Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-30 @ 9:29 AM
Study NCT ID:
NCT01197534
Status:
COMPLETED
Last Update Posted:
2014-04-17
First Post:
2010-09-08
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Disease Modifying Anti-rheumatic Drug (DMARD) But Not Responding.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C523665', 'term': 'fostamatinib'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dave.goldstraw@astrazeneca.com', 'phone': '+44 (0)1625 512415', 'title': 'Dave Goldstraw', 'organization': 'AstraZeneca Pharmaceuticals'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '52 weeks', 'description': 'For placebo treated patients time frame includes both placebo (24 weeks) and fostamatinib (28 weeks) treatment. 11 SAEs occurred during the 24 week placebo treated period.', 'eventGroups': [{'id': 'EG000', 'title': 'FOSTA 100 MG BID', 'description': 'Dosing Group A', 'otherNumAtRisk': 308, 'otherNumAffected': 170, 'seriousNumAtRisk': 308, 'seriousNumAffected': 30}, {'id': 'EG001', 'title': 'FOSTA 100 MG BID (4 WKS) THEN 150 MG QD', 'description': 'Dosing Group B', 'otherNumAtRisk': 298, 'otherNumAffected': 152, 'seriousNumAtRisk': 298, 'seriousNumAffected': 25}, {'id': 'EG002', 'title': 'PLACEBO (24 WKS) THEN FOSTA 100 MG BID - FOSTA Period', 'description': 'Dosing Group C', 'otherNumAtRisk': 302, 'otherNumAffected': 42, 'seriousNumAtRisk': 302, 'seriousNumAffected': 10}, {'id': 'EG003', 'title': 'PLACEBO (24 WKS) THEN FOSTA 100 MG BID - Placebo Period', 'otherNumAtRisk': 302, 'otherNumAffected': 77, 'seriousNumAtRisk': 302, 'seriousNumAffected': 10}], 'otherEvents': [{'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numEvents': 44, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 298, 'numEvents': 47, 'numAffected': 47}, {'groupId': 'EG002', 'numAtRisk': 302, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 302, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numEvents': 20, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 298, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 302, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 302, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'NASOPHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numEvents': 37, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 298, 'numEvents': 29, 'numAffected': 29}, {'groupId': 'EG002', 'numAtRisk': 302, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 302, 'numEvents': 16, 'numAffected': 16}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'ALANINE AMINOTRANSFERASE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numEvents': 21, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 298, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 302, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 302, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'ASPARTATE AMINOTRANSFERASE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 298, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 302, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 302, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'BLOOD PRESSURE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 298, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 302, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 302, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'RHEUMATOID ARTHRITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numEvents': 19, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 298, 'numEvents': 23, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 302, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 302, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numEvents': 19, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 298, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 302, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 302, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'HYPERTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numEvents': 68, 'numAffected': 68}, {'groupId': 'EG001', 'numAtRisk': 298, 'numEvents': 55, 'numAffected': 55}, {'groupId': 'EG002', 'numAtRisk': 302, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG003', 'numAtRisk': 302, 'numEvents': 16, 'numAffected': 16}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}], 'seriousEvents': [{'term': 'LEUKOPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 302, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 302, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'ANGINA PECTORIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 298, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 302, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 302, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'ATRIAL FIBRILLATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 298, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 302, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 302, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'ATRIAL FLUTTER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 302, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 302, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'CARDIAC ARREST', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 302, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 302, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'LEFT VENTRICULAR FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 302, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 302, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'MYOCARDIAL INFARCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 302, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 302, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'VENTRICULAR FIBRILLATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 302, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 302, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'MACULAR HOLE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 298, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 302, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 302, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'COLITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 298, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 302, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 302, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'COLITIS ULCERATIVE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 302, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 302, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 302, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 302, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'GASTRITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 302, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 302, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'GASTRITIS EROSIVE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 302, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 302, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'GASTRITIS HAEMORRHAGIC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 302, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 302, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'LOWER GASTROINTESTINAL HAEMORRHAGE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 302, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 302, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'OESOPHAGITIS ULCERATIVE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 302, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 302, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'PANCREATITIS CHRONIC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 302, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 302, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'STOMATITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 302, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 302, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'VOMITING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 298, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 302, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 302, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'NON-CARDIAC CHEST PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 302, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 302, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'CHOLECYSTITIS ACUTE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 298, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 302, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 302, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'CHOLELITHIASIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 298, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 302, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 302, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'HEPATOCELLULAR INJURY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 302, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 302, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'NON-ALCOHOLIC STEATOHEPATITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 302, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 302, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'ACUTE SINUSITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 302, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 302, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'ARTHRITIS BACTERIAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 302, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 302, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'ATYPICAL PNEUMONIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 302, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 302, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'BRONCHITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 302, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 302, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'BRONCHITIS BACTERIAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 298, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 302, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 302, 'numEvents': 0, 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[{'groupId': 'EG000', 'numAtRisk': 308, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 298, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 302, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 302, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'PULMONARY EMBOLISM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 302, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 302, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'PULMONARY TOXICITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 298, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 302, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 302, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'RESPIRATORY FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 298, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 302, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 302, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'DEEP VEIN THROMBOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 298, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 302, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 302, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'MALIGNANT HYPERTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 298, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 302, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 302, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Proportion of Patients With ACR20 at Week 24, Comparison Between Fostamatinib and Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '308', 'groupId': 'OG000'}, {'value': '298', 'groupId': 'OG001'}, {'value': '302', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'FOSTA 100 MG BID PO', 'description': 'Dosing Group A'}, {'id': 'OG001', 'title': 'FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO', 'description': 'Dosing Group B'}, {'id': 'OG002', 'title': 'PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO', 'description': 'Dosing Group C'}], 'classes': [{'categories': [{'measurements': [{'value': '39.6', 'groupId': 'OG000'}, {'value': '39.6', 'groupId': 'OG001'}, {'value': '24.5', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001', 'OG002'], 'paramType': 'Weighted difference in proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.15', 'ciLowerLimit': '0.08', 'ciUpperLimit': '0.22', 'pValueComment': 'Week 24', 'groupDescription': 'Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment difference in proportion of responders using a Mantel Haenszel approach stratified by background use of DMARD and pooled country.