value': '22.6', 'groupId': 'OG000'}]}]}, {'title': 'Year 6, Week 48, n=187', 'categories': [{'measurements': [{'value': '25.1', 'groupId': 'OG000'}]}]}, {'title': 'Year 7, Week 48, n=126', 'categories': [{'measurements': [{'value': '30.2', 'groupId': 'OG000'}]}]}, {'title': 'Year 8, Week 48, n=65', 'categories': [{'measurements': [{'value': '29.2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Week 384', 'description': 'Systemic Lupus International Collaborative Clinics/American College of Rheumatology (SLICC/ACR) Damage Index is a tool used to assess non-reversible organ damage in SLE patients. Damage Index is used to assess 12 systems by 41 items. Score is given as 1 or sometimes 2, if occur more than once, so that that the maximum possible score is 47. Higher damage index scores early in disease are associated with a poor prognosis and with increased mortality. Damage index was assessed at BL (Day 0), Week 48 in first year, at Week 48 in subsequent years up to 8 years. Percentage of participants with worsening in damage index (change \\>0) are summarized. The BL is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Only those participants available at the specified time points were analyzed ( n=X).', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT Population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Time Point', 'denoms': [{'units': 'Participants', 'counts': [{'value': '268', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Belimumab 10 mg/kg IV', 'description': 'Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.'}], 'classes': [{'title': 'MCS, Year 1, Week 48, n= 259', 'categories': [{'measurements': [{'value': '2.47', 'spread': '10.113', 'groupId': 'OG000'}]}]}, {'title': 'MCS, Year 2, Week 48, n= 255', 'categories': [{'measurements': [{'value': '2.99', 'spread': '10.428', 'groupId': 'OG000'}]}]}, {'title': 'MCS, Year 3, Week 48, n= 236', 'categories': [{'measurements': [{'value': '2.54', 'spread': '10.399', 'groupId': 'OG000'}]}]}, {'title': 'MCS, Year 4, Week 48, n= 212', 'categories': [{'measurements': [{'value': '2.52', 'spread': '11.099', 'groupId': 'OG000'}]}]}, {'title': 'MCS, Year 5, Week 48, n= 193', 'categories': [{'measurements': [{'value': '2.22', 'spread': '11.22', 'groupId': 'OG000'}]}]}, {'title': 'MCS, Year 6, Week 48, n= 185', 'categories': [{'measurements': [{'value': '2.71', 'spread': '11.274', 'groupId': 'OG000'}]}]}, {'title': 'MCS, Year 7, Week 48, n= 126', 'categories': [{'measurements': [{'value': '3.19', 'spread': '11.269', 'groupId': 'OG000'}]}]}, {'title': 'MCS, Year 8, Week 48, n= 65', 'categories': [{'measurements': [{'value': '3.91', 'spread': '11.066', 'groupId': 'OG000'}]}]}, {'title': 'PCS, Year 1, Week 48, n= 259', 'categories': [{'measurements': [{'value': '3.41', 'spread': '8.603', 'groupId': 'OG000'}]}]}, {'title': 'PCS, Year 2, Week 48, n= 255', 'categories': [{'measurements': [{'value': '4.64', 'spread': '8.3', 'groupId': 'OG000'}]}]}, {'title': 'PCS, Year 3, Week 48, n= 236', 'categories': [{'measurements': [{'value': '5.93', 'spread': '8.51', 'groupId': 'OG000'}]}]}, {'title': 'PCS, Year 4, Week 48, n= 212', 'categories': [{'measurements': [{'value': '5.01', 'spread': '8.752', 'groupId': 'OG000'}]}]}, {'title': 'PCS, Year 5, Week 48, n= 193', 'categories': [{'measurements': [{'value': '6.12', 'spread': '9.314', 'groupId': 'OG000'}]}]}, {'title': 'PCS, Year 6, Week 48, n= 185', 'categories': [{'measurements': [{'value': '4.79', 'spread': '9.406', 'groupId': 'OG000'}]}]}, {'title': 'PCS, Year 7, Week 48, n= 126', 'categories': [{'measurements': [{'value': '7.7', 'spread': '9.887', 'groupId': 'OG000'}]}]}, {'title': 'PCS, Year 8, Week 48, n= 65', 'categories': [{'measurements': [{'value': '6.73', 'spread': '10.107', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Week 384', 'description': 'The SF-36v2 is a participant-reported short form survey to measure functional health and well-being. There are 36 items grouped into eight health domains: Vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health. SF-36v2 gives a score (0-100) for each of these domains as well as summary score for the physical component score (PCS) and mental component score (MCS) based on the responses by participants. The lower the score the more disability and the higher the score the less disability. The BL is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from BL was calculated as the individual post-BL value minus the BL value. Only those participants available at the specified time points were analyzed ( n=X).', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT Population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints', 'denoms': [{'units': 'Participants', 'counts': [{'value': '268', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Belimumab 10 mg/kg IV', 'description': 'Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.'}], 'classes': [{'title': 'Bodily pain, Year 1 , Week 48, n= 261', 'categories': [{'measurements': [{'value': '9.7', 'spread': '23.36', 'groupId': 'OG000'}]}]}, {'title': 'Bodily pain, Year 2 , Week 48, n= 255', 'categories': [{'measurements': [{'value': '9.2', 'spread': '24.389', 'groupId': 'OG000'}]}]}, {'title': 'Bodily pain, Year 3 , Week 48, n= 236', 'categories': [{'measurements': [{'value': '10.97', 'spread': '23.409', 'groupId': 'OG000'}]}]}, {'title': 'Bodily pain, Year 4 , Week 48, n= 212', 'categories': [{'measurements': [{'value': '8.33', 'spread': '24.181', 'groupId': 'OG000'}]}]}, {'title': 'Bodily pain, Year 5 , Week 48, n= 193', 'categories': [{'measurements': [{'value': '10.88', 'spread': '24.549', 'groupId': 'OG000'}]}]}, {'title': 'Bodily pain, Year 6 , Week 48, n= 185', 'categories': [{'measurements': [{'value': '8.82', 'spread': '23.636', 'groupId': 'OG000'}]}]}, {'title': 'Bodily pain, Year 7 , Week 48, n= 126', 