Ignite Creation Date:
2025-12-25 @ 4:16 AM
Ignite Modification Date:
2026-02-03 @ 8:27 AM
Study NCT ID:
NCT02149420
Status:
COMPLETED
Last Update Posted:
2021-10-04
First Post:
2013-09-09
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
PD of VAY736 in Patients With Primary Sjögren's Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['France', 'Netherlands', 'United States']}, 'interventionBrowseModule': {'meshes': [{'id': 'C000656267', 'term': 'ianalumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Novartis.email@novartis.com', 'phone': '862-778-8300', 'title': 'Study Director', 'organization': 'Novartis Pharmaceuticals'}, 'certainAgreement': {'otherDetails': "The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date subject has provided informed consent until end of study (Week 28 or when B cell recovery was demonstrated, up to 3 years).', 'description': 'All AEs were reported until week 52. After week 52 only AEs related to VAY736 and AEs related to infection, potential malignant events and neutropenia were recorded.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Placebo', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 9, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'VAY736 3mg/kg', 'description': 'VAY736 3mg/kg', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'VAY736 10mg/kg', 'description': 'VAY736 10mg/kg', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 11, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Open Label VAY736 10mg/kg', 'description': 'Open label VAY736 10mg/kg', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 5, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Chalazion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Keratitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Vitreous detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Auriculotemporal syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Noninfective sialoadenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Seasonal allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Gastrointestinal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Tooth infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Urogenital infection bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Ligament rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Limb injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Rotator cuff syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': "Sjogren's syndrome", 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Synovitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Postmenopausal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Photosensitivity reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}], 'seriousEvents': [{'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Jaw fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Ovarian cyst torsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Change in EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'single dose iv of Placebo'}, {'id': 'OG001', 'title': 'VAY736 3 mg/kg', 'description': 'single dose iv of VAY736 at a dose of 3mg/kg'}, {'id': 'OG002', 'title': 'VAY736 10 mg/kg', 'description': 'single dose iv of VAY736 at a dose of 10mg/kg'}, {'id': 'OG003', 'title': 'VAY736 Combined', 'description': 'Combining VAY736 3mg/kg and VAY736 10mg/kg'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '11.1', 'spread': '4.08', 'groupId': 'OG000'}, {'value': '14.5', 'spread': '9.44', 'groupId': 'OG001'}, {'value': '11.5', 'spread': '4.38', 'groupId': 'OG002'}, {'value': '12.5', 'spread': '6.38', 'groupId': 'OG003'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '10.2', 'spread': '5.29', 'groupId': 'OG000'}, {'value': '10.7', 'spread': '7.69', 'groupId': 'OG001'}, {'value': '10.0', 'spread': '5.36', 'groupId': 'OG002'}, {'value': '10.2', 'spread': '6.01', 'groupId': 'OG003'}]}]}, {'title': 'Change from Baseline to Week 12', 'categories': [{'measurements': [{'value': '-0.9', 'spread': '2.98', 'groupId': 'OG000'}, {'value': '-3.8', 'spread': '8.66', 'groupId': 'OG001'}, {'value': '-1.5', 'spread': '3.00', 'groupId': 'OG002'}, {'value': '-2.3', 'spread': '5.40', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.678', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.93', 'ciLowerLimit': '-5.007', 'ciUpperLimit': '3.180', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '2.058', 'groupDescription': 'Per protocol the primary analysis was between placebo and the combined VAY736 groups at Week 12.', 'statisticalMethod': 'repeated measures Bayesian analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'with baseline as a covariate'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, week 12', 'description': "The effect of VAY736 on clinical disease activity was measured by the change in ESSDAI (EULAR Sjögren's syndrome disease activity index) between baseline and week 12. The instrument contains 12 organ-specific domains contributing to disease activity. For each domain, features of disease activity are scored in 3 or 4 levels according to their severity. These scores are then summed across the 12 domains in a weighted manner to provide the total score (range 0-123). A reduction from baseline indicates improvement in patients.