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '24 weeks', 'description': "ACR20: American College of Rheumatology 20% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as CRP) and the physician and patient's own assessments of disease activity, pain and physical function. BID = twice daily, CRP = C-reactive protein, DMARD = disease-modifying anti-rheumatic drug, PO = orally, QD = once a day.", 'unitOfMeasure': 'Percentage of responders', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.'}, {'type': 'SECONDARY', 'title': 'Proportion of Patients Achieving ACR20, Comparison Between Fostamatinib and Placebo at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '606', 'groupId': 'OG000'}, {'value': '302', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FOSTA 100 MG BID PO (Combined)', 'description': 'Dosing Group A and B combined'}, {'id': 'OG001', 'title': 'PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO', 'description': 'Dosing Group C'}], 'classes': [{'categories': [{'measurements': [{'value': '16.0', 'groupId': 'OG000'}, {'value': '8.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Weighted difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.08', 'ciLowerLimit': '0.04', 'ciUpperLimit': '0.12', 'groupDescription': 'Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': '95% confidence intervals and p-values are calculated using a Mantel Haenszel approach stratified by background use of DMARD and pooled country.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '1 week', 'description': "ACR20: American College of Rheumatology 20% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as CRP) and the physician and patient's own assessments of disease activity, pain and physical function. BID = twice daily, CRP = C-reactive protein, DMARD = Disease-modifying anti-rheumatic drug, PO = orally, QD = once a day.", 'unitOfMeasure': 'Percentage of responders', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.'}, {'type': 'SECONDARY', 'title': 'Proportion of Patients Achieving ACR50, Comparison Between Fostamatinib and Placebo at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '308', 'groupId': 'OG000'}, {'value': '298', 'groupId': 'OG001'}, {'value': '302', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'FOSTA 100 MG BID PO', 'description': 'Dosing Group A'}, {'id': 'OG001', 'title': 'FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO', 'description': 'Dosing Group B'}, {'id': 'OG002', 'title': 'PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO', 'description': 'Dosing Group C'}], 'classes': [{'categories': [{'measurements': [{'value': '20.8', 'groupId': 'OG000'}, {'value': '18.1', 'groupId': 'OG001'}, {'value': '8.3', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Weighted difference in proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.13', 'ciLowerLimit': '0.07', 'ciUpperLimit': '0.18', 'groupDescription': 'Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': '95% confidence intervals and p-values are calculated using a Mantel Haenszel approach stratified by background use of DMARD and pooled country.', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Weighted difference in proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.10', 'ciLowerLimit': '0.05', 'ciUpperLimit': '0.15', 'groupDescription': 'Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': '95% confidence intervals and p-values are calculated using a Mantel Haenszel approach stratified by background use of DMARD and pooled country.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '24 weeks', 'description': "ACR50: American College of Rheumatology 50% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as CRP) and the physician and patient's own assessments of disease activity, pain and physical function. BID = twice daily, CRP = C-reactive protein, DMARD = Disease-modifying anti-rheumatic drug, PO = orally, QD = once a day.", 'unitOfMeasure': 'Percentage of responders', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.'}, {'type': 'SECONDARY', 'title': 'Proportion of Patients Achieving ACR70, Comparison Between Fostamatinib and Placebo at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '308', 'groupId': 'OG000'}, {'value': '298', 'groupId': 'OG001'}, {'value': '302', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'FOSTA 100 MG BID PO', 'description': 'Dosing Group A'}, {'id': 'OG001', 'title': 'FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO', 'description': 'Dosing Group B'}, {'id': 'OG002', 'title': 'PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO', 'description': 'Dosing Group C'}], 'classes': [{'categories': [{'measurements': [{'value': '9.1', 'groupId': 'OG000'}, {'value': '6.0', 'groupId': 'OG001'}, {'value': '2.6', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Weighted difference in proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.07', 'ciLowerLimit': '0.03', 'ciUpperLimit': '0.10', 'groupDescription': 'Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': '95% confidence intervals and p-values are calculated using a Mantel Haenszel approach stratified by background use of DMARD and pooled country.', 'testedNonInferiority': False}, {'pValue': '0.033', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Weighted difference in proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.03', 'ciLowerLimit': '0.00', 'ciUpperLimit': '0.07', 'groupDescription': 'Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': '95% confidence intervals and p-values are calculated using a Mantel Haenszel approach stratified by background use of DMARD and pooled country.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '24 weeks', 'description': "ACR70: American College of Rheumatology 70% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as CRP) and the physician and patient's own assessments of disease activity, pain and physical function. BID = twice daily, CRP = C-reactive protein, DMARD = Disease-modifying anti-rheumatic drug, PO = orally, QD = once a day.", 'unitOfMeasure': 'Percentage of responders', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.'