'categories': [{'measurements': [{'value': '14.48', 'spread': '24.969', 'groupId': 'OG000'}]}]}, {'title': 'Bodily pain, Year 8 , Week 48, n= 65', 'categories': [{'measurements': [{'value': '11.94', 'spread': '22.93', 'groupId': 'OG000'}]}]}, {'title': 'General health, Year 1 , Week 48, n= 260', 'categories': [{'measurements': [{'value': '5.66', 'spread': '14.693', 'groupId': 'OG000'}]}]}, {'title': 'General health, Year 2 , Week 48, n= 255', 'categories': [{'measurements': [{'value': '6.14', 'spread': '15.156', 'groupId': 'OG000'}]}]}, {'title': 'General health, Year 3 , Week 48, n= 236', 'categories': [{'measurements': [{'value': '8.84', 'spread': '15.929', 'groupId': 'OG000'}]}]}, {'title': 'General health, Year 4 , Week 48, n= 212', 'categories': [{'measurements': [{'value': '7.29', 'spread': '16.069', 'groupId': 'OG000'}]}]}, {'title': 'General health, Year 5 , Week 48, n= 193', 'categories': [{'measurements': [{'value': '9.19', 'spread': '17.742', 'groupId': 'OG000'}]}]}, {'title': 'General health, Year 6 , Week 48, n= 185', 'categories': [{'measurements': [{'value': '7.24', 'spread': '18.187', 'groupId': 'OG000'}]}]}, {'title': 'General health, Year 7 , Week 48, n= 126', 'categories': [{'measurements': [{'value': '8.71', 'spread': '18.693', 'groupId': 'OG000'}]}]}, {'title': 'General health, Year 8 , Week 48, n= 65', 'categories': [{'measurements': [{'value': '8.18', 'spread': '19.994', 'groupId': 'OG000'}]}]}, {'title': 'Mental health, Year 1 , Week 48, n= 260', 'categories': [{'measurements': [{'value': '4', 'spread': '17.71', 'groupId': 'OG000'}]}]}, {'title': 'Mental health, Year 2 , Week 48, n= 255', 'categories': [{'measurements': [{'value': '3.62', 'spread': '17.46', 'groupId': 'OG000'}]}]}, {'title': 'Mental health, Year 3 , Week 48, n= 236', 'categories': [{'measurements': [{'value': '2.34', 'spread': '17.817', 'groupId': 'OG000'}]}]}, {'title': 'Mental health, Year 4 , Week 48, n= 212', 'categories': [{'measurements': [{'value': '2.33', 'spread': '20.172', 'groupId': 'OG000'}]}]}, {'title': 'Mental health, Year 5 , Week 48, n= 193', 'categories': [{'measurements': [{'value': '1.78', 'spread': '20.662', 'groupId': 'OG000'}]}]}, {'title': 'Mental health, Year 6 , Week 48, n= 185', 'categories': [{'measurements': [{'value': '3.6', 'spread': '19.968', 'groupId': 'OG000'}]}]}, {'title': 'Mental health, Year 7 , Week 48, n= 126', 'categories': [{'measurements': [{'value': '4.39', 'spread': '19.811', 'groupId': 'OG000'}]}]}, {'title': 'Mental health, Year 8 , Week 48, n= 65', 'categories': [{'measurements': [{'value': '6.08', 'spread': '18.551', 'groupId': 'OG000'}]}]}, {'title': 'Physical functioning, Year 1 , Week 48, n= 260', 'categories': [{'measurements': [{'value': '6.34', 'spread': '21.498', 'groupId': 'OG000'}]}]}, {'title': 'Physical functioning, Year 2 , Week 48, n= 255', 'categories': [{'measurements': [{'value': '6.25', 'spread': '21.185', 'groupId': 'OG000'}]}]}, {'title': 'Physical functioning, Year 3 , Week 48, n= 236', 'categories': [{'measurements': [{'value': '7.85', 'spread': '21.994', 'groupId': 'OG000'}]}]}, {'title': 'Physical functioning, Year 4 , Week 48, n= 212', 'categories': [{'measurements': [{'value': '6.38', 'spread': '22.112', 'groupId': 'OG000'}]}]}, {'title': 'Physical functioning, Year 5 , Week 48, n= 193', 'categories': [{'measurements': [{'value': '7.62', 'spread': '24.486', 'groupId': 'OG000'}]}]}, {'title': 'Physical functioning, Year 6 , Week 48, n= 185', 'categories': [{'measurements': [{'value': '6.72', 'spread': '24.81', 'groupId': 'OG000'}]}]}, {'title': 'Physical functioning, Year 7 , Week 48, n= 126', 'categories': [{'measurements': [{'value': '11.25', 'spread': '26.422', 'groupId': 'OG000'}]}]}, {'title': 'Physical functioning, Year 8 , Week 48, n= 65', 'categories': [{'measurements': [{'value': '11.83', 'spread': '27.065', 'groupId': 'OG000'}]}]}, {'title': 'Role emotional, Year 1 , Week 48, n= 261', 'categories': [{'measurements': [{'value': '4.96', 'spread': '25.714', 'groupId': 'OG000'}]}]}, {'title': 'Role emotional, Year 2 , Week 48, n= 254', 'categories': [{'measurements': [{'value': '4.74', 'spread': '27.92', 'groupId': 'OG000'}]}]}, {'title': 'Role emotional, Year 3 , Week 48, n= 236', 'categories': [{'measurements': [{'value': '3.73', 'spread': '28.258', 'groupId': 'OG000'}]}]}, {'title': 'Role emotional, Year 4 , Week 48, n= 212', 'categories': [{'measurements': [{'value': '3.32', 'spread': '28.237', 'groupId': 'OG000'}]}]}, {'title': 'Role emotional, Year 5 , Week 48, n= 193', 'categories': [{'measurements': [{'value': '3.61', 'spread': '28.774', 'groupId': 'OG000'}]}]}, {'title': 'Role emotional, Year 6 , Week 48, n= 185', 'categories': [{'measurements': [{'value': '3.13', 'spread': '31.614', 'groupId': 'OG000'}]}]}, {'title': 'Role emotional, Year 7 , Week 48, n= 126', 'categories': [{'measurements': [{'value': '3.27', 'spread': '30.385', 'groupId': 'OG000'}]}]}, {'title': 'Role emotional, Year 8 , Week 48, n=65', 'categories': [{'measurements': [{'value': '7.18', 'spread': '33.91', 'groupId': 'OG000'}]}]}, {'title': 'Role physical, Year 1 , Week 48, n= 260', 'categories': [{'measurements': [{'value': '8.91', 'spread': '26.393', 'groupId': 'OG000'}]}]}, {'title': 'Role physical, Year 2 , Week 48, n= 253', 'categories': [{'measurements': [{'value': '8', 'spread': '27.106', 'groupId': 'OG000'}]}]}, {'title': 'Role physical, Year 3 , Week 48, n= 236', 'categories': [{'measurements': [{'value': '10.05', 'spread': '26.525', 'groupId': 'OG000'}]}]}, {'title': 'Role physical, Year 4 , Week 48, n= 212', 'categories': [{'measurements': [{'value': '8.27', 'spread': '28.998', 'groupId': 'OG000'}]}]}, {'title': 'Role physical, Year 5 , Week 48, n= 193', 'categories': [{'measurements': [{'value': '10.86', 'spread': '29.839', 'groupId': 'OG000'}]}]}, {'title': 'Role physical, Year 6 , Week 48, n= 185', 