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PD analysis set'}, {'type': 'SECONDARY', 'title': "Change in EULAR Sjögren's Syndrome Patient Response Index (ESSPRI)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'single dose iv of Placebo'}, {'id': 'OG001', 'title': 'VAY736 3 mg/kg', 'description': 'single dose iv of VAY736 at a dose of 3mg/kg'}, {'id': 'OG002', 'title': 'VAY736 10 mg/kg', 'description': 'single dose iv of VAY736 at a dose of 10mg/kg'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '5.967', 'spread': '2.2179', 'groupId': 'OG000'}, {'value': '6.049', 'spread': '1.2759', 'groupId': 'OG001'}, {'value': '6.235', 'spread': '1.5379', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '5.926', 'spread': '1.5822', 'groupId': 'OG000'}, {'value': '6.173', 'spread': '1.4753', 'groupId': 'OG001'}, {'value': '4.568', 'spread': '2.5966', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline to Week 12', 'categories': [{'measurements': [{'value': '-0.041', 'spread': '1.7805', 'groupId': 'OG000'}, {'value': '0.123', 'spread': '1.0120', 'groupId': 'OG001'}, {'value': '-1.667', 'spread': '1.8918', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, week 12', 'description': 'The ESSPRI is a patient self-reported outcome measure to assess dryness, limb pain, fatigue and mental fatigue, where each of the domains normally reported as 0 (not at all) to 10 (extremely severe). The final ESSPRI score is the average of three: dryness, pain and fatigue. A reduction from baseline indicates the improvement of symptoms. During the study all individual scores were reported as 1 to 10 instead. A linear transformation was reported to map the scores to the range of 0-10.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PD analysis set'}, {'type': 'SECONDARY', 'title': 'Change in Short Form (36) Health Survey (SF-36)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'single dose iv of Placebo'}, {'id': 'OG001', 'title': 'VAY736 3 mg/kg', 'description': 'single dose iv of VAY736 at a dose of 3mg/kg'}, {'id': 'OG002', 'title': 'VAY736 10 mg/kg', 'description': 'single dose iv of VAY736 at a dose of 10mg/kg'}], 'classes': [{'title': 'Physical component score: Baseline', 'categories': [{'measurements': [{'value': '46.886', 'spread': '6.3905', 'groupId': 'OG000'}, {'value': '39.445', 'spread': '4.2857', 'groupId': 'OG001'}, {'value': '46.015', 'spread': '9.3533', 'groupId': 'OG002'}]}]}, {'title': 'Physical component score: Week 12', 'categories': [{'measurements': [{'value': '44.788', 'spread': '8.3513', 'groupId': 'OG000'}, {'value': '45.493', 'spread': '7.3060', 'groupId': 'OG001'}, {'value': '47.671', 'spread': '9.2804', 'groupId': 'OG002'}]}]}, {'title': 'Physical component score: Change from Baseline', 'categories': [{'measurements': [{'value': '-2.098', 'spread': '7.9084', 'groupId': 'OG000'}, {'value': '6.048', 'spread': '4.7189', 'groupId': 'OG001'}, {'value': '1.656', 'spread': '5.4113', 'groupId': 'OG002'}]}]}, {'title': 'Mental component score: Baseline', 'categories': [{'measurements': [{'value': '36.913', 'spread': '15.2776', 'groupId': 'OG000'}, {'value': '37.517', 'spread': '6.8994', 'groupId': 'OG001'}, {'value': '43.628', 'spread': '11.3667', 'groupId': 'OG002'}]}]}, {'title': 'Mental component score: Week 12', 'categories': [{'measurements': [{'value': '41.012', 'spread': '13.2991', 'groupId': 'OG000'}, {'value': '40.170', 'spread': '11.9815', 'groupId': 'OG001'}, {'value': '46.700', 'spread': '11.3182', 'groupId': 'OG002'}]}]}, {'title': 'Mental component score: Change from Baseline', 'categories': [{'measurements': [{'value': '4.099', 'spread': '5.3361', 'groupId': 'OG000'}, {'value': '2.653', 'spread': '17.1261', 'groupId': 'OG001'}, {'value': '3.073', 'spread': '11.5823', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, week 12', 'description': 'The SF-36 is a 36-item, patient self-reported outcome measure (questionnaires) of patient health. The outcome of the questionnaires in eight scales results in two summary scores, physical component and mental component, both ranging from 0 - 100. An increase from baseline in either component summary score indicates reduced disease burden.