}, {'type': 'SECONDARY', 'title': 'ACRn - Comparison Between Fostamatinib and Placebo at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '308', 'groupId': 'OG000'}, {'value': '298', 'groupId': 'OG001'}, {'value': '302', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'FOSTA 100 MG BID PO', 'description': 'Dosing Group A'}, {'id': 'OG001', 'title': 'FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO', 'description': 'Dosing Group B'}, {'id': 'OG002', 'title': 'PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO', 'description': 'Dosing Group C'}], 'classes': [{'categories': [{'measurements': [{'value': '20.75', 'spread': '31.203', 'groupId': 'OG000'}, {'value': '18.31', 'spread': '28.427', 'groupId': 'OG001'}, {'value': '9.84', 'spread': '23.219', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'Nominal p-value presented for treatment comparison. Outcome was not formally tested within the predefined multiplicity procedure. As this is a non-parametric test, p-values alone are presented rather than an estimated treatment difference.', 'groupDescription': 'Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.', 'statisticalMethod': 'Van Elteren', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-values are estimated using the Van Elteren test stratified by background use of DMARD and pooled country.', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'pValueComment': 'Nominal p-value presented for treatment comparison. Outcome was not formally tested within the predefined multiplicity procedure. As this is a non-parametric test, p-values alone are presented rather than an estimated treatment difference.', 'groupDescription': 'Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.', 'statisticalMethod': 'Van Elteren', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-values are estimated using the Van Elteren test stratified by background use of DMARD and pooled country.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 24 weeks', 'description': "ACRn: American College of Rheumatology index of RA improvement, based on smallest percentage improvement in the count of swollen joints (out of 28 joints), count of tender joints (out of 28 joints), or in blood test measures of inflammation (such as CRP) or the physician or patient's own assessments of disease activity, pain and physical function. Scores are reported as a percentage improvement on a scale of -100 to +100, with larger values representing a better clinical outcome. BID = twice daily, CI = confidence interval, CRP = C-reactive protein, DMARD = Disease-modifying anti-rheumatic drug, PO = orally, QD = once a day. Mean refers to change at Week 24.", 'unitOfMeasure': 'Percentage improvement from baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.'}, {'type': 'SECONDARY', 'title': 'Proportion of Patients Achieving DAS28-CRP <2.6 at Week 12, Comparison Between Fostamatinib and Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '308', 'groupId': 'OG000'}, {'value': '298', 'groupId': 'OG001'}, {'value': '302', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'FOSTA 100 MG BID PO', 'description': 'Dosing Group A'}, {'id': 'OG001', 'title': 'FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO', 'description': 'Dosing Group B'}, {'id': 'OG002', 'title': 'PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO', 'description': 'Dosing Group C'}], 'classes': [{'categories': [{'measurements': [{'value': '17.2', 'groupId': 'OG000'}, {'value': '10.7', 'groupId': 'OG001'}, {'value': '3.0', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.1', 'ciLowerLimit': '3.42', 'ciUpperLimit': '14.80', 'estimateComment': 'An odds ratio \\>1 indicates a benefit towards fostamatinib.', 'groupDescription': 'Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Odds ratio and 95% confidence intervals calculated using Logistic Regression with treatment, background use of DMARD and pooled country as factors.', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.0', 'ciLowerLimit': '1.88', 'ciUpperLimit': '8.65', 'estimateComment': 'An odds ratio \\>1 indicates a benefit towards fostamatinib.', 'groupDescription': 'Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Odds ratio and 95% confidence intervals calculated using Logistic Regression with treatment, background use of DMARD and pooled country as factors.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks', 'description': "DAS28-CRP: Disease Activity Score based on a count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (CRP) and the patient's own assessment. Scores can take any positive value with a lower value indicating a better clinical condition. A DAS28-CRP score of \\<2.6 is indicative of remission of RA symptoms. BID = twice daily, CRP = C-reactive protein, DMARD = Disease-modifying anti-rheumatic drug, OR = odds ratio, PO = orally, QD = once a day.", 'unitOfMeasure': 'Percentage of responders', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.'}, {'type': 'SECONDARY', 'title': 'Proportion of Patients Achieving DAS28-CRP <2.6 at Week 24, Comparison Between Fostamatinib and Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '308', 'groupId': 'OG000'}, {'value': '298', 'groupId': 'OG001'}, {'value': '302', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'FOSTA 100 MG BID PO', 'description': 'Dosing Group A'}, {'id': 'OG001', 'title': 'FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO', 'description': 'Dosing Group B'}, {'id': 'OG002', 'title': 'PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO', 'description': 'Dosing Group C'}], 'classes': [{'categories': [{'measurements': [{'value': '41.3', 'groupId': 'OG000'}, {'value': '12.8', 'groupId': 'OG001'}, {'value': '2.3', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.3', 'ciLowerLimit': '3.23', 'ciUpperLimit': '16.65', 'estimateComment': 'An odds ratio \\>1 indicates a benefit towards fostamatinib.', 'groupDescription': 'Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Odds ratio and 95% confidence intervals calculated using Logistic Regression with treatment, background use of DMARD and pooled country as factors.', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.4', 'ciLowerLimit': '2.81', 'ciUpperLimit': '14.71', 'estimateComment': 'An odds ratio \\>1 indicates a benefit towards fostamatinib.', 'groupDescription': 'Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Odds ratio and 95% confidence intervals calculated using Logistic Regression with treatment, background use of DMARD and pooled country as factors.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '24 weeks', 'description': "DAS28-CRP: Disease Activity Score based on a count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (CRP) and the patient's own assessment. Scores can take any positive value with a lower value indicating a better clinical condition. A DAS28-CRP score of \\<2.6 is indicative of remission of RA symptoms. BID = twice daily, CRP = C-reactive protein, DMARD = Disease-modifying anti-rheumatic drug, OR=odds ratio, PO = orally, QD=once a day.", 'unitOfMeasure': 'Percentage of responders', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.'