'categories': [{'measurements': [{'value': '6.91', 'spread': '30.995', 'groupId': 'OG000'}]}]}, {'title': 'Role physical, Year 7 , Week 48, n= 126', 'categories': [{'measurements': [{'value': '13.53', 'spread': '31.347', 'groupId': 'OG000'}]}]}, {'title': 'Role physical, Year 8 , Week 48, n= 65', 'categories': [{'measurements': [{'value': '11.51', 'spread': '34.385', 'groupId': 'OG000'}]}]}, {'title': 'Social functioning, Year 1 , Week 48, n= 261', 'categories': [{'measurements': [{'value': '7.61', 'spread': '26.901', 'groupId': 'OG000'}]}]}, {'title': 'Social functioning, Year 2 , Week 48, n= 255', 'categories': [{'measurements': [{'value': '7.21', 'spread': '27.218', 'groupId': 'OG000'}]}]}, {'title': 'Social functioning, Year 3 , Week 48, n= 236', 'categories': [{'measurements': [{'value': '9.59', 'spread': '27.989', 'groupId': 'OG000'}]}]}, {'title': 'Social functioning, Year 4 , Week 48, n= 212', 'categories': [{'measurements': [{'value': '6.9', 'spread': '28.598', 'groupId': 'OG000'}]}]}, {'title': 'Social functioning, Year 5 , Week 48, n= 193', 'categories': [{'measurements': [{'value': '8.16', 'spread': '30.079', 'groupId': 'OG000'}]}]}, {'title': 'Social functioning, Year 6 , Week 48, n= 185', 'categories': [{'measurements': [{'value': '6.96', 'spread': '28.695', 'groupId': 'OG000'}]}]}, {'title': 'Social functioning, Year 7 , Week 48, n= 126', 'categories': [{'measurements': [{'value': '10.32', 'spread': '31.784', 'groupId': 'OG000'}]}]}, {'title': 'Social functioning, Year 8 , Week 48, n= 65', 'categories': [{'measurements': [{'value': '9.81', 'spread': '32.135', 'groupId': 'OG000'}]}]}, {'title': 'Vitality, Year 1 , Week 48, n= 260', 'categories': [{'measurements': [{'value': '8.87', 'spread': '21.449', 'groupId': 'OG000'}]}]}, {'title': 'Vitality, Year 2 , Week 48, n= 255', 'categories': [{'measurements': [{'value': '7.13', 'spread': '22.287', 'groupId': 'OG000'}]}]}, {'title': 'Vitality, Year 3 , Week 48, n= 236', 'categories': [{'measurements': [{'value': '8.17', 'spread': '20.742', 'groupId': 'OG000'}]}]}, {'title': 'Vitality, Year 4 , Week 48, n= 212', 'categories': [{'measurements': [{'value': '8.04', 'spread': '21.742', 'groupId': 'OG000'}]}]}, {'title': 'Vitality, Year 5 , Week 48, n= 193', 'categories': [{'measurements': [{'value': '8.23', 'spread': '24.937', 'groupId': 'OG000'}]}]}, {'title': 'Vitality, Year 6 , Week 48, n= 185', 'categories': [{'measurements': [{'value': '6.93', 'spread': '23.023', 'groupId': 'OG000'}]}]}, {'title': 'Vitality, Year 7 , Week 48, n= 126', 'categories': [{'measurements': [{'value': '11.69', 'spread': '22.709', 'groupId': 'OG000'}]}]}, {'title': 'Vitality, Year 8 , Week 48, n= 65', 'categories': [{'measurements': [{'value': '6.47', 'spread': '22.033', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Week 384', 'description': 'The SF-36v2 is a participant-reported survey to measure functional health and well-being. There are 36 items grouped into eight health domains: Vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health. SF-36v2 gives a score (0-100) for each of these domains as well as summary score for the physical component score (PCS) and mental component score (MCS) based on the responses by participants. The lower the score the more disability and the higher the score the less disability. The BL is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from BL was calculated as the individual post-BL value minus the BL value. Only those participants available at the specified time points were analyzed ( n=X).', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT Population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in FACIT-Fatigue Scale Total Score at Indicated Time Point', 'denoms': [{'units': 'Participants', 'counts': [{'value': '268', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Belimumab 10 mg/kg IV', 'description': 'Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.'}], 'classes': [{'title': 'Year 1, Week 48, n= 260', 'categories': [{'measurements': [{'value': '4.91', 'spread': '10.785', 'groupId': 'OG000'}]}]}, {'title': 'Year 2, Week 48, n= 252', 'categories': [{'measurements': [{'value': '4.82', 'spread': '11.414', 'groupId': 'OG000'}]}]}, {'title': 'Year 3, Week 48, n= 235', 'categories': [{'measurements': [{'value': '4.85', 'spread': '11.614', 'groupId': 'OG000'}]}]}, {'title': 'Year 4, Week 48, n= 210', 'categories': [{'measurements': [{'value': '4.14', 'spread': '11.269', 'groupId': 'OG000'}]}]}, {'title': 'Year 5, Week 48, n= 193', 'categories': [{'measurements': [{'value': '4.81', 'spread': '11.962', 'groupId': 'OG000'}]}]}, {'title': 'Year 6, Week 48, n= 184', 'categories': [{'measurements': [{'value': '3.7', 'spread': '11.787', 'groupId': 'OG000'}]}]}, {'title': 'Year 7, Week 48, n= 126', 'categories': [{'measurements': [{'value': '5.74', 'spread': '11.644', 'groupId': 'OG000'}]}]}, {'title': 'Year 8, Week 48, n= 65', 'categories': [{'measurements': [{'value': '4.28', 'spread': '10.949', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Week 384', 'description': 'The FACIT-F scale measures the severity and impact of fatigue on functioning and health related quality of life experienced in the past 7 days. FACIT-Fatigue scale total score was assessed at BL (Day 0), Wk 48 in first year, at Wk 48 in subsequent Yrs up to 8 Yrs.The level of fatigue is measured by 13 questions assessed on a four-point scale (0=not at all fatigued; 1=a little bit fatigued; 2=somewhat fatigued; 3=quite a bit fatigued; 4=very much fatigued; possible total score of 0 to 52). Change from BL in FACIT-Fatigue scale total score are summarized. The BL is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from BL was calculated as the individual post-BL value minus the BL value. A negative change from BL represents a worsening condition. Only those participants available at the specified time points were analyzed ( n=X).', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT Population'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Improvement in FACIT-Fatigue Scale Score Exceeding the MCID at Indicated Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '268', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Belimumab 10 mg/kg IV', 'description': 'Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.'