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PD analysis set'}, {'type': 'SECONDARY', 'title': 'Change in Multidimensional Fatigue Inventory (MFI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'single dose iv of Placebo'}, {'id': 'OG001', 'title': 'VAY736 3 mg/kg', 'description': 'single dose iv of VAY736 at a dose of 3mg/kg'}, {'id': 'OG002', 'title': 'VAY736 10 mg/kg', 'description': 'single dose iv of VAY736 at a dose of 10mg/kg'}], 'classes': [{'title': 'General Fatigue: Baseline', 'categories': [{'measurements': [{'value': '14.0', 'spread': '4.72', 'groupId': 'OG000'}, {'value': '17.0', 'spread': '2.37', 'groupId': 'OG001'}, {'value': '15.9', 'spread': '3.34', 'groupId': 'OG002'}]}]}, {'title': 'General Fatigue: Week 12', 'categories': [{'measurements': [{'value': '12.8', 'spread': '4.84', 'groupId': 'OG000'}, {'value': '14.2', 'spread': '6.40', 'groupId': 'OG001'}, {'value': '12.4', 'spread': '3.99', 'groupId': 'OG002'}]}]}, {'title': 'General Fatigue: Change from Baseline', 'categories': [{'measurements': [{'value': '-1.2', 'spread': '1.64', 'groupId': 'OG000'}, {'value': '-2.8', 'spread': '5.04', 'groupId': 'OG001'}, {'value': '-3.5', 'spread': '4.12', 'groupId': 'OG002'}]}]}, {'title': 'Physical Fatigue: Baseline', 'categories': [{'measurements': [{'value': '12.9', 'spread': '4.14', 'groupId': 'OG000'}, {'value': '15.7', 'spread': '2.34', 'groupId': 'OG001'}, {'value': '14.2', 'spread': '3.41', 'groupId': 'OG002'}]}]}, {'title': 'Physical Fatigue: Week 12', 'categories': [{'measurements': [{'value': '12.2', 'spread': '3.99', 'groupId': 'OG000'}, {'value': '11.2', 'spread': '5.15', 'groupId': 'OG001'}, {'value': '10.4', 'spread': '4.66', 'groupId': 'OG002'}]}]}, {'title': 'Physical Fatigue: Change from Baseline', 'categories': [{'measurements': [{'value': '-0.7', 'spread': '1.32', 'groupId': 'OG000'}, {'value': '-4.5', 'spread': '6.57', 'groupId': 'OG001'}, {'value': '-3.8', 'spread': '4.77', 'groupId': 'OG002'}]}]}, {'title': 'Mental Fatigue: Baseline', 'categories': [{'measurements': [{'value': '11.9', 'spread': '4.78', 'groupId': 'OG000'}, {'value': '14.3', 'spread': '3.78', 'groupId': 'OG001'}, {'value': '13.0', 'spread': '3.28', 'groupId': 'OG002'}]}]}, {'title': 'Mental Fatigue: Week 12', 'categories': [{'measurements': [{'value': '11.7', 'spread': '4.12', 'groupId': 'OG000'}, {'value': '11.3', 'spread': '4.18', 'groupId': 'OG001'}, {'value': '9.8', 'spread': '5.17', 'groupId': 'OG002'}]}]}, {'title': 'Mental Fatigue: Change from Baseline', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '2.95', 'groupId': 'OG000'}, {'value': '-3.0', 'spread': '6.07', 'groupId': 'OG001'}, {'value': '-3.2', 'spread': '5.84', 'groupId': 'OG002'}]}]}, {'title': 'Reduced motivation: Baseline', 'categories': [{'measurements': [{'value': '12.4', 'spread': '4.93', 'groupId': 'OG000'}, {'value': '12.3', 'spread': '3.93', 'groupId': 'OG001'}, {'value': '10.9', 'spread': '2.68', 'groupId': 'OG002'}]}]}, {'title': 'Reduced motivation: Week 12', 'categories': [{'measurements': [{'value': '12.0', 'spread': '5.32', 'groupId': 'OG000'}, {'value': '10.0', 'spread': '4.52', 'groupId': 'OG001'}, {'value': '9.8', 'spread': '4.97', 'groupId': 'OG002'}]}]}, {'title': 'Reduced motivation: Change from Baseline', 'categories': [{'measurements': [{'value': '-0.4', 'spread': '2.40', 'groupId': 'OG000'}, {'value': '-2.3', 'spread': '4.50', 'groupId': 'OG001'}, {'value': '-1.1', 'spread': '4.56', 'groupId': 'OG002'}]}]}, {'title': 'Reduced activity: Baseline', 'categories': [{'measurements': [{'value': '11.8', 'spread': '2.86', 'groupId': 'OG000'}, {'value': '10.8', 'spread': '1.72', 'groupId': 'OG001'}, {'value': '12.2', 'spread': '2.69', 'groupId': 'OG002'}]}]}, {'title': 'Reduced activity: Week 12', 'categories': [{'measurements': [{'value': '10.4', 'spread': '3.81', 'groupId': 'OG000'}, {'value': '8.7', 'spread': '3.61', 'groupId': 'OG001'}, {'value': '9.3', 'spread': '5.08', 'groupId': 'OG002'}]}]}, {'title': 'Reduced activity: Change from Baseline', 'categories': [{'measurements': [{'value': '-1.3', 'spread': '1.80', 'groupId': 'OG000'}, {'value': '-2.2', 'spread': '4.83', 'groupId': 'OG001'}, {'value': '-2.9', 'spread': '4.25', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, week 12', 'description': 'The MFI is a patient self-reported outcome measure (questionnaires) to assess fatigue covering the following dimensions: General Fatigue, Physical Fatigue, Mental Fatigue, Reduced Motivation and Reduced Activity. Each dimension has a posible range from 4-20. A reduction