}, {'type': 'SECONDARY', 'title': 'Proportion of Patients Achieving DAS28 EULAR Response at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '308', 'groupId': 'OG000'}, {'value': '298', 'groupId': 'OG001'}, {'value': '302', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'FOSTA 100 MG BID PO', 'description': 'Dosing Group A'}, {'id': 'OG001', 'title': 'FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO', 'description': 'Dosing Group B'}, {'id': 'OG002', 'title': 'PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO', 'description': 'Dosing Group C'}], 'classes': [{'title': 'No response', 'categories': [{'measurements': [{'value': '42.9', 'spread': '1.46', 'groupId': 'OG000', 'lowerLimit': '0.20', 'upperLimit': '0.68'}, {'value': '45.3', 'spread': '1.34', 'groupId': 'OG001', 'lowerLimit': '0.26', 'upperLimit': '0.89'}, {'value': '64.6', 'spread': '1.30', 'groupId': 'OG002', 'lowerLimit': '0.20', 'upperLimit': '0.65'}]}]}, {'title': 'Moderate response', 'categories': [{'measurements': [{'value': '33.8', 'groupId': 'OG000'}, {'value': '34.9', 'groupId': 'OG001'}, {'value': '29.1', 'groupId': 'OG002'}]}]}, {'title': 'Good response', 'categories': [{'measurements': [{'value': '23.4', 'groupId': 'OG000'}, {'value': '19.8', 'groupId': 'OG001'}, {'value': '6.3', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.84', 'ciLowerLimit': '2.06', 'ciUpperLimit': '3.91', 'pValueComment': 'Nominal p-value presented for treatment comparison. Outcome was not formally tested within the predefined multiplicity procedure.', 'estimateComment': 'An odds ratio \\> 1 indicates a benefit towards fostamatinib.', 'groupDescription': 'Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.', 'statisticalMethod': 'Proportional odds model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'No Response, moderate response and good response are included in the model, with treatment, background use of DMARD and pooled country as factors.', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.44', 'ciLowerLimit': '1.77', 'ciUpperLimit': '3.37', 'pValueComment': 'Nominal p-value presented for treatment comparison. Outcome was not formally tested within the predefined multiplicity procedure.', 'estimateComment': 'An odds ratio \\> 1 indicates a benefit towards fostamatinib.', 'groupDescription': 'Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.', 'statisticalMethod': 'Proportional odds model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'No Response, moderate response and good response are included in the model, with treatment, background use of DMARD and pooled country as factors.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '24 weeks', 'description': 'Change in DAS28 was derived for each post baseline scheduled assessment and categorised using the European League Against Rheumatism (EULAR) response criteria. BID = twice daily, DAS28 = Disease Activity Score based on a 28-joint count, DMARD = disease-modifying anti-rheumatic drug, OR=odds ratio, PO = orally, QD = once a day.', 'unitOfMeasure': 'Percentage of responders', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.'}, {'type': 'SECONDARY', 'title': 'HAQ-DI Response - Comparison of the Change(>=0.22) From Baseline Between Fostamatinib and Placebo at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '308', 'groupId': 'OG000'}, {'value': '298', 'groupId': 'OG001'}, {'value': '302', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'FOSTA 100 MG BID PO', 'description': 'Dosing Group A'}, {'id': 'OG001', 'title': 'FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO', 'description': 'Dosing Group B'}, {'id': 'OG002', 'title': 'PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO', 'description': 'Dosing Group C'}], 'classes': [{'categories': [{'measurements': [{'value': '46.1', 'groupId': 'OG000'}, {'value': '42.3', 'groupId': 'OG001'}, {'value': '26.5', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.4', 'ciLowerLimit': '1.73', 'ciUpperLimit': '3.46', 'estimateComment': 'An odds ratio \\>1 indicates a benefit towards fostamatinib.', 'groupDescription': 'Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Odds ratio and 95% confidence intervals calculated using Logistic Regression with treatment, background use of DMARD and pooled country as factors.', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.1', 'ciLowerLimit': '1.46', 'ciUpperLimit': '2.94', 'estimateComment': 'An odds ratio \\>1 indicates a benefit towards fostamatinib.', 'groupDescription': 'Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Odds ratio and 95% confidence intervals calculated using Logistic Regression with treatment, background use of DMARD and pooled country as factors.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and 24 weeks', 'description': 'HAQ-DI: Health Assessment Questionnaire - Disability Index, a measure of physical function. The HAQ-DI score is then calculated by summing the category scores from 8 sub-categories (ie, scores for patient ability in dressing and grooming, rising, eating, walking, hygiene, reach, grip and common daily activities) and dividing by the number of categories completed. The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability. The HAQ-DI response is a reduction from baseline in HAQ-DI score greater than or equal to the minimally important difference (0.22). BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, OR = odds ratio, PO = orally, QD = once a day.', 'unitOfMeasure': 'Percentage of responders', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 24 in mTSS, Comparison Between Fostamatinib and Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '308', 'groupId': 'OG000'}, {'value': '298', 'groupId': 'OG001'}, {'value': '302', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'FOSTA 100 MG BID PO', 'description': 'Dosing Group A'}, {'id': 'OG001', 'title': 'FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO', 'description': 'Dosing Group B'}, {'id': 'OG002', 'title': 'PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO', 'description': 'Dosing Group C'}], 'classes': [{'categories': [{'measurements': [{'value': '0.64', 'spread': '3.130', 'groupId': 'OG000'}, {'value': '0.37', 'spread': '3.095', 'groupId': 'OG001'}, {'value': '1.16', 'spread': '5.849', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.904', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'As this is a non-parametric test, p-values alone are presented rather than an estimated treatment difference.', 'groupDescription': 'This analysis is performed using an ANCOVA model on the ranks of the change from baseline, by pooled country and background use of DMARD, including a term for the ranks of the baseline score as a covariate.