Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2025-12-26 @ 1:31 AM
Study NCT ID:
NCT00712933
Status:
COMPLETED
Last Update Posted:
2019-12-05
First Post:
2008-07-08
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Continuation Trial for Subjects With Lupus That Completed Protocol HGS1006-C1056 or HGS1006-C1057
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Australia', 'China', 'Costa Rica']}, '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 SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus)', 'description': 'The MITT consisted of all randomized participants who received at least one dose of trial medication.', 'eventGroups': [{'id': 'EG000', 'title': 'Belimumab 10mg/kg IV', 'description': 'Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial.', 'otherNumAtRisk': 735, 'deathsNumAtRisk': 735, 'otherNumAffected': 614, 'seriousNumAtRisk': 735, 'deathsNumAffected': 11, 'seriousNumAffected': 231}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 407, 'numAffected': 205}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 396, 'numAffected': 155}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 235, 'numAffected': 143}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 217, 'numAffected': 134}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 274, 'numAffected': 132}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 176, 'numAffected': 120}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 141, 'numAffected': 102}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Urinary tract infection bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 163, 'numAffected': 87}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 196, 'numAffected': 84}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 151, 'numAffected': 82}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 92, 'numAffected': 73}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 99, 'numAffected': 68}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 111, 'numAffected': 67}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 77, 'numAffected': 64}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 97, 'numAffected': 64}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 82, 'numAffected': 61}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 78, 'numAffected': 60}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 80, 'numAffected': 60}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 61, 'numAffected': 56}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 77, 'numAffected': 56}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 56, 'numAffected': 55}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 64, 'numAffected': 55}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Upper respiratory tract infection bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 108, 'numAffected': 54}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 59, 'numAffected': 52}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 70, 'numAffected': 50}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 57, 'numAffected': 49}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 59, 'numAffected': 49}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 73, 'numAffected': 49}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 62, 'numAffected': 48}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Bronchitis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 81, 'numAffected': 48}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 56, 'numAffected': 47}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 64, 'numAffected': 46}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 56, 'numAffected': 45}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 89, 'numAffected': 45}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 55, 'numAffected': 44}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 50, 'numAffected': 39}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 192, 'numAffected': 39}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pharyngitis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 85, 'numAffected': 39}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 41, 'numAffected': 38}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Rhinitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 47, 'numAffected': 37}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}], 'seriousEvents': [{'term': 'Pneumonia bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 16, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 14, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Lupus nephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 14, 'numAffected': 12}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Urinary tract infection bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 11, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Osteonecrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 10, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': "Raynaud's phenomenon", 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 9, 'numAffected': 5}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Lupus vasculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Bacterial pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Bacterial sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'SLE arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Systemic lupus erythematosus rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Abortion spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Abscess soft tissue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Acute sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Bronchitis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Cervical dysplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Cervix carcinoma stage 0', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Cytomegalovirus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Diarrhoea infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Drug hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Escherichia infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Fibromyalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Foot fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Haemolytic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Nephrotic syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Ovarian cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pelvic fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pyelonephritis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Radius fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Respiratory tract infection viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Soft tissue infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Subcutaneous abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Uterine leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Vasculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Wound infection bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Abdominal adhesions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Abdominal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Abdominal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Abscess of salivary gland', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Acinetobacter bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Acinetobacter infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Acute respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Agranulocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Amoebic dysentery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Anal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Aortic dissection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Aortic stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Aortic valve sclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Atelectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Atrioventricular block second degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Benign breast neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Benign neoplasm of skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Biliary dilatation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Bladder diverticulum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': "Bowen's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Bronchitis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Bursitis infective', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Bursitis infective staphylococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Cardiac tamponade', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Cardiogenic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Cellulitis staphylococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Cerebral thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Cholangitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Complication associated with device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Coronary artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Craniocerebral injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Cutaneous tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Cystitis haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Disseminated intravascular coagulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Drug eruption', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Duodenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Dysfunctional uterine bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Endometriosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Enterococcal bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Enterocolitis infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Erysipelas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Escherichia bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Escherichia sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Extrapyramidal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Face oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Femoral neck fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Fibula fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Food poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Fungaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Gallbladder non-functioning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Gastroenteritis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Gastrointestinal fungal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Gastrointestinal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Gastrointestinal viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Gestational diabetes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Haematemesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Haemorrhagic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Haemorrhagic ovarian cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Haemorrhoidal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Haemothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Hepatitis A', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Herpes zoster cutaneous disseminated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Hypoalbuminaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Infectious colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Infectious pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Intracranial pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Intraductal papilloma of breast', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Invasive ductal breast carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Joint abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Joint dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Joint tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Kidney infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Kyphosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Lacunar stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Latent tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Ligament sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Lower limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Lower respiratory tract inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Lupus enteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Lupus hepatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Lupus myocarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Lupus pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Maculopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Mania', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Meningitis aseptic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Mouth ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Myasthenia gravis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Neuropsychiatric lupus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Obesity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Osteochondrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Osteomyelitis chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Ovarian cyst ruptured', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Ovarian cyst torsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Panic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Papillary thyroid cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Paraplegia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Parasitic gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Parovarian cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pathological fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pelvic inflammatory disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pemphigoid', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pericarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pericarditis lupus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Peripheral artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Peripheral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Peripheral swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Peritonitis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Portal vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Post procedural fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Post procedural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Postoperative wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Proctitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pulmonary congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pulmonary haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pulmonary mycosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pulmonary tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pyoderma gangrenosum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Rectal adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Rectal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Rectal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Renal colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Renal impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Renal tubular acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Renal tubular necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Rhinitis hypertrophic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Salmonella bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Sialoadenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Skin candida', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Spinal compression fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Staphylococcal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Streptococcal bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Subdural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Tendon rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Tension headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Thrombotic thrombocytopenic purpura', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Tibia fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Tracheitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Tubo-ovarian abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Ulna fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Upper limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Upper respiratory tract infection bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Urinary tract infection fungal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Uterine haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Uterine polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Varicose vein', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Vertigo positional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Vulval cancer stage 0', 'stats': [{'groupId': 'EG000', 'numAtRisk': 735, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Adverse Events (AE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '735', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Belimumab 10mg/kg IV', 'description': 'Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial.'}], 'classes': [{'title': 'Any-time post Baseline,n=735', 'denoms': [{'units': 'Participants', 'counts': [{'value': '735', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '706', 'groupId': 'OG000'}]}]}, {'title': 'Year 0-1,n=735', 'denoms': [{'units': 'Participants', 'counts': [{'value': '735', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '617', 'groupId': 'OG000'}]}]}, {'title': 'Year 1-2 ,n =701', 'denoms': [{'units': 'Participants', 'counts': [{'value': '701', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '502', 'groupId': 'OG000'}]}]}, {'title': 'Year 2-3, n= 620', 'denoms': [{'units': 'Participants', 'counts': [{'value': '620', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '441', 'groupId': 'OG000'}]}]}, {'title': 'Year 3-4,n= 514', 'denoms': [{'units': 'Participants', 'counts': [{'value': '514', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '344', 'groupId': 'OG000'}]}]}, {'title': 'Year 4-5,n= 442', 'denoms': [{'units': 'Participants', 'counts': [{'value': '442', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '261', 'groupId': 'OG000'}]}]}, {'title': 'Year 5-6, n =345', 'denoms': [{'units': 'Participants', 'counts': [{'value': '345', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '181', 'groupId': 'OG000'}]}]}, {'title': 'Year 6-7, n= 219', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000'}]}]}, {'title': 'Year 7-8, n = 65', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}]}]}, {'title': 'Year 8 plus,n = 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 9 years', 'description': 'An adverse event is defined as any unfavorable or unintended sign, symptom, or disease that is temporally associated with the use of a study agent but is not necessarily caused by the study agent. This includes worsening (example: increase in frequency or severity) of preexisting conditions. Participants with incidences of any event at any time post-baseline are presented by yearly interval. Only treatment-emergent AEs are summarized.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT Population'}, {'type': 'PRIMARY', 'title': 'AE Rates by System Organ Class (SOC) During the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '735', 'groupId': 'OG000'}]}, {'units': 'Subject years', 'counts': [{'value': '3352', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Belimumab 10mg/kg IV', 'description': 'Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial.'}], 'classes': [{'title': 'Infections and infestations', 'categories': [{'measurements': [{'value': '101.8', 'groupId': 'OG000'}]}]}, {'title': 'Gastrointestinal disorders', 'categories': [{'measurements': [{'value': '32.8', 'groupId': 'OG000'}]}]}, {'title': 'Musculoskeletal and connective tissuedisorder', 'categories': [{'measurements': [{'value': '32.8', 'groupId': 'OG000'}]}]}, {'title': 'Nervous system disorders', 'categories': [{'measurements': [{'value': '22.6', 'groupId': 'OG000'}]}]}, {'title': 'Skin and subcutaneous and tissue disorders', 'categories': [{'measurements': [{'value': '22.5', 'groupId': 'OG000'}]}]}, {'title': 'Respiratory,thoracic and mediastinal disorder', 'categories': [{'measurements': [{'value': '14.9', 'groupId': 'OG000'}]}]}, {'title': 'Vascular disorders', 'categories': [{'measurements': [{'value': '13.3', 'groupId': 'OG000'}]}]}, {'title': 'General disorders and administration sitecondition', 'categories': [{'measurements': [{'value': '11.8', 'groupId': 'OG000'}]}]}, {'title': 'Injury, poisoning andprocedural complications', 'categories': [{'measurements': [{'value': '11.5', 'groupId': 'OG000'}]}]}, {'title': 'Blood and lymphatic system disorders', 'categories': [{'measurements': [{'value': '7.5', 'groupId': 'OG000'}]}]}, {'title': 'Eye disorders', 'categories': [{'measurements': [{'value': '6.6', 'groupId': 'OG000'}]}]}, {'title': 'Reproductive system and breast disorders', 'categories': [{'measurements': [{'value': '6.4', 'groupId': 'OG000'}]}]}, {'title': 'Investigations', 'categories': [{'measurements': [{'value': '5.8', 'groupId': 'OG000'}]}]}, {'title': 'Psychiatric disorders', 'categories': [{'measurements': [{'value': '5.6', 'groupId': 'OG000'}]}]}, {'title': 'Renal and urinary and disorder', 'categories': [{'measurements': [{'value': '5.3', 'groupId': 'OG000'}]}]}, {'title': 'Metabolism and nutrition disorder', 'categories': [{'measurements': [{'value': '3.6', 'groupId': 'OG000'}]}]}, {'title': 'Cardiac disorders', 'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000'}]}]}, {'title': 'Ear and labyrinth disorder', 'categories': [{'measurements': [{'value': '2.4', 'groupId': 'OG000'}]}]}, {'title': 'Neoplasms benign,malignant andunspecified', 'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000'}]}]}, {'title': 'Hepatobiliary disorders', 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000'}]}]}, {'title': 'Immune system disorder', 'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000'}]}]}, {'title': 'Endocrine disorders', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000'}]}]}, {'title': 'Social circumstances', 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000'}]}]}, {'title': 'Congenital, familial and genetic disorders', 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000'}]}]}, {'title': 'Pregnancy, puerperium and perinatal conditions', 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000'}]}]}, {'title': 'Product Issues', 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 9 years', '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 AEs are summarized. The event rate of an AE was calculated as the number of events per 100 participant years. Participant years were calculated as sum across all participants (\\[last visit of interval day - first visit of interval day + 1\\] divided by365). Participant years excluded between study gaps if participant had not started extension study on date of last visit of parent study.', 'unitOfMeasure': 'Adverse events per 100 participant years', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Subject years', 'denomUnitsSelected': 'Subject years', 'populationDescription': 'MITT Population'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Serious Adverse Events (SAE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '735', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Belimumab 10mg/kg IV', 'description': 'Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial.'}], 'classes': [{'title': 'Any post-Baseline,n=735', 'denoms': [{'units': 'Participants', 'counts': [{'value': '735', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '231', 'groupId': 'OG000'}]}]}, {'title': 'Year 0-1,n=735', 'denoms': [{'units': 'Participants', 'counts': [{'value': '735', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000'}]}]}, {'title': 'Year 1-2,n = 701', 'denoms': [{'units': 'Participants', 'counts': [{'value': '701', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}]}]}, {'title': 'Year 2-3,n = 620', 'denoms': [{'units': 'Participants', 'counts': [{'value': '620', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000'}]}]}, {'title': 'Year 3-4,n= 514', 'denoms': [{'units': 'Participants', 'counts': [{'value': '514', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}]}]}, {'title': 'Year 4-5 ,n= 442', 'denoms': [{'units': 'Participants', 'counts': [{'value': '442', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}]}]}, {'title': 'Year 5-6,n=345', 'denoms': [{'units': 'Participants', 'counts': [{'value': '345', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': 'Year 6-7,n= 219', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'Year 7-8,n= 65', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Year 8 plus,n= 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 9 years', 'description': 'An adverse event resulting in death, is life threatening (ie, an immediate threat to life), inpatient hospitalization, prolongation of existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect or any other situation which is medically important is categorized as SAE. Only treatment-emergent AEs are summarized.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT Population'}, {'type': 'PRIMARY', 'title': 'SAE Rates by SOC During the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '735', 'groupId': 'OG000'}]}, {'units': 'Subject years', 'counts': [{'value': '3352', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Belimumab 10mg/kg IV', 'description': 'Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial.'}], 'classes': [{'title': 'Infections and infestations', 'categories': [{'measurements': [{'value': '5.1', 'groupId': 'OG000'}]}]}, {'title': 'Blood and lymphatic system disorders', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000'}]}]}, {'title': 'Musculoskeletal and connective tissue disorder', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000'}]}]}, {'title': 'Gastrointestinal disorders', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000'}]}]}, {'title': 'Renal and urinary disorders', 'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000'}]}]}, {'title': 'Vascular disorders', 'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000'}]}]}, {'title': 'Injury, poisoning andprocedural complications', 'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000'}]}]}, {'title': 'General disorders and administration sitecondition', 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000'}]}]}, {'title': 'Nervous system disorders', 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000'}]}]}, {'title': 'Respiratory, thoracic and mediastinal disorder', 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000'}]}]}, {'title': 'Cardiac disorders', 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000'}]}]}, {'title': 'Skin and subcutaneous tissue disorders', 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000'}]}]}, {'title': 'Neoplasms benign, malignant and unspecified', 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000'}]}]}, {'title': 'Reproductive system and breast disorder', 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000'}]}]}, {'title': 'Psychiatric disorders', 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000'}]}]}, {'title': 'Hepatobiliary disorders', 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000'}]}]}, {'title': 'Metabolism and nutrition disorders', 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000'}]}]}, {'title': 'Pregnancy, puerperium and perinatal condition', 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000'}]}]}, {'title': 'Endocrine disorders', 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000'}]}]}, {'title': 'Immune system disorders', 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000'}]}]}, {'title': 'Ear and labyrinth disorders', 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000'}]}]}, {'title': 'Eye disorders', 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 9 years', '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 event rate of an SAE was calculated as the number of events per 100 participant years. Participants years were calculated as = sum across all participants (\\[last visit of interval day - first visit of interval day + 1\\] divided by 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 per 100 participant years', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Subject years', 'denomUnitsSelected': 'Subject years', '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': '735', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Belimumab 10mg/kg IV', 'description': 'Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial.'