from baseline in MFI indicates improvement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PD analysis set'}, {'type': 'SECONDARY', 'title': "Change in the Physician's Global Assessment of Overall Disease Activity by Means of Visual Analog Scale (VAS)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'single dose iv of Placebo'}, {'id': 'OG001', 'title': 'VAY736 3 mg/kg', 'description': 'single dose iv of VAY736 at a dose of 3mg/kg'}, {'id': 'OG002', 'title': 'VAY736 10 mg/kg', 'description': 'single dose iv of VAY736 at a dose of 10mg/kg'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '57.3', 'spread': '17.73', 'groupId': 'OG000'}, {'value': '66.2', 'spread': '17.53', 'groupId': 'OG001'}, {'value': '65.0', 'spread': '11.74', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '59.8', 'spread': '23.35', 'groupId': 'OG000'}, {'value': '43.0', 'spread': '23.82', 'groupId': 'OG001'}, {'value': '48.5', 'spread': '17.33', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline to Week 12', 'categories': [{'measurements': [{'value': '2.4', 'spread': '12.21', 'groupId': 'OG000'}, {'value': '-23.2', 'spread': '31.10', 'groupId': 'OG001'}, {'value': '-16.5', 'spread': '18.96', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, week 12', 'description': 'The visual analogue scale used is a 100 mm VAS ranging from "no disease" (0 mm) to "maximal disease activity" (100 mm).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PD analysis set'}, {'type': 'SECONDARY', 'title': "Change in the Patient's Global Assessment of Overall Disease Activity by Means of Visual Analog Scale (VAS)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'single dose iv of Placebo'}, {'id': 'OG001', 'title': 'VAY736 3 mg/kg', 'description': 'single dose iv of VAY736 at a dose of 3mg/kg'}, {'id': 'OG002', 'title': 'VAY736 10 mg/kg', 'description': 'single dose iv of VAY736 at a dose of 10mg/kg'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '56.2', 'spread': '24.86', 'groupId': 'OG000'}, {'value': '67.2', 'spread': '13.69', 'groupId': 'OG001'}, {'value': '59.8', 'spread': '24.30', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '55.2', 'spread': '21.57', 'groupId': 'OG000'}, {'value': '44.2', 'spread': '22.75', 'groupId': 'OG001'}, {'value': '40.8', 'spread': '20.49', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline to Week 12', 'categories': [{'measurements': [{'value': '-1.0', 'spread': '17.71', 'groupId': 'OG000'}, {'value': '-23.0', 'spread': '25.73', 'groupId': 'OG001'}, {'value': '-19.0', 'spread': '21.08', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, week 12', 'description': 'The visual analogue scale used is a 100 mm VAS ranging from "no disease" (0 mm) to "maximal disease activity" (100 mm).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PD analysis set'}, {'type': 'SECONDARY', 'title': 'VAY736 Serum Concentration - AUCinf', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'VAY736 3 mg/kg', 'description': 'single dose iv of VAY736 at a dose of 3mg/kg'}, {'id': 'OG001', 'title': 'VAY736 10 mg/kg', 'description': 'single dose iv of VAY736 at a dose of 10mg/kg'}, {'id': 'OG002', 'title': 'Open Label VAY736', 'description': 'Open label VAY736 10mg/kg'}], 'classes': [{'categories': [{'measurements': [{'value': '389', 'groupId': 'OG000', 'lowerLimit': '186', 'upperLimit': '457'}, {'value': '1140', 'groupId': 'OG001', 'lowerLimit': '515', 'upperLimit': '1610'}, {'value': '971', 'groupId': 'OG002', 'lowerLimit': '849', 'upperLimit': '1340'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '0, 1, 2, 3, 6, 9, 12, 16, 20, 24 and approximately 52 weeks.', 'description': 'The area under the serum concentration-time curve from time zero to infinity \\[mass × time / volume\\]. The concentration of VAY736 was measured in the serum.', 'unitOfMeasure': 'day*ug/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis set'}, {'type': 'SECONDARY', 'title': 'VAY736 Serum Concentration - AUClast', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'VAY736 3 mg/kg', 'description': 'single dose iv of VAY736 at a dose of 3mg/kg'}, {'id': 'OG001', 'title': 'VAY736 10 mg/kg', 'description': 'single dose iv of VAY736 at a dose of 10mg/kg'}, {'id': 'OG002', 'title': 'Open Label VAY736', 'description': 'Open label VAY736 10mg/kg'}], 'classes': [{'categories': [{'measurements': [{'value': '385', 'groupId': 'OG000', 'lowerLimit': '184', 'upperLimit': '457'}, {'value': '1140', 'groupId': 'OG001', 'lowerLimit': '514', 'upperLimit': '1610'}, {'value': '971', 'groupId': 'OG002', 'lowerLimit': '848', 'upperLimit': '1340'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '0, 1, 2, 3, 6, 9, 12, 