}], 'classes': [{'title': 'Year 1, Week 48', 'categories': [{'measurements': [{'value': '50.4', 'groupId': 'OG000'}]}]}, {'title': 'Year 2, Week 48', 'categories': [{'measurements': [{'value': '45.9', 'groupId': 'OG000'}]}]}, {'title': 'Year 3, Week 48', 'categories': [{'measurements': [{'value': '44.4', 'groupId': 'OG000'}]}]}, {'title': 'Year 4, Week 48', 'categories': [{'measurements': [{'value': '36.2', 'groupId': 'OG000'}]}]}, {'title': 'Year 5, Week 48', 'categories': [{'measurements': [{'value': '40.3', 'groupId': 'OG000'}]}]}, {'title': 'Year 6, Week 48', 'categories': [{'measurements': [{'value': '33.2', 'groupId': 'OG000'}]}]}, {'title': 'Year 7, Week 48', 'categories': [{'measurements': [{'value': '26.1', 'groupId': 'OG000'}]}]}, {'title': 'Year 8, Week 48', 'categories': [{'measurements': [{'value': '13.1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Week 384', 'description': 'The FACIT-F scale measures the severity and impact of fatigue on functioning and health related quality of life experienced in the past 7 days. FACIT-Fatigue scale total score was assessed at BL (Day 0), Week 48 in first year, at Week 48 in subsequent years up to 8 years. The level of fatigue is measured by 13 questions assessed on a four-point scale (0=not at all fatigued; 1=a little bit fatigued; 2=somewhat fatigued; 3=quite a bit fatigued; 4=very much fatigued; possible total score of 0 to 52). Percentage of participants with improvement in FACIT-Fatigue scale score exceeding the minimum clinically important difference (MCID) (\\>=4 points) are summarized. Only those participants available at the specified time points were analyzed ( n=X).', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT Population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Belimumab 10 mg/kg IV', 'description': 'Participants, who had received belimumab 1milligram per kilogram (mg/kg) or 10 mg/kg or placebo in study HGS1006-C1056 , received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '268'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '140'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '128'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '25'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'Non-compliance with study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '31'}]}, {'type': 'Sponsor decision to end study', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}]}, {'type': 'Subject incarcerated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Developed withdrawal criteria- pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Subject moved out of state', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Elected to exit due to site closure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}], 'preAssignmentDetails': 'Participants with systemic lupus erythematosus who completed the Phase 3 HGS1006-C1056 were enrolled to receive belimumab'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '268', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Belimumab 10 mg/kg IV', 'description': 'Participants, who had received belimumab 1milligram per kilogram (mg/kg) or 10 mg/kg or placebo in study HGS1006-C1056 , received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '42.8', 'spread': '11.33', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '250', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Black or African American/African Heritage', 'categories': [{'measurements': [{'value': '57', 'groupId': 'BG000'}]}]}, {'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}, {'title': 'Asian: Central Asian Heritage', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Asian: East Asian Heritage', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Asian: Japanese Heritage', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'Asian: South Asian Heritage', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Asian: Southeast Asian Heritage', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'White: Middle East/North African Heritage', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'White: White/Caucasian/European Heritage', 'categories': [{'measurements': [{'value': '183', 'groupId': 'BG000'}]}]}, {'title': 'Mixed Race', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 268}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-10', 'studyFirstSubmitDate': '2008-07-28', 'resultsFirstSubmitDate': '2015-11-19', 'studyFirstSubmitQcDate': '2008-07-29', 'lastUpdatePostDateStruct': {'date': '2016-03-28', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-03-10', 'studyFirstPostDateStruct': {'date': '2008-07-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-03-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With the Indicated Type of Adverse Event (AEs) and Serious Adverse Event (SAEs)', 'timeFrame': 'Up to Week 440', 'description': 'An AE is defined as any untoward medical occurrence in a participant (par.) temporally associated with the use of a investigational product (IP), whether or not considered related to the IP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of an IP. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is an important medical event that jeopardizes the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, or is associated with liver injury and impaired liver function. Only those participants available at the specified time points (represented by n=X, in the category titles) were analyzed.'