}], 'classes': [{'title': 'Year1,Week4,APTT,n=208', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': '5.27', 'groupId': 'OG000'}]}]}, {'title': 'Year1,Week12,APTT,n=208', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.1', 'spread': '12.31', 'groupId': 'OG000'}]}]}, {'title': 'Year1,Week24,APTT,n=686', 'denoms': [{'units': 'Participants', 'counts': [{'value': '686', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '9.10', 'groupId': 'OG000'}]}]}, {'title': 'Year1,Week36,APTT,n=193', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.5', 'spread': '5.75', 'groupId': 'OG000'}]}]}, {'title': 'Year1,Week48,APTT,n=666', 'denoms': [{'units': 'Participants', 'counts': [{'value': '666', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.8', 'spread': '9.48', 'groupId': 'OG000'}]}]}, {'title': 'Year2,Week24,APTT,n=625', 'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.7', 'spread': '9.74', 'groupId': 'OG000'}]}]}, {'title': 'Year2,Week48,APTT,n=572', 'denoms': [{'units': 'Participants', 'counts': [{'value': '572', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.7', 'spread': '9.66', 'groupId': 'OG000'}]}]}, {'title': 'Year3,Week24,APTT,n=521', 'denoms': [{'units': 'Participants', 'counts': [{'value': '521', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.4', 'spread': '10.01', 'groupId': 'OG000'}]}]}, {'title': 'Year3,Week48,APTT,n=470', 'denoms': [{'units': 'Participants', 'counts': [{'value': '470', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.9', 'spread': '11.41', 'groupId': 'OG000'}]}]}, {'title': 'Year4,Week24,APTT,n=422', 'denoms': [{'units': 'Participants', 'counts': [{'value': '422', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.5', 'spread': '10.70', 'groupId': 'OG000'}]}]}, {'title': 'Year4,Week48,APTT,n=412', 'denoms': [{'units': 'Participants', 'counts': [{'value': '412', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.2', 'spread': '6.63', 'groupId': 'OG000'}]}]}, {'title': 'Year5,Week24,APTT,n=383', 'denoms': [{'units': 'Participants', 'counts': [{'value': '383', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.1', 'spread': '10.71', 'groupId': 'OG000'}]}]}, {'title': 'Year5,Week48,APTT,n=349', 'denoms': [{'units': 'Participants', 'counts': [{'value': '349', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.5', 'spread': '6.35', 'groupId': 'OG000'}]}]}, {'title': 'Year6,Week24,APTT,n=292', 'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.8', 'spread': '6.58', 'groupId': 'OG000'}]}]}, {'title': 'Year6,Week48,APTT,n=277', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.3', 'spread': '7.91', 'groupId': 'OG000'}]}]}, {'title': 'Year7,Week24,APTT,n=177', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.4', 'spread': '14.52', 'groupId': 'OG000'}]}]}, {'title': 'Year7,Week48,APTT,n=131', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.1', 'spread': '6.23', 'groupId': 'OG000'}]}]}, {'title': 'Year8,Week24,APTT,n=52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.6', 'spread': '7.54', 'groupId': 'OG000'}]}]}, {'title': 'Year8,Week48,APTT,n=13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.2', 'spread': '3.98', 'groupId': 'OG000'}]}]}, {'title': 'Year9,Week24,APTT,n=6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.0', 'spread': '6.39', 'groupId': 'OG000'}]}]}, {'title': 'Year9,Week48,APTT,n=1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.0', 'spread': 'NA', 'comment': 'NA indicates standard deviation was not calculable for a single data point', 'groupId': 'OG000'}]}]}, {'title': 'Exit, APTT,n=586', 'denoms': [{'units': 'Participants', 'counts': [{'value': '586', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.2', 'spread': '10.71', 'groupId': 'OG000'}]}]}, {'title': '8 Week,Follow up,n=524', 'denoms': [{'units': 'Participants', 'counts': [{'value': '524', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.4', 'spread': '8.14', 'groupId': 'OG000'}]}]}, {'title': 'Year1,Week4,PT,n=205', 'denoms': [{'units': 'Participants', 'counts': [{'value': '205', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.22', 'spread': '5.139', 'groupId': 'OG000'}]}]}, {'title': 'Year1,Week12,PT,n=206', 'denoms': [{'units': 'Participants', 'counts': [{'value': '206', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.71', 'spread': '19.533', 'groupId': 'OG000'}]}]}, {'title': 'Year1,Week24,PT,n=686', 'denoms': [{'units': 'Participants', 'counts': [{'value': '686', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.43', 'spread': '8.267', 'groupId': 'OG000'}]}]}, {'title': 'Year1,Week36,PT,n=193', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.13', 'spread': '3.357', 'groupId': 'OG000'}]}]}, {'title': 'Year1,Week48,PT,n=666', 'denoms': [{'units': 'Participants', 'counts': [{'value': '666', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.45', 'spread': '8.174', 'groupId': 'OG000'}]}]}, {'title': 'Year2,Week24,PT,n=626', 'denoms': [{'units': 'Participants', 'counts': [{'value': '626', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.15', 'spread': '11.528', 'groupId': 'OG000'}]}]}, {'title': 'Year2,Week48,PT,n=572', 'denoms': [{'units': 'Participants', 'counts': [{'value': '572', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.26', 'spread': '8.925', 'groupId': 'OG000'}]}]}, {'title': 'Year3,Week24,PT,n=521', 'denoms': [{'units': 'Participants', 'counts': [{'value': '521', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.12', 'spread': '9.609', 'groupId': 'OG000'}]}]}, {'title': 'Year3,Week48,PT,n=469', 'denoms': [{'units': 'Participants', 'counts': [{'value': '469', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.63', 'spread': '14.334', 'groupId': 'OG000'}]}]}, {'title': 'Year4,Week24,PT,n=422', 'denoms': [{'units': 'Participants', 'counts': [{'value': '422', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.06', 'spread': '10.458', 'groupId': 'OG000'}]}]}, {'title': 'Year4,Week48,PT,n=412', 'denoms': [{'units': 'Participants', 'counts': [{'value': '412', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.40', 'spread': '4.228', 'groupId': 'OG000'}]}]}, {'title': 'Year5,Week24,PT,n=384', 'denoms': [{'units': 'Participants', 'counts': [{'value': '384', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.14', 'spread': '10.810', 'groupId': 'OG000'}]}]}, {'title': 'Year5,Week48,PT,n=349', 'denoms': [{'units': 'Participants', 'counts': [{'value': '349', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.61', 'spread': '11.276', 'groupId': 'OG000'}]}]}, {'title': 'Year6,Week24,PT,n=292', 'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.64', 'spread': '8.023', 'groupId': 'OG000'}]}]}, {'title': 'Year6,Week48,PT,n=278', 'denoms': [{'units': 'Participants', 'counts': [{'value': '278', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.85', 'spread': '12.414', 'groupId': 'OG000'}]}]}, {'title': 'Year7,Week24,PT,n=177', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.76', 'spread': '14.272', 'groupId': 'OG000'}]}]}, {'title': 'Year7,Week48,PT,n=131', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.36', 'spread': '2.290', 'groupId': 'OG000'}]}]}, {'title': 'Year8,Week24,PT,n=52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.21', 'spread': '6.716', 'groupId': 'OG000'}]}]}, {'title': 'Year8,Week48,PT,n=13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.52', 'spread': '0.600', 'groupId': 'OG000'}]}]}, {'title': 'Year9,Week24,PT,n=6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.50', 'spread': '0.657', 'groupId': 'OG000'}]}]}, {'title': 'Year9,Week48,PT,n=1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.00', 'spread': 'NA', 'comment': 'NA indicates standard deviation was not calculable for a single data point', 'groupId': 'OG000'}]}]}, {'title': 'Exit,PT, n=587', 'denoms': [{'units': 'Participants', 'counts': [{'value': '587', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.25', 'spread': '9.973', 'groupId': 'OG000'}]}]}, {'title': '8 Week, Follow up,n=524', 'denoms': [{'units': 'Participants', 'counts': [{'value': '524', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.50', 'spread': '4.965', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and up to 9 years', 'description': 'Hematology parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 hematology parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in APTT and PT is summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were 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. NA indicates standard deviation was not calculable for a single data point', 'unitOfMeasure': 'Seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT Population'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '735', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Belimumab 10mg/kg IV', 'description': 'Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial.'}], 'classes': [{'title': 'Baso,Year1,Week4,n=693', 'denoms': [{'units': 'Participants', 'counts': [{'value': '693', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.002', 'spread': '0.0172', 'groupId': 'OG000'}]}]}, {'title': 'Baso,Year1,Week12,n=694', 'denoms': [{'units': 'Participants', 'counts': [{'value': '694', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.002', 'spread': '0.0187', 'groupId': 'OG000'}]}]}, {'title': 'Baso,Year1,Week24,n=696', 'denoms': [{'units': 'Participants', 'counts': [{'value': '696', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.002', 'spread': '0.0176', 'groupId': 'OG000'}]}]}, {'title': 'Baso,Year1,Week36,n=682', 'denoms': [{'units': 'Participants', 'counts': [{'value': '682', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.002', 'spread': '0.0179', 'groupId': 'OG000'}]}]}, {'title': 'Baso,Year1,Week48,n=684', 'denoms': [{'units': 'Participants', 'counts': [{'value': '684', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.003', 'spread': '0.0183', 'groupId': 'OG000'}]}]}, {'title': 'Baso,Year2,Week24,n=629', 'denoms': [{'units': 'Participants', 'counts': [{'value': '629', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.004', 'spread': '0.0190', 'groupId': 'OG000'}]}]}, {'title': 'Baso,Year2,Week48,n=589', 'denoms': [{'units': 'Participants', 'counts': [{'value': '589', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.004', 'spread': '0.0200', 'groupId': 'OG000'}]}]}, {'title': 'Baso,Year3,Week24,n=533', 'denoms': [{'units': 'Participants', 'counts': [{'value': '533', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.005', 'spread': '0.0165', 'groupId': 'OG000'}]}]}, {'title': 'Baso,Year3,Week48,n=476', 'denoms': [{'units': 'Participants', 'counts': [{'value': '476', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.008', 'spread': '0.0194', 'groupId': 'OG000'}]}]}, {'title': 'Baso,Year4,Week24,n=446', 'denoms': [{'units': 'Participants', 'counts': [{'value': '446', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.007', 'spread': '0.0192', 'groupId': 'OG000'}]}]}, {'title': 'Baso,Year4,Week48,n=423', 'denoms': [{'units': 'Participants', 'counts': [{'value': '423', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.008', 'spread': '0.0202', 'groupId': 'OG000'}]}]}, {'title': 'Baso,Year5,Week24,n=389', 'denoms': [{'units': 'Participants', 'counts': [{'value': '389', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.007', 'spread': '0.0191', 'groupId': 'OG000'}]}]}, {'title': 'Baso,Year5,Week48,n=360', 'denoms': [{'units': 'Participants', 'counts': [{'value': '360', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.005', 'spread': '0.0191', 'groupId': 'OG000'}]}]}, {'title': 'Baso,Year6,Week24,n=306', 'denoms': [{'units': 'Participants', 'counts': [{'value': '306', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.006', 'spread': '0.0184', 'groupId': 'OG000'}]}]}, {'title': 'Baso,Year6,Week48,n=282', 'denoms': [{'units': 'Participants', 'counts': [{'value': '282', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.007', 'spread': '0.0198', 'groupId': 'OG000'}]}]}, {'title': 'Baso,Year7,Week24,n=181', 'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.007', 'spread': '0.0211', 'groupId': 'OG000'}]}]}, {'title': 'Baso,Year7,Week48,n=130', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.012', 'spread': '0.0259', 'groupId': 'OG000'}]}]}, {'title': 'Baso,Year8,Week24,n=52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.014', 'spread': '0.0187', 'groupId': 'OG000'}]}]}, {'title': 'Baso,Year8,Week48,n=13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.001', 'spread': '0.0166', 'groupId': 'OG000'}]}]}, {'title': 'Baso,Year9,Week24,n=6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.003', 'spread': '0.0082', 'groupId': 'OG000'}]}]}, {'title': 'Baso,Year9,Week48,n=1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.010', 'spread': 'NA', 'comment': 'NA indicates standard deviation was not calculable for a single data point.', 'groupId': 'OG000'}]}]}, {'title': 'Baso,Exit,n=614', 'denoms': [{'units': 'Participants', 'counts': [{'value': '614', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.005', 'spread': '0.0204', 'groupId': 'OG000'}]}]}, {'title': 'Baso,8 Week,Follow up,n=532', 'denoms': [{'units': 'Participants', 'counts': [{'value': '532', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.009', 'spread': '0.0253', 'groupId': 'OG000'}]}]}, {'title': 'Eos,Year1,Week4,n=693', 'denoms': [{'units': 'Participants', 'counts': [{'value': '693', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.007', 'spread': '0.1597', 'groupId': 'OG000'}]}]}, {'title': 'Eos,Year1,Week12,n=694', 'denoms': [{'units': 'Participants', 'counts': [{'value': '694', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.003', 'spread': '0.1595', 'groupId': 'OG000'}]}]}, {'title': 'Eos,Year1,Week24,n=696', 'denoms': [{'units': 'Participants', 'counts': [{'value': '696', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.000', 'spread': '0.1614', 'groupId': 'OG000'}]}]}, {'title': 'Eos,Year1,Week36,n=682', 'denoms': [{'units': 'Participants', 'counts': [{'value': '682', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.020', 'spread': '0.1866', 'groupId': 'OG000'}]}]}, {'title': 'Eos,Year1,Week48,n=684', 'denoms': [{'units': 'Participants', 'counts': [{'value': '684', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.001', 'spread': '0.1763', 'groupId': 'OG000'}]}]}, {'title': 'Eos,Year2,Week24,n=629', 'denoms': [{'units': 'Participants', 'counts': [{'value': '629', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.004', 'spread': '0.1605', 'groupId': 'OG000'}]}]}, {'title': 'Eos,Year2,Week48,n=589', 'denoms': [{'units': 'Participants', 'counts': [{'value': '589', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.004', 'spread': '0.1858', 'groupId': 'OG000'}]}]}, {'title': 'Eos,Year3,Week24,n=533', 'denoms': [{'units': 'Participants', 'counts': [{'value': '533', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.011', 'spread': '0.2074', 'groupId': 'OG000'}]}]}, {'title': 'Eos,Year3,Week48,n=476', 'denoms': [{'units': 'Participants', 'counts': [{'value': '476', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.026', 'spread': '0.2053', 'groupId': 'OG000'}]}]}, {'title': 'Eos,Year4,Week24,n=446', 'denoms': [{'units': 'Participants', 'counts': [{'value': '446', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.041', 'spread': '0.1792', 'groupId': 'OG000'}]}]}, {'title': 'Eos,Year4,Week48,n=423', 'denoms': [{'units': 'Participants', 'counts': [{'value': '423', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.047', 'spread': '0.1676', 'groupId': 'OG000'}]}]}, {'title': 'Eos,Year5,Week24,n=389', 'denoms': [{'units': 'Participants', 'counts': [{'value': '389', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.035', 'spread': '0.1949', 'groupId': 'OG000'}]}]}, {'title': 'Eos,Year5,Week48,n=360', 'denoms': [{'units': 'Participants', 'counts': [{'value': '360', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.045', 'spread': '0.1807', 'groupId': 'OG000'}]}]}, {'title': 'Eos,Year6,Week24,n=306', 'denoms': [{'units': 'Participants', 'counts': [{'value': '306', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.046', 'spread': '0.1801', 'groupId': 'OG000'}]}]}, {'title': 'Eos,Year6,Week48,n=282', 'denoms': [{'units': 'Participants', 'counts': [{'value': '282', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.037', 'spread': '0.1976', 'groupId': 'OG000'}]}]}, {'title': 'Eos,Year7,Week24,n=181', 'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.046', 'spread': '0.1710', 'groupId': 'OG000'}]}]}, {'title': 'Eos,Year7,Week48,n=130', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.020', 'spread': '0.2276', 'groupId': 'OG000'}]}]}, {'title': 'Eos,Year8,Week24,n=52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.017', 'spread': '0.1753', 'groupId': 'OG000'}]}]}, {'title': 'Eos,Year8,Week48,n=13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.041', 'spread': '0.1130', 'groupId': 'OG000'}]}]}, {'title': 'Eos,Year9,Week24,n=6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.088', 'spread': '0.1078', 'groupId': 'OG000'}]}]}, {'title': 'Eos,Year9,Week48,n=1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.040', 'spread': 'NA', 'comment': 'NA indicates standard deviation was not calculable for a single data point.', 'groupId': 'OG000'}]}]}, {'title': 'Eos, Exit, n=614', 'denoms': [{'units': 'Participants', 'counts': [{'value': '614', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.026', 'spread': '0.1754', 'groupId': 'OG000'}]}]}, {'title': 'Eso, 8 Week Follow up, n=532', 'denoms': [{'units': 'Participants', 'counts': [{'value': '532', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.030', 'spread': '0.1920', 'groupId': 'OG000'}]}]}, {'title': 'Leu,Year1,Week4,n=696', 'denoms': [{'units': 'Participants', 'counts': [{'value': '696', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.16', 'spread': '1.928', 'groupId': 'OG000'}]}]}, {'title': 'Leu,Year1,Week12,n=697', 'denoms': [{'units': 'Participants', 'counts': [{'value': '697', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.19', 'spread': '2.106', 'groupId': 'OG000'}]}]}, {'title': 'Leu,Year1,Week24,n=697', 'denoms': [{'units': 'Participants', 'counts': [{'value': '697', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.04', 'spread': '2.142', 'groupId': 'OG000'}]}]}, {'title': 'Leu,Year1,Week36,n=682', 'denoms': [{'units': 'Participants', 'counts': [{'value': '682', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.05', 'spread': '2.190', 'groupId': 'OG000'}]}]}, {'title': 'Leu,Year1,Week48,n=684', 'denoms': [{'units': 'Participants', 'counts': [{'value': '684', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.02', 'spread': '2.274', 'groupId': 'OG000'}]}]}, {'title': 'Leu,Year2,Week24,n=630', 'denoms': [{'units': 'Participants', 'counts': [{'value': '630', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.19', 'spread': '2.287', 'groupId': 'OG000'}]}]}, {'title': 'Leu,Year2,Week48,n=589', 'denoms': [{'units': 'Participants', 'counts': [{'value': '589', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.11', 'spread': '2.449', 'groupId': 'OG000'}]}]}, {'title': 'Leu,Year3,Week24,n=533', 'denoms': [{'units': 'Participants', 'counts': [{'value': '533', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.03', 'spread': '2.544', 'groupId': 'OG000'}]}]}, {'title': 'Leu,Year3,Week24,n=476', 'denoms': [{'units': 'Participants', 'counts': [{'value': '476', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.06', 'spread': '2.393', 'groupId': 'OG000'}]}]}, {'title': 'Leu,Year4,Week24,n=446', 'denoms': [{'units': 'Participants', 'counts': [{'value': '446', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.01', 'spread': '2.520', 'groupId': 'OG000'}]}]}, {'title': 'Leu,Year4,Week48,n=423', 'denoms': [{'units': 'Participants', 'counts': [{'value': '423', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.06', 'spread': '2.661', 'groupId': 'OG000'}]}]}, {'title': 'Leu,Year5,Week24,n=389', 'denoms': [{'units': 'Participants', 'counts': [{'value': '389', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.05', 'spread': '2.430', 'groupId': 'OG000'}]}]}, {'title': 'Leu,Year5,Week48,n=360', 'denoms': [{'units': 'Participants', 'counts': [{'value': '360', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.06', 'spread': '2.463', 'groupId': 'OG000'}]}]}, {'title': 'Leu,Year6,Week24,n=306', 'denoms': [{'units': 'Participants', 'counts': [{'value': '306', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.04', 'spread': '2.449', 'groupId': 'OG000'}]}]}, {'title': 'Leu,Year6,Week48,n=282', 'denoms': [{'units': 'Participants', 'counts': [{'value': '282', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.17', 'spread': '2.579', 'groupId': 'OG000'}]}]}, {'title': 'Leu,Year7,Week24,n=181', 'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.12', 'spread': '2.395', 'groupId': 'OG000'}]}]}, {'title': 'Leu,Year7,Week48,n=130', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.48', 'spread': '2.354', 'groupId': 'OG000'}]}]}, {'title': 'Leu,Year8,Week24,n=52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.38', 'spread': '2.761', 'groupId': 'OG000'}]}]}, {'title': 'Leu,Year8,Week48,n=13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.65', 'spread': '3.136', 'groupId': 'OG000'}]}]}, {'title': 'Leu,Year9,Week24,n=6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.35', 'spread': '3.422', 'groupId': 'OG000'}]}]}, {'title': 'Leu,Year9,Week48,n=1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.90', 'spread': 'NA', 'comment': 'NA indicates standard deviation was not calculable for a single data point.', 'groupId': 'OG000'}]}]}, {'title': 'Leu, Exit, n=614', 'denoms': [{'units': 'Participants', 'counts': [{'value': '614', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.18', 'spread': '2.650', 'groupId': 'OG000'}]}]}, {'title': 'Leu, 8 Week Follow up,n=532', 'denoms': [{'units': 'Participants', 'counts': [{'value': '532', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.21', 'spread': '2.496', 'groupId': 'OG000'}]}]}, {'title': 'Lymp,Year1,Week4,n=693', 'denoms': [{'units': 'Participants', 'counts': [{'value': '693', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.093', 'spread': '0.5986', 'groupId': 'OG000'}]}]}, {'title': 'Lymp,Year1,Week12,n=694', 'denoms': [{'units': 'Participants', 'counts': [{'value': '694', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.107', 'spread': '0.6607', 'groupId': 'OG000'}]}]}, {'title': 'Lymp,Year1,Week24,n=696', 'denoms': [{'units': 'Participants', 'counts': [{'value': '696', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.066', 'spread': '0.6544', 'groupId': 'OG000'}]}]}, {'title': 'Lymp,Year1,Week36,n=682', 'denoms': [{'units': 'Participants', 'counts': [{'value': '682', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.119', 'spread': '0.6583', 'groupId': 'OG000'}]}]}, {'title': 'Lymp,Year1,Week48,n=684', 'denoms': [{'units': 'Participants', 'counts': [{'value': '684', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.048', 'spread': '0.6361', 'groupId': 'OG000'}]}]}, {'title': 'Lymp,Year2,Week24,n=629', 'denoms': [{'units': 'Participants', 'counts': [{'value': '629', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.051', 'spread': '0.6898', 'groupId': 'OG000'}]}]}, {'title': 'Lymp,Year2,Week48,n=589', 'denoms': [{'units': 'Participants', 'counts': [{'value': '589', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.067', 'spread': '0.6971', 'groupId': 'OG000'}]}]}, {'title': 'Lymp,Year3,Week24,n=533', 'denoms': [{'units': 'Participants', 'counts': [{'value': '533', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.057', 'spread': '0.6717', 'groupId': 'OG000'}]}]}, {'title': 'Lymp,Year3,Week48,n=476', 'denoms': [{'units': 'Participants', 'counts': [{'value': '476', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.038', 'spread': '0.6676', 'groupId': 'OG000'}]}]}, {'title': 'Lymp,Year4,Week24,n=446', 'denoms': [{'units': 'Participants', 'counts': [{'value': '446', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.054', 'spread': '0.6858', 'groupId': 'OG000'}]}]}, {'title': 'Lymp,Year4,Week48,n=423', 'denoms': [{'units': 'Participants', 'counts': [{'value': '423', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.067', 'spread': '0.7186', 'groupId': 'OG000'}]}]}, {'title': 'Lymp,Year5,Week24,n=389', 'denoms': [{'units': 'Participants', 'counts': [{'value': '389', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.023', 'spread': '0.6810', 'groupId': 'OG000'}]}]}, {'title': 'Lymp,Year5,Week48,n=360', 'denoms': [{'units': 'Participants', 'counts': [{'value': '360', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.078', 'spread': '0.7485', 'groupId': 'OG000'}]}]}, {'title': 'Lymp,Year6,Week24,n=306', 'denoms': [{'units': 'Participants', 'counts': [{'value': '306', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.147', 'spread': '0.7251', 'groupId': 'OG000'}]}]}, {'title': 'Lymp,Year6,Week48,n=282', 'denoms': [{'units': 'Participants', 'counts': [{'value': '282', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.168', 'spread': '0.7523', 'groupId': 'OG000'}]}]}, {'title': 'Lymp,Year7,Week24,n=181', 'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.175', 'spread': '0.7670', 'groupId': 'OG000'}]}]}, {'title': 'Lymp,Year7,Week48,n=130', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.169', 'spread': '0.6639', 'groupId': 'OG000'}]}]}, {'title': 'Lymp,Year8,Week24,n=52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.300', 'spread': '0.7553', 'groupId': 'OG000'}]}]}, {'title': 'Lymp,Year8,Week48,n=13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.052', 'spread': '0.5252', 'groupId': 'OG000'}]}]}, {'title': 'Lymp,Year9,Week24,n=6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.032', 'spread': '0.6156', 'groupId': 'OG000'}]}]}, {'title': 'Lymp,Year9,Week48,n=1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.460', 'spread': 'NA', 'comment': 'NA indicates standard deviation was not calculable for a single data point', 'groupId': 'OG000'}]}]}, {'title': 'Lymp,Exit,n=614', 'denoms': [{'units': 'Participants', 'counts': [{'value': '614', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.128', 'spread': '0.7808', 'groupId': 'OG000'}]}]}, {'title': 'Lymp,8 Week Follow up,n=532', 'denoms': [{'units': 'Participants', 'counts': [{'value': '532', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.140', 'spread': '0.7453', 'groupId': 'OG000'}]}]}, {'title': 'Mono,Year1,Week4,n=693', 'denoms': [{'units': 'Participants', 'counts': [{'value': '693', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.025', 'spread': '0.2108', 'groupId': 'OG000'}]}]}, {'title': 'Mono,Year1,Week12,n=694', 'denoms': [{'units': 'Participants', 'counts': [{'value': '694', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.036', 'spread': '0.2043', 'groupId': 'OG000'}]}]}, {'title': 'Mono,Year1,Week24,n=696', 'denoms': [{'units': 'Participants', 'counts': [{'value': '696', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.028', 'spread': '0.2127', 'groupId': 'OG000'}]}]}, {'title': 'Mono,Year1,Week36,n=682', 'denoms': [{'units': 'Participants', 'counts': [{'value': '682', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.053', 'spread': '0.2053', 'groupId': 'OG000'}]}]}, {'title': 'Mono,Year1,Week48,n=684', 'denoms': [{'units': 'Participants', 'counts': [{'value': '684', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.050', 'spread': '0.2069', 'groupId': 'OG000'}]}]}, {'title': 'Mono,Year2,Week24,n=629', 'denoms': [{'units': 'Participants', 'counts': [{'value': '629', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.034', 'spread': '0.1992', 'groupId': 'OG000'}]}]}, {'title': 'Mono,Year2,Week48,n=589', 'denoms': [{'units': 'Participants', 'counts': [{'value': '589', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.050', 'spread': '0.2172', 'groupId': 'OG000'}]}]}, {'title': 'Mono,Year3,Week24,n=533', 'denoms': [{'units': 'Participants', 'counts': [{'value': '533', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.053', 'spread': '0.2314', 'groupId': 'OG000'}]}]}, {'title': 'Mono,Year3,Week48,n=476', 'denoms': [{'units': 'Participants', 'counts': [{'value': '476', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.084', 'spread': '0.1994', 'groupId': 'OG000'}]}]}, {'title': 'Mono,Year4,Week24,n=446', 'denoms': [{'units': 'Participants', 'counts': [{'value': '446', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.071', 'spread': '0.2085', 'groupId': 'OG000'}]}]}, {'title': 'Mono,Year4,Week48,n=423', 'denoms': [{'units': 'Participants', 'counts': [{'value': '423', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.076', 'spread': '0.2040', 'groupId': 'OG000'}]}]}, {'title': 'Mono,Year5,Week24,n=389', 'denoms': [{'units': 'Participants', 'counts': [{'value': '389', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.089', 'spread': '0.2015', 'groupId': 'OG000'}]}]}, {'title': 'Mono,Year5,Week48,n=360', 'denoms': [{'units': 'Participants', 'counts': [{'value': '360', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.088', 'spread': '0.2044', 'groupId': 'OG000'}]}]}, {'title': 'Mono,Year6,Week24,n=306', 'denoms': [{'units': 'Participants', 'counts': [{'value': '306', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.087', 'spread': '0.2043', 'groupId': 'OG000'}]}]}, {'title': 'Mono,Year6,Week48,n=282', 'denoms': [{'units': 'Participants', 'counts': [{'value': '282', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.086', 'spread': '0.2063', 'groupId': 'OG000'}]}]}, {'title': 'Mono,Year7,Week24,n=181', 'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.113', 'spread': '0.2155', 'groupId': 'OG000'}]}]}, {'title': 'Mono,Year7,Week48,n=130', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.134', 'spread': '0.2090', 'groupId': 'OG000'}]}]}, {'title': 'Mono,Year8,Week24,n=52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.173', 'spread': '0.2014', 'groupId': 'OG000'}]}]}, {'title': 'Mono,Year8,Week48,n=13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.021', 'spread': '0.1503', 'groupId': 'OG000'}]}]}, {'title': 'Mono,Year9,Week24,n=6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.022', 'spread': '0.1931', 'groupId': 'OG000'}]}]}, {'title': 'Mono,Year9,Week48,n=1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.120', 'spread': 'NA', 'comment': 'NA indicates standard deviation was not calculable for a single data point', 'groupId': 'OG000'}]}]}, {'title': 'Mono, Exit,n=614', 'denoms': [{'units': 'Participants', 