16, 20, 24 and approximately 52 weeks.', 'description': 'The area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration \\[mass × time / volume\\]. The concentration of VAY736 was measured in the serum.', 'unitOfMeasure': 'day*ug/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis set'}, {'type': 'SECONDARY', 'title': 'VAY736 Serum Concentration - CL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'VAY736 3 mg/kg', 'description': 'single dose iv of VAY736 at a dose of 3mg/kg'}, {'id': 'OG001', 'title': 'VAY736 10 mg/kg', 'description': 'single dose iv of VAY736 at a dose of 10mg/kg'}, {'id': 'OG002', 'title': 'Open Label VAY736', 'description': 'Open label VAY736 10mg/kg'}], 'classes': [{'categories': [{'measurements': [{'value': '0.594', 'groupId': 'OG000', 'lowerLimit': '0.427', 'upperLimit': '0.844'}, {'value': '0.584', 'groupId': 'OG001', 'lowerLimit': '0.550', 'upperLimit': '1.30'}, {'value': '0.686', 'groupId': 'OG002', 'lowerLimit': '0.427', 'upperLimit': '0.750'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '0, 1, 2, 3, 6, 9, 12, 16, 20, 24 and approximately 52 weeks.', 'description': 'The systemic (or total body) clearance from serum following intravenous administration \\[volume / time\\]. The concentration of VAY736 was measured in the serum.', 'unitOfMeasure': 'L/day', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis set'}, {'type': 'SECONDARY', 'title': 'VAY736 Serum Concentration - Cmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'VAY736 3 mg/kg', 'description': 'single dose iv of VAY736 at a dose of 3mg/kg'}, {'id': 'OG001', 'title': 'VAY736 10 mg/kg', 'description': 'single dose iv of VAY736 at a dose of 10mg/kg'}, {'id': 'OG002', 'title': 'Open Label VAY736', 'description': 'Open label VAY736 10mg/kg'}], 'classes': [{'categories': [{'measurements': [{'value': '65.0', 'groupId': 'OG000', 'lowerLimit': '45.4', 'upperLimit': '76.5'}, {'value': '213', 'groupId': 'OG001', 'lowerLimit': '150', 'upperLimit': '283'}, {'value': '205', 'groupId': 'OG002', 'lowerLimit': '174', 'upperLimit': '217'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '0, 1, 2, 3, 6, 9, 12, 16, 20, 24 and approximately 52 weeks.', 'description': 'The observed maximum serum concentration following drug administration \\[mass / volume\\]. The concentration of VAY736 was measured in the serum.', 'unitOfMeasure': 'ug/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis set'}, {'type': 'SECONDARY', 'title': 'VAY736 Serum Concentration - T1/2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'VAY736 3 mg/kg', 'description': 'single dose iv of VAY736 at a dose of 3mg/kg'}, {'id': 'OG001', 'title': 'VAY736 10 mg/kg', 'description': 'single dose iv of VAY736 at a dose of 10mg/kg'}, {'id': 'OG002', 'title': 'Open Label VAY736', 'description': 'Open label VAY736 10mg/kg'}], 'classes': [{'categories': [{'measurements': [{'value': '8.43', 'groupId': 'OG000', 'lowerLimit': '6.99', 'upperLimit': '13.8'}, {'value': '9.51', 'groupId': 'OG001', 'lowerLimit': '5.38', 'upperLimit': '15.2'}, {'value': '11.0', 'groupId': 'OG002', 'lowerLimit': '4.94', 'upperLimit': '17.4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '0, 1, 2, 3, 6, 9, 12, 16, 20, 24 and approximately 52 weeks.', 'description': 'Apparent terminal half-life, determined as the ln2/lambda\\_z or 0.693/lambda\\_z. The concentration of VAY736 was measured in the serum.', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis set'}, {'type': 'SECONDARY', 'title': 'VAY736 Serum Concentration - Tmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'VAY736 3 mg/kg', 'description': 'single dose iv of VAY736 at a dose of 3mg/kg'}, {'id': 'OG001', 'title': 'VAY736 10 mg/kg', 'description': 'single dose iv of VAY736 at a dose of 10mg/kg'}, {'id': 'OG002', 'title': 'Open Label VAY736', 'description': 'Open label VAY736 10mg/kg'}], 'classes': [{'categories': [{'measurements': [{'value': '2.03', 'groupId': 'OG000', 'lowerLimit': '2.00', 'upperLimit': '2.20'}, {'value': '2.03', 'groupId': 'OG001', 'lowerLimit': '2.00', 'upperLimit': '2.30'}, {'value': '2.10', 'groupId': 'OG002', 'lowerLimit': '2.02', 'upperLimit': '2.17'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '0, 1, 2, 3, 6, 9, 12, 16, 20, 24 and approximately 52 weeks.', 'description': 'The time to reach the maximum concentration after drug administration \\[time\\]. The concentration of VAY736 was measured in the serum.', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis set'}, {'type': 'SECONDARY', 'title': 'VAY736 Serum Concentration - Vz', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'VAY736 3 mg/kg', 'description': 'single dose iv of VAY736 at a dose of 3mg/kg'}, {'id': 'OG001', 'title': 'VAY736 10 mg/kg', 'description': 'single dose iv of VAY736 at a dose of 10mg/kg'}, {'id': 'OG002', 'title': 'Open Label VAY736', 'description': 'Open label VAY736 10mg/kg'}], 'classes': [{'categories': [{'measurements': [{'value': '7.83', 'groupId': 'OG000', 'lowerLimit': '6.55', 'upperLimit': '10.7'}, {'value': '8.68', 'groupId': 'OG001', 'lowerLimit': '7.15', 'upperLimit': '12.4'}, {'value': '10.3', 'groupId': 'OG002', 'lowerLimit': '4.93', 'upperLimit': '18.