}, {'measure': 'AE Rates by System Organ Class (SOC) During the Study', 'timeFrame': 'Up Week 440', 'description': 'AE rates by SOC adjusting for participant-years on study drug anytime post Baseline are summarized, which included the follow up visits. Only treatment-emergent adverse events (AEs) are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. The event rate of an AE was calculated as the number of events per 100 participant years: Event Rate = 100\\* Number of Events / Participant Years. Participant years were calculated as sum across all participants (\\[last visit of interval day - first visit of interval day + 1\\]/365). Participant years excluded between study gaps if participant had not started extension study on date of last visit of parent study.'}, {'measure': 'SAE Rates by System Organ Class (SOC) During the Study', 'timeFrame': 'Up to Week 440', 'description': 'SAE rates by SOC adjusting for participants-years on study drug anytime post Baseline are summarized, which included the follow up visits. Only treatment-emergent SAEs are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. The event rate of an SAE was calculated as the number of events per 100 participant years: Event Rate = 100\\* Number of Events / participants Years. participants years were calculated as = sum across all participants (\\[last visit of interval day - first visit of interval day + 1\\]/365). participants years excluded between study gaps if participant had not started extension study on date of last visit of parent study.'}, {'measure': 'Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points', 'timeFrame': 'Up to Week 440', 'description': 'Hematology parameters were assessed at Baseline (BL) (Day 0), Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in APTT and PT is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post- Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.'}, {'measure': 'Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points', 'timeFrame': 'Up to Week 440', 'description': 'Hematology parameters were assessed at Baseline (BL) (Day 0), Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in basophils, eosinophils, lymphocytes, monocytes, neutrophils, neutrophils segmented and platelets is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post- Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.'}, {'measure': 'Change From Baseline in Erythrocytes at the Indicated Time Points', 'timeFrame': 'Up to Week 440', 'description': 'Hematology parameters were assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in erythrocytes is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post- Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.'}, {'measure': 'Change From Baseline in Hematocrit at the Indicated Time Points', 'timeFrame': 'Up to Week 440', 'description': 'Hematology parameters were assessed at Baseline (BL) (Day 0), Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in hematocrit is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post- Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.'}, {'measure': 'Change From Baseline in Hemoglobin at the Indicated Time Points', 'timeFrame': 'Up to Week 440', 'description': 'Hematology parameters were assessed at Baseline (BL) (Day 0), Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in hemoglobin is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post- Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.'}, {'measure': 'Change From Baseline in Albumin and Protein at the Indicated Time Points', 'timeFrame': 'Up to Week 440', 'description': 'Clinical chemistry parameters were assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in albumin and protein is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post- Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.'}, {'measure': 'Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points', 'timeFrame': 'Up to Week 440', 'description': 'Clinical chemistry parameters were assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in blood urea nitrogen, glucose, calcium, carbon dioxide, chloride, magnesium, phosphate, potassium and sodium is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post- Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.'}, {'measure': 'Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points', 'timeFrame': 'Up to Week 440', 'description': 'Clinical chemistry parameters were assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in urate, creatinine and bilirubin is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post- Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.'}, {'measure': 'Change From Baseline in Creatinine Clearance at the Indicated Time Points', 'timeFrame': 'Up to Week 440', 'description': 'Clinical chemistry parameters were assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in creatinine clearance is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post- Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.'}, {'measure': 'Change From Baseline in BUN/Creatinine at the Indicated Time Points', 'timeFrame': 'Up to Week 440', 'description': 'Clinical chemistry parameters were assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in BUN/creatinine is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post- Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.'}, {'measure': 'Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points', 'timeFrame': 'Up to Week 432', 'description': 'Clinical chemistry parameters were assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 432 weeks and at exit visit. Change from Baseline in alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, gamma glutamyl transferase and lactate dehydrogenase is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post- Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.'