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Residuals from ANCOVA are analysed using a Cochran-Mantel-Haenszel approach, adjusting for the effects of pooled country and background use of DMARD.', 'testedNonInferiority': False}, {'pValue': '0.342', 'groupIds': ['OG001', 'OG002'], 'pValueComment': 'As this is a non-parametric test, p-values alone are presented rather than an estimated treatment difference.', 'groupDescription': 'This analysis is performed using an ANCOVA model on the ranks of the change from baseline, by pooled country and background use of DMARD, including a term for the ranks of the baseline score as a covariate.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Residuals from ANCOVA are analysed using a Cochran-Mantel-Haenszel approach, adjusting for the effects of pooled country and background use of DMARD.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 24 weeks', 'description': 'mTSS: modified total sharp score, a measure of structural progression based upon X-rays. Hand and foot joints are scored for erosions and joint space narrowing and the results summed to give a value between 0 and 448. A higher value represents more serious progression of the disease. After disregarding ineligible records, patients with 2 or more non-missing values have had missing data imputed via linear extrapolation/interpolation methods. Patients with only 1 result were excluded from the analysis. ANCOVA = analysis of covariance, BID = twice daily, IP = investigational product, QD = once a day.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set includes patients who received at least 1 dose of IP. Patients were analysed by randomised treatment in accordance with the intention to treat principle. Measurements at 2 timepoints are required for a patient to be included in the analysis; therefore patients with only 1 result have been excluded from the analysis population.'}, {'type': 'SECONDARY', 'title': 'SF-36 - Comparison of the Change in PCS From Baseline Between Fostamatinib and Placebo at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '308', 'groupId': 'OG000'}, {'value': '298', 'groupId': 'OG001'}, {'value': '302', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'FOSTA 100 MG BID PO', 'description': 'Dosing Group A'}, {'id': 'OG001', 'title': 'FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO', 'description': 'Dosing Group B'}, {'id': 'OG002', 'title': 'PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO', 'description': 'Dosing Group C'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'spread': '7.2', 'groupId': 'OG000'}, {'value': '4', 'spread': '6.6', 'groupId': 'OG001'}, {'value': '2', 'spread': '5.7', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Treatment difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.47', 'ciLowerLimit': '1.47', 'ciUpperLimit': '3.48', 'pValueComment': 'Nominal p-value presented for treatment comparison. Outcome was not formally tested within the predefined multiplicity procedure.', 'groupDescription': 'Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Including terms for baseline as continuous covariate and treatment, background use of DMARD and pooled country as factors.', 'testedNonInferiority': False}, {'pValue': '0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Treatment difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.64', 'ciLowerLimit': '0.63', 'ciUpperLimit': '2.65', 'pValueComment': 'Nominal p-value presented for treatment comparison. Outcome was not formally tested within the predefined multiplicity procedure.', 'groupDescription': 'Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Including terms for baseline as continuous covariate and treatment, background use of DMARD and pooled country as factors.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 24 weeks', 'description': 'SF-36: 36-item Short Form Health Survey, a measure of health related quality of life. Scores for 8 sub-domains (Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Function, Role-Emotional and Mental Health) are derived and normalised to a scale of 0-100. Physical and mental component scores (PCS and MCS) are derived by multiplying each of these 8 scores by a constant, summing them and standardising against a population with mean of 50+/- 10. Higher scores represent a better quality of life. Mean changes from baseline score are presented as increases from baseline (defined as post-baseline minus baseline); larger changes indicate a better clinical condition. ANCOVA = analysis of covariance, BID = twice daily, DMARD = disease modifying antirheumatic drugs, PO = orally, QD = once a day.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.'}, {'type': 'SECONDARY', 'title': 'SF-36 - Comparison of the Change in MCS From Baseline Between Fostamatinib and Placebo at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '308', 'groupId': 'OG000'}, {'value': '298', 'groupId': 'OG001'}, {'value': '302', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'FOSTA 100 MG BID PO', 'description': 'Dosing Group A'}, {'id': 'OG001', 'title': 'FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO', 'description': 'Dosing Group B'}, {'id': 'OG002', 'title': 'PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO', 'description': 'Dosing Group C'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'spread': '7.5', 'groupId': 'OG000'}, {'value': '3', 'spread': '8.4', 'groupId': 'OG001'}, {'value': '1', 'spread': '6.3', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Treatment difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.09', 'ciLowerLimit': '0.97', 'ciUpperLimit': '3.20', 'pValueComment': 'Nominal p-value presented for treatment comparison. Outcome was not formally tested within the predefined multiplicity procedure.', 'groupDescription': 'Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Including terms for baseline as continuous covariate and treatment, background use of DMARD and pooled country as factors.', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Treatment difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.96', 'ciLowerLimit': '0.83', 'ciUpperLimit': '3.08', 'pValueComment': 'Nominal p-value presented for treatment comparison. Outcome was not formally tested within the predefined multiplicity procedure.', 'groupDescription': 'Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Including terms for baseline as continuous covariate and treatment, background use of DMARD and pooled country as factors.