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '0, 1, 2, 3, 6, 9, 12, 16, 20, 24 and approximately 52 weeks.', 'description': 'The volume of distribution during the terminal elimination phase following intravenous administration \\[volume\\]. The concentration of VAY736 was measured in the serum.', 'unitOfMeasure': 'L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis set'}, {'type': 'PRIMARY', 'title': 'Overall Incidence of Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'single dose iv of Placebo'}, {'id': 'OG001', 'title': 'VAY736 3 mg/kg', 'description': 'single dose iv of VAY736 at a dose of 3mg/kg'}, {'id': 'OG002', 'title': 'VAY736 10 mg/kg', 'description': 'single dose iv of VAY736 at a dose of 10mg/kg'}, {'id': 'OG003', 'title': 'VAY736 Combined', 'description': 'Combining VAY736 3mg/kg and VAY736 10mg/kg'}], 'classes': [{'title': 'Subjects with AEs', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}]}, {'title': 'Subjects with AEs within 24hr of infusion', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}]}, {'title': 'Subjects with AEs post 24hr of infusion', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}]}, {'title': 'Subjects with Study drug-related AEs', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}]}, {'title': 'Subjects with Infusion related AEs', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to Week 24', 'description': 'Number of subjects with Adverse Events during the double blind treatment period.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'single dose iv of Placebo (+ Option to receive Open label VAY736 10 mg/kg at Week 24)'}, {'id': 'FG001', 'title': 'VAY736 3 mg/kg', 'description': 'single dose iv of VAY736 at a dose of 3mg/kg'}, {'id': 'FG002', 'title': 'VAY736 10 mg/kg', 'description': 'single dose iv of VAY736 at a dose of 10mg/kg'}], 'periods': [{'title': 'Core Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '12'}]}, {'type': 'Safety Analysis Set', 'comment': 'all patients that received study drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '12'}]}, {'type': 'PK Analysis Set', 'comment': 'at least one valid PK concentration measurement', 'achievements': [{'comment': 'for patients entering open label VAY736 10 mg/kg at Week 24', 'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '12'}]}, {'type': 'PD (Pharmacodynamics) Analysis Set', 'comment': 'all patients with PD data, who received at least one dose of study drug.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Administrative problems', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}, {'title': 'Open Label VAY736 10 mg/kg Extension', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Patients received single dose of VAY736 10mg/kg at Week 24.', 'groupId': 'FG000', 'numSubjects': '5'}, {'comment': 'Only patients origianally randomized to Placebo were allowed to enter this Period.', 'groupId': 'FG001', 'numSubjects': '0'}, {'comment': 'Only patients origianally randomized to Placebo were allowed to enter this Period.', 'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Administrative problems', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'A total of 27 patients were enrolled and randomized into the study at one site in Germany.', 'preAssignmentDetails': 'The patients were enrolled in 2 sequential cohorts:\n\nCohort 1: Six patients were randomized to receive a single dose iv of VAY736 at a dose of 3mg/kg or placebo at a 2:1 ratio.\n\nCohort 2: Twenty one patients were randomized to receive a single iv dose of VAY736 at a dose of 10.0 mg/kg or 3.0 mg/kg or placebo at a 6:1:3 ratio.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'single dose iv of Placebo'}, {'id': 'BG001', 'title': 'VAY736 3 mg/kg', 'description': 'single dose iv of VAY736 at a dose of 3mg/kg'}, {'id': 'BG002', 'title': 'VAY736 10 mg/kg', 'description': 'single dose iv of VAY736 at a dose of 10mg/kg'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '46.7', 'spread': '11.29', 'groupId': 'BG000'}, {'value': '46.8', 'spread': '8.75', 'groupId': 'BG001'}, {'value': '55.3', 'spread': '13.35', 'groupId': 'BG002'}, {'value': '50.5', 'spread': '12.16', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-10-31', 'size': 1054109, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-01-23T08:18', 'hasProtocol': True}, {'date': '2017-01-11', 'size': 314936, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-01-23T08:18', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Treatment was unblinded at an individual patient level at Week 24 to determine their progress in the study (follow-up, open-label VAY736 or End of Study Visit).'