}, {'measure': 'Number of Participants With the Indicated Immunogenic Response', 'timeFrame': 'Up to Week 440', 'description': 'Immunogenic response was assessed by binding confirmatory assay at Baseline (BL) (Day 0), at Week 24 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Number of participants with the indicated immunogenic response are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Results of binding confirmatory assay were categorized as negative, persistent positive (defined as a positive immunogenic response that occurs at least 2 consecutive assessments or a single result at the final assessment) or transient positive (defined as a single positive immunogenic response that does not occur at the final assessment). Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.'}, {'measure': 'Systolic Blood Pressure and Diastolic Blood Pressure at Indicated Time Points.', 'timeFrame': 'Up to Week 432', 'description': 'Systolic blood pressure (SBP) and diastolic blood pressure (DBP) was measured at Baseline (BL) (Day 0), at Week 24 and 48 in first year, at Week 24 and 48 in subsequent years up to 432 weeks and at exit visit. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.'}, {'measure': 'Percentage of Participants With at Least 25% Increase From Baseline in Creatinine at Indicated Time Points.', 'timeFrame': 'Up to Week 440', 'description': 'Serum creatinine was assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Percentage of participants with at least 25% increase from baseline in creatinine are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.'}, {'measure': 'Percentage of Participants With at Least 25% Reduction From Baseline in Creatinine at Indicated Time Points. Amongst Subjects With Abnormal (>124 Umol/L) Creatinine at Baseline by Year Interval.', 'timeFrame': 'Up to Week 440', 'description': 'Serum creatinine was assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Percentage of participants with at least 25% reduction from baseline in creatinine are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Serum Immunoglobulins Below the Lower Limit of Normal at Indicated Time Points.', 'timeFrame': 'Up to Week 392', 'description': 'Serum immunoglobulin G (IgG) was collected at Baseline (BL) (Day 0), at Week 24 and Week 48 in first year, at Week 48 in subsequent years up to 8 years and at follow-up (up to 8 weeks post last infusion). Number of participants with serum immunoglobulins below the lower limit of normal (LLN) (\\<0.5 nanograms per milliliter \\[ng/mL\\]) are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.'}, {'measure': 'Percentage of Participants Achieving SRI Response at Indicated Time Points', 'timeFrame': 'Up to Week 440', 'description': 'The percentage of participants achieving a SLE Responder Index (SRI) response at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion) are summarized. The BL is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Response is defined as:\\>=4 point reduction from the BL in the safety of estrogen in lupus national assessment (SELENA) SLE disease activity index (SLEDAI) score and no worsening (increase of \\<0.30 points from the BL) in Physicians Global Assessment (PGA), and no new British Isles Lupus Assessment Group (BILAG) A organ domain score or 2 new BILAG B organ domain scores compared with the BL. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.'}, {'measure': 'Observed Anti-double Stranded DNA Levels at Indicated Time Points.', 'timeFrame': 'Up to Week 432', 'description': 'Anti-double stranded deoxyribonucleic acid (anti-dsDNA) levels were assessed at Baseline (BL) (Day 0), at Week 24 and 48 in first year, at Week 24 and 48 in subsequent years up to 432 weeks in participants who were positive at baseline (anti-dsDNA \\>=30 International Units/milliliter \\[IU/mL\\]). Observed anti-dsDNA levels are summarized. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.'}, {'measure': 'Median Percent Change From Baseline in Anti-double Stranded DNA at Indicated Time Points.', 'timeFrame': 'Up to Week 432', 'description': 'Anti-dsDNA levels were assessed at Baseline (BL) (Day 0), 24 and 48 in first year, at Week 24 and 48 in subsequent years up to 432 weeks and at exit visit in participants who were positive at baseline (anti-dsDNA ≥30 IU/mL). Median percent change from Baseline in anti-dsDNA levels are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Percent change from Baseline is calculated as: 100 x (\\[Post-Dose Visit Value - Baseline\\] / Baseline). Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.'}, {'measure': 'Observed Complement C3 and C4 Levels at Indicated Time Points', 'timeFrame': 'Up to Week 440', 'description': 'Complement C3 and C4 levels were assessed at Baseline (BL) (Day 0), at Week 24 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at exit visit in participants with low complements at Baseline (C3 \\<90 milligram per deciliter (mg/dL) and C4 \\<16 mg/dL). Observed complement C3 and C4 levels are summarized. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.'}, {'measure': 'Median Percent Change From Baseline in Complement C3 and C4 Levels at Indicated Time Points', 'timeFrame': 'Up to Week 432', 'description': 'Complement C3 and C4 levels were assessed at Baseline (BL) (Day 0), 24 and 48 in first year, at Week 24 and 48 in subsequent years up to 432 weeks and at exit visit in participants with low complements at Baseline (C3 \\<90 milligrams per decilitre (mg/dL) and C4 \\<16 mg/dL). Median percent change from Baseline in complement C3 and C4 levels are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Percent change from Baseline is calculated as: 100 x (\\[Post-Dose Visit Value - Baseline\\] / Baseline). Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.'