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 24 weeks', 'description': 'SF-36: 36-item Short Form Health Survey, a measure of health related quality of life. Scores for 8 sub-domains (Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Function, Role-Emotional and Mental Health) are derived and normalised to a scale of 0-100. Physical and mental component scores (PCS and MCS) are derived by multiplying each of these 8 scores by a constant, summing them and standardising against a population with mean of 50+/- 10. Higher scores represent a better quality of life. Mean changes from baseline score are presented as increases from baseline (defined as post-baseline minus baseline); larger changes indicate a better clinical condition. ANCOVA = analysis of covariance, BID = twice daily, DMARD = disease modifying antirheumatic drugs, PO = orally, QD = once a day.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'FOSTA 100 MG BID PO', 'description': 'Dosing Group A'}, {'id': 'FG001', 'title': 'FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO', 'description': 'Dosing Group B'}, {'id': 'FG002', 'title': 'PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO', 'description': 'Dosing Group C'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Patients who received treatment', 'groupId': 'FG000', 'numSubjects': '308'}, {'comment': 'Patients who received treatment', 'groupId': 'FG001', 'numSubjects': '298'}, {'comment': 'Patients who received treatment', 'groupId': 'FG002', 'numSubjects': '302'}]}, {'type': 'Randomised But Did Not Receive Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'Adverse event / Other', 'groupId': 'FG001', 'numSubjects': '2'}, {'comment': 'Eligibility criteria not fulfilled / Severe non-compliance to protocol', 'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Number of patients who completed treatment includes patients who had a dose reduction.', 'groupId': 'FG000', 'numSubjects': '174'}, {'comment': 'Number of patients who completed treatment includes patients who had a dose reduction.', 'groupId': 'FG001', 'numSubjects': '168'}, {'comment': 'Number of patients who completed treatment includes patients who had a dose reduction.', 'groupId': 'FG002', 'numSubjects': '129'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '134'}, {'groupId': 'FG001', 'numSubjects': '130'}, {'groupId': 'FG002', 'numSubjects': '173'}]}], 'dropWithdraws': [{'type': 'Not reported', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '16'}]}, {'type': 'Enrolment in long term extension', 'reasons': [{'groupId': 'FG000', 'numSubjects': '57'}, {'groupId': 'FG001', 'numSubjects': '66'}, {'groupId': 'FG002', 'numSubjects': '119'}]}, {'type': 'Severe non-compliance to protocol', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Lack of therapeutic response', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '9'}]}, {'type': 'Dev. of study specific discont. criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '36'}, {'groupId': 'FG002', 'numSubjects': '24'}]}]}], 'recruitmentDetails': 'A total of 1632 patients were enrolled: 308, 300 \\& 305 were randomised to Groups A, B \\& C, respectively (308, 298 \\& 302 received at least 1 dose of investigational product).', 'preAssignmentDetails': 'A total of 719 patients failed screening.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '308', 'groupId': 'BG000'}, {'value': '298', 'groupId': 'BG001'}, {'value': '302', 'groupId': 'BG002'}, {'value': '908', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'FOSTA 100 MG BID PO', 'description': 'Dosing Group A'}, {'id': 'BG001', 'title': 'FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO', 'description': 'Dosing Group B'}, {'id': 'BG002', 'title': 'PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO', 'description': 'Dosing Group C'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53', 'spread': '12.3', 'groupId': 'BG000'}, {'value': '54', 'spread': '11.6', 'groupId': 'BG001'}, {'value': '53', 'spread': '11.8', 'groupId': 'BG002'}, {'value': '53', 'spread': '11.9', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '245', 'groupId': 'BG000'}, {'value': '245', 'groupId': 'BG001'}, {'value': '252', 'groupId': 'BG002'}, {'value': '742', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '166', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '254', 'groupId': 'BG000'}, {'value': '235', 'groupId': 'BG001'}, {'value': '241', 'groupId': 'BG002'}, {'value': '730', 'groupId': 'BG003'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '49', 'groupId': 'BG003'}]}]}, {'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}, {'title': 'Indian or Pakistani', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '84', 'groupId': 'BG003'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 913}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-03-13', 'studyFirstSubmitDate': '2010-09-08', 'resultsFirstSubmitDate': '2013-11-22', 'studyFirstSubmitQcDate': '2010-09-08', 'lastUpdatePostDateStruct': {'date': '2014-04-17', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-03-13', 'studyFirstPostDateStruct': {'date': '2010-09-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-04-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Patients With ACR20 at Week 24, Comparison Between Fostamatinib and Placebo', 'timeFrame': '24 weeks', 'description': "ACR20: American College of Rheumatology 20% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as CRP) and the physician and patient's own assessments of disease activity, pain and physical function. BID = twice daily, CRP = C-reactive protein, DMARD = disease-modifying anti-rheumatic drug, PO = orally, QD = once a day."}], 'secondaryOutcomes': [{'measure': 'Proportion of Patients Achieving ACR20, Comparison Between Fostamatinib and Placebo at Week 1', 'timeFrame': '1 week', 'description': "ACR20: American College of Rheumatology 20% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as CRP) and the physician and patient's own assessments of disease activity, pain and physical function. BID = twice daily, CRP = C-reactive protein, DMARD = Disease-modifying anti-rheumatic drug, PO = orally, QD = once a day."