'counts': [{'value': '614', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.083', 'spread': '0.2157', 'groupId': 'OG000'}]}]}, {'title': 'Mono, 8 Week Follow up, n=532', 'denoms': [{'units': 'Participants', 'counts': [{'value': '532', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.084', 'spread': '0.2189', 'groupId': 'OG000'}]}]}, {'title': 'Neu,Yaer1,Week4,n=688', 'denoms': [{'units': 'Participants', 'counts': [{'value': '688', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.024', 'spread': '2.0482', 'groupId': 'OG000'}]}]}, {'title': 'Neru,Year1,Week12,n=690', 'denoms': [{'units': 'Participants', 'counts': [{'value': '690', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.047', 'spread': '2.1575', 'groupId': 'OG000'}]}]}, {'title': 'Neu,Year1,Week24,n=691', 'denoms': [{'units': 'Participants', 'counts': [{'value': '691', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.059', 'spread': '2.1845', 'groupId': 'OG000'}]}]}, {'title': 'Neu,Year1,Week36,n=677', 'denoms': [{'units': 'Participants', 'counts': [{'value': '677', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.141', 'spread': '2.1907', 'groupId': 'OG000'}]}]}, {'title': 'Neu,Year1,Week48,n=679', 'denoms': [{'units': 'Participants', 'counts': [{'value': '679', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.078', 'spread': '2.3164', 'groupId': 'OG000'}]}]}, {'title': 'Neu,Year2,Week24,n=624', 'denoms': [{'units': 'Participants', 'counts': [{'value': '624', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.286', 'spread': '2.2746', 'groupId': 'OG000'}]}]}, {'title': 'Neu,Year2,Week48,n=584', 'denoms': [{'units': 'Participants', 'counts': [{'value': '584', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.230', 'spread': '2.3963', 'groupId': 'OG000'}]}]}, {'title': 'Neu,Year3,Week24,n=528', 'denoms': [{'units': 'Participants', 'counts': [{'value': '528', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.135', 'spread': '2.4914', 'groupId': 'OG000'}]}]}, {'title': 'Neu,Year3,Week48,n=471', 'denoms': [{'units': 'Participants', 'counts': [{'value': '471', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.049', 'spread': '2.3683', 'groupId': 'OG000'}]}]}, {'title': 'Neu,Year4,Week24,n=446', 'denoms': [{'units': 'Participants', 'counts': [{'value': '446', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.104', 'spread': '2.3846', 'groupId': 'OG000'}]}]}, {'title': 'Neu,Year4,Week48,n=423', 'denoms': [{'units': 'Participants', 'counts': [{'value': '423', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.160', 'spread': '2.5563', 'groupId': 'OG000'}]}]}, {'title': 'Neu,Year5,Week24,n=384', 'denoms': [{'units': 'Participants', 'counts': [{'value': '384', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.031', 'spread': '2.3060', 'groupId': 'OG000'}]}]}, {'title': 'Neu,Year5,Week48,n=356', 'denoms': [{'units': 'Participants', 'counts': [{'value': '356', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.198', 'spread': '2.3952', 'groupId': 'OG000'}]}]}, {'title': 'Neu,Year6,Week24,n=306', 'denoms': [{'units': 'Participants', 'counts': [{'value': '306', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.151', 'spread': '2.3083', 'groupId': 'OG000'}]}]}, {'title': 'Neu,Year6,Week48,n=282', 'denoms': [{'units': 'Participants', 'counts': [{'value': '282', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.060', 'spread': '2.4314', 'groupId': 'OG000'}]}]}, {'title': 'Neu,Year7,Week24,n=181', 'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.129', 'spread': '2.3908', 'groupId': 'OG000'}]}]}, {'title': 'Neu,Year7,Week48,n=130', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.687', 'spread': '3.0412', 'groupId': 'OG000'}]}]}, {'title': 'Neu,Year8,Week24,n=52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.092', 'spread': '2.3908', 'groupId': 'OG000'}]}]}, {'title': 'Neu,Year8,Week48,n=13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.687', 'spread': '3.0412', 'groupId': 'OG000'}]}]}, {'title': 'Neu,Year9,Week24,n=6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.257', 'spread': '2.9192', 'groupId': 'OG000'}]}]}, {'title': 'Neu,Year9,Week48,n=1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '735', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.300', 'spread': 'NA', 'comment': 'NA indicates standard deviation was not calculable for a single data point', 'groupId': 'OG000'}]}]}, {'title': 'Neu, Exit, n=609', 'denoms': [{'units': 'Participants', 'counts': [{'value': '609', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.006', 'spread': '2.5612', 'groupId': 'OG000'}]}]}, {'title': 'Neu,8 Week Follow up,n=528', 'denoms': [{'units': 'Participants', 'counts': [{'value': '528', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.001', 'spread': '2.3935', 'groupId': 'OG000'}]}]}, {'title': 'NeuBF,Year1,Week4,n=4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.013', 'spread': '0.1473', 'groupId': 'OG000'}]}]}, {'title': 'NeuBF,Year1,Week12,n=4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.073', 'spread': '0.1106', 'groupId': 'OG000'}]}]}, {'title': 'NeuBF,Year1,Week24,n=5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.000', 'spread': '0.2699', 'groupId': 'OG000'}]}]}, {'title': 'NeuBF,Year1,Week36,n=4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.045', 'spread': '0.0465', 'groupId': 'OG000'}]}]}, {'title': 'NeuBF,Year1,Week48,n=2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.105', 'spread': '0.1909', 'groupId': 'OG000'}]}]}, {'title': 'NeuBF,Year2,Week24,n=1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.120', 'spread': 'NA', 'comment': 'NA indicates standard deviation was not calculable for a single data point.', 'groupId': 'OG000'}]}]}, {'title': 'NeuBF,Year2,Week48,n=0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'NeuBF,Year3,Week24,n=1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.070', 'spread': 'NA', 'comment': 'NA indicates standard deviation was not calculable for a single data point.', 'groupId': 'OG000'}]}]}, {'title': 'NeuBF,Year3,Week48,n=0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'NeuBF,Year7,Week24,n=0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'NeuBF,Exit,n=2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.465', 'spread': '0.6435', 'groupId': 'OG000'}]}]}, {'title': 'NeuS,Year1,Week4,n=693', 'denoms': [{'units': 'Participants', 'counts': [{'value': '693', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.021', 'spread': '2.0450', 'groupId': 'OG000'}]}]}, {'title': 'NeuS,Year1,Week12,n=694', 'denoms': [{'units': 'Participants', 'counts': [{'value': '694', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.051', 'spread': '2.1519', 'groupId': 'OG000'}]}]}, {'title': 'NeuS,Year1,Week24,n=696', 'denoms': [{'units': 'Participants', 'counts': [{'value': '696', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.055', 'spread': '2.1757', 'groupId': 'OG000'}]}]}, {'title': 'NeuS,Year1,Week36,n=682', 'denoms': [{'units': 'Participants', 'counts': [{'value': '682', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.139', 'spread': '2.1819', 'groupId': 'OG000'}]}]}, {'title': 'NeuS,Year1,Week48,n=684', 'denoms': [{'units': 'Participants', 'counts': [{'value': '684', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.079', 'spread': '2.3128', 'groupId': 'OG000'}]}]}, {'title': 'NeuS,Year2,Week24,n=629', 'denoms': [{'units': 'Participants', 'counts': [{'value': '629', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.289', 'spread': '2.2609', 'groupId': 'OG000'}]}]}, {'title': 'NeuS,Year2,Week48,n=589', 'denoms': [{'units': 'Participants', 'counts': [{'value': '589', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.226', 'spread': '2.3846', 'groupId': 'OG000'}]}]}, {'title': 'NeuS,Year3,Week24,n=533', 'denoms': [{'units': 'Participants', 'counts': [{'value': '533', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.130', 'spread': '2.4736', 'groupId': 'OG000'}]}]}, {'title': 'NeuS,Year3,Week48,n=476', 'denoms': [{'units': 'Participants', 'counts': [{'value': '476', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.041', 'spread': '2.3547', 'groupId': 'OG000'}]}]}, {'title': 'NeuS,Year4,Week24,n=446', 'denoms': [{'units': 'Participants', 'counts': [{'value': '446', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.097', 'spread': '2.3804', 'groupId': 'OG000'}]}]}, {'title': 'NeuS,Year4,Week48,n=423', 'denoms': [{'units': 'Participants', 'counts': [{'value': '423', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.158', 'spread': '2.5542', 'groupId': 'OG000'}]}]}, {'title': 'NeuS,Year5,Week24,n=389', 'denoms': [{'units': 'Participants', 'counts': [{'value': '389', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.024', 'spread': '2.2893', 'groupId': 'OG000'}]}]}, {'title': 'NeuS,Year5,Week48,n=360', 'denoms': [{'units': 'Participants', 'counts': [{'value': '360', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.184', 'spread': '2.3831', 'groupId': 'OG000'}]}]}, {'title': 'NeuS,Year6,Week24,n=306', 'denoms': [{'units': 'Participants', 'counts': [{'value': '306', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.147', 'spread': '2.3029', 'groupId': 'OG000'}]}]}, {'title': 'NeuS,Year6,Week48,n=282', 'denoms': [{'units': 'Participants', 'counts': [{'value': '282', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.058', 'spread': '2.4310', 'groupId': 'OG000'}]}]}, {'title': 'NeuS,Year7,Week24,n=181', 'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.151', 'spread': '2.2248', 'groupId': 'OG000'}]}]}, {'title': 'NeuS,Year7,Week48,n=130', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.191', 'spread': '2.2514', 'groupId': 'OG000'}]}]}, {'title': 'NeuS,Year8,Week24,n=52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.092', 'spread': '2.3908', 'groupId': 'OG000'}]}]}, {'title': 'NeuS,Year8,Week48,n=13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.687', 'spread': '3.0412', 'groupId': 'OG000'}]}]}, {'title': 'NeuS,Year9,Week24,n=6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.257', 'spread': '2.9192', 'groupId': 'OG000'}]}]}, {'title': 'NeuS,Year9,Week48,n=1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.300', 'spread': 'NA', 'comment': 'NA indicates standard deviation was not calculable for a single data point', 'groupId': 'OG000'}]}]}, {'title': 'NeuS,Exit,n=614', 'denoms': [{'units': 'Participants', 'counts': [{'value': '614', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.008', 'spread': '2.5501', 'groupId': 'OG000'}]}]}, {'title': 'NeuS,8 Week Followup,n=532', 'denoms': [{'units': 'Participants', 'counts': [{'value': '532', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.007', 'spread': '2.3824', 'groupId': 'OG000'}]}]}, {'title': 'Plt,Year1,Week4,n=683', 'denoms': [{'units': 'Participants', 'counts': [{'value': '683', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.1', 'spread': '38.82', 'groupId': 'OG000'}]}]}, {'title': 'Plt,Year1,Week12,n=690', 'denoms': [{'units': 'Participants', 'counts': [{'value': '690', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.6', 'spread': '43.63', 'groupId': 'OG000'}]}]}, {'title': 'Plt,Year1,Week24,n=687', 'denoms': [{'units': 'Participants', 'counts': [{'value': '687', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'spread': '47.73', 'groupId': 'OG000'}]}]}, {'title': 'Plt,Year1,Week36,n=680', 'denoms': [{'units': 'Participants', 'counts': [{'value': '680', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.9', 'spread': '50.25', 'groupId': 'OG000'}]}]}, {'title': 'Plt,Year1,Week48,n=677', 'denoms': [{'units': 'Participants', 'counts': [{'value': '677', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-9.3', 'spread': '50.81', 'groupId': 'OG000'}]}]}, {'title': 'Plt,Year2,Week24,n=631', 'denoms': [{'units': 'Participants', 'counts': [{'value': '631', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-15.4', 'spread': '53.80', 'groupId': 'OG000'}]}]}, {'title': 'Plt,Year2,Week48,n=583', 'denoms': [{'units': 'Participants', 'counts': [{'value': '583', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-20.3', 'spread': '56.39', 'groupId': 'OG000'}]}]}, {'title': 'Plt,Year3,Week24,n=526', 'denoms': [{'units': 'Participants', 'counts': [{'value': '526', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-19.9', 'spread': '57.88', 'groupId': 'OG000'}]}]}, {'title': 'Plt,Year3,Week48,n=476', 'denoms': [{'units': 'Participants', 'counts': [{'value': '476', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-13.4', 'spread': '65.16', 'groupId': 'OG000'}]}]}, {'title': 'Plt,Year4,Week24,n=441', 'denoms': [{'units': 'Participants', 'counts': [{'value': '441', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-14.0', 'spread': '59.05', 'groupId': 'OG000'}]}]}, {'title': 'Plt,Year4,Week48,n=420', 'denoms': [{'units': 'Participants', 'counts': [{'value': '420', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-18.2', 'spread': '63.80', 'groupId': 'OG000'}]}]}, {'title': 'Plt,Year5,Week24,n=388', 'denoms': [{'units': 'Participants', 'counts': [{'value': '388', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-19.3', 'spread': '61.49', 'groupId': 'OG000'}]}]}, {'title': 'Plt,Year5,Week48,n=360', 'denoms': [{'units': 'Participants', 'counts': [{'value': '360', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-17.9', 'spread': '63.36', 'groupId': 'OG000'}]}]}, {'title': 'Plt,Year6,Week24,n=305', 'denoms': [{'units': 'Participants', 'counts': [{'value': '305', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-13.3', 'spread': '61.54', 'groupId': 'OG000'}]}]}, {'title': 'Plt,Year6,Week48,n=282', 'denoms': [{'units': 'Participants', 'counts': [{'value': '282', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-13.4', 'spread': '60.89', 'groupId': 'OG000'}]}]}, {'title': 'Plt,Year7,Week24,n=181', 'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-15.3', 'spread': '63.95', 'groupId': 'OG000'}]}]}, {'title': 'Plt,Year7,Week48,n=130', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-16.3', 'spread': '70.75', 'groupId': 'OG000'}]}]}, {'title': 'Plt,Year8,Week24,n=52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.3', 'spread': '80.69', 'groupId': 'OG000'}]}]}, {'title': 'Plt,Year8,Week48,n=13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-29.9', 'spread': '88.66', 'groupId': 'OG000'}]}]}, {'title': 'Plt,Year9,Week24,n=6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.0', 'spread': '82.67', 'groupId': 'OG000'}]}]}, {'title': 'Plt,Year9,Week48,n=1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '57.0', 'spread': 'NA', 'comment': 'NA indicates standard deviation was not calculable for a single data point', 'groupId': 'OG000'}]}]}, {'title': 'Plt,Exit,n=613', 'denoms': [{'units': 'Participants', 'counts': [{'value': '613', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-11.0', 'spread': '64.36', 'groupId': 'OG000'}]}]}, {'title': 'Plt,8Week Followup,n=530', 'denoms': [{'units': 'Participants', 'counts': [{'value': '530', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-11.2', 'spread': '60.57', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and up to 9 years', 'description': 'Hematology parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 hematology parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Plt, Lymp, Leu, Eos, Baso, Mono, Neu, NeuBF, and NueS are summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were 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. NA indicates standard deviation was not calculable for a single data point.', 'unitOfMeasure': 'Billion cells per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT Population'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Hemoglobin (Hg) at the Indicated Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '735', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Belimumab 10mg/kg IV', 'description': 'Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial.'}], 'classes': [{'title': 'Hg,Year1, Week 4,n=697', 'denoms': [{'units': 'Participants', 'counts': [{'value': '697', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'spread': '7.05', 'groupId': 'OG000'}]}]}, {'title': 'Hg,Year1,Week12,n=698', 'denoms': [{'units': 'Participants', 'counts': [{'value': '698', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '8.75', 'groupId': 'OG000'}]}]}, {'title': 'Hg,Year1,Week24,n=699', 'denoms': [{'units': 'Participants', 'counts': [{'value': '699', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '9.48', 'groupId': 'OG000'}]}]}, {'title': 'Hg,Year1,Week36,n=688', 'denoms': [{'units': 'Participants', 'counts': [{'value': '688', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '9.90', 'groupId': 'OG000'}]}]}, {'title': 'Hg,Year1,Week48,n=686', 'denoms': [{'units': 'Participants', 'counts': [{'value': '686', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': '11.03', 'groupId': 'OG000'}]}]}, {'title': 'Hg,Year2,Week24,n=635', 'denoms': [{'units': 'Participants', 'counts': [{'value': '635', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': '11.31', 'groupId': 'OG000'}]}]}, {'title': 'Hg,Year2,Week48,n=591', 'denoms': [{'units': 'Participants', 'counts': [{'value': '591', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.3', 'spread': '12.12', 'groupId': 'OG000'}]}]}, {'title': 'Hg,Year3,Week24,n=534', 'denoms': [{'units': 'Participants', 'counts': [{'value': '534', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.2', 'spread': '12.79', 'groupId': 'OG000'}]}]}, {'title': 'Hg,Year3,Week48,n=478', 'denoms': [{'units': 'Participants', 'counts': [{'value': '478', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.9', 'spread': '12.67', 'groupId': 'OG000'}]}]}, {'title': 'Hg,Year4,Week24,n=446', 'denoms': [{'units': 'Participants', 'counts': [{'value': '446', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.6', 'spread': '12.93', 'groupId': 'OG000'}]}]}, {'title': 'Hg,Year,Week48,n=424', 'denoms': [{'units': 'Participants', 'counts': [{'value': '424', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.4', 'spread': '13.59', 'groupId': 'OG000'}]}]}, {'title': 'Hg,Year5,Week24,n=390', 'denoms': [{'units': 'Participants', 'counts': [{'value': '390', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.9', 'spread': '12.76', 'groupId': 'OG000'}]}]}, {'title': 'Hg,Year5,Week48,n=362', 'denoms': [{'units': 'Participants', 'counts': [{'value': '362', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.2', 'spread': '13.26', 'groupId': 'OG000'}]}]}, {'title': 'Hg,Year6,Week24,n=306', 'denoms': [{'units': 'Participants', 'counts': [{'value': '306', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.7', 'spread': '13.19', 'groupId': 'OG000'}]}]}, {'title': 'Hg,Year6,Week48,n=282', 'denoms': [{'units': 'Participants', 'counts': [{'value': '282', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.3', 'spread': '13.83', 'groupId': 'OG000'}]}]}, {'title': 'Hg,Year7,Week24,n=181', 'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.9', 'spread': '14.54', 'groupId': 'OG000'}]}]}, {'title': 'Hg,Year7,Week48,n=130', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.0', 'spread': '14.66', 'groupId': 'OG000'}]}]}, {'title': 'Hg,Year8,Week24,n=52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.5', 'spread': '14.84', 'groupId': 'OG000'}]}]}, {'title': 'Hg,Year8,Week48,n=13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'spread': '13.95', 'groupId': 'OG000'}]}]}, {'title': 'Hg,Year9,Week24,n=6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.7', 'spread': '20.67', 'groupId': 'OG000'}]}]}, {'title': 'Hg,Year9,Week48,n=1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-29.0', 'spread': 'NA', 'comment': 'NA indicates standard deviation was not calculable for a single data point.', 'groupId': 'OG000'}]}]}, {'title': 'Hg,Exit,n=619', 'denoms': [{'units': 'Participants', 'counts': [{'value': '619', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.2', 'spread': '13.90', 'groupId': 'OG000'}]}]}, {'title': 'Hg,8 Week Follow up,n=534', 'denoms': [{'units': 'Participants', 'counts': [{'value': '534', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.8', 'spread': '13.71', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and up to 9 years', 'description': 'Hematology parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 hematology parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Hg is summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were 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. NA indicates standard deviation was not calculable for a single data point.', 'unitOfMeasure': 'Gram per liter (g/L)', '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': '735', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Belimumab 10mg/kg IV', 'description': 'Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial.'}], 'classes': [{'title': 'Hematocrit,Year1,Week4,n=697', 'denoms': [{'units': 'Participants', 'counts': [{'value': '697', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.01', 'spread': '2.250', 'groupId': 'OG000'}]}]}, {'title': 'Hematocrit,Year1,Week12,n=698', 'denoms': [{'units': 'Participants', 'counts': [{'value': '698', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.38', 'spread': '2.729', 'groupId': 'OG000'}]}]}, {'title': 'Hematocrit,Year1,Week24,n=699', 'denoms': [{'units': 'Participants', 'counts': [{'value': '699', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.75', 'spread': '2.928', 'groupId': 'OG000'}]}]}, {'title': 'Hematocrit,Year1,Week36,n=688', 'denoms': [{'units': 'Participants', 'counts': [{'value': '688', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.53', 'spread': '2.954', 'groupId': 'OG000'}]}]}, {'title': 'Hematocrit,Year1,Week48,n=686', 'denoms': [{'units': 'Participants', 'counts': [{'value': '686', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.35', 'spread': '3.286', 'groupId': 'OG000'}]}]}, {'title': 'Hematocrit,Year2,Week24,n=635', 'denoms': [{'units': 'Participants', 'counts': [{'value': '635', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.94', 'spread': '3.427', 'groupId': 'OG000'}]}]}, {'title': 'Hematocrit,Year2,Week48,n=591', 'denoms': [{'units': 'Participants', 'counts': [{'value': '591', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.78', 'spread': '3.584', 'groupId': 'OG000'}]}]}, {'title': 'Hematocrit,Year3,Week24,n=534', 'denoms': [{'units': 'Participants', 'counts': [{'value': '534', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.29', 'spread': '3.828', 'groupId': 'OG000'}]}]}, {'title': 'Hematocrit,Year3,Week48,n=478', 'denoms': [{'units': 'Participants', 'counts': [{'value': '478', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.39', 'spread': '3.800', 'groupId': 'OG000'}]}]}, {'title': 'Hematocrit,Year4,Week24,n=446', 'denoms': [{'units': 'Participants', 'counts': [{'value': '446', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.67', 'spread': '3.834', 'groupId': 'OG000'}]}]}, {'title': 'Hematocrit,Year4,Week48,n=424', 'denoms': [{'units': 'Participants', 'counts': [{'value': '424', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.15', 'spread': '3.998', 'groupId': 'OG000'}]}]}, {'title': 'Hematocrit,Year5,Week24,n=390', 'denoms': [{'units': 'Participants', 'counts': [{'value': '390', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.69', 'spread': '3.776', 'groupId': 'OG000'}]}]}, {'title': 'Hematocrit,Year5,Week48,n=362', 'denoms': [{'units': 'Participants', 'counts': [{'value': '362', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.98', 'spread': '3.842', 'groupId': 'OG000'}]}]}, {'title': 'Hematocrit,Year6,Week24,n=306', 'denoms': [{'units': 'Participants', 'counts': [{'value': '306', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.93', 'spread': '3.939', 'groupId': 'OG000'}]}]}, {'title': 'Hematocrit,Year6,Week48,n=282', 'denoms': [{'units': 'Participants', 'counts': [{'value': '282', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.07', 'spread': '4.023', 'groupId': 'OG000'}]}]}, {'title': 'Hematocrit,Year7,Week24,n=181', 'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.81', 'spread': '4.251', 'groupId': 'OG000'}]}]}, {'title': 'Hematocrit,Year7,Week48,n=130', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.11', 'spread': '4.238', 'groupId': 'OG000'}]}]}, {'title': 'Hematocrit,Year8,Week24,n=52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.42', 'spread': '4.390', 'groupId': 'OG000'}]}]}, {'title': 'Hematocrit,Year8,Week48,n=13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.48', 'spread': '4.234', 'groupId': 'OG000'}]}]}, {'title': 'Hematocrit,Year9,Week24,n=6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.03', 'spread': '6.001', 'groupId': 'OG000'}]}]}, {'title': 'Hematocrit,Year9,Week48,n=1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-6.00', 'spread': 'NA', 'comment': 'NA indicates standard deviation was not calculable for a single data point', 'groupId': 'OG000'}]}]}, {'title': 'Hematocrit,Exit,n=619', 'denoms': [{'units': 'Participants', 'counts': [{'value': '619', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.91', 'spread': '4.202', 'groupId': 'OG000'}]}]}, {'title': 'Hematocrit,8 Week Follow up,n=534', 'denoms': [{'units': 'Participants', 'counts': [{'value': '534', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.85', 'spread': '4.077', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and up to 9 years', 'description': 'Hematology parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 hematology parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks). Change from Baseline in Hematocrit is summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were 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. NA indicates standard deviation was not calculable for a single data point.', 'unitOfMeasure': 'Percentage of blood by volume', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT Population'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Erythrocytes (Eryth) at the Indicated Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '735', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Belimumab 10mg/kg IV', 'description': 'Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial.'}], 'classes': [{'title': 'Eryth,Year1,Week4,n=697', 'denoms': [{'units': 'Participants', 'counts': [{'value': '697', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.00', 'spread': '0.231', 'groupId': 'OG000'}]}]}, {'title': 'Eryth,Year1,Week12,n=698', 'denoms': [{'units': 'Participants', 'counts': [{'value': '698', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.04', 'spread': '0.280', 'groupId': 'OG000'}]}]}, {'title': 'Eryth,Year1,Week24,n=699', 'denoms': [{'units': 'Participants', 'counts': [{'value': '699', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.06', 'spread': '0.293', 'groupId': 'OG000'}]}]}, {'title': 'Eryth,Year1,Week36,n=688', 'denoms': [{'units': 'Participants', 'counts': [{'value': '688', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.06', 'spread': '0.299', 'groupId': 'OG000'}]}]}, {'title': 'Eryth,Year1,Week48,n=686', 'denoms': [{'units': 'Participants', 'counts': [{'value': '686', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.06', 'spread': '0.328', 'groupId': 'OG000'}]}]}, {'title': 'Eryth,Year2,Week24,n=635', 'denoms': [{'units': 'Participants', 'counts': [{'value': '635', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.07', 'spread': '0.335', 'groupId': 'OG000'}]}]}, {'title': 'Eryth,Year2,Week48,n=591', 'denoms': [{'units': 'Participants', 'counts': [{'value': '591', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.04', 'spread': '0.362', 'groupId': 'OG000'}]}]}, {'title': 'Eryth,Year3,Week24,n=534', 'denoms': [{'units': 'Participants', 'counts': [{'value': '534', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.04', 'spread': '0.364', 'groupId': 'OG000'}]}]}, {'title': 'Eryth,Year3,Week48,n=478', 'denoms': [{'units': 'Participants', 'counts': [{'value': '478', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.05', 'spread': '0.381', 'groupId': 'OG000'}]}]}, {'title': 'Eryth,Year4,Week24,n=446', 'denoms': [{'units': 'Participants', 'counts': [{'value': '446', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.06', 'spread': '0.372', 'groupId': 'OG000'}]}]}, {'title': 'Eryth,Year,Week48,n=424', 'denoms': [{'units': 'Participants', 'counts': [{'value': '424', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.05', 'spread': '0.379', 'groupId': 'OG000'}]}]}, {'title': 'Eryth,Year5,Week24,n=390', 'denoms': [{'units': 'Participants', 'counts': [{'value': '390', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.09', 'spread': '0.375', 'groupId': 'OG000'}]}]}, {'title': 'Eryth,Year5,Week48,n=362', 'denoms': [{'units': 'Participants', 'counts': [{'value': '362', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.11', 'spread': '0.383', 'groupId': 'OG000'}]}]}, {'title': 'Eryth,Year6,Week24,n=306', 'denoms': [{'units': 'Participants', 'counts': [{'value': '306', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.12', 'spread': '0.396', 'groupId': 'OG000'}]}]}, {'title': 'Eryth,Year6,Week48,n=282', 'denoms': [{'units': 'Participants', 'counts': [{'value': '282', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.17', 'spread': '0.408', 'groupId': 'OG000'}]}]}, {'title': 'Eryth,Year7,Week24,n=181', 'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.17', 'spread': '0.415', 'groupId': 'OG000'}]}]}, {'title': 'Eryth,Year7,Week48,n=130', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.22', 'spread': '0.387', 'groupId': 'OG000'}]}]}, {'title': 'Eryth,Year8,Week24,n=52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.21', 'spread': '0.375', 'groupId': 'OG000'}]}]}, {'title': 'Eryth,Year8,Week48,n=13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.15', 'spread': '0.207', 'groupId': 'OG000'}]}]}, {'title': 'Eryth,Year9,Week24,n=6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.30', 'spread': '0.374', 'groupId': 'OG000'}]}]}, {'title': 'Eryth,Year9,Week48,n=1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.20', 'spread': 'NA', 'comment': 'NA indicates standard deviation was not calculable for a single data point.', 'groupId': 'OG000'}]}]}, {'title': 'Eryth,Exit,n=619', 'denoms': [{'units': 'Participants', 'counts': [{'value': '619', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.14', 'spread': '0.431', 'groupId': 'OG000'}]}]}, {'title': 'Eryth,8 Week Follow up,n=534', 'denoms': [{'units': 'Participants', 'counts': [{'value': '534', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.13', 'spread': '0.411', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and up to 9 years', 'description': 'Hematology parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 hematology parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Erythrocytes is summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were 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. NA indicates standard deviation was not calculable for a single data point.', 'unitOfMeasure': 'Trillions cells per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT Population'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '735', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Belimumab 10mg/kg IV', 'description': 'Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial.'