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2018-02-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-30', 'studyFirstSubmitDate': '2013-09-09', 'resultsFirstSubmitDate': '2019-01-23', 'studyFirstSubmitQcDate': '2014-05-26', 'lastUpdatePostDateStruct': {'date': '2021-10-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-01-23', 'studyFirstPostDateStruct': {'date': '2014-05-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Change in EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI)", 'timeFrame': 'Baseline, week 12', 'description': "The effect of VAY736 on clinical disease activity was measured by the change in ESSDAI (EULAR Sjögren's syndrome disease activity index) between baseline and week 12. The instrument contains 12 organ-specific domains contributing to disease activity. For each domain, features of disease activity are scored in 3 or 4 levels according to their severity. These scores are then summed across the 12 domains in a weighted manner to provide the total score (range 0-123). A reduction from baseline indicates improvement in patients."}, {'measure': 'Overall Incidence of Adverse Events', 'timeFrame': 'Baseline to Week 24', 'description': 'Number of subjects with Adverse Events during the double blind treatment period.'}], 'secondaryOutcomes': [{'measure': "Change in EULAR Sjögren's Syndrome Patient Response Index (ESSPRI)", 'timeFrame': 'Baseline, week 12', 'description': 'The ESSPRI is a patient self-reported outcome measure to assess dryness, limb pain, fatigue and mental fatigue, where each of the domains normally reported as 0 (not at all) to 10 (extremely severe). The final ESSPRI score is the average of three: dryness, pain and fatigue. A reduction from baseline indicates the improvement of symptoms. During the study all individual scores were reported as 1 to 10 instead. A linear transformation was reported to map the scores to the range of 0-10.'}, {'measure': 'Change in Short Form (36) Health Survey (SF-36)', 'timeFrame': 'Baseline, week 12', 'description': 'The SF-36 is a 36-item, patient self-reported outcome measure (questionnaires) of patient health. The outcome of the questionnaires in eight scales results in two summary scores, physical component and mental component, both ranging from 0 - 100. An increase from baseline in either component summary score indicates reduced disease burden.'}, {'measure': 'Change in Multidimensional Fatigue Inventory (MFI)', 'timeFrame': 'Baseline, week 12', 'description': 'The MFI is a patient self-reported outcome measure (questionnaires) to assess fatigue covering the following dimensions: General Fatigue, Physical Fatigue, Mental Fatigue, Reduced Motivation and Reduced Activity. Each dimension has a posible range from 4-20. A reduction from baseline in MFI indicates improvement.'}, {'measure': "Change in the Physician's Global Assessment of Overall Disease Activity by Means of Visual Analog Scale (VAS)", 'timeFrame': 'Baseline, week 12', 'description': 'The visual analogue scale used is a 100 mm VAS ranging from "no disease" (0 mm) to "maximal disease activity" (100 mm).'}, {'measure': "Change in the Patient's Global Assessment of Overall Disease Activity by Means of Visual Analog Scale (VAS)", 'timeFrame': 'Baseline, week 12', 'description': 'The visual analogue scale used is a 100 mm VAS ranging from "no disease" (0 mm) to "maximal disease activity" (100 mm).'}, {'measure': 'VAY736 Serum Concentration - AUCinf', 'timeFrame': '0, 1, 2, 3, 6, 9, 12, 16, 20, 24 and approximately 52 weeks.', 'description': 'The area under the serum concentration-time curve from time zero to infinity \\[mass × time / volume\\]. The concentration of VAY736 was measured in the serum.'}, {'measure': 'VAY736 Serum Concentration - AUClast', 'timeFrame': '0, 1, 2, 3, 6, 9, 12, 16, 20, 24 and approximately 52 weeks.', 'description': 'The area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration \\[mass × time / volume\\]. The concentration of VAY736 was measured in the serum.'}, {'measure': 'VAY736 Serum Concentration - CL', 'timeFrame': '0, 1, 2, 3, 6, 9, 12, 16, 20, 24 and approximately 52 weeks.', 'description': 'The systemic (or total body) clearance from serum following intravenous administration \\[volume / time\\]. The concentration of VAY736 was measured in the serum.'