}, {'measure': 'Percent of Participants With Daily Prednisone Dose Reduction at Indicated Time Points.', 'timeFrame': 'Up to Week 432', 'description': 'Trends for reduction in prednisone use in participants receiving belimumab were observed up to 432 weeks. Percentage of participants with daily prednisone dose reduced to \\<=7.5 mg/day from \\>7.5 mg/kg at the Baseline are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.'}, {'measure': 'Percent of Participants With >= 50% Reduction in Proteinuria at Indicated Time Points.', 'timeFrame': 'Up to Week 432', 'description': 'Proteinuria is defined as the presence of an excess of serum proteins in the urine. Trends for reduction in proteinuria in participants receiving belimumab were assessed up to 432 weeks and at Exit visit. Percentage of participants with \\>= 50% reduction in proteinuria among participants with Baseline proteinuria \\>0.5 g/24 hour (hr) are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.'}, {'measure': 'Observed B-cell Levels at Indicated Time Points.', 'timeFrame': 'Up to Week 432', 'description': 'B-cell levels were assessed at Baseline (BL) (Day 0), Week (Wk) 24 and 48 in first year, at Week 24 and 48 in subsequent years up to 432 weeks and at exit visit. Observed absolute B cell subsets (CD20+), CD19+/27BRIGHT/38BRIGHT SLE subset, CD19+20-27hi+ short-lived plasma cells (SLPC), CD20+/138+ plasmacytoid, CD20+/27+ memory, CD20+/27- naïve, CD20+/69+activated, CD20-/138+ plasma cells, Total CD19+ B-cells (CD19+) levels are summarized. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.'}, {'measure': 'Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.', 'timeFrame': 'Up to Week 432', 'description': 'B-cell levels were assessed at Baseline (BL) (Day 0), Week (Wk) 24 and 48 in first year, at Week 24 and 48 in subsequent years up to 432 weeks and at exit visit. Median percent change from Baseline in absolute B cell subsets (CD20+), CD19+/27BRIGHT/38BRIGHT SLE subset, CD19+20-27hi+ short-lived plasma cells (SLPC), CD20+/138+ plasmacytoid, CD20+/27+ memory, CD20+/27- naïve, CD20+/69+activated, CD20-/138+ plasma cells, Total CD19+ B-cells (CD19+) levels are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Percent change from Baseline is calculated as: 100 x (\\[Post-Dose Visit Value - Baseline\\] / Baseline). Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.'}, {'measure': 'Percentage of Participants With Worsening in SLICC/ACR Damage Index at Indicated Time Points', 'timeFrame': 'Up to Week 384', 'description': 'Systemic Lupus International Collaborative Clinics/American College of Rheumatology (SLICC/ACR) Damage Index is a tool used to assess non-reversible organ damage in SLE patients. Damage Index is used to assess 12 systems by 41 items. Score is given as 1 or sometimes 2, if occur more than once, so that that the maximum possible score is 47. Higher damage index scores early in disease are associated with a poor prognosis and with increased mortality. Damage index was assessed at BL (Day 0), Week 48 in first year, at Week 48 in subsequent years up to 8 years. Percentage of participants with worsening in damage index (change \\>0) are summarized. The BL is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Only those participants available at the specified time points were analyzed ( n=X).'}, {'measure': 'Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Time Point', 'timeFrame': 'Up to Week 384', 'description': 'The SF-36v2 is a participant-reported short form survey to measure functional health and well-being. There are 36 items grouped into eight health domains: Vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health. SF-36v2 gives a score (0-100) for each of these domains as well as summary score for the physical component score (PCS) and mental component score (MCS) based on the responses by participants. The lower the score the more disability and the higher the score the less disability. The BL is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from BL was calculated as the individual post-BL value minus the BL value. Only those participants available at the specified time points were analyzed ( n=X).'}, {'measure': 'Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints', 'timeFrame': 'Up to Week 384', 'description': 'The SF-36v2 is a participant-reported survey to measure functional health and well-being. There are 36 items grouped into eight health domains: Vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health. SF-36v2 gives a score (0-100) for each of these domains as well as summary score for the physical component score (PCS) and mental component score (MCS) based on the responses by participants. The lower the score the more disability and the higher the score the less disability. The BL is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from BL was calculated as the individual post-BL value minus the BL value. Only those participants available at the specified time points were analyzed ( n=X).'}, {'measure': 'Change From Baseline in FACIT-Fatigue Scale Total Score at Indicated Time Point', 'timeFrame': 'Up to Week 384', 'description': 'The FACIT-F scale measures the severity and impact of fatigue on functioning and health related quality of life experienced in the past 7 days. FACIT-Fatigue scale total score was assessed at BL (Day 0), Wk 48 in first year, at Wk 48 in subsequent Yrs up to 8 Yrs.The level of fatigue is measured by 13 questions assessed on a four-point scale (0=not at all fatigued; 1=a little bit fatigued; 2=somewhat fatigued; 3=quite a bit fatigued; 4=very much fatigued; possible total score of 0 to 52). Change from BL in FACIT-Fatigue scale total score are summarized. The BL is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from BL was calculated as the individual post-BL value minus the BL value. A negative change from BL represents a worsening condition. Only those participants available at the specified time points were analyzed ( n=X).'