}], 'classes': [{'title': 'Ca,Year1,Week4,n=697', 'denoms': [{'units': 'Participants', 'counts': [{'value': '697', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0030', 'spread': '0.0763', 'groupId': 'OG000'}]}]}, {'title': 'Ca,Year1,Week12,n=696', 'denoms': [{'units': 'Participants', 'counts': [{'value': '696', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0020', 'spread': '0.0749', 'groupId': 'OG000'}]}]}, {'title': 'Ca,Year1,Week24,n=696', 'denoms': [{'units': 'Participants', 'counts': [{'value': '696', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.0035', 'spread': '0.0750', 'groupId': 'OG000'}]}]}, {'title': 'Ca,Year1,Week36,n=677', 'denoms': [{'units': 'Participants', 'counts': [{'value': '677', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0024', 'spread': '0.0836', 'groupId': 'OG000'}]}]}, {'title': 'Ca,Year1,Week48,n=687', 'denoms': [{'units': 'Participants', 'counts': [{'value': '687', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.0065', 'spread': '0.0778', 'groupId': 'OG000'}]}]}, {'title': 'Ca,Year2,Week24,n=636', 'denoms': [{'units': 'Participants', 'counts': [{'value': '636', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.0075', 'spread': '0.0764', 'groupId': 'OG000'}]}]}, {'title': 'Ca,Year2,Week48,n=587', 'denoms': [{'units': 'Participants', 'counts': [{'value': '587', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.0091', 'spread': '0.0837', 'groupId': 'OG000'}]}]}, {'title': 'Ca,Year3,Week24,n=526', 'denoms': [{'units': 'Participants', 'counts': [{'value': '526', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.0047', 'spread': '0.0810', 'groupId': 'OG000'}]}]}, {'title': 'Ca,Year3,Week48,n=481', 'denoms': [{'units': 'Participants', 'counts': [{'value': '481', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.0123', 'spread': '0.0800', 'groupId': 'OG000'}]}]}, {'title': 'Ca,Year4,Week24,n=438', 'denoms': [{'units': 'Participants', 'counts': [{'value': '438', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.0056', 'spread': '0.0771', 'groupId': 'OG000'}]}]}, {'title': 'Ca,Year,Week48,n=418', 'denoms': [{'units': 'Participants', 'counts': [{'value': '418', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.0193', 'spread': '0.0805', 'groupId': 'OG000'}]}]}, {'title': 'Ca,Year5,Week24,n=387', 'denoms': [{'units': 'Participants', 'counts': [{'value': '387', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.0129', 'spread': '0.0885', 'groupId': 'OG000'}]}]}, {'title': 'Ca,Year5,Week48,n=358', 'denoms': [{'units': 'Participants', 'counts': [{'value': '358', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.0140', 'spread': '0.0919', 'groupId': 'OG000'}]}]}, {'title': 'Ca,Year6,Week24,n=303', 'denoms': [{'units': 'Participants', 'counts': [{'value': '303', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.0053', 'spread': '0.0903', 'groupId': 'OG000'}]}]}, {'title': 'Ca,Year6,Week48,n=283', 'denoms': [{'units': 'Participants', 'counts': [{'value': '283', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.0146', 'spread': '0.0870', 'groupId': 'OG000'}]}]}, {'title': 'Ca,Year7,Week24,n=182', 'denoms': [{'units': 'Participants', 'counts': [{'value': '182', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.0076', 'spread': '0.0839', 'groupId': 'OG000'}]}]}, {'title': 'Ca,Year7,Week48,n=130', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.0079', 'spread': '0.1172', 'groupId': 'OG000'}]}]}, {'title': 'Ca,Year8,Week24,n=51', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0003', 'spread': '0.0806', 'groupId': 'OG000'}]}]}, {'title': 'Ca,Year8,Week48,n=13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.0395', 'spread': '0.0611', 'groupId': 'OG000'}]}]}, {'title': 'Ca,Year9,Week24,n=6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.0402', 'spread': '0.0336', 'groupId': 'OG000'}]}]}, {'title': 'Ca,Year9,Week48,n=1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.0642', 'spread': 'NA', 'comment': 'NA indicates standard deviation was not calculable for a single data point.', 'groupId': 'OG000'}]}]}, {'title': 'Ca,Exit,n=619', 'denoms': [{'units': 'Participants', 'counts': [{'value': '619', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0006', 'spread': '0.0864', 'groupId': 'OG000'}]}]}, {'title': 'Ca,8 Week Follow up,n=534', 'denoms': [{'units': 'Participants', 'counts': [{'value': '534', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.0014', 'spread': '0.0909', 'groupId': 'OG000'}]}]}, {'title': 'CO2,Year1,Week4,n=701', 'denoms': [{'units': 'Participants', 'counts': [{'value': '701', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.0', 'spread': '2.77', 'groupId': 'OG000'}]}]}, {'title': 'CO2,Year1,Week12,n=700', 'denoms': [{'units': 'Participants', 'counts': [{'value': '700', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '2.76', 'groupId': 'OG000'}]}]}, {'title': 'CO2,Year1,Week24,n=701', 'denoms': [{'units': 'Participants', 'counts': [{'value': '701', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '2.73', 'groupId': 'OG000'}]}]}, {'title': 'CO2,Year1,Week36,n=682', 'denoms': [{'units': 'Participants', 'counts': [{'value': '682', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '2.73', 'groupId': 'OG000'}]}]}, {'title': 'CO2,Year1,Week48,n=692', 'denoms': [{'units': 'Participants', 'counts': [{'value': '692', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '2.78', 'groupId': 'OG000'}]}]}, {'title': 'CO2,Year2,Week24,n=641', 'denoms': [{'units': 'Participants', 'counts': [{'value': '641', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'spread': '2.94', 'groupId': 'OG000'}]}]}, {'title': 'CO2,Year2,Week48,n=692', 'denoms': [{'units': 'Participants', 'counts': [{'value': '692', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'spread': '2.87', 'groupId': 'OG000'}]}]}, {'title': 'CO2,Year3,Week24,n=531', 'denoms': [{'units': 'Participants', 'counts': [{'value': '531', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'spread': '2.90', 'groupId': 'OG000'}]}]}, {'title': 'CO2,Year3,Week48,n=486', 'denoms': [{'units': 'Participants', 'counts': [{'value': '486', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'spread': '2.75', 'groupId': 'OG000'}]}]}, {'title': 'CO2,Year4,Week24,n=438', 'denoms': [{'units': 'Participants', 'counts': [{'value': '438', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.0', 'spread': '2.76', 'groupId': 'OG000'}]}]}, {'title': 'CO2,Year4,Week48,n=418', 'denoms': [{'units': 'Participants', 'counts': [{'value': '418', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'spread': '3.04', 'groupId': 'OG000'}]}]}, {'title': 'CO2,Year5,Week24,n=393', 'denoms': [{'units': 'Participants', 'counts': [{'value': '393', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'spread': '2.90', 'groupId': 'OG000'}]}]}, {'title': 'CO2,Year5,Week48,n=361', 'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.8', 'spread': '2.82', 'groupId': 'OG000'}]}]}, {'title': 'CO2,Year6,Week24,n=303', 'denoms': [{'units': 'Participants', 'counts': [{'value': '303', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.0', 'spread': '2.86', 'groupId': 'OG000'}]}]}, {'title': 'CO2,Year6,Week48,n=284', 'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'spread': '2.76', 'groupId': 'OG000'}]}]}, {'title': 'CO2,Year7,Week24,n=182', 'denoms': [{'units': 'Participants', 'counts': [{'value': '182', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '2.78', 'groupId': 'OG000'}]}]}, {'title': 'CO2,Year7,Week48,n=130', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '2.67', 'groupId': 'OG000'}]}]}, {'title': 'CO2,Year8,Week24,n=52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': '2.78', 'groupId': 'OG000'}]}]}, {'title': 'CO2,Year8,Week48,n=13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '3.38', 'groupId': 'OG000'}]}]}, {'title': 'CO2,Year9,Week24,n=6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.82', 'groupId': 'OG000'}]}]}, {'title': 'CO2,Year9,Week48,n=1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.0', 'spread': 'NA', 'comment': 'NA indicates standard deviation was not calculable for a single data point.', 'groupId': 'OG000'}]}]}, {'title': 'CO2,Exit,n=625', 'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'spread': '3.00', 'groupId': 'OG000'}]}]}, {'title': 'CO2,8 week Follow up,n=538', 'denoms': [{'units': 'Participants', 'counts': [{'value': '538', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'spread': '3.00', 'groupId': 'OG000'}]}]}, {'title': 'Chloride,Year1,Week4,n=707', 'denoms': [{'units': 'Participants', 'counts': [{'value': '707', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '2.33', 'groupId': 'OG000'}]}]}, {'title': 'Chloride,Year1,Week12,n=704', 'denoms': [{'units': 'Participants', 'counts': [{'value': '704', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.6', 'spread': '2.56', 'groupId': 'OG000'}]}]}, {'title': 'Chloride,Year1,Week24,n=703', 'denoms': [{'units': 'Participants', 'counts': [{'value': '703', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.6', 'spread': '2.42', 'groupId': 'OG000'}]}]}, {'title': 'Chloride,Year1,Week36,n=684', 'denoms': [{'units': 'Participants', 'counts': [{'value': '684', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.6', 'spread': '2.47', 'groupId': 'OG000'}]}]}, {'title': 'Chloride,Year1,Week48,n=693', 'denoms': [{'units': 'Participants', 'counts': [{'value': '693', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '2.44', 'groupId': 'OG000'}]}]}, {'title': 'Chloride,Year2,Week24,n=643', 'denoms': [{'units': 'Participants', 'counts': [{'value': '643', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.5', 'spread': '2.62', 'groupId': 'OG000'}]}]}, {'title': 'Chloride,Year2,Week48,n=598', 'denoms': [{'units': 'Participants', 'counts': [{'value': '598', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.5', 'spread': '2.81', 'groupId': 'OG000'}]}]}, {'title': 'Chloride,Year3,Week24,n=535', 'denoms': [{'units': 'Participants', 'counts': [{'value': '535', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': '3.04', 'groupId': 'OG000'}]}]}, {'title': 'Chloride,Year3,Week48,n=488', 'denoms': [{'units': 'Participants', 'counts': [{'value': '488', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.6', 'spread': '2.73', 'groupId': 'OG000'}]}]}, {'title': 'Chloride,Year4,Week24,n=439', 'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.5', 'spread': '2.74', 'groupId': 'OG000'}]}]}, {'title': 'Chloride,Year4,Week48,n=421', 'denoms': [{'units': 'Participants', 'counts': [{'value': '421', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': '2.84', 'groupId': 'OG000'}]}]}, {'title': 'Chloride,Year5,Week24,n=392', 'denoms': [{'units': 'Participants', 'counts': [{'value': '392', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.6', 'spread': '2.95', 'groupId': 'OG000'}]}]}, {'title': 'Chloride,Year5,Week48,n=362', 'denoms': [{'units': 'Participants', 'counts': [{'value': '362', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.6', 'spread': '2.77', 'groupId': 'OG000'}]}]}, {'title': 'Chloride,Year6,Week24,n=304', 'denoms': [{'units': 'Participants', 'counts': [{'value': '304', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': '2.74', 'groupId': 'OG000'}]}]}, {'title': 'Chloride,Year6,Week48,n=286', 'denoms': [{'units': 'Participants', 'counts': [{'value': '286', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.8', 'spread': '2.67', 'groupId': 'OG000'}]}]}, {'title': 'Chloride,Year7,Week24,n=183', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': '2.57', 'groupId': 'OG000'}]}]}, {'title': 'Chloride,Year7,Week48,n=130', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.1', 'spread': '2.73', 'groupId': 'OG000'}]}]}, {'title': 'Chloride,Year8,Week24,n=52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.3', 'spread': '2.86', 'groupId': 'OG000'}]}]}, {'title': 'Chloride,Year8,Week48,n=13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.2', 'spread': '3.54', 'groupId': 'OG000'}]}]}, {'title': 'Chloride,Year9,Week24,n=6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.2', 'spread': '1.47', 'groupId': 'OG000'}]}]}, {'title': 'Chloride,Year9,Week48,n=1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': 'NA', 'comment': 'NA indicates standard deviation was not calculable for a single data point.', 'groupId': 'OG000'}]}]}, {'title': 'Chloride,Exit,n=624', 'denoms': [{'units': 'Participants', 'counts': [{'value': '624', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '3.06', 'groupId': 'OG000'}]}]}, {'title': 'Chloride,8 Week Follow up,n=538', 'denoms': [{'units': 'Participants', 'counts': [{'value': '538', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '2.82', 'groupId': 'OG000'}]}]}, {'title': 'Mg,Year1,Week4,n=707', 'denoms': [{'units': 'Participants', 'counts': [{'value': '707', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.003', 'spread': '0.0583', 'groupId': 'OG000'}]}]}, {'title': 'Mg,Year1,Week 12,n=705', 'denoms': [{'units': 'Participants', 'counts': [{'value': '705', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.006', 'spread': '0.0647', 'groupId': 'OG000'}]}]}, {'title': 'Mg,Year1,Week 24,n=703', 'denoms': [{'units': 'Participants', 'counts': [{'value': '703', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.003', 'spread': '0.0604', 'groupId': 'OG000'}]}]}, {'title': 'Mg,Year1,Week 36,n=684', 'denoms': [{'units': 'Participants', 'counts': [{'value': '684', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.004', 'spread': '0.0616', 'groupId': 'OG000'}]}]}, {'title': 'Mg,Year1,Week 48,n=693', 'denoms': [{'units': 'Participants', 'counts': [{'value': '693', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.002', 'spread': '0.0597', 'groupId': 'OG000'}]}]}, {'title': 'Mg,Year2,Week 24,n=643', 'denoms': [{'units': 'Participants', 'counts': [{'value': '643', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.002', 'spread': '0.0694', 'groupId': 'OG000'}]}]}, {'title': 'Mg,Year2,Week 48,n=598', 'denoms': [{'units': 'Participants', 'counts': [{'value': '598', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.001', 'spread': '0.0711', 'groupId': 'OG000'}]}]}, {'title': 'Mg,Year3,Week 24,n=535', 'denoms': [{'units': 'Participants', 'counts': [{'value': '535', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.010', 'spread': '0.0668', 'groupId': 'OG000'}]}]}, {'title': 'Mg,Year3,Week 48,n=488', 'denoms': [{'units': 'Participants', 'counts': [{'value': '488', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.010', 'spread': '0.0669', 'groupId': 'OG000'}]}]}, {'title': 'Mg,Year4,Week 24,n=439', 'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.016', 'spread': '0.0700', 'groupId': 'OG000'}]}]}, {'title': 'Mg,Year4,Week 48,n=421', 'denoms': [{'units': 'Participants', 'counts': [{'value': '421', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.017', 'spread': '0.0709', 'groupId': 'OG000'}]}]}, {'title': 'Mg,Year 5,Week 24,n=393', 'denoms': [{'units': 'Participants', 'counts': [{'value': '393', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.016', 'spread': '0.0673', 'groupId': 'OG000'}]}]}, {'title': 'Mg,Year 5,Week 48,n=362', 'denoms': [{'units': 'Participants', 'counts': [{'value': '362', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.021', 'spread': '0.0688', 'groupId': 'OG000'}]}]}, {'title': 'Mg,Year 6,Week 24,n=304', 'denoms': [{'units': 'Participants', 'counts': [{'value': '304', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.013', 'spread': '0.0718', 'groupId': 'OG000'}]}]}, {'title': 'Mg,Year 6,Week 48,n=286', 'denoms': [{'units': 'Participants', 'counts': [{'value': '286', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.011', 'spread': '0.0639', 'groupId': 'OG000'}]}]}, {'title': 'Mg,Year 7,Week 24,n=183', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.010', 'spread': '0.0692', 'groupId': 'OG000'}]}]}, {'title': 'Mg,Year 7,Week 48,n=130', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.013', 'spread': '0.0635', 'groupId': 'OG000'}]}]}, {'title': 'Mg,Year 8,Week 24,n=52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.025', 'spread': '0.0702', 'groupId': 'OG000'}]}]}, {'title': 'Mg,Year 8,Week 48,n=13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.042', 'spread': '0.0685', 'groupId': 'OG000'}]}]}, {'title': 'Mg,Year 9,Week 24,n=6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.030', 'spread': '0.0613', 'groupId': 'OG000'}]}]}, {'title': 'Mg,Year 9,Week 48,n=1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.040', 'spread': 'NA', 'comment': 'NA indicates standard deviation was not calculable for a single data point.', 'groupId': 'OG000'}]}]}, {'title': 'Mg, Exit,n=625', 'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.022', 'spread': '0.0738', 'groupId': 'OG000'}]}]}, {'title': 'Mg,8 Week Follow up,n=539', 'denoms': [{'units': 'Participants', 'counts': [{'value': '539', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.021', 'spread': '0.0729', 'groupId': 'OG000'}]}]}, {'title': 'Phos, Year1, Week4,n=707', 'denoms': [{'units': 'Participants', 'counts': [{'value': '707', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0102', 'spread': '0.1908', 'groupId': 'OG000'}]}]}, {'title': 'Phos, Year1, Week12,n=705', 'denoms': [{'units': 'Participants', 'counts': [{'value': '705', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0004', 'spread': '0.1999', 'groupId': 'OG000'}]}]}, {'title': 'Phos, Year1, Week24,n=703', 'denoms': [{'units': 'Participants', 'counts': [{'value': '703', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.0126', 'spread': '0.1964', 'groupId': 'OG000'}]}]}, {'title': 'Phos, Year1, Week 36,n=684', 'denoms': [{'units': 'Participants', 'counts': [{'value': '684', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0101', 'spread': '0.1976', 'groupId': 'OG000'}]}]}, {'title': 'Phos, Year1, Week48,n=693', 'denoms': [{'units': 'Participants', 'counts': [{'value': '693', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.0110', 'spread': '0.2086', 'groupId': 'OG000'}]}]}, {'title': 'Phos, Year2, Week24,n=643', 'denoms': [{'units': 'Participants', 'counts': [{'value': '643', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.0026', 'spread': '0.2138', 'groupId': 'OG000'}]}]}, {'title': 'Phos, Year2, Week48,n=598', 'denoms': [{'units': 'Participants', 'counts': [{'value': '598', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.0044', 'spread': '0.2062', 'groupId': 'OG000'}]}]}, {'title': 'Phos, Year3, Week24,n=535', 'denoms': [{'units': 'Participants', 'counts': [{'value': '535', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.0109', 'spread': '0.2028', 'groupId': 'OG000'}]}]}, {'title': 'Phos, Year3, Week48,n=488', 'denoms': [{'units': 'Participants', 'counts': [{'value': '488', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.0185', 'spread': '0.2138', 'groupId': 'OG000'}]}]}, {'title': 'Phos, Year4, Week24,n=439', 'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.0072', 'spread': '0.2067', 'groupId': 'OG000'}]}]}, {'title': 'Phos, Year4, Week48,n=421', 'denoms': [{'units': 'Participants', 'counts': [{'value': '421', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.0143', 'spread': '0.2118', 'groupId': 'OG000'}]}]}, {'title': 'Phos, Year5, Week24,n=393', 'denoms': [{'units': 'Participants', 'counts': [{'value': '393', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.0199', 'spread': '0.2751', 'groupId': 'OG000'}]}]}, {'title': 'Phos, Year5, Week48,n=362', 'denoms': [{'units': 'Participants', 'counts': [{'value': '362', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.0320', 'spread': '0.2145', 'groupId': 'OG000'}]}]}, {'title': 'Phos, Year6, Week24,n=304', 'denoms': [{'units': 'Participants', 'counts': [{'value': '304', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.0238', 'spread': '0.2214', 'groupId': 'OG000'}]}]}, {'title': 'Phos, Year6, Week48,n=286', 'denoms': [{'units': 'Participants', 'counts': [{'value': '286', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.0123', 'spread': '0.2113', 'groupId': 'OG000'}]}]}, {'title': 'Phos, Year 7, Week 24,n=183', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.0196', 'spread': '0.1970', 'groupId': 'OG000'}]}]}, {'title': 'Phos, Year 7, Week 48,n=130', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.0101', 'spread': '0.1912', 'groupId': 'OG000'}]}]}, {'title': 'Phos, Year 8, Week 24,n=52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.0041', 'spread': '0.2038', 'groupId': 'OG000'}]}]}, {'title': 'Phos, Year 8, Week48,n=13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.0340', 'spread': '0.1337', 'groupId': 'OG000'}]}]}, {'title': 'Phos, Year9, Week 24,n=6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.0803', 'spread': '0.0823', 'groupId': 'OG000'}]}]}, {'title': 'Phos, Year 9, Week 48,n=1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0447', 'spread': 'NA', 'comment': 'NA indicates standard deviation was not calculable for a single data point.', 'groupId': 'OG000'}]}]}, {'title': 'Phos, Exit, n=625', 'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.0111', 'spread': '0.2243', 'groupId': 'OG000'}]}]}, {'title': 'Phos, 8 Week Follow up,n=539', 'denoms': [{'units': 'Participants', 'counts': [{'value': '539', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.0034', 'spread': '0.2233', 'groupId': 'OG000'}]}]}, {'title': 'K, Year 1, Week 4, n=701', 'denoms': [{'units': 'Participants', 'counts': [{'value': '701', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.07', 'spread': '0.411', 'groupId': 'OG000'}]}]}, {'title': 'K, Year 1, Week 12, n=700', 'denoms': [{'units': 'Participants', 'counts': [{'value': '700', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.03', 'spread': '0.380', 'groupId': 'OG000'}]}]}, {'title': 'K, Year 1, Week 24, n=701', 'denoms': [{'units': 'Participants', 'counts': [{'value': '701', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.01', 'spread': '0.377', 'groupId': 'OG000'}]}]}, {'title': 'K, Year 1, Week 36, n=682', 'denoms': [{'units': 'Participants', 'counts': [{'value': '682', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.04', 'spread': '0.387', 'groupId': 'OG000'}]}]}, {'title': 'K, Year 1, Week 48, n=692', 'denoms': [{'units': 'Participants', 'counts': [{'value': '692', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.01', 'spread': '0.377', 'groupId': 'OG000'}]}]}, {'title': 'K, Year 2, Week 24, n=641', 'denoms': [{'units': 'Participants', 'counts': [{'value': '641', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.01', 'spread': '0.393', 'groupId': 'OG000'}]}]}, {'title': 'K, Year 2, Week 48, n=592', 'denoms': [{'units': 'Participants', 'counts': [{'value': '592', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.02', 'spread': '0.372', 'groupId': 'OG000'}]}]}, {'title': 'K, Year 3, Week 24, n=531', 'denoms': [{'units': 'Participants', 'counts': [{'value': '531', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.05', 'spread': '0.401', 'groupId': 'OG000'}]}]}, {'title': 'K, Year 3, Week 48, n=486', 'denoms': [{'units': 'Participants', 'counts': [{'value': '486', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.06', 'spread': '0.421', 'groupId': 'OG000'}]}]}, {'title': 'K, Year 4, Week 24, n=438', 'denoms': [{'units': 'Participants', 'counts': [{'value': '438', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.06', 'spread': '0.408', 'groupId': 'OG000'}]}]}, {'title': 'K, Year 4, Week 48, n=418', 'denoms': [{'units': 'Participants', 'counts': [{'value': '418', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.03', 'spread': '0.397', 'groupId': 'OG000'}]}]}, {'title': 'K, Year 5, Week 24, n=393', 'denoms': [{'units': 'Participants', 'counts': [{'value': '393', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.08', 'spread': '0.427', 'groupId': 'OG000'}]}]}, {'title': 'K, Year 5, Week 48, n=362', 'denoms': [{'units': 'Participants', 'counts': [{'value': '362', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.02', 'spread': '0.404', 'groupId': 'OG000'}]}]}, {'title': 'K, Year 6, Week 24, n=303', 'denoms': [{'units': 'Participants', 'counts': [{'value': '303', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.06', 'spread': '0.429', 'groupId': 'OG000'}]}]}, {'title': 'K, Year 6, Week 48, n=284', 'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.05', 'spread': '0.437', 'groupId': 'OG000'}]}]}, {'title': 'K, Year 7, Week 24, n=182', 'denoms': [{'units': 'Participants', 'counts': [{'value': '182', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.05', 'spread': '0.445', 'groupId': 'OG000'}]}]}, {'title': 'K, Year 7, Week 48, n=130', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.05', 'spread': '0.413', 'groupId': 'OG000'}]}]}, {'title': 'K, Year 8, Week 24, n=52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.02', 'spread': '0.418', 'groupId': 'OG000'}]}]}, {'title': 'K, Year 8, Week 48, n=13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.12', 'spread': '0.300', 'groupId': 'OG000'}]}]}, {'title': 'K, Year 9, Week 24, n=6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.05', 'spread': '0.259', 'groupId': 'OG000'}]}]}, {'title': 'K, Year 9, Week 48, n=1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'NA indicates standard deviation was not calculable for a single data point.', 'groupId': 'OG000'}]}]}, {'title': 'K, Exit, n=624', 'denoms': [{'units': 'Participants', 'counts': [{'value': '624', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.06', 'spread': '0.435', 'groupId': 'OG000'}]}]}, {'title': 'K, 8 Week Follow up, n=537', 'denoms': [{'units': 'Participants', 'counts': [{'value': '537', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.07', 'spread': '0.452', 'groupId': 'OG000'}]}]}, {'title': 'Na, Year 1, Week 4, n=707', 'denoms': [{'units': 'Participants', 'counts': [{'value': '707', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '2.07', 'groupId': 'OG000'}]}]}, {'title': 'Na, Year 1, Week 12, n=705', 'denoms': [{'units': 'Participants', 'counts': [{'value': '705', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '2.25', 'groupId': 'OG000'}]}]}, {'title': 'Na, Year 1, Week 24, n=703', 'denoms': [{'units': 'Participants', 'counts': [{'value': '703', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '2.16', 'groupId': 'OG000'}]}]}, {'title': 'Na, Year 1, Week 36, n=684', 'denoms': [{'units': 'Participants', 'counts': [{'value': '684', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '2.10', 'groupId': 'OG000'}]}]}, {'title': 'Na, Year 1, Week 48, n=693', 'denoms': [{'units': 'Participants', 'counts': [{'value': '693', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '2.09', 'groupId': 'OG000'}]}]}, {'title': 'Na, Year 2, Week 24, n=643', 'denoms': [{'units': 'Participants', 'counts': [{'value': '643', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.0', 'spread': '2.30', 'groupId': 'OG000'}]}]}, {'title': 'Na, Year 2, Week 48, n=598', 'denoms': [{'units': 'Participants', 'counts': [{'value': '598', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '2.63', 'groupId': 'OG000'}]}]}, {'title': 'Na, Year 3, Week 24, n=535', 'denoms': [{'units': 'Participants', 'counts': [{'value': '535', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '2.54', 'groupId': 'OG000'}]}]}, {'title': 'Na, Year 3, Week 48, n=488', 'denoms': [{'units': 'Participants', 'counts': [{'value': '488', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '2.36', 'groupId': 'OG000'}]}]}, {'title': 'Na, Year 4, Week 24, n=439', 'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '2.31', 'groupId': 'OG000'}]}]}, {'title': 'Na, Year 4, Week 48, n=421', 'denoms': [{'units': 'Participants', 'counts': [{'value': '421', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '2.36', 'groupId': 'OG000'}]}]}, {'title': 'Na, Year 5, Week 24, n=393', 'denoms': [{'units': 'Participants', 'counts': [{'value': '393', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '2.61', 'groupId': 'OG000'}]}]}, {'title': 'Na, Year 5, Week 48, n=362', 'denoms': [{'units': 'Participants', 'counts': [{'value': '362', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '2.18', 'groupId': 'OG000'}]}]}, {'title': 'Na, Year 6, Week 24, n=304', 'denoms': [{'units': 'Participants', 'counts': [{'value': '304', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '2.22', 'groupId': 'OG000'}]}]}, {'title': 'Na, Year 6, Week 48, n=286', 'denoms': [{'units': 'Participants', 'counts': [{'value': '286', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '2.44', 'groupId': 'OG000'}]}]}, {'title': 'Na, Year 7, Week 24, n=183', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '2.22', 'groupId': 'OG000'}]}]}, {'title': 'Na, Year 7, Week 48, n=130', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '2.38', 'groupId': 'OG000'}]}]}, {'title': 'Na, Year 8, Week 24, n=52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '2.67', 'groupId': 'OG000'}]}]}, {'title': 'Na, Year 8, Week 48, n=13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '2.14', 'groupId': 'OG000'}]}]}, {'title': 'Na, Year 9, Week 24, n=6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': '1.79', 'groupId': 'OG000'}]}]}, {'title': 'Na, Year 9, Week 48, n=1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.0', 'spread': 'NA', 'comment': 'NA indicates standard deviation was not calculable for a single data point.', 'groupId': 'OG000'}]}]}, {'title': 'Na, Exist, n=624', 'denoms': [{'units': 'Participants', 'counts': [{'value': '624', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '2.55', 'groupId': 'OG000'}]}]}, {'title': 'Na, 8 Week Follow up, n=538', 'denoms': [{'units': 'Participants', 'counts': [{'value': '538', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '2.36', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and up to 9 years', 'description': 'Electrolytes parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 electrolytes parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Ca,CO2, Chloride, Mg, Phos, K and Na were summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were 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. NA indicates standard deviation was not calculable for a single data point.', 'unitOfMeasure': 'Millimoles per liter (mmol/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT Population'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Blood Urea Nitrogen/Creatinine (BUN/Cr) at the Indicated Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '735', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Belimumab 10mg/kg IV', 'description': 'Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial.'