}, {'measure': 'Proportion of Patients Achieving ACR50, Comparison Between Fostamatinib and Placebo at Week 24', 'timeFrame': '24 weeks', 'description': "ACR50: American College of Rheumatology 50% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as CRP) and the physician and patient's own assessments of disease activity, pain and physical function. BID = twice daily, CRP = C-reactive protein, DMARD = Disease-modifying anti-rheumatic drug, PO = orally, QD = once a day."}, {'measure': 'Proportion of Patients Achieving ACR70, Comparison Between Fostamatinib and Placebo at Week 24', 'timeFrame': '24 weeks', 'description': "ACR70: American College of Rheumatology 70% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as CRP) and the physician and patient's own assessments of disease activity, pain and physical function. BID = twice daily, CRP = C-reactive protein, DMARD = Disease-modifying anti-rheumatic drug, PO = orally, QD = once a day."}, {'measure': 'ACRn - Comparison Between Fostamatinib and Placebo at Week 24', 'timeFrame': 'Baseline and 24 weeks', 'description': "ACRn: American College of Rheumatology index of RA improvement, based on smallest percentage improvement in the count of swollen joints (out of 28 joints), count of tender joints (out of 28 joints), or in blood test measures of inflammation (such as CRP) or the physician or patient's own assessments of disease activity, pain and physical function. Scores are reported as a percentage improvement on a scale of -100 to +100, with larger values representing a better clinical outcome. BID = twice daily, CI = confidence interval, CRP = C-reactive protein, DMARD = Disease-modifying anti-rheumatic drug, PO = orally, QD = once a day. Mean refers to change at Week 24."}, {'measure': 'Proportion of Patients Achieving DAS28-CRP <2.6 at Week 12, Comparison Between Fostamatinib and Placebo', 'timeFrame': '12 weeks', 'description': "DAS28-CRP: Disease Activity Score based on a count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (CRP) and the patient's own assessment. Scores can take any positive value with a lower value indicating a better clinical condition. A DAS28-CRP score of \\<2.6 is indicative of remission of RA symptoms. BID = twice daily, CRP = C-reactive protein, DMARD = Disease-modifying anti-rheumatic drug, OR = odds ratio, PO = orally, QD = once a day."}, {'measure': 'Proportion of Patients Achieving DAS28-CRP <2.6 at Week 24, Comparison Between Fostamatinib and Placebo', 'timeFrame': '24 weeks', 'description': "DAS28-CRP: Disease Activity Score based on a count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (CRP) and the patient's own assessment. Scores can take any positive value with a lower value indicating a better clinical condition. A DAS28-CRP score of \\<2.6 is indicative of remission of RA symptoms. BID = twice daily, CRP = C-reactive protein, DMARD = Disease-modifying anti-rheumatic drug, OR=odds ratio, PO = orally, QD=once a day."}, {'measure': 'Proportion of Patients Achieving DAS28 EULAR Response at Week 24', 'timeFrame': '24 weeks', 'description': 'Change in DAS28 was derived for each post baseline scheduled assessment and categorised using the European League Against Rheumatism (EULAR) response criteria. BID = twice daily, DAS28 = Disease Activity Score based on a 28-joint count, DMARD = disease-modifying anti-rheumatic drug, OR=odds ratio, PO = orally, QD = once a day.'}, {'measure': 'HAQ-DI Response - Comparison of the Change(>=0.22) From Baseline Between Fostamatinib and Placebo at Week 24', 'timeFrame': 'Baseline and 24 weeks', 'description': 'HAQ-DI: Health Assessment Questionnaire - Disability Index, a measure of physical function. The HAQ-DI score is then calculated by summing the category scores from 8 sub-categories (ie, scores for patient ability in dressing and grooming, rising, eating, walking, hygiene, reach, grip and common daily activities) and dividing by the number of categories completed. The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability. The HAQ-DI response is a reduction from baseline in HAQ-DI score greater than or equal to the minimally important difference (0.22). BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, OR = odds ratio, PO = orally, QD = once a day.'}, {'measure': 'Change From Baseline to Week 24 in mTSS, Comparison Between Fostamatinib and Placebo', 'timeFrame': 'Baseline and 24 weeks', 'description': 'mTSS: modified total sharp score, a measure of structural progression based upon X-rays. Hand and foot joints are scored for erosions and joint space narrowing and the results summed to give a value between 0 and 448. A higher value represents more serious progression of the disease. After disregarding ineligible records, patients with 2 or more non-missing values have had missing data imputed via linear extrapolation/interpolation methods. Patients with only 1 result were excluded from the analysis. ANCOVA = analysis of covariance, BID = twice daily, IP = investigational product, QD = once a day.'}, {'measure': 'SF-36 - Comparison of the Change in PCS From Baseline Between Fostamatinib and Placebo at Week 24', 'timeFrame': 'Baseline and 24 weeks', 'description': 'SF-36: 36-item Short Form Health Survey, a measure of health related quality of life. Scores for 8 sub-domains (Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Function, Role-Emotional and Mental Health) are derived and normalised to a scale of 0-100. Physical and mental component scores (PCS and MCS) are derived by multiplying each of these 8 scores by a constant, summing them and standardising against a population with mean of 50+/- 10. Higher scores represent a better quality of life. Mean changes from baseline score are presented as increases from baseline (defined as post-baseline minus baseline); larger changes indicate a better clinical condition. ANCOVA = analysis of covariance, BID = twice daily, DMARD = disease modifying antirheumatic drugs, PO = orally, QD = once a day.'}, {'measure': 'SF-36 - Comparison of the Change in MCS From Baseline Between Fostamatinib and Placebo at Week 24', 'timeFrame': 'Baseline and 24 weeks', 'description': 'SF-36: 36-item Short Form Health Survey, a measure of health related quality of life. Scores for 8 sub-domains (Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Function, Role-Emotional and Mental Health) are derived and normalised to a scale of 0-100. Physical and