}, {'measure': 'Percentage of Participants With Improvement in FACIT-Fatigue Scale Score Exceeding the MCID at Indicated Time Points', 'timeFrame': 'Up to Week 384', 'description': 'The FACIT-F scale measures the severity and impact of fatigue on functioning and health related quality of life experienced in the past 7 days. FACIT-Fatigue scale total score was assessed at BL (Day 0), Week 48 in first year, at Week 48 in subsequent years up to 8 years. The level of fatigue is measured by 13 questions assessed on a four-point scale (0=not at all fatigued; 1=a little bit fatigued; 2=somewhat fatigued; 3=quite a bit fatigued; 4=very much fatigued; possible total score of 0 to 52). Percentage of participants with improvement in FACIT-Fatigue scale score exceeding the minimum clinically important difference (MCID) (\\>=4 points) are summarized. Only those participants available at the specified time points were analyzed ( n=X).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Systemic Lupus Erythematosus', 'Belimumab', 'SLE', 'Antibodies', 'Lupus', 'Autoimmune Diseases'], 'conditions': ['Systemic Lupus Erythematosus']}, 'referencesModule': {'references': [{'pmid': '30320964', 'type': 'DERIVED', 'citation': 'Strand V, Berry P, Lin X, Asukai Y, Punwaney R, Ramachandran S. Long-Term Impact of Belimumab on Health-Related Quality of Life and Fatigue in Patients With Systemic Lupus Erythematosus: Six Years of Treatment. Arthritis Care Res (Hoboken). 2019 Jun;71(6):829-838. doi: 10.1002/acr.23788. Epub 2019 Apr 29.'}, {'pmid': '29409143', 'type': 'DERIVED', 'citation': 'Furie RA, Wallace DJ, Aranow C, Fettiplace J, Wilson B, Mistry P, Roth DA, Gordon D. Long-Term Safety and Efficacy of Belimumab in Patients With Systemic Lupus Erythematosus: A Continuation of a Seventy-Six-Week Phase III Parent Study in the United States. Arthritis Rheumatol. 2018 Jun;70(6):868-877. doi: 10.1002/art.40439. Epub 2018 Apr 25.'}]}, 'descriptionModule': {'briefSummary': 'This is a continuation study to provide continuing treatment to subjects who completed study HGS1006-C1056 in the United States, to evaluate the long-term safety and efficacy of belimumab(LymphoStat-B™) in subjects with SLE disease.', 'detailedDescription': 'This is a long-term continuation study to provide continuing treatment to subjects who completed study HGS1006-C1056 in the United States. This study is to evaluate the long-term safety and efficacy of belimumab (LymphoStat-B™) in subjects with SLE disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have completed the HGS1006-C1056 protocol in the United States through Week 72 visit.\n* Be able to receive 1st dose of belimumab for HGS 1006-c1066 four weeks after last dose in HGS1006-c1056.\n\nExclusion Criteria:\n\n* Have developed any other medical disease or condition that has made the subject unsuitable for this study in the opinion of their physician.'}, 'identificationModule': {'nctId': 'NCT00724867', 'briefTitle': 'A Continuation Trial for Subjects With Lupus Who Completed Protocol HGS1006-C1056 in the United States', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'A Multi-Center, Continuation Trial of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects With Systemic Lupus Erythematosus (SLE) Who Completed the Phase 3 Protocol HGS1006-C1056 in the United States', 'orgStudyIdInfo': {'id': '112233'}, 'secondaryIdInfos': [{'id': 'HGS1006-C1066', 'type': 'OTHER', 'domain': 'Human Genome Sciences'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Belimumab 1 mg/kg', 'description': 'Belimumab 1 mg/kg IV every 28 days', 'interventionNames': ['Biological: Belimumab 1 mg/kg']}, {'type': 'EXPERIMENTAL', 'label': 'Belimumab 10 mg/kg', 'description': 'Belimumab 10 mg/kg IV every 28 days', 'interventionNames': ['Biological: Belimumab 10 mg/kg']}], 'interventions': [{'name': 'Belimumab 1 mg/kg', 'type': 'BIOLOGICAL', 'otherNames': ['BENLYSTA', 'HGS1006', 'LymphoStat-B™'], 'description': 'Belimumab 1 mg/kg IV over one hour every 28 days', 'armGroupLabels': ['Belimumab 1 mg/kg']}, {'name': 'Belimumab 10 mg/kg', 'type': 'BIOLOGICAL', 'otherNames': ['LymphoStat-B™', 'BENLYSTA', 'HGS1006'], 'description': 'Belimumab 10 mg/kg IV over one hour every 28 days', 'armGroupLabels': ['Belimumab 10 mg/kg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35249', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85032', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85724', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '90806', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '91786', 'city': 'Upland', 'state': 'California', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 34.09751, 'lon': -117.64839}}, {'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33180', 'city': 'Aventura', 'state': 'Florida', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 25.95648, 'lon': -80.13921}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '33614', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30303', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '46321', 'city': 'Munster', 'state': 'Indiana', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 41.56448, 'lon': -87.51254}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '70809', 'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}, {'zip': '21205', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21502', 'city': 'Cumberland', 'state': 'Maryland', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 39.65287, 'lon': -78.76252}}, {'zip': '21740', 'city': 'Hagerstown', 'state': 'Maryland', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 39.64176, 'lon': -77.71999}}, {'zip': '48109-5542', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 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