}], 'classes': [{'title': 'BUN/Cr,Year1,Week4,n=707', 'denoms': [{'units': 'Participants', 'counts': [{'value': '707', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'spread': '4.66', 'groupId': 'OG000'}]}]}, {'title': 'BUN/Cr,Year1,Week12,n=705', 'denoms': [{'units': 'Participants', 'counts': [{'value': '705', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'spread': '4.88', 'groupId': 'OG000'}]}]}, {'title': 'BUN/CrYear1,Week24,n=703', 'denoms': [{'units': 'Participants', 'counts': [{'value': '703', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.7', 'spread': '5.02', 'groupId': 'OG000'}]}]}, {'title': 'BUN/Cr,Year1,Week36,n=683', 'denoms': [{'units': 'Participants', 'counts': [{'value': '683', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'spread': '5.61', 'groupId': 'OG000'}]}]}, {'title': 'BUN/Cr,Year1,Week48,n=693', 'denoms': [{'units': 'Participants', 'counts': [{'value': '693', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'spread': '5.26', 'groupId': 'OG000'}]}]}, {'title': 'BUN/Cr,Year2,Week24,n=643', 'denoms': [{'units': 'Participants', 'counts': [{'value': '643', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '5.68', 'groupId': 'OG000'}]}]}, {'title': 'BUN/Cr,Year2,Week48,n=598', 'denoms': [{'units': 'Participants', 'counts': [{'value': '598', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.5', 'spread': '5.55', 'groupId': 'OG000'}]}]}, {'title': 'BUN/Cr,Year3,Week24,n=535', 'denoms': [{'units': 'Participants', 'counts': [{'value': '535', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.4', 'spread': '5.48', 'groupId': 'OG000'}]}]}, {'title': 'BUN/Cr,Year3,Week48,n=488', 'denoms': [{'units': 'Participants', 'counts': [{'value': '488', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.2', 'spread': '5.92', 'groupId': 'OG000'}]}]}, {'title': 'BUN/Cr,Year4,Week24,n=439', 'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.4', 'spread': '5.65', 'groupId': 'OG000'}]}]}, {'title': 'BUN/Cr,Year 4,Week48,n=421', 'denoms': [{'units': 'Participants', 'counts': [{'value': '421', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': '5.85', 'groupId': 'OG000'}]}]}, {'title': 'BUN/Cr,Year5,Week24,n=393', 'denoms': [{'units': 'Participants', 'counts': [{'value': '393', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': '5.51', 'groupId': 'OG000'}]}]}, {'title': 'BUN/Cr,Year5,Week48,n=362', 'denoms': [{'units': 'Participants', 'counts': [{'value': '362', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': '5.62', 'groupId': 'OG000'}]}]}, {'title': 'BUN/Cr,Year6,Week24,n=304', 'denoms': [{'units': 'Participants', 'counts': [{'value': '304', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': '5.35', 'groupId': 'OG000'}]}]}, {'title': 'BUN/Cr,Year6,Week48,n=286', 'denoms': [{'units': 'Participants', 'counts': [{'value': '286', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.3', 'spread': '5.74', 'groupId': 'OG000'}]}]}, {'title': 'BUN/Cr,Year7,Week24,n=183', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.8', 'spread': '5.68', 'groupId': 'OG000'}]}]}, {'title': 'BUN/Cr,Year7,Week48,n=130', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.2', 'spread': '5.47', 'groupId': 'OG000'}]}]}, {'title': 'BUN/Cr,Year8,Week24,n=52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.3', 'spread': '4.64', 'groupId': 'OG000'}]}]}, {'title': 'BUN/Cr,Year8,Week48,n=13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.5', 'spread': '6.04', 'groupId': 'OG000'}]}]}, {'title': 'BUN/Cr,Year9,Week24,n=6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.5', 'spread': '3.08', 'groupId': 'OG000'}]}]}, {'title': 'BUN/Cr,Year9,Week48,n=1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'spread': '2.0', 'groupId': 'OG000'}]}]}, {'title': 'BUN/Cr,Exit,n=625', 'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.9', 'spread': '6.05', 'groupId': 'OG000'}]}]}, {'title': 'BUN/Cr,8 Week Follow up,n=539', 'denoms': [{'units': 'Participants', 'counts': [{'value': '539', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.9', 'spread': '5.91', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and up to 9 years', 'description': 'Other chemistries parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 other chemistries parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in BUN/Cr is summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were 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 Albumin (Alb) and Protein (Pro) at the Indicated Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '735', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Belimumab 10mg/kg IV', 'description': 'Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial.'}], 'classes': [{'title': 'Alb,Year1,Week4,n=707', 'denoms': [{'units': 'Participants', 'counts': [{'value': '707', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '2.36', 'groupId': 'OG000'}]}]}, {'title': 'Alb,Year1,Week12,n=705', 'denoms': [{'units': 'Participants', 'counts': [{'value': '705', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '2.67', 'groupId': 'OG000'}]}]}, {'title': 'Alb,Year1,Week24,n=703', 'denoms': [{'units': 'Participants', 'counts': [{'value': '703', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.6', 'spread': '3.03', 'groupId': 'OG000'}]}]}, {'title': 'Alb,Year1,Week36,n=684', 'denoms': [{'units': 'Participants', 'counts': [{'value': '684', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': '3.23', 'groupId': 'OG000'}]}]}, {'title': 'Alb,Year1,Week48,n=693', 'denoms': [{'units': 'Participants', 'counts': [{'value': '693', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.2', 'spread': '3.52', 'groupId': 'OG000'}]}]}, {'title': 'Alb,Year2,Week24,n=643', 'denoms': [{'units': 'Participants', 'counts': [{'value': '643', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.2', 'spread': '3.49', 'groupId': 'OG000'}]}]}, {'title': 'Alb,Year2,Week48,n=598', 'denoms': [{'units': 'Participants', 'counts': [{'value': '598', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.2', 'spread': '3.67', 'groupId': 'OG000'}]}]}, {'title': 'Alb,Year3,Week24,n=535', 'denoms': [{'units': 'Participants', 'counts': [{'value': '535', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.2', 'spread': '3.78', 'groupId': 'OG000'}]}]}, {'title': 'Alb,Year3,Week48,n=488', 'denoms': [{'units': 'Participants', 'counts': [{'value': '488', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.4', 'spread': '4.02', 'groupId': 'OG000'}]}]}, {'title': 'Alb,Year4,Week24,n=439', 'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.7', 'spread': '4.02', 'groupId': 'OG000'}]}]}, {'title': 'Alb,Year 4,Week48,n=421', 'denoms': [{'units': 'Participants', 'counts': [{'value': '421', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.9', 'spread': '4.04', 'groupId': 'OG000'}]}]}, {'title': 'Alb,Year5,Week24,n=393', 'denoms': [{'units': 'Participants', 'counts': [{'value': '393', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.9', 'spread': '3.85', 'groupId': 'OG000'}]}]}, {'title': 'Alb,Year5,Week48,n=362', 'denoms': [{'units': 'Participants', 'counts': [{'value': '362', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.3', 'spread': '3.89', 'groupId': 'OG000'}]}]}, {'title': 'Alb,Year6,Week24,n=304', 'denoms': [{'units': 'Participants', 'counts': [{'value': '304', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.2', 'spread': '3.78', 'groupId': 'OG000'}]}]}, {'title': 'Alb,Year6,Week48,n=286', 'denoms': [{'units': 'Participants', 'counts': [{'value': '286', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.1', 'spread': '4.07', 'groupId': 'OG000'}]}]}, {'title': 'Alb,Year7,Week24,n=183', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.0', 'spread': '3.60', 'groupId': 'OG000'}]}]}, {'title': 'Alb,Year7,Week48,n=130', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.3', 'spread': '3.92', 'groupId': 'OG000'}]}]}, {'title': 'Alb,Year8,Week24,n=52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.9', 'spread': '4.16', 'groupId': 'OG000'}]}]}, {'title': 'Alb,Year8,Week48,n=13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.1', 'spread': '4.11', 'groupId': 'OG000'}]}]}, {'title': 'Alb,Year9,Week24,n=6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': '3.01', 'groupId': 'OG000'}]}]}, {'title': 'Alb,Year9,Week48,n=1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': 'NA', 'comment': 'NA indicates standard deviation was not calculable for a single data point.', 'groupId': 'OG000'}]}]}, {'title': 'Alb,Exit,n=625', 'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.8', 'spread': '4.74', 'groupId': 'OG000'}]}]}, {'title': 'Alb,8 Week Follow up,n=539', 'denoms': [{'units': 'Participants', 'counts': [{'value': '539', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.7', 'spread': '4.66', 'groupId': 'OG000'}]}]}, {'title': 'Pro,Year1,Week4,n=707', 'denoms': [{'units': 'Participants', 'counts': [{'value': '707', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.4', 'spread': '3.81', 'groupId': 'OG000'}]}]}, {'title': 'Pro,Year1,Week12,n=705', 'denoms': [{'units': 'Participants', 'counts': [{'value': '705', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.0', 'spread': '4.30', 'groupId': 'OG000'}]}]}, {'title': 'Pro,Year1,Week24,n=703', 'denoms': [{'units': 'Participants', 'counts': [{'value': '703', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.9', 'spread': '4.68', 'groupId': 'OG000'}]}]}, {'title': 'Pro,Year1,Week36,n=684', 'denoms': [{'units': 'Participants', 'counts': [{'value': '684', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.3', 'spread': '4.75', 'groupId': 'OG000'}]}]}, {'title': 'Pro,Year1,Week48,n=693', 'denoms': [{'units': 'Participants', 'counts': [{'value': '693', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.8', 'spread': '4.94', 'groupId': 'OG000'}]}]}, {'title': 'Pro,Year2,Week24,n=643', 'denoms': [{'units': 'Participants', 'counts': [{'value': '643', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.3', 'spread': '5.05', 'groupId': 'OG000'}]}]}, {'title': 'Pro,Year2,Week48,n=598', 'denoms': [{'units': 'Participants', 'counts': [{'value': '598', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.7', 'spread': '5.53', 'groupId': 'OG000'}]}]}, {'title': 'Pro,Year3,Week24,n=535', 'denoms': [{'units': 'Participants', 'counts': [{'value': '535', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.1', 'spread': '5.62', 'groupId': 'OG000'}]}]}, {'title': 'Pro,Year3,Week48,n=488', 'denoms': [{'units': 'Participants', 'counts': [{'value': '488', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.5', 'spread': '5.91', 'groupId': 'OG000'}]}]}, {'title': 'Pro,Year4,Week24,n=439', 'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.2', 'spread': '5.87', 'groupId': 'OG000'}]}]}, {'title': 'Pro,Year 4,Week48,n=421', 'denoms': [{'units': 'Participants', 'counts': [{'value': '421', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.2', 'spread': '6.07', 'groupId': 'OG000'}]}]}, {'title': 'Pro,Year5,Week24,n=393', 'denoms': [{'units': 'Participants', 'counts': [{'value': '393', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.5', 'spread': '5.75', 'groupId': 'OG000'}]}]}, {'title': 'Pro,Year5,Week48,n=362', 'denoms': [{'units': 'Participants', 'counts': [{'value': '362', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.6', 'spread': '5.78', 'groupId': 'OG000'}]}]}, {'title': 'Pro,Year6,Week24,n=304', 'denoms': [{'units': 'Participants', 'counts': [{'value': '304', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.9', 'spread': '5.57', 'groupId': 'OG000'}]}]}, {'title': 'Pro,Year6,Week48,n=286', 'denoms': [{'units': 'Participants', 'counts': [{'value': '286', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.0', 'spread': '5.79', 'groupId': 'OG000'}]}]}, {'title': 'Pro,Year7,Week24,n=183', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.3', 'spread': '5.36', 'groupId': 'OG000'}]}]}, {'title': 'Pro,Year7,Week48,n=130', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.9', 'spread': '5.32', 'groupId': 'OG000'}]}]}, {'title': 'Pro,Year8,Week24,n=52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.1', 'spread': '6.38', 'groupId': 'OG000'}]}]}, {'title': 'Pro,Year8,Week48,n=13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.8', 'spread': '5.02', 'groupId': 'OG000'}]}]}, {'title': 'Pro,Year9,Week24,n=6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-7.7', 'spread': '7.03', 'groupId': 'OG000'}]}]}, {'title': 'Pro,Year9,Week48,n=1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': 'NA', 'comment': 'NA indicates standard deviation was not calculable for a single data point.', 'groupId': 'OG000'}]}]}, {'title': 'Pro,Exit,n=625', 'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.4', 'spread': '6.45', 'groupId': 'OG000'}]}]}, {'title': 'Pro,8 Week Follow up,n=539', 'denoms': [{'units': 'Participants', 'counts': [{'value': '539', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.7', 'spread': '6.42', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and up to 9 years', 'description': 'Other chemistries parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 other chemistries parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Alb and Protein were summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were 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. NA indicates standard deviation was not calculable for a single data point.', 'unitOfMeasure': 'Grams per liter (g/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT Population'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in BUN and Glucose at the Indicated Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '735', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Belimumab 10mg/kg IV', 'description': 'Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial.'}], 'classes': [{'title': 'BUN,Year1,Week4,n=707', 'denoms': [{'units': 'Participants', 'counts': [{'value': '707', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0299', 'spread': '1.6783', 'groupId': 'OG000'}]}]}, {'title': 'BUN,Year1,Week12,n=705', 'denoms': [{'units': 'Participants', 'counts': [{'value': '705', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0402', 'spread': '1.9768', 'groupId': 'OG000'}]}]}, {'title': 'BUN,Year1,Week24,n=703', 'denoms': [{'units': 'Participants', 'counts': [{'value': '703', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.1443', 'spread': '1.3723', 'groupId': 'OG000'}]}]}, {'title': 'BUN,Year1,Week36,n=683', 'denoms': [{'units': 'Participants', 'counts': [{'value': '683', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.0592', 'spread': '1.6916', 'groupId': 'OG000'}]}]}, {'title': 'BUN,Year1,Week48,n=693', 'denoms': [{'units': 'Participants', 'counts': [{'value': '693', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.0406', 'spread': '1.5541', 'groupId': 'OG000'}]}]}, {'title': 'BUN,Year2,Week24,n=643', 'denoms': [{'units': 'Participants', 'counts': [{'value': '643', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.0760', 'spread': '1.6652', 'groupId': 'OG000'}]}]}, {'title': 'BUN,Year2,Week48,n=598', 'denoms': [{'units': 'Participants', 'counts': [{'value': '598', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0631', 'spread': '1.6429', 'groupId': 'OG000'}]}]}, {'title': 'BUN,Year3,Week24,n=535', 'denoms': [{'units': 'Participants', 'counts': [{'value': '535', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0524', 'spread': '1.6850', 'groupId': 'OG000'}]}]}, {'title': 'BUN,Year3,Week48,n=488', 'denoms': [{'units': 'Participants', 'counts': [{'value': '488', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.1013', 'spread': '1.6910', 'groupId': 'OG000'}]}]}, {'title': 'BUN,Year4,Week24,n=439', 'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0967', 'spread': '1.9398', 'groupId': 'OG000'}]}]}, {'title': 'BUN,Year 4,Week48,n=421', 'denoms': [{'units': 'Participants', 'counts': [{'value': '421', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0672', 'spread': '2.1393', 'groupId': 'OG000'}]}]}, {'title': 'BUN,Year5,Week24,n=393', 'denoms': [{'units': 'Participants', 'counts': [{'value': '393', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.0291', 'spread': '2.0169', 'groupId': 'OG000'}]}]}, {'title': 'BUN,Year5,Week48,n=362', 'denoms': [{'units': 'Participants', 'counts': [{'value': '362', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0899', 'spread': '2.0903', 'groupId': 'OG000'}]}]}, {'title': 'BUN,Year6,Week24,n=304', 'denoms': [{'units': 'Participants', 'counts': [{'value': '304', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0959', 'spread': '1.9852', 'groupId': 'OG000'}]}]}, {'title': 'BUN,Year6,Week48,n=286', 'denoms': [{'units': 'Participants', 'counts': [{'value': '286', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.2325', 'spread': '2.2724', 'groupId': 'OG000'}]}]}, {'title': 'BUN,Year7,Week24,n=183', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.0026', 'spread': '1.6623', 'groupId': 'OG000'}]}]}, {'title': 'BUN,Year7,Week48,n=130', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.1455', 'spread': '1.7145', 'groupId': 'OG000'}]}]}, {'title': 'BUN,Year8,Week24,n=52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.5458', 'spread': '1.7299', 'groupId': 'OG000'}]}]}, {'title': 'BUN,Year8,Week48,n=13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.3883', 'spread': '1.4603', 'groupId': 'OG000'}]}]}, {'title': 'BUN,Year9,Week24,n=6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.1648', 'spread': '1.0466', 'groupId': 'OG000'}]}]}, {'title': 'BUN,Year9,Week48,n=1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.5700', 'spread': 'NA', 'comment': 'NA indicates standard deviation was not calculable for a single data point.', 'groupId': 'OG000'}]}]}, {'title': 'BUN,Exit,n=625', 'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.2448', 'spread': '2.4618', 'groupId': 'OG000'}]}]}, {'title': 'BUN,8 Week Follow up,n=539', 'denoms': [{'units': 'Participants', 'counts': [{'value': '539', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0822', 'spread': '2.5567', 'groupId': 'OG000'}]}]}, {'title': 'Glucose,Year1,Week4,n=707', 'denoms': [{'units': 'Participants', 'counts': [{'value': '707', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.0031', 'spread': '1.0221', 'groupId': 'OG000'}]}]}, {'title': 'Glucose,Year1,Week12,n=705', 'denoms': [{'units': 'Participants', 'counts': [{'value': '705', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0333', 'spread': '1.0627', 'groupId': 'OG000'}]}]}, {'title': 'Glucose,Year1,Week24,n=702', 'denoms': [{'units': 'Participants', 'counts': [{'value': '702', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.0396', 'spread': '1.2656', 'groupId': 'OG000'}]}]}, {'title': 'Glucose,Year1,Week36,n=684', 'denoms': [{'units': 'Participants', 'counts': [{'value': '684', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0099', 'spread': '1.0269', 'groupId': 'OG000'}]}]}, {'title': 'Glucose,Year1,Week48,n=693', 'denoms': [{'units': 'Participants', 'counts': [{'value': '693', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0010', 'spread': '1.1726', 'groupId': 'OG000'}]}]}, {'title': 'Glucose,Year2,Week24,n=643', 'denoms': [{'units': 'Participants', 'counts': [{'value': '643', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0143', 'spread': '1.3227', 'groupId': 'OG000'}]}]}, {'title': 'Glucose,Year2,Week48,n=598', 'denoms': [{'units': 'Participants', 'counts': [{'value': '598', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.0082', 'spread': '1.1352', 'groupId': 'OG000'}]}]}, {'title': 'Glucose,Year3,Week24,n=535', 'denoms': [{'units': 'Participants', 'counts': [{'value': '535', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.0159', 'spread': '1.3222', 'groupId': 'OG000'}]}]}, {'title': 'Glucose,Year3,Week48,n=488', 'denoms': [{'units': 'Participants', 'counts': [{'value': '488', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0309', 'spread': '1.1841', 'groupId': 'OG000'}]}]}, {'title': 'Glucose,Year4,Week24,n=439', 'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.0160', 'spread': '1.2213', 'groupId': 'OG000'}]}]}, {'title': 'Glucose,Year 4,Week48,n=421', 'denoms': [{'units': 'Participants', 'counts': [{'value': '421', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.0259', 'spread': '1.1936', 'groupId': 'OG000'}]}]}, {'title': 'Glucose,Year5,Week24,n=393', 'denoms': [{'units': 'Participants', 'counts': [{'value': '393', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0554', 'spread': '1.1255', 'groupId': 'OG000'}]}]}, {'title': 'Glucose,Year5,Week48,n=362', 'denoms': [{'units': 'Participants', 'counts': [{'value': '362', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0655', 'spread': '1.2946', 'groupId': 'OG000'}]}]}, {'title': 'Glucose,Year6,Week24,n=303', 'denoms': [{'units': 'Participants', 'counts': [{'value': '303', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.1290', 'spread': '1.1163', 'groupId': 'OG000'}]}]}, {'title': 'Glucose,Year6,Week48,n=286', 'denoms': [{'units': 'Participants', 'counts': [{'value': '286', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.2001', 'spread': '1.2411', 'groupId': 'OG000'}]}]}, {'title': 'Glucose,Year7,Week24,n=183', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.2303', 'spread': '1.0514', 'groupId': 'OG000'}]}]}, {'title': 'Glucose,Year7,Week48,n=130', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.2335', 'spread': '0.8346', 'groupId': 'OG000'}]}]}, {'title': 'Glucose,Year8,Week24,n=52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.3301', 'spread': '0.9052', 'groupId': 'OG000'}]}]}, {'title': 'Glucose,Year8,Week48,n=13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.1431', 'spread': '0.8115', 'groupId': 'OG000'}]}]}, {'title': 'Glucose,Year9,Week24,n=6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.2128', 'spread': '0.4914', 'groupId': 'OG000'}]}]}, {'title': 'Glucose,Year9,Week48,n=1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.4739', 'spread': 'NA', 'comment': 'NA indicates standard deviation was not calculable for a single data point', 'groupId': 'OG000'}]}]}, {'title': 'Glucose,Exit,n=624', 'denoms': [{'units': 'Participants', 'counts': [{'value': '624', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.1842', 'spread': '1.8723', 'groupId': 'OG000'}]}]}, {'title': 'Glucose,8 Week Follow up,n=539', 'denoms': [{'units': 'Participants', 'counts': [{'value': '539', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0338', 'spread': '1.4139', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and up to 9 years', 'description': 'Other chemistries parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 other chemistries were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in BUN and Glucose were summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were 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. NA indicates standard deviation was not calculable for a single data point.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT Population'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '735', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Belimumab 10mg/kg IV', 'description': 'Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial.'