}, {'measure': 'VAY736 Serum Concentration - Cmax', 'timeFrame': '0, 1, 2, 3, 6, 9, 12, 16, 20, 24 and approximately 52 weeks.', 'description': 'The observed maximum serum concentration following drug administration \\[mass / volume\\]. The concentration of VAY736 was measured in the serum.'}, {'measure': 'VAY736 Serum Concentration - T1/2', 'timeFrame': '0, 1, 2, 3, 6, 9, 12, 16, 20, 24 and approximately 52 weeks.', 'description': 'Apparent terminal half-life, determined as the ln2/lambda\\_z or 0.693/lambda\\_z. The concentration of VAY736 was measured in the serum.'}, {'measure': 'VAY736 Serum Concentration - Tmax', 'timeFrame': '0, 1, 2, 3, 6, 9, 12, 16, 20, 24 and approximately 52 weeks.', 'description': 'The time to reach the maximum concentration after drug administration \\[time\\]. The concentration of VAY736 was measured in the serum.'}, {'measure': 'VAY736 Serum Concentration - Vz', 'timeFrame': '0, 1, 2, 3, 6, 9, 12, 16, 20, 24 and approximately 52 weeks.', 'description': 'The volume of distribution during the terminal elimination phase following intravenous administration \\[volume\\]. The concentration of VAY736 was measured in the serum.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ["primary Sjögren's syndrome, pharmacodynamics"], 'conditions': ["Primary Sjögren's Syndrome"]}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=419', 'label': 'A Plain Language Trial Summary is available on novartisclinicaltrials.com'}]}, 'descriptionModule': {'briefSummary': 'This study was designed to evaluate the safety, tolerability, pharmacokinetics and therapeutic efficacy of a single intravenous infusion of VAY7346 monoclonal antibody in pSS patients', 'detailedDescription': 'Patients were enrolled in 2 sequential cohorts:\n\nCohort 1: 6 patients received 3 mg/kg or Placebo (2:1 ratio) Cohort 2: 21 patients received 10 mg/kg, 3 mg/kg or Placebo (6:1:3 ratio)\n\nAt week 24 the blind was broken to assess continuation in the trial:\n\n* If a patient received VAY736 and their B cell recovery was demonstrated at Week 24, then patients completed the trial.\n* If a patient received VAY736 and their B cell recovery was NOT demonstrated at Week 24, then patients were followed up until B cell recovery was demonstrated\n* If a patient received placebo, they were offered the option of receiving open-label VAY736 (10 mg/kg) in a separate treatment arm.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'INCLUSION CRITERIA:\n\n* Fulfilled revised European US consensus criteria for pSS\n* ESSDAI value ≥ 6\n* Elevated serum titers at screening of ANA (≥ 1:160)\n* Seropositive at screening for anti-SSA and/or anti-SSB antibodies\n* Stimulated whole salivary flow rate at screening of \\> 0 mL/min\n\nEXCLUSION CRITERIA:\n\n\\- Prior or previous use of (specific dosages and intervals prior to study start may apply): B-cell depleting therapy (e.g., rituximab), Prednisone, anti-BAFF mAb, CTLA4-Fc Ig (abatacept), anti-TNF-α mAb, cyclophosphamide, azathioprine and medications known to cause dry mouth.\n\nHydroxychloroquine or methotrexate in a consistent dose for ≥ 3 months prior to randomization is allowed\n\n* Active or recent history of clinically significant infection\n* Vaccination within 2 month prior to study\n* History of primary or secondary immunodeficiency'}, 'identificationModule': {'nctId': 'NCT02149420', 'acronym': 'CVAY736X2201', 'briefTitle': "PD of VAY736 in Patients With Primary Sjögren's Syndrome", 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': "A Single Dose, Double-blind, Placebo-controlled, Parallel Study to Assess the Pharmacodynamics, Pharmacokinetics and Safety and Tolerability of VAY736 in Patients With Primary Sjögren's Syndrome", 'orgStudyIdInfo': {'id': 'CVAY736X2201'}, 'secondaryIdInfos': [{'id': '2013-000250-22', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'VAY736 3 mg/kg', 'description': 'single dose iv of VAY736 at a dose of 3mg/kg', 'interventionNames': ['Drug: VAY736']}, {'type': 'EXPERIMENTAL', 'label': 'VAY736 10 mg/kg', 'description': 'single dose iv of VAY736 at a dose of 10mg/kg', 'interventionNames': ['Drug: VAY736']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'single dose iv of Placebo. At Week 24 patients were offered to receive open label VAY736 10 mg/kg.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'VAY736', 'type': 'DRUG', 'armGroupLabels': ['VAY736 10 mg/kg', 'VAY736 3 mg/kg']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10117', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}