}], 'classes': [{'title': 'Urate,Year1,Week4,n=707', 'denoms': [{'units': 'Participants', 'counts': [{'value': '707', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.0332', 'spread': '45.8504', 'groupId': 'OG000'}]}]}, {'title': 'Urate,Year1,Week12,n=704', 'denoms': [{'units': 'Participants', 'counts': [{'value': '704', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.4089', 'spread': '54.3182', 'groupId': 'OG000'}]}]}, {'title': 'Urate,Year1,Week24,n=703', 'denoms': [{'units': 'Participants', 'counts': [{'value': '703', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.0510', 'spread': '49.2328', 'groupId': 'OG000'}]}]}, {'title': 'Urate,Year1,Week36,n=684', 'denoms': [{'units': 'Participants', 'counts': [{'value': '684', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.6713', 'spread': '50.7341', 'groupId': 'OG000'}]}]}, {'title': 'Urate,Year1,Week48,n=693', 'denoms': [{'units': 'Participants', 'counts': [{'value': '693', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.5147', 'spread': '50.5928', 'groupId': 'OG000'}]}]}, {'title': 'Urate,Year2,Week24,n=643', 'denoms': [{'units': 'Participants', 'counts': [{'value': '643', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.7246', 'spread': '55.7467', 'groupId': 'OG000'}]}]}, {'title': 'Urate,Year2,Week48,n=598', 'denoms': [{'units': 'Participants', 'counts': [{'value': '598', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.1255', 'spread': '60.0251', 'groupId': 'OG000'}]}]}, {'title': 'Urate,Year3,Week24,n=535', 'denoms': [{'units': 'Participants', 'counts': [{'value': '535', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.7497', 'spread': '60.4118', 'groupId': 'OG000'}]}]}, {'title': 'Urate,Year3,Week48,n=488', 'denoms': [{'units': 'Participants', 'counts': [{'value': '488', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.9744', 'spread': '63.6876', 'groupId': 'OG000'}]}]}, {'title': 'Urate,Year4,Week24,n=439', 'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.9658', 'spread': '66.6167', 'groupId': 'OG000'}]}]}, {'title': 'Urate,Year 4,Week48,n=421', 'denoms': [{'units': 'Participants', 'counts': [{'value': '421', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.0772', 'spread': '67.9587', 'groupId': 'OG000'}]}]}, {'title': 'Urate,Year5,Week24,n=393', 'denoms': [{'units': 'Participants', 'counts': [{'value': '393', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.5634', 'spread': '66.9130', 'groupId': 'OG000'}]}]}, {'title': 'Urate,Year5,Week48,n=362', 'denoms': [{'units': 'Participants', 'counts': [{'value': '362', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.8979', 'spread': '67.3843', 'groupId': 'OG000'}]}]}, {'title': 'Urate,Year6,Week24,n=304', 'denoms': [{'units': 'Participants', 'counts': [{'value': '304', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.9530', 'spread': '62.3168', 'groupId': 'OG000'}]}]}, {'title': 'Urate,Year6,Week48,n=286', 'denoms': [{'units': 'Participants', 'counts': [{'value': '286', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.1244', 'spread': '67.3175', 'groupId': 'OG000'}]}]}, {'title': 'Urate,Year7,Week24,n=183', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.1521', 'spread': '53.0854', 'groupId': 'OG000'}]}]}, {'title': 'Urate,Year7,Week48,n=130', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.0062', 'spread': '58.3577', 'groupId': 'OG000'}]}]}, {'title': 'Urate,Year8,Week24,n=52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.1003', 'spread': '51.8840', 'groupId': 'OG000'}]}]}, {'title': 'Urate,Year8,Week48,n=13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '29.2043', 'spread': '80.1811', 'groupId': 'OG000'}]}]}, {'title': 'Urate,Year9,Week24,n=6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.2187', 'spread': '45.1947', 'groupId': 'OG000'}]}]}, {'title': 'Urate,Year9,Week48,n=1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-69.6640', 'spread': 'NA', 'comment': 'NA indicates standard deviation was not calculable for a single data point.', 'groupId': 'OG000'}]}]}, {'title': 'Urate,Exit,n=625', 'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.6479', 'spread': '74.4078', 'groupId': 'OG000'}]}]}, {'title': 'Urate,8 Week Follow up,n=539', 'denoms': [{'units': 'Participants', 'counts': [{'value': '539', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.7404', 'spread': '75.5887', 'groupId': 'OG000'}]}]}, {'title': 'Cr,Year1,Week4,n=707', 'denoms': [{'units': 'Participants', 'counts': [{'value': '707', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.913', 'spread': '14.2222', 'groupId': 'OG000'}]}]}, {'title': 'Cr,Year1,Week12,n=705', 'denoms': [{'units': 'Participants', 'counts': [{'value': '705', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.751', 'spread': '14.0933', 'groupId': 'OG000'}]}]}, {'title': 'Cr,Year1,Week24,n=703', 'denoms': [{'units': 'Participants', 'counts': [{'value': '703', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.823', 'spread': '9.5372', 'groupId': 'OG000'}]}]}, {'title': 'Cr,Year1,Week36,n=684', 'denoms': [{'units': 'Participants', 'counts': [{'value': '684', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.313', 'spread': '13.1107', 'groupId': 'OG000'}]}]}, {'title': 'Cr,Year1,Week48,n=693', 'denoms': [{'units': 'Participants', 'counts': [{'value': '693', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.439', 'spread': '11.1364', 'groupId': 'OG000'}]}]}, {'title': 'Cr,Year2,Week24,n=643', 'denoms': [{'units': 'Participants', 'counts': [{'value': '643', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.217', 'spread': '13.9502', 'groupId': 'OG000'}]}]}, {'title': 'Cr,Year2,Week48,n=598', 'denoms': [{'units': 'Participants', 'counts': [{'value': '598', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.922', 'spread': '13.6541', 'groupId': 'OG000'}]}]}, {'title': 'Cr,Year3,Week24,n=535', 'denoms': [{'units': 'Participants', 'counts': [{'value': '535', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.870', 'spread': '17.8146', 'groupId': 'OG000'}]}]}, {'title': 'Cr,Year3,Week48,n=488', 'denoms': [{'units': 'Participants', 'counts': [{'value': '488', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.844', 'spread': '17.7059', 'groupId': 'OG000'}]}]}, {'title': 'Crea,Year4,Week24,n=439', 'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.196', 'spread': '22.2874', 'groupId': 'OG000'}]}]}, {'title': 'Crea,Year 4,Week48,n=421', 'denoms': [{'units': 'Participants', 'counts': [{'value': '421', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.145', 'spread': '30.9370', 'groupId': 'OG000'}]}]}, {'title': 'Cr,Year5,Week24,n=393', 'denoms': [{'units': 'Participants', 'counts': [{'value': '393', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.999', 'spread': '32.6689', 'groupId': 'OG000'}]}]}, {'title': 'Cr,Year5,Week48,n=362', 'denoms': [{'units': 'Participants', 'counts': [{'value': '362', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.918', 'spread': '28.8788', 'groupId': 'OG000'}]}]}, {'title': 'Cr,Year6,Week24,n=304', 'denoms': [{'units': 'Participants', 'counts': [{'value': '304', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.125', 'spread': '24.2374', 'groupId': 'OG000'}]}]}, {'title': 'Cr,Year6,Week48,n=286', 'denoms': [{'units': 'Participants', 'counts': [{'value': '286', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.534', 'spread': '28.8012', 'groupId': 'OG000'}]}]}, {'title': 'Cr,Year7,Week24,n=183', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.511', 'spread': '15.6881', 'groupId': 'OG000'}]}]}, {'title': 'Cr,Year7,Week48,n=130', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.586', 'spread': '14.0864', 'groupId': 'OG000'}]}]}, {'title': 'Cr,Year8,Week24,n=52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.659', 'spread': '16.3056', 'groupId': 'OG000'}]}]}, {'title': 'Cr,Year8,Week48,n=13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-6.175', 'spread': '6.6311', 'groupId': 'OG000'}]}]}, {'title': 'Cr,Year9,Week24,n=6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-8.933', 'spread': '5.6925', 'groupId': 'OG000'}]}]}, {'title': 'Cr,Year9,Week48,n=1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.040', 'spread': 'NA', 'comment': 'NA indicates standard deviation was not calculable for a single data point.', 'groupId': 'OG000'}]}]}, {'title': 'Cr,Exit,n=624', 'denoms': [{'units': 'Participants', 'counts': [{'value': '624', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.606', 'spread': '35.9813', 'groupId': 'OG000'}]}]}, {'title': 'Cr,8 Week Follow up,n=539', 'denoms': [{'units': 'Participants', 'counts': [{'value': '539', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.108', 'spread': '39.0635', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and up to 9 years', 'description': 'Other chemistries parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 other chemistries were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Cr and Urate were summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were 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. NA indicates standard deviation was not calculable for a single data point.', 'unitOfMeasure': 'Micromoles per liter (µmol/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT Population'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '735', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Belimumab 10mg/kg IV', 'description': 'Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial.'}], 'classes': [{'title': 'ALT, Year 1 Week 4, n=707', 'denoms': [{'units': 'Participants', 'counts': [{'value': '707', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'spread': '10.18', 'groupId': 'OG000'}]}]}, {'title': 'ALT, Year 1 Week 12, n=705', 'denoms': [{'units': 'Participants', 'counts': [{'value': '705', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.9', 'spread': '12.31', 'groupId': 'OG000'}]}]}, {'title': 'ALT, Year 1 Week 24, n=703', 'denoms': [{'units': 'Participants', 'counts': [{'value': '703', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.9', 'spread': '19.46', 'groupId': 'OG000'}]}]}, {'title': 'ALT, Year 1 Week 36, n=684', 'denoms': [{'units': 'Participants', 'counts': [{'value': '684', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.0', 'spread': '15.61', 'groupId': 'OG000'}]}]}, {'title': 'ALT, Year 1 Week 48, n=693', 'denoms': [{'units': 'Participants', 'counts': [{'value': '693', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.7', 'spread': '15.04', 'groupId': 'OG000'}]}]}, {'title': 'ALT, Year 2 Week 24, n=643', 'denoms': [{'units': 'Participants', 'counts': [{'value': '643', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '23.56', 'groupId': 'OG000'}]}]}, {'title': 'ALT, Year 2 Week 48, n=598', 'denoms': [{'units': 'Participants', 'counts': [{'value': '598', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.7', 'spread': '57.67', 'groupId': 'OG000'}]}]}, {'title': 'ALT, Year 3 Week 24, n=535', 'denoms': [{'units': 'Participants', 'counts': [{'value': '535', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.3', 'spread': '14.40', 'groupId': 'OG000'}]}]}, {'title': 'ALT, Year 3 Week 48, n=488', 'denoms': [{'units': 'Participants', 'counts': [{'value': '488', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '21.21', 'groupId': 'OG000'}]}]}, {'title': 'ALT, Year 4 Week 24, n=439', 'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '18.72', 'groupId': 'OG000'}]}]}, {'title': 'ALT, Year 4 Week 48, n=421', 'denoms': [{'units': 'Participants', 'counts': [{'value': '421', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.6', 'spread': '17.59', 'groupId': 'OG000'}]}]}, {'title': 'ALT, Year 5 Week 24, n=393', 'denoms': [{'units': 'Participants', 'counts': [{'value': '393', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.3', 'spread': '18.74', 'groupId': 'OG000'}]}]}, {'title': 'ALT, Year 5 Week 48, n=362', 'denoms': [{'units': 'Participants', 'counts': [{'value': '362', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'spread': '22.72', 'groupId': 'OG000'}]}]}, {'title': 'ALT, Year 6 Week 24, n=304', 'denoms': [{'units': 'Participants', 'counts': [{'value': '304', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'spread': '20.54', 'groupId': 'OG000'}]}]}, {'title': 'ALT, Year 6 Week 48, n=286', 'denoms': [{'units': 'Participants', 'counts': [{'value': '286', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.9', 'spread': '20.94', 'groupId': 'OG000'}]}]}, {'title': 'ALT, Year 7 Week 24, n=183', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.3', 'spread': '19.46', 'groupId': 'OG000'}]}]}, {'title': 'ALT, Year 7 Week 48, n=130', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '16.79', 'groupId': 'OG000'}]}]}, {'title': 'ALT, Year 8 Week 24, n=52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.7', 'spread': '31.15', 'groupId': 'OG000'}]}]}, {'title': 'ALT, Year 8 Week 48, n=13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.8', 'spread': '33.54', 'groupId': 'OG000'}]}]}, {'title': 'ALT, Year 9 Week 24, n=6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.3', 'spread': '27.77', 'groupId': 'OG000'}]}]}, {'title': 'ALT, Year 9 Week 48, n=1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-6.0', 'spread': 'NA', 'comment': 'NA indicates standard deviation was not calculable for a single data point.', 'groupId': 'OG000'}]}]}, {'title': 'ALT, Exit, n=624', 'denoms': [{'units': 'Participants', 'counts': [{'value': '624', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.6', 'spread': '17.03', 'groupId': 'OG000'}]}]}, {'title': 'ALT, 8 Week follow-up, n=539', 'denoms': [{'units': 'Participants', 'counts': [{'value': '539', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.8', 'spread': '17.06', 'groupId': 'OG000'}]}]}, {'title': 'ALP, Year 1 Week 4, n=707', 'denoms': [{'units': 'Participants', 'counts': [{'value': '707', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '11.85', 'groupId': 'OG000'}]}]}, {'title': 'ALP, Year 1 Week 12, n=705', 'denoms': [{'units': 'Participants', 'counts': [{'value': '705', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.5', 'spread': '13.31', 'groupId': 'OG000'}]}]}, {'title': 'ALP, Year 1 Week 24, n=703', 'denoms': [{'units': 'Participants', 'counts': [{'value': '703', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.1', 'spread': '17.76', 'groupId': 'OG000'}]}]}, {'title': 'ALP, Year 1 Week 36, n=684', 'denoms': [{'units': 'Participants', 'counts': [{'value': '684', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.7', 'spread': '22.81', 'groupId': 'OG000'}]}]}, {'title': 'ALP, Year 1 Week 48, n=693', 'denoms': [{'units': 'Participants', 'counts': [{'value': '693', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.6', 'spread': '21.18', 'groupId': 'OG000'}]}]}, {'title': 'ALP, Year 2 Week 24, n=643', 'denoms': [{'units': 'Participants', 'counts': [{'value': '643', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.1', 'spread': '21.58', 'groupId': 'OG000'}]}]}, {'title': 'ALP, Year 2 Week 48, n=598', 'denoms': [{'units': 'Participants', 'counts': [{'value': '598', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.1', 'spread': '23.23', 'groupId': 'OG000'}]}]}, {'title': 'ALP, Year 3 Week 24, n=535', 'denoms': [{'units': 'Participants', 'counts': [{'value': '535', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.9', 'spread': '18.95', 'groupId': 'OG000'}]}]}, {'title': 'ALP, Year 3 Week 48, n=488', 'denoms': [{'units': 'Participants', 'counts': [{'value': '488', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.3', 'spread': '22.22', 'groupId': 'OG000'}]}]}, {'title': 'ALP, Year 4 Week 24, n=439', 'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.2', 'spread': '21.56', 'groupId': 'OG000'}]}]}, {'title': 'ALP, Year 4 Week 48, n=421', 'denoms': [{'units': 'Participants', 'counts': [{'value': '421', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.1', 'spread': '27.35', 'groupId': 'OG000'}]}]}, {'title': 'ALP, Year 5 Week 24, n=393', 'denoms': [{'units': 'Participants', 'counts': [{'value': '393', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.2', 'spread': '21.01', 'groupId': 'OG000'}]}]}, {'title': 'ALP, Year 5 Week 48, n=362', 'denoms': [{'units': 'Participants', 'counts': [{'value': '362', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.5', 'spread': '20.61', 'groupId': 'OG000'}]}]}, {'title': 'ALP, Year 6 Week 24, n=304', 'denoms': [{'units': 'Participants', 'counts': [{'value': '304', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.4', 'spread': '23.28', 'groupId': 'OG000'}]}]}, {'title': 'ALP, Year 6 Week 48, n=286', 'denoms': [{'units': 'Participants', 'counts': [{'value': '286', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11.5', 'spread': '27.39', 'groupId': 'OG000'}]}]}, {'title': 'ALP, Year 7 Week 24, n=183', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10.9', 'spread': '28.08', 'groupId': 'OG000'}]}]}, {'title': 'ALP, Year 7 Week 48, n=130', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.5', 'spread': '22.50', 'groupId': 'OG000'}]}]}, {'title': 'ALP, Year 8 Week 24, n=52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '12.9', 'spread': '26.64', 'groupId': 'OG000'}]}]}, {'title': 'ALP, Year 8 Week 48, n=13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.1', 'spread': '30.04', 'groupId': 'OG000'}]}]}, {'title': 'ALP, Year 9 Week 24, n=6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.2', 'spread': '35.43', 'groupId': 'OG000'}]}]}, {'title': 'ALP, Year 9 Week 48, n=1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '12.0', 'spread': 'NA', 'comment': 'NA indicates standard deviation was not calculable for a single data point.', 'groupId': 'OG000'}]}]}, {'title': 'ALP, Exit, n=625', 'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.5', 'spread': '25.35', 'groupId': 'OG000'}]}]}, {'title': 'ALP, 8 Week follow-up, n=539', 'denoms': [{'units': 'Participants', 'counts': [{'value': '539', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.1', 'spread': '23.00', 'groupId': 'OG000'}]}]}, {'title': 'AST, Year 1 Week 4, n=701', 'denoms': [{'units': 'Participants', 'counts': [{'value': '701', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.6', 'spread': '10.56', 'groupId': 'OG000'}]}]}, {'title': 'AST, Year 1 Week 12, n=700', 'denoms': [{'units': 'Participants', 'counts': [{'value': '700', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.3', 'spread': '14.12', 'groupId': 'OG000'}]}]}, {'title': 'AST, Year 1 Week 24, n=701', 'denoms': [{'units': 'Participants', 'counts': [{'value': '701', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.0', 'spread': '20.79', 'groupId': 'OG000'}]}]}, {'title': 'AST, Year 1 Week 36, n=682', 'denoms': [{'units': 'Participants', 'counts': [{'value': '682', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.0', 'spread': '17.88', 'groupId': 'OG000'}]}]}, {'title': 'AST, Year 1 Week 48, n=692', 'denoms': [{'units': 'Participants', 'counts': [{'value': '692', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.9', 'spread': '14.38', 'groupId': 'OG000'}]}]}, {'title': 'AST, Year 2 Week 24, n=641', 'denoms': [{'units': 'Participants', 'counts': [{'value': '641', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'spread': '22.22', 'groupId': 'OG000'}]}]}, {'title': 'AST, Year 2 Week 48, n=592', 'denoms': [{'units': 'Participants', 'counts': [{'value': '592', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.9', 'spread': '57.25', 'groupId': 'OG000'}]}]}, {'title': 'AST, Year 3 Week 24, n=531', 'denoms': [{'units': 'Participants', 'counts': [{'value': '531', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.4', 'spread': '13.26', 'groupId': 'OG000'}]}]}, {'title': 'AST, Year 3 Week 48, n=486', 'denoms': [{'units': 'Participants', 'counts': [{'value': '486', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'spread': '17.23', 'groupId': 'OG000'}]}]}, {'title': 'AST, Year 4 Week 24, n=438', 'denoms': [{'units': 'Participants', 'counts': [{'value': '438', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.9', 'spread': '14.60', 'groupId': 'OG000'}]}]}, {'title': 'AST, Year 4 Week 48, n=418', 'denoms': [{'units': 'Participants', 'counts': [{'value': '418', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.7', 'spread': '15.32', 'groupId': 'OG000'}]}]}, {'title': 'AST, Year 5 Week 24, n=393', 'denoms': [{'units': 'Participants', 'counts': [{'value': '393', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.3', 'spread': '16.07', 'groupId': 'OG000'}]}]}, {'title': 'AST, Year 5 Week 48, n=362', 'denoms': [{'units': 'Participants', 'counts': [{'value': '362', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.8', 'spread': '18.57', 'groupId': 'OG000'}]}]}, {'title': 'AST, Year 6 Week 24, n=303', 'denoms': [{'units': 'Participants', 'counts': [{'value': '303', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'spread': '16.95', 'groupId': 'OG000'}]}]}, {'title': 'AST, Year 6 Week 48, n=284', 'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'spread': '19.00', 'groupId': 'OG000'}]}]}, {'title': 'AST, Year 7 Week 24, n=182', 'denoms': [{'units': 'Participants', 'counts': [{'value': '182', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.6', 'spread': '13.43', 'groupId': 'OG000'}]}]}, {'title': 'AST, Year 7 Week 48, n=130', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'spread': '10.78', 'groupId': 'OG000'}]}]}, {'title': 'AST, Year 8 Week 24, n=52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.0', 'spread': '33.93', 'groupId': 'OG000'}]}]}, {'title': 'AST, Year 8 Week 48, n=13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.8', 'spread': '24.01', 'groupId': 'OG000'}]}]}, {'title': 'AST, Year 9 Week 24, n=6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.7', 'spread': '19.63', 'groupId': 'OG000'}]}]}, {'title': 'AST, Year 9 Week 48, n=1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': 'NA', 'comment': 'NA indicates standard deviation was not calculable for a single data point.', 'groupId': 'OG000'}]}]}, {'title': 'AST, Exit, n=625', 'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.6', 'spread': '18.88', 'groupId': 'OG000'}]}]}, {'title': 'AST, 8 Week follow-up, n=539', 'denoms': [{'units': 'Participants', 'counts': [{'value': '539', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.1', 'spread': '16.58', 'groupId': 'OG000'}]}]}, {'title': 'GGT, Year 1 Week 4, n=707', 'denoms': [{'units': 'Participants', 'counts': [{'value': '707', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'spread': '23.39', 'groupId': 'OG000'}]}]}, {'title': 'GGT, Year 1 Week 12, n=705', 'denoms': [{'units': 'Participants', 'counts': [{'value': '705', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.4', 'spread': '23.12', 'groupId': 'OG000'}]}]}, {'title': 'GGT, Year 1 Week 24, n=703', 'denoms': [{'units': 'Participants', 'counts': [{'value': '703', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'spread': '39.50', 'groupId': 'OG000'}]}]}, {'title': 'GGT, Year 1 Week 36, n=684', 'denoms': [{'units': 'Participants', 'counts': [{'value': '684', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': '64.60', 'groupId': 'OG000'}]}]}, {'title': 'GGT, Year 1 Week 48, n=693', 'denoms': [{'units': 'Participants', 'counts': [{'value': '693', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.9', 'spread': '35.99', 'groupId': 'OG000'}]}]}, {'title': 'GGT, Year 2 Week 24, n=643', 'denoms': [{'units': 'Participants', 'counts': [{'value': '643', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.7', 'spread': '34.81', 'groupId': 'OG000'}]}]}, {'title': 'GGT, Year 2 Week 48, n=598', 'denoms': [{'units': 'Participants', 'counts': [{'value': '598', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '34.63', 'groupId': 'OG000'}]}]}, {'title': 'GGT, Year 3 Week 24, n=535', 'denoms': [{'units': 'Participants', 'counts': [{'value': '535', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.6', 'spread': '33.88', 'groupId': 'OG000'}]}]}, {'title': 'GGT, Year 3 Week 48, n=488', 'denoms': [{'units': 'Participants', 'counts': [{'value': '488', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.7', 'spread': '45.42', 'groupId': 'OG000'}]}]}, {'title': 'GGT, Year 4 Week 24, n=439', 'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '39.13', 'groupId': 'OG000'}]}]}, {'title': 'GGT, Year 4 Week 48, n=421', 'denoms': [{'units': 'Participants', 'counts': [{'value': '421', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.1', 'spread': '54.41', 'groupId': 'OG000'}]}]}, {'title': 'GGT, Year 5 Week 24, n=393', 'denoms': [{'units': 'Participants', 'counts': [{'value': '393', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.0', 'spread': '37.17', 'groupId': 'OG000'}]}]}, {'title': 'GGT, Year 5 Week 48, n=362', 'denoms': [{'units': 'Participants', 'counts': [{'value': '362', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.7', 'spread': '43.39', 'groupId': 'OG000'}]}]}, {'title': 'GGT, Year 6 Week 24, n=304', 'denoms': [{'units': 'Participants', 'counts': [{'value': '304', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.0', 'spread': '42.04', 'groupId': 'OG000'}]}]}, {'title': 'GGT, Year 6 Week 48, n=286', 'denoms': [{'units': 'Participants', 'counts': [{'value': '286', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.3', 'spread': '41.84', 'groupId': 'OG000'}]}]}, {'title': 'GGT, Year 7 Week 24, n=183', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.8', 'spread': '37.06', 'groupId': 'OG000'}]}]}, {'title': 'GGT, Year 7 Week 48, n=130', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.0', 'spread': '27.86', 'groupId': 'OG000'}]}]}, {'title': 'GGT, Year 8 Week 24, n=52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.7', 'spread': '39.90', 'groupId': 'OG000'}]}]}, {'title': 'GGT, Year 8 Week 48, n=13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'spread': '27.97', 'groupId': 'OG000'}]}]}, {'title': 'GGT, Year 9 Week 24, n=6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '13.3', 'spread': '26.96', 'groupId': 'OG000'}]}]}, {'title': 'GGT, Year 9 Week 48, n=1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-7.0', 'spread': 'NA', 'comment': 'NA indicates standard deviation was not calculable for a single data point.', 'groupId': 'OG000'}]}]}, {'title': 'GGT, Exit, n=625', 'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': '41.40', 'groupId': 'OG000'}]}]}, {'title': 'GGT, 8 Week follow-up, n=539', 'denoms': [{'units': 'Participants', 'counts': [{'value': '539', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '39.22', 'groupId': 'OG000'}]}]}, {'title': 'LDH, Year 1 Week 4, n=701', 'denoms': [{'units': 'Participants', 'counts': [{'value': '701', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.1', 'spread': '77.93', 'groupId': 'OG000'}]}]}, {'title': 'LDH, Year 1 Week 12, n=700', 'denoms': [{'units': 'Participants', 'counts': [{'value': '700', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-6.0', 'spread': '80.55', 'groupId': 'OG000'}]}]}, {'title': 'LDH, Year 1 Week 24, n=701', 'denoms': [{'units': 'Participants', 'counts': [{'value': '701', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-6.6', 'spread': '80.09', 'groupId': 'OG000'}]}]}, {'title': 'LDH, Year 1 Week 36, n=682', 'denoms': [{'units': 'Participants', 'counts': [{'value': '682', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-8.8', 'spread': '80.05', 'groupId': 'OG000'}]}]}, {'title': 'LDH, Year 1 Week 48, n=692', 'denoms': [{'units': 'Participants', 'counts': [{'value': '692', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-7.3', 'spread': '81.32', 'groupId': 'OG000'}]}]}, {'title': 'LDH, Year 2 Week 24, n=641', 'denoms': [{'units': 'Participants', 'counts': [{'value': '641', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-9.4', 'spread': '85.83', 'groupId': 'OG000'}]}]}, {'title': 'LDH, Year 2 Week 48, n=592', 'denoms': [{'units': 'Participants', 'counts': [{'value': '592', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-9.6', 'spread': '95.52', 'groupId': 'OG000'}]}]}, {'title': 'LDH, Year 3 Week 24, n=532', 'denoms': [{'units': 'Participants', 'counts': [{'value': '532', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-11.8', 'spread': '93.90', 'groupId': 'OG000'}]}]}, {'title': 'LDH, Year 3 Week 48, n=486', 'denoms': [{'units': 'Participants', 'counts': [{'value': '486', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-15.1', 'spread': '94.65', 'groupId': 'OG000'}]}]}, {'title': 'LDH, Year 4 Week 24, n=438', 'denoms': [{'units': 'Participants', 'counts': [{'value': '438', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-16.5', 'spread': '99.93', 'groupId': 'OG000'}]}]}, {'title': 'LDH, Year 4 Week 48, n=418', 'denoms': [{'units': 'Participants', 'counts': [{'value': '418', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-16.9', 'spread': '102.11', 'groupId': 'OG000'}]}]}, {'title': 'LDH, Year 5 Week 24, n=393', 'denoms': [{'units': 'Participants', 'counts': [{'value': '393', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-17.5', 'spread': '106.45', 'groupId': 'OG000'}]}]}, {'title': 'LDH, Year 5 Week 48, n=362', 'denoms': [{'units': 'Participants', 'counts': [{'value': '362', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-19.8', 'spread': '108.33', 'groupId': 'OG000'}]}]}, {'title': 'LDH, Year 6 Week 24, n=303', 'denoms': [{'units': 'Participants', 'counts': [{'value': '303', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-21.7', 'spread': '115.77', 'groupId': 'OG000'}]}]}, {'title': 'LDH, Year 6 Week 48, n=284', 'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-21.3', 'spread': '122.62', 'groupId': 'OG000'}]}]}, {'title': 'LDH, Year 7 Week 24, n=182', 'denoms': [{'units': 'Participants', 'counts': [{'value': '182', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-15.2', 'spread': '44.05', 'groupId': 'OG000'}]}]}, {'title': 'LDH, Year 7 Week 48, n=130', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-16.3', 'spread': '42.51', 'groupId': 'OG000'}]}]}, {'title': 'LDH, Year 8 Week 24, n=52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-14.3', 'spread': '40.14', 'groupId': 'OG000'}]}]}, {'title': 'LDH, Year 8 Week 48, n=13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-31.5', 'spread': '53.04', 'groupId': 'OG000'}]}]}, {'title': 'LDH, Year 9 Week 24, n=6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-27.2', 'spread': '32.64', 'groupId': 'OG000'}]}]}, {'title': 'LDH, Year 9 Week 48, n=1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-65.0', 'spread': 'NA', 'comment': 'NA indicates standard deviation was not calculable for a single data point.', 'groupId': 'OG000'}]}]}, {'title': 'LDH, Exit, n=624', 'denoms': [{'units': 'Participants', 'counts': [{'value': '624', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-13.1', 'spread': '90.39', 'groupId': 'OG000'}]}]}, {'title': 'LDH, 8 Week follow-up, n=538', 'denoms': [{'units': 'Participants', 'counts': [{'value': '538', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-12.7', 'spread': '95.65', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and up to 9 years', 'description': 'Liver function parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 liver function parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in ALT, ALP, AST, GGT and LDH were summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were 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.NA indicates standard deviation was not calculable for a single data point.', 'unitOfMeasure': 'International Units/liter (IU/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT Population'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Bilirubin (Bili) Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '735', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Belimumab 10mg/kg IV', 'description': 'Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial.'}], 'classes': [{'title': 'Year 1 Week 4, n=707', 'denoms': [{'units': 'Participants', 'counts': [{'value': '707', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.142', 'spread': '2.8398', 'groupId': 'OG000'}]}]}, {'title': 'Year 1 Week 12, n=705', 'denoms': [{'units': 'Participants', 'counts': [{'value': '705', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.008', 'spread': '2.6383', 'groupId': 'OG000'}]}]}, {'title': 'Year 1 Week 24, n=703', 'denoms': [{'units': 'Participants', 'counts': [{'value': '703', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.217', 'spread': '3.1280', 'groupId': 'OG000'}]}]}, {'title': 'Year 1 Week 36, n=684', 'denoms': [{'units': 'Participants', 'counts': [{'value': '684', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.173', 'spread': '2.7566', 'groupId': 'OG000'}]}]}, {'title': 'Year 1 Week 48, n=693', 'denoms': [{'units': 'Participants', 'counts': [{'value': '693', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.367', 'spread': '2.8441', 'groupId': 'OG000'}]}]}, {'title': 'Year 2 Week 24, n=643', 'denoms': [{'units': 'Participants', 'counts': [{'value': '643', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.488', 'spread': '2.9346', 'groupId': 'OG000'}]}]}, {'title': 'Year 2 Week 48, n=598', 'denoms': [{'units': 'Participants', 'counts': [{'value': '598', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.540', 'spread': '3.2181', 'groupId': 'OG000'}]}]}, {'title': 'Year 3 Week 24, n=535', 'denoms': [{'units': 'Participants', 'counts': [{'value': '535', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.606', 'spread': '3.1612', 'groupId': 'OG000'}]}]}, {'title': 'Year 3 Week 48, n=488', 'denoms': [{'units': 'Participants', 'counts': [{'value': '488', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.637', 'spread': '3.2474', 'groupId': 'OG000'}]}]}, {'title': 'Year 4 Week 24, n=439', 'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.548', 'spread': '2.9773', 'groupId': 'OG000'}]}]}, {'title': 'Year 4 Week 48, n=421', 'denoms': [{'units': 'Participants', 'counts': [{'value': '421', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.629', 'spread': '3.4680', 'groupId': 'OG000'}]}]}, {'title': 'Year 5 Week 24, n=393', 'denoms': [{'units': 'Participants', 'counts': [{'value': '393', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.410', 'spread': '2.6931', 'groupId': 'OG000'}]}]}, {'title': 'Year 5 Week 48, n=362', 'denoms': [{'units': 'Participants', 'counts': [{'value': '362', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.788', 'spread': '3.1324', 'groupId': 'OG000'}]}]}, {'title': 'Year 6 Week 24, n=304', 'denoms': [{'units': 'Participants', 'counts': [{'value': '304', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.801', 'spread': '2.9946', 'groupId': 'OG000'}]}]}, {'title': 'Year 6 Week 48, n=285', 'denoms': [{'units': 'Participants', 'counts': [{'value': '285', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.638', 'spread': '3.0669', 'groupId': 'OG000'}]}]}, {'title': 'Year 7 Week 24, n=183', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.938', 'spread': '2.8158', 'groupId': 'OG000'}]}]}, {'title': 'Year 7 Week 48, n=130', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.129', 'spread': '3.0314', 'groupId': 'OG000'}]}]}, {'title': 'Year 8 Week 24, n=52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.280', 'spread': '3.0707', 'groupId': 'OG000'}]}]}, {'title': 'Year 8 Week 48, n=13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.768', 'spread': '3.0434', 'groupId': 'OG000'}]}]}, {'title': 'Year 9 Week 24, n=6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.028', 'spread': '2.0182', 'groupId': 'OG000'}]}]}, {'title': 'Year 9 Week 48, n=1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.870', 'spread': 'NA', 'comment': 'NA indicates standard deviation was not calculable for a single data point.', 'groupId': 'OG000'}]}]}, {'title': 'Exit, n=624', 'denoms': [{'units': 'Participants', 'counts': [{'value': '624', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.573', 'spread': '3.3274', 'groupId': 'OG000'}]}]}, {'title': '8 Week follow-up, n=539', 'denoms': [{'units': 'Participants', 'counts': [{'value': '539', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.572', 'spread': '3.1052', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and up to 9 years', 'description': 'Liver function parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 liver function parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Bili were summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were 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. NA indicates standard deviation was not calculable for a single data point.', 'unitOfMeasure': 'µmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT Population'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Immunoglobulin G (IgG) Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '735', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Belimumab 10mg/kg IV', 'description': 'Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial.'}], 'classes': [{'title': 'Year 1 Week 12, n=213', 'denoms': [{'units': 'Participants', 'counts': [{'value': '213', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.571', 'spread': '2.2970', 'groupId': 'OG000'}]}]}, {'title': 'Year 1 Week 24, n=709', 'denoms': [{'units': 'Participants', 'counts': [{'value': '709', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.963', 'spread': '2.7334', 'groupId': 'OG000'}]}]}, {'title': 'Year 1 Week 48, n=695', 'denoms': [{'units': 'Participants', 'counts': [{'value': '695', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.507', 'spread': '3.1054', 'groupId': 'OG000'}]}]}, {'title': 'Year 2 Week 24, n=482', 'denoms': [{'units': 'Participants', 'counts': [{'value': '482', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.058', 'spread': '3.6147', 'groupId': 'OG000'}]}]}, {'title': 'Year 2 Week 48, n=605', 'denoms': [{'units': 'Participants', 'counts': [{'value': '605', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.232', 'spread': '3.7414', 'groupId': 'OG000'}]}]}, {'title': 'Year 3 Week 24, n=143', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.453', 'spread': '3.7073', 'groupId': 'OG000'}]}]}, {'title': 'Year 3 Week 48, n=405', 'denoms': [{'units': 'Participants', 'counts': [{'value': '405', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.791', 'spread': '4.0450', 'groupId': 'OG000'}]}]}, {'title': 'Year 4 Week 24, n=146', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.839', 'spread': '4.1411', 'groupId': 'OG000'}]}]}, {'title': 'Year 4 Week 48, n=362', 'denoms': [{'units': 'Participants', 'counts': [{'value': '362', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.794', 'spread': '3.8780', 'groupId': 'OG000'}]}]}, {'title': 'Year 5 Week 24, n=111', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.356', 'spread': '3.6399', 'groupId': 'OG000'}]}]}, {'title': 'Year 5 Week 48, n=322', 'denoms': [{'units': 'Participants', 'counts': [{'value': '322', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.323', 'spread': '4.0169', 'groupId': 'OG000'}]}]}, {'title': 'Year 6 Week 24, n=71', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.111', 'spread': '3.8846', 'groupId': 'OG000'}]}]}, {'title': 'Year 6 Week 48, n=268', 'denoms': [{'units': 'Participants', 'counts': [{'value': '268', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.697', 'spread': '3.9599', 'groupId': 'OG000'}]}]}, {'title': 'Year 7 Week 24, n=50', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.803', 'spread': '3.5908', 'groupId': 'OG000'}]}]}, {'title': 'Year 7 Week 48, n=115', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.982', 'spread': '4.0769', 'groupId': 'OG000'}]}]}, {'title': 'Year 8 Week 24, n=18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-6.016', 'spread': '3.8450', 'groupId': 'OG000'}]}]}, {'title': 'Year 8 Week 48, n=12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.520', 'spread': '5.1564', 'groupId': 'OG000'}]}]}, {'title': 'Year 9 Week 48, n=1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.710', 'spread': 'NA', 'comment': 'NA indicates standard deviation was not calculable for a single data point.', 'groupId': 'OG000'}]}]}, {'title': 'Exit, n=627', 'denoms': [{'units': 'Participants', 'counts': [{'value': '627', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.138', 'spread': '4.0025', 'groupId': 'OG000'}]}]}, {'title': '8 Week Follow up, n=543', 'denoms': [{'units': 'Participants', 'counts': [{'value': '543', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.325', 'spread': '4.0246', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and up to 9 years', 'description': 'Immunoglobulin (Ig) parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 Ig parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Ig G were summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were 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. NA indicates standard deviation was not calculable for a single data point.', 'unitOfMeasure': 'g/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT Population'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Immunogenic Response by Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '735', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Belimumab 10mg/kg IV', 'description': 'Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial.'}], 'classes': [{'title': 'Year 0-1 Negative, n=717', 'denoms': [{'units': 'Participants', 'counts': [{'value': '717', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '707', 'groupId': 'OG000'}]}]}, {'title': 'Year 1-2 Negative, n=684', 'denoms': [{'units': 'Participants', 'counts': [{'value': '684', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '656', 'groupId': 'OG000'}]}]}, {'title': 'Year 2-3 Negative, n=590', 'denoms': [{'units': 'Participants', 'counts': [{'value': '590', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '577', 'groupId': 'OG000'}]}]}, {'title': 'Year 3-4, Negative, n=502', 'denoms': [{'units': 'Participants', 'counts': [{'value': '502', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '498', 'groupId': 'OG000'}]}]}, {'title': 'Year 4-5 Negative, n=432', 'denoms': [{'units': 'Participants', 'counts': [{'value': '432', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '432', 'groupId': 'OG000'}]}]}, {'title': 'Year 5-6 Negative, n=336', 'denoms': [{'units': 'Participants', 'counts': [{'value': '336', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '336', 'groupId': 'OG000'}]}]}, {'title': 'Year 6-7 Negative, n=212', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '212', 'groupId': 'OG000'}]}]}, {'title': 'Year 7-8 Negative, n=64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}]}]}, {'title': 'Year 8 plus Negative, n=6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Year 0-1 Transient +, n=717', 'denoms': [{'units': 'Participants', 'counts': [{'value': '717', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Year 1-2 Transient + n=684', 'denoms': [{'units': 'Participants', 'counts': [{'value': '684', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}, {'title': 'Year 2-3 Transient +, n=590', 'denoms': [{'units': 'Participants', 'counts': [{'value': '590', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Year 3-4 Transient +, n=502', 'denoms': [{'units': 'Participants', 'counts': [{'value': '502', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Year 4-5 Transient +, n=432', 'denoms': [{'units': 'Participants', 'counts': [{'value': '432', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Year 5-6 Transient +, n=336', 'denoms': [{'units': 'Participants', 'counts': [{'value': '336', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Year 6-7 Transient +, n=212', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Year 7-8 Transient +, n=64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Year 8 plus Transient +, n=6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Year 0-1 Persistent+,n=717', 'denoms': [{'units': 'Participants', 'counts': [{'value': '717', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Year 1-2 Persistent+,n=684', 'denoms': [{'units': 'Participants', 'counts': [{'value': '684', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Year 2-3 Persistent+,n=590', 'denoms': [{'units': 'Participants', 'counts': [{'value': '590', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Year 3-4 Persistent+,n=502', 'denoms': [{'units': 'Participants', 'counts': [{'value': '502', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Year 4-5 Persistent+,n=432', 'denoms': [{'units': 'Participants', 'counts': [{'value': '432', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Year 5-6 Persistent+,n=336', 'denoms': [{'units': 'Participants', 'counts': [{'value': '336', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Year 6-7 Persistent+,n=212', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Year 7-8 Persistent+,n=64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Year 8 plus Persistent+,n=6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Year 0-1 Unknown, n=717', 'denoms': [{'units': 'Participants', 'counts': [{'value': '717', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Year 1-2 Unknown, n=684', 'denoms': [{'units': 'Participants', 'counts': [{'value': '684', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Year 2-3 Unknown, n=590', 'denoms': [{'units': 'Participants', 'counts': [{'value': '590', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Year 3-4 Unknown, n=502', 'denoms': [{'units': 'Participants', 'counts': [{'value': '502', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Year 4-5 Unknown, n=432', 'denoms': [{'units': 'Participants', 'counts': [{'value': '432', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Year 5-6 Unknown, n=336', 'denoms': [{'units': 'Participants', 'counts': [{'value': '336', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Year 6-7 Unknown, n=212', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Year 7-8 Unknown, n=64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Year 8 plus Unknown, n=6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 9 years', 'description': 'Immunogenic response was analyzed using serum samples for anti-belimumab antibody measurements in MITT population. Categories of response are Negative, Transient Positive (+) means single + response that does not occur at the final assessment, and Persistent + means + response that occurs at least 2 consecutive assessments or a single result 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': 'Number of Participants With IgG Values Below the Lower Limit of Normal by Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '735', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Belimumab 10mg/kg IV', 'description': 'Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial.'}], 'classes': [{'title': 'Baseline, n=735', 'denoms': [{'units': 'Participants', 'counts': [{'value': '735', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Any Time Post Baseline, n=735', 'denoms': [{'units': 'Participants', 'counts': [{'value': '735', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}]}]}, {'title': 'Year 0-1, n=735', 'denoms': [{'units': 'Participants', 'counts': [{'value': '735', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}, {'title': 'Year 1-2, n=701', 'denoms': [{'units': 'Participants', 'counts': [{'value': '701', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}]}]}, {'title': 'Year 2-3, n=620', 'denoms': [{'units': 'Participants', 'counts': [{'value': '620', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}, {'title': 'Year 3-4, n=514', 'denoms': [{'units': 'Participants', 'counts': [{'value': '514', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}, {'title': 'Year 4-5, n=442', 'denoms': [{'units': 'Participants', 'counts': [{'value': '442', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}, {'title': 'Year 5-6, n=345', 'denoms': [{'units': 'Participants', 'counts': [{'value': '345', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Year 6-7, n=219', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Year 7-8, n=65', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'More than 8 Years, n=6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 9 years', 'description': 'Blood samples were collected to evaluate IgG levels at Baseline and at Weeks 12, 24 and 48 during Year 1. From Year 2-9, IgG was evaluated at Week 24 and 48 ; Exit visit and at follow-up visit (up to 8 weeks post last infusion). Number of participants with IgG immunoglobulin values below the LLN at each one year interval are presented. Baseline includes Extension Year 1 Day 0 values for MITT participants treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants treated with Belimumab in the parent study. If a participant had more than one response within a year, then the last response within the year interval (usually the Week 48 assessment) was summarized. 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': 'Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '227', 'groupId': 'OG001'}, {'value': '462', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants With no Prednisone and Other Steroids at Baseline', 'description': 'Participants were not receiving prednisone and other steroids at Baseline.'}, {'id': 'OG001', 'title': 'Participants With Baseline Daily Dose of >0 to <=7.5 mg', 'description': 'Participants were receiving a daily dose of \\>0 to \\<=7.5 mg of prednisone and other steroids at Baseline.'}, {'id': 'OG002', 'title': 'Participants With Baseline Daily Dose of >7.5 to <=40 mg', 'description': 'Participants were receiving a daily dose of \\>7.5 to \\<=40 mg of prednisone and other steroids at Baseline.'}, {'id': 'OG003', 'title': 'Participants With Baseline Daily Dose of >40 mg', 'description': 'Participants were receiving a daily dose of \\>40 mg of prednisone and other steroids at Baseline.'}], 'classes': [{'title': 'Total daily dose=0, Year 1, Week 24', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Total daily dose >0 to <=7.5, Year 1, Week 24', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Total daily dose >7.5 to <=40, Year 1, Week 24', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '376', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Total daily dose >40, Year 1, Week 24', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Total daily dose=0, Year 1, Week 48', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Total daily dose >0 to <=7.5, Year 1, Week 48', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '180', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Total daily dose >7.5 to <=40, Year 1, Week 48', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '301', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Total daily dose >40, Year 1, Week 48', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Total daily dose=0, Year 2, Week 24', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Total daily dose >0 to <=7.5, Year 2, Week 24', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '157', 'groupId': 'OG001'}, {'value': '145', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Total daily dose >7.5 to <=40, Year 2, Week 24', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '237', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Total daily dose >40, Year 2, Week 24', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Total daily dose=0, Year 2, Week 48', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Total daily dose >0 to <=7.5, Year 2, Week 48', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}, {'value': '163', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Total daily dose >7.5 to <=40, Year 2, Week 48', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '195', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Total daily dose >40, Year 2, Week 48', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Total daily dose=0, Year 3, Week 24', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Total daily dose >0 to <=7.5, Year 3, Week 24', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}, {'value': '159', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Total daily dose >7.5 to <=40, Year 3, Week 24', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '157', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Total daily dose >40, Year 3, Week 24', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Total daily dose=0, Year 3, Week 48', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Total daily dose >0 to <=7.5, Year 3, Week 48', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Total daily dose >7.5 to <=40, Year 3, Week 48', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '145', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Total daily dose >40, Year 3, Week 48', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Total daily dose=0, Year 4, Week 24', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Total daily dose >0 to <=7.5, Year 4, Week 24', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Total daily dose >7.5 to <=40, Year 4, Week 24', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '120', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Total daily dose >40, Year 4, Week 24', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Total daily dose=0, Year 4, Week 48', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Total daily dose >0 to <=7.5, Year 4, Week 48', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '129', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Total daily dose >7.5 to <=40, Year 4, Week 48', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '108', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Total daily dose >40, Year 4, Week 48', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Total daily dose=0, Year 5, Week 24', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Total daily dose >0 to <=7.5, Year 5, Week 24', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '124', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Total daily dose >7.5 to <=40, Year 5, Week 24', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Total daily dose >40, Year 5, Week 24', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Total daily dose=0, Year 5, Week 48', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Total daily dose >0 to <=7.5, Year 5, Week 48', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '119', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Total daily dose >7.5 to <=40, Year 5, Week 48', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Total daily dose >40, Year 5, Week 48', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Total daily dose=0, Year 6, Week 24', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Total daily dose >0 to <=7.5, Year 6, Week 24', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Total daily dose >7.5 to <=40, Year 6, Week 24', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Total daily dose >40, Year 6, Week 24', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Total daily dose=0, Year 6, Week 48', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Total daily dose >0 to <=7.5, Year 6, Week 48', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '90', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Total daily dose >7.5 to <=40, Year 6, Week 48', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Total daily dose >40, Year 6, Week 48', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Total daily dose=0, Year 7, Week 24', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Total daily dose >0 to <=7.5, Year 7, Week 24', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Total daily dose >7.5 to <=40, Year 7, Week 24', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Total daily dose >40, Year 7, Week 24', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Total daily dose=0, Year 7, Week 48', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Total daily dose >0 to <=7.5, Year 7, Week 48', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Total daily dose >7.5 to <=40, Year 7, Week 48', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Total daily dose >40, Year 7, Week 48', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Total daily dose=0, Year 8, Week 24', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Total daily dose >0 to <=7.5, Year 8, Week 24', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Total daily dose >7.5 to <=40, Year 8, Week 24', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Total daily dose >40, Year 8, Week 24', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Total daily dose=0, Year 8, Week 48', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Total daily dose >0 to <=7.5, Year 8, Week 48', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Total daily dose >7.5 to <=40, Year 8, Week 48', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Total daily dose >40, Year 8, Week 48', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Total daily dose=0, Year 9, Week 24', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Total daily dose >0 to <=7.5, Year 9, Week 24', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Total daily dose >7.5 to <=40, Year 9, Week 24', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Total daily dose >40, Year 9, Week 24', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Total daily dose=0, Year 9, Week 48', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Total daily dose >0 to <=7.5, Year 9, Week 48', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Total daily dose >7.5 to <=40, Year 9, Week 48', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Total daily dose >40, Year 9, Week 48', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 9 years', 'description': "Participants who had improving SLE disease activity for at least 8 weeks, at the investigator's discretion, the steroid dose was reduced by reduction to 7.5 mg/day. If the participant continued to have stable or improving disease activity after 4 weeks on a reduced dose, then the investigator considered reducing the dose again. Baseline includes extension Year 1 Day 0 values for MITT participants treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants treated with Belimumab in the parent study. Number of participants with shifts from Baseline total daily dose category by visit is summarized.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT Population'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Any SLICC/ ACR Damage Index Worsening (Change > 0) From Baseline by Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '735', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Belimumab 10mg/kg IV', 'description': 'Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial.'}], 'classes': [{'title': 'Year 1,Week 48, n=716', 'denoms': [{'units': 'Participants', 'counts': [{'value': '716', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}]}]}, {'title': 'Year 2,Week 48, n=667', 'denoms': [{'units': 'Participants', 'counts': [{'value': '667', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}]}]}, {'title': 'Year 3,Week 48, n=580', 'denoms': [{'units': 'Participants', 'counts': [{'value': '580', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}]}]}, {'title': 'Year 4,Week 48, n=488', 'denoms': [{'units': 'Participants', 'counts': [{'value': '488', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}]}]}, {'title': 'Year 5,Week 48, n=423', 'denoms': [{'units': 'Participants', 'counts': [{'value': '423', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}]}]}, {'title': 'Year 6,Week 48, n=330', 'denoms': [{'units': 'Participants', 'counts': [{'value': '330', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}]}]}, {'title': 'Year 7,Week 48, n=213', 'denoms': [{'units': 'Participants', 'counts': [{'value': '213', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}]}]}, {'title': 'Year 8,Week 48, n=65', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Year 9,Week 48, n=6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 9 years', 'description': 'The SLICC/ACR Damage Index was assessed every 48 weeks and at the exit visit as a measure of disease activity. It was developed to assess the accumulated damage since the onset of the disease. The number of participants with worsening in their SLICC/ACR Damage Index score compared with Baseline have been presented. Worsening was defined as a change in score (post-Baseline visit score - Baseline score) \\> 0. Baseline includes extension Year 1 Day 0 values for MITT participants treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants treated with Belimumab in the parent study. For years in which a participant was withdrawn from the study, the exit visit assessment was used in place of the Week 48 assessment for the year. This value was not carried forward through later years. 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'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Belimumab 10mg/kg IV', 'description': 'Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '735'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '368'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '367'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '69'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '22'}]}, {'type': 'Non-compliance with study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': 'Other Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '37'}]}, {'type': 'Sponsor decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}]}, {'type': 'Withdrew consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Hip replacement surgery', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Involved in Clinical research', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Participant hospitalized', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Participant travelled overseas', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Death of patient', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Other Physician decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Not committed to contraception', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Participant received medication', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '36'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '151'}]}]}], 'recruitmentDetails': 'This was a multi-center, continuation trial of belimumab and was conducted at 115 centers in 28 countries. Participants with Systemic Lupus Erythematosus (SLE), who had completed the Phase 3 HGS1006-C1056 or HGS1006-C1057 trial or participants who had previously received subcutaneous belimumab in Protocol HGS1006-C1070 were included in this trial.', 'preAssignmentDetails': '738 participants were enrolled in the study and 735 received at least one dose of belimumab.Out of 735 participants, 368 completed the study and 370 withdrew from the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '735', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Belimumab 10mg/kg IV', 'description': 'Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37.2', 'spread': '11.17', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '695', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '40', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Black or African American/African Heritage', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}, {'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '225', 'groupId': 'BG000'}]}]}, {'title': 'East Asian Heritage', 'categories': [{'measurements': [{'value': '118', 'groupId': 'BG000'}]}]}, {'title': 'South Asian Heritage', 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}]}]}, {'title': 'Southeast Asian Heritage', 'categories': [{'measurements': [{'value': '58', 'groupId': 'BG000'}]}]}, {'title': 'Middle East/North African Heritage', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}]}]}, {'title': 'White/Caucasian/European Heritage', 'categories': [{'measurements': [{'value': '256', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Modified Intention to Treat (MITT) includes all participants who were enrolled in BEL112234 and were treated with at least one dose of belimumab in the continuation study.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 738}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-05-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2016-12-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-19', 'studyFirstSubmitDate': '2008-07-08', 'resultsFirstSubmitDate': '2017-11-08', 'studyFirstSubmitQcDate': '2008-07-09', 'lastUpdatePostDateStruct': {'date': '2019-12-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-12-15', 'studyFirstPostDateStruct': {'date': '2008-07-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-01-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-12-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Adverse Events (AE)', 'timeFrame': 'Up to 9 years', 'description': 'An adverse event is defined as any unfavorable or unintended sign, symptom, or disease that is temporally associated with the use of a study agent but is not necessarily caused by the study agent. This includes worsening (example: increase in frequency or severity) of preexisting conditions. Participants with incidences of any event at any time post-baseline are presented by yearly interval. Only treatment-emergent AEs are summarized.'}, {'measure': 'AE Rates by System Organ Class (SOC) During the Study', 'timeFrame': 'Up to 9 years', '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 AEs are summarized. The event rate of an AE was calculated as the number of events per 100 participant years. Participant years were calculated as sum across all participants (\\[last visit of interval day - first visit of interval day + 1\\] divided by365). Participant years excluded between study gaps if participant had not started extension study on date of last visit of parent study.'}, {'measure': 'Number of Participants With Serious Adverse Events (SAE)', 'timeFrame': 'Up to 9 years', 'description': 'An adverse event resulting in death, is life threatening (ie, an immediate threat to life), inpatient hospitalization, prolongation of existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect or any other situation which is medically important is categorized as SAE. Only treatment-emergent AEs are summarized.'}, {'measure': 'SAE Rates by SOC During the Study', 'timeFrame': 'Up to 9 years', '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 event rate of an SAE was calculated as the number of events per 100 participant years. Participants years were calculated as = sum across all participants (\\[last visit of interval day - first visit of interval day + 1\\] divided by 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': 'Baseline and up to 9 years', 'description': 'Hematology parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 hematology parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in APTT and PT is summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were 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. NA indicates standard deviation was not calculable for a single data point'}, {'measure': 'Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points', 'timeFrame': 'Baseline and up to 9 years', 'description': 'Hematology parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 hematology parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Plt, Lymp, Leu, Eos, Baso, Mono, Neu, NeuBF, and NueS are summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were 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. NA indicates standard deviation was not calculable for a single data point.'}, {'measure': 'Change From Baseline in Hemoglobin (Hg) at the Indicated Time Points', 'timeFrame': 'Baseline and up to 9 years', 'description': 'Hematology parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 hematology parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Hg is summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were 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. NA indicates standard deviation was not calculable for a single data point.'}, {'measure': 'Change From Baseline in Hematocrit at the Indicated Time Points', 'timeFrame': 'Baseline and up to 9 years', 'description': 'Hematology parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 hematology parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks). Change from Baseline in Hematocrit is summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were 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. NA indicates standard deviation was not calculable for a single data point.'}, {'measure': 'Change From Baseline in Erythrocytes (Eryth) at the Indicated Time Points', 'timeFrame': 'Baseline and up to 9 years', 'description': 'Hematology parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 hematology parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Erythrocytes is summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were 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. NA indicates standard deviation was not calculable for a single data point.'}, {'measure': 'Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points', 'timeFrame': 'Baseline and up to 9 years', 'description': 'Electrolytes parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 electrolytes parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Ca,CO2, Chloride, Mg, Phos, K and Na were summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were 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. NA indicates standard deviation was not calculable for a single data point.'}, {'measure': 'Change From Baseline in Blood Urea Nitrogen/Creatinine (BUN/Cr) at the Indicated Time Points', 'timeFrame': 'Baseline and up to 9 years', 'description': 'Other chemistries parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 other chemistries parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in BUN/Cr is summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were 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 (Alb) and Protein (Pro) at the Indicated Time Points', 'timeFrame': 'Baseline and up to 9 years', 'description': 'Other chemistries parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 other chemistries parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Alb and Protein were summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were 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. NA indicates standard deviation was not calculable for a single data point.'}, {'measure': 'Change From Baseline in BUN and Glucose at the Indicated Time Points', 'timeFrame': 'Baseline and up to 9 years', 'description': 'Other chemistries parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 other chemistries were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in BUN and Glucose were summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were 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. NA indicates standard deviation was not calculable for a single data point.'}, {'measure': 'Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points', 'timeFrame': 'Baseline and up to 9 years', 'description': 'Other chemistries parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 other chemistries were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Cr and Urate were summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were 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. NA indicates standard deviation was not calculable for a single data point.'}, {'measure': 'Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels', 'timeFrame': 'Baseline and up to 9 years', 'description': 'Liver function parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 liver function parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in ALT, ALP, AST, GGT and LDH were summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were 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.NA indicates standard deviation was not calculable for a single data point.'}, {'measure': 'Change From Baseline in Bilirubin (Bili) Levels', 'timeFrame': 'Baseline and up to 9 years', 'description': 'Liver function parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 liver function parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Bili were summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were 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. NA indicates standard deviation was not calculable for a single data point.'}, {'measure': 'Change From Baseline in Immunoglobulin G (IgG) Levels', 'timeFrame': 'Baseline and up to 9 years', 'description': 'Immunoglobulin (Ig) parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 Ig parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Ig G were summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were 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. NA indicates standard deviation was not calculable for a single data point.'}, {'measure': 'Number of Participants With Immunogenic Response by Year', 'timeFrame': 'Up to 9 years', 'description': 'Immunogenic response was analyzed using serum samples for anti-belimumab antibody measurements in MITT population. Categories of response are Negative, Transient Positive (+) means single + response that does not occur at the final assessment, and Persistent + means + response that occurs at least 2 consecutive assessments or a single result at the final assessment. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.'}, {'measure': 'Number of Participants With IgG Values Below the Lower Limit of Normal by Year', 'timeFrame': 'Up to 9 years', 'description': 'Blood samples were collected to evaluate IgG levels at Baseline and at Weeks 12, 24 and 48 during Year 1. From Year 2-9, IgG was evaluated at Week 24 and 48 ; Exit visit and at follow-up visit (up to 8 weeks post last infusion). Number of participants with IgG immunoglobulin values below the LLN at each one year interval are presented. Baseline includes Extension Year 1 Day 0 values for MITT participants treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants treated with Belimumab in the parent study. If a participant had more than one response within a year, then the last response within the year interval (usually the Week 48 assessment) was summarized. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.'}, {'measure': 'Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit', 'timeFrame': 'Up to 9 years', 'description': "Participants who had improving SLE disease activity for at least 8 weeks, at the investigator's discretion, the steroid dose was reduced by reduction to 7.5 mg/day. If the participant continued to have stable or improving disease activity after 4 weeks on a reduced dose, then the investigator considered reducing the dose again. Baseline includes extension Year 1 Day 0 values for MITT participants treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants treated with Belimumab in the parent study. Number of participants with shifts from Baseline total daily dose category by visit is summarized."}, {'measure': 'Number of Participants With Any SLICC/ ACR Damage Index Worsening (Change > 0) From Baseline by Visit', 'timeFrame': 'Up to 9 years', 'description': 'The SLICC/ACR Damage Index was assessed every 48 weeks and at the exit visit as a measure of disease activity. It was developed to assess the accumulated damage since the onset of the disease. The number of participants with worsening in their SLICC/ACR Damage Index score compared with Baseline have been presented. Worsening was defined as a change in score (post-Baseline visit score - Baseline score) \\> 0. Baseline includes extension Year 1 Day 0 values for MITT participants treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants treated with Belimumab in the parent study. For years in which a participant was withdrawn from the study, the exit visit assessment was used in place of the Week 48 assessment for the year. This value was not carried forward through later years. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['SLE', 'Belimumab', 'Antibodies', 'Systemic Lupus Erythematosus', 'Lupus', 'Autoimmune Diseases'], 'conditions': ['Systemic Lupus Erythematosus']}, 'referencesModule': {'references': [{'pmid': '26936891', 'type': 'BACKGROUND', 'citation': 'Bruce IN, Urowitz M, van Vollenhoven R, Aranow C, Fettiplace J, Oldham M, Wilson B, Molta C, Roth D, Gordon D. Long-term organ damage accrual and safety in patients with SLE treated with belimumab plus standard of care. Lupus. 2016 Jun;25(7):699-709. doi: 10.1177/0961203315625119. Epub 2016 Mar 1.'}, {'pmid': '31302695', 'type': 'BACKGROUND', 'citation': 'van Vollenhoven RF, Navarra SV, Levy RA, Thomas M, Heath A, Lustine T, Adamkovic A, Fettiplace J, Wang ML, Ji B, Roth D. Long-term safety and limited organ damage in patients with systemic lupus erythematosus treated with belimumab: a Phase III study extension. Rheumatology (Oxford). 2020 Feb 1;59(2):281-291. doi: 10.1093/rheumatology/kez279.'}, {'pmid': '33051264', 'type': 'DERIVED', 'citation': 'Urowitz MB, Ohsfeldt RL, Wielage RC, Dever JJ, Zakerifar M, Asukai Y, Ramachandran S, Joshi AV. Comparative analysis of long-term organ damage in patients with systemic lupus erythematosus using belimumab versus standard therapy: a post hoc longitudinal study. Lupus Sci Med. 2020 Oct;7(1):e000412. doi: 10.1136/lupus-2020-000412.'}]}, 'descriptionModule': {'briefSummary': 'This is a long-term continuation study to provide continuing treatment to subjects with SLE.', 'detailedDescription': 'This trial is a long-term continuation study to provide continuing treatment to subjects with System Lupus Erythematosus (SLE).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have completed the HGS 1006-C1056 or HGS 1006-C1057 protocol through the Week 72 or Week 48 visits, respectively.\n\nExclusion Criteria:\n\n* Have developed any other medical disease or condition that has made the patient unsuitable for this study in the opinion of their physician.'}, 'identificationModule': {'nctId': 'NCT00712933', 'briefTitle': 'A Continuation Trial for Subjects With Lupus That Completed Protocol HGS1006-C1056 or HGS1006-C1057', '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 or HGS1006-C1057', 'orgStudyIdInfo': {'id': '112234'}, 'secondaryIdInfos': [{'id': '2007-007648-85', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': '1 mg/kg dose of belimumab given IV every 28 days.', 'interventionNames': ['Drug: belimumab']}, {'type': 'EXPERIMENTAL', 'label': '2.', 'description': '10 mg/kg dose of belimumab given IV every 28 days.', 'interventionNames': ['Drug: belimumab']}], 'interventions': [{'name': 'belimumab', 'type': 'DRUG', 'otherNames': ['LymphoStat-B™', 'HGS1006'], 'description': 'Recombinant, fully human, monoclonal antibody\n\nComparison of the 1 mg/kg and 10 mg/kg dose of belimumab given IV every 28 days.', 'armGroupLabels': ['1', '2.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1015', 'city': 'Ciudad Autonoma de Buenos Aires', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'GSK Investigational Site'}, {'zip': 'C1419AHN', 'city': 'Ciudad Autonoma de Buenos Aires', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'GSK Investigational Site'}, {'zip': 'B1904CFH,', 'city': 'La Plata', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': -34.92126, 'lon': -57.95442}}, {'zip': '2000', 'city': 'Rosario', 'state': 'Santa Fe Province', 'country': 'Argentina', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': -32.94682, 'lon': -60.63932}}, {'zip': 'T4000AXL', 'city': 'San Miguel de Tucumán', 'state': 'Tucumán Province', 'country': 'Argentina', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': -26.81601, 'lon': -65.21051}}, {'zip': 'C1280AEB', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'C1417EYG', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'C1426AAL', 'city': 'Ciudad Autonoma Buenos Aires', 'country': 'Argentina', 'facility': 'GSK Investigational Site'}, {'zip': 'A-1100', 'city': 'Vienna', 'country': 'Austria', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '4000', 'city': 'Liège', 'country': 'Belgium', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'zip': '40.150-410', 'city': 'Salvador', 'state': 'Estado de Bahia', 'country': 'Brazil', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': -12.97563, 'lon': -38.49096}}, {'zip': '74110-120', 'city': 'Goiânia', 'state': 'Goiás', 'country': 'Brazil', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': -16.67861, 'lon': -49.25389}}, {'zip': '36010-570', 'city': 'Juiz de Fora', 'state': 'Minas Gerais', 'country': 'Brazil', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': -21.76417, 'lon': -43.35028}}, {'zip': '50670-420', 'city': 'Recife', 'state': 'Pernambuco', 'country': 'Brazil', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': -8.05389, 'lon': -34.88111}}, {'zip': '90610000', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'zip': '04039-901', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '13083-888', 'city': 'Campinas', 'country': 'Brazil', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': -22.90556, 'lon': -47.06083}}, {'zip': '22411-001', 'city': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}, {'zip': '04032-060', 'city': 'São Paulo', 'country': 'Brazil', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '04266-010', 'city': 'São Paulo', 'country': 'Brazil', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': 'M5T 2S8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H3G 1A4', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': '2570017', 'city': 'Viña del Mar', 'state': 'Región de Valparaíso', 'country': 'Chile', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': -33.02457, 'lon': -71.55183}}, {'zip': '8431657', 'city': 'Santiago', 'country': 'Chile', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'city': 'Barranquilla', 'country': 'Colombia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 10.96854, 'lon': -74.78132}}, {'city': 'Bogotá', 'country': 'Colombia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 4.60971, 'lon': -74.08175}}, {'city': 'Bucaramanga', 'country': 'Colombia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 7.125, 'lon': -73.11895}}, {'city': 'Medellín', 'country': 'Colombia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 6.245, 'lon': -75.57151}}, {'zip': '625 00', 'city': 'Brno - Bohunice', 'country': 'Czechia', 'facility': 'GSK Investigational Site'}, {'zip': '500 05', 'city': 'Hradec Králové', 'country': 'Czechia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 50.20923, 'lon': 15.83277}}, {'zip': '775 20', 'city': 'Olomouc', 'country': 'Czechia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 49.59552, 'lon': 17.25175}}, {'zip': '128 50', 'city': 'Prague', 'country': 'Czechia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '92150', 'city': 'Suresnes', 'country': 'France', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 48.87143, 'lon': 2.22929}}, {'zip': '79106', 'city': 'Freiburg im Breisgau', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}, {'zip': '91054', 'city': 'Erlangen', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 49.59099, 'lon': 11.00783}}, {'zip': '60590', 'city': 'Frankfurt am Main', 'state': 'Hesse', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}, {'zip': '30625', 'city': 'Hanover', 'state': 'Lower Saxony', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': '55131', 'city': 'Mainz', 'state': 'Rhineland-Palatinate', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'zip': '04103', 'city': 'Leipzig', 'state': 'Saxony', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': '07743', 'city': 'Jena', 'state': 'Thuringia', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 50.92878, 'lon': 11.5899}}, {'zip': '10117', 'city': 'Berlin', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '14059', 'city': 'Berlin', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '24105', 'city': 'Kiel', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 54.32133, 'lon': 10.13489}}, {'city': 'Chai Wan', 'country': 'Hong Kong', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 22.26718, 'lon': 114.24051}}, {'city': 'New Territories', 'country': 'Hong Kong', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 22.42441, 'lon': 114.11095}}, {'zip': '560034', 'city': 'Bangalore', 'country': 'India', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}, {'zip': '500482', 'city': 'Hyderabad, Andhra Pradesh', 'country': 'India', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 17.38405, 'lon': 78.45636}}, {'zip': '226003', 'city': 'Lucknow', 'country': 'India', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 26.83928, 'lon': 80.92313}}, {'zip': '500003', 'city': 'Secunderabad', 'country': 'India', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 17.50427, 'lon': 78.54263}}, {'zip': '695029', 'city': 'Trivandrum', 'country': 'India', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 8.4855, 'lon': 76.94924}}, {'zip': '84101', 'city': 'Beersheba', 'country': 'Israel', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 31.25181, 'lon': 34.7913}}, {'zip': '31048', 'city': 'Haifa', 'country': 'Israel', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'zip': '31096', 'city': 'Haifa', 'country': 'Israel', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'zip': '34362', 'city': 'Haifa', 'country': 'Israel', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'zip': '49100', 'city': 'Petah Tikva', 'country': 'Israel', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}, {'zip': '52621', 'city': 'Ramat Gan', 'country': 'Israel', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 32.08227, 'lon': 34.81065}}, {'zip': '76100', 'city': 'Rehovot', 'country': 'Israel', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 31.89421, 'lon': 34.81199}}, {'zip': '00152', 'city': 'Roma', 'country': 'Italy', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '44160', 'city': 'Guadalajara', 'state': 'Jalisco', 'country': 'Mexico', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 20.67738, 'lon': -103.34749}}, {'zip': '44280', 'city': 'Guadalajara', 'state': 'Jalisco', 'country': 'Mexico', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 20.67738, 'lon': -103.34749}}, {'zip': '7760', 'city': 'México', 'country': 'Mexico', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 31.00435, 'lon': -108.15213}}, {'zip': '78240', 'city': 'San Luis Potosí City', 'country': 'Mexico', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 22.15234, 'lon': -100.97135}}, {'zip': '6229 HX', 'city': 'Maastricht', 'country': 'Netherlands', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}, {'zip': '3015 CE', 'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'zip': '3083 AN', 'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'city': 'Surco', 'state': 'Lima region', 'country': 'Peru', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': -11.88401, 'lon': -76.44002}}, {'zip': 'Callao 2', 'city': 'Callao', 'country': 'Peru', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': -12.05162, 'lon': -77.13452}}, {'zip': 'Lima 27', 'city': 'Lima', 'country': 'Peru', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': -12.04318, 'lon': -77.02824}}, {'zip': '6000', 'city': 'Cebu City', 'country': 'Philippines', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 10.31672, 'lon': 123.89071}}, {'zip': '8000', 'city': 'Davao City', 'country': 'Philippines', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 7.07306, 'lon': 125.61278}}, {'zip': '1740', 'city': 'Las Piñas', 'country': 'Philippines', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 14.45056, 'lon': 120.98278}}, {'zip': '1000', 'city': 'Manila', 'country': 'Philippines', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 14.6042, 'lon': 120.9822}}, {'zip': '1102', 'city': 'Quezon City', 'country': 'Philippines', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 14.6488, 'lon': 121.0509}}, {'zip': '1008', 'city': 'Sampaloc Manila', 'country': 'Philippines', 'facility': 'GSK Investigational Site'}, {'zip': '26-200', 'city': 'Gmina Końskie', 'country': 'Poland', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 51.19166, 'lon': 20.40607}}, {'zip': '00716', 'city': 'Ponce', 'country': 'Puerto Rico', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 18.01031, 'lon': -66.62398}}, {'zip': '00936-5067', 'city': 'San Juan', 'country': 'Puerto Rico', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}, {'zip': '020125', 'city': 'Bucharest', 'country': 'Romania', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '020475', 'city': 'Bucharest', 'country': 'Romania', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '021392', 'city': 'Bucharest', 'country': 'Romania', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '400006', 'city': 'Cluj-Napoca', 'country': 'Romania', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 46.76667, 'lon': 23.6}}, {'zip': '115522', 'city': 'Moscow', 'country': 'Russia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '190068', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '191015', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '194291', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '150003', 'city': 'Yaroslavl', 'country': 'Russia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 57.62987, 'lon': 39.87368}}, {'zip': '150023', 'city': 'Yaroslavl', 'country': 'Russia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 57.62987, 'lon': 39.87368}}, {'zip': '921 12', 'city': 'Piešťany', 'country': 'Slovakia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 48.59479, 'lon': 17.82591}}, {'zip': '602-715', 'city': 'Busan', 'country': 'South Korea', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '302-799', 'city': 'Daejeon', 'country': 'South Korea', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}, {'zip': '400-711', 'city': 'Incheon', 'country': 'South Korea', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'zip': '602-739', 'city': 'Pusan', 'country': 'South Korea', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 36.3809, 'lon': 128.3681}}, {'zip': '137-701', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '443-721', 'city': 'Suwon, Kyonggi-do', 'country': 'South Korea', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}, {'zip': '08036', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28046', 'city': 'Madrid', 'country': 'Spain', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': 'SE-171 76', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'zip': '662', 'city': 'Dalin Township, Chiayi County', 'country': 'Taiwan', 'facility': 'GSK Investigational Site'}, {'zip': '333', 'city': 'Gueishan Township,Taoyuan County', 'country': 'Taiwan', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 24.99368, 'lon': 121.29696}}, {'zip': '970', 'city': 'Hualien City', 'country': 'Taiwan', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 23.97694, 'lon': 121.60444}}, {'zip': '807', 'city': 'Kaohsiung City', 'country': 'Taiwan', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}, {'zip': '813', 'city': 'Kaohsiung City', 'country': 'Taiwan', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}, {'zip': '833', 'city': 'Kaohsiung City', 'country': 'Taiwan', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}, {'zip': '402', 'city': 'Taichung', 'country': 'Taiwan', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}, {'zip': '404', 'city': 'Taichung', 'country': 'Taiwan', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}, {'zip': '40705', 'city': 'Taichung', 'country': 'Taiwan', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}, {'zip': '100', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': 'SE1 7EH', 'city': 'London', 'country': 'United Kingdom', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'NE7 7DN', 'city': 'Newcastle upon Tyne', 'country': 'United Kingdom', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 54.97328, 'lon': -1.61396}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'ipdSharingStatementModule': {'url': 'https://clinicalstudydatarequest.com/Posting.aspx?ID=20055', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'IPD is available via the Clinical Study Data Request site (click on the link provided below)', 'ipdSharing': 'YES', 'description': 'IPD for this study will be made available via the Clinical Study Data Request site.', 'accessCriteria': 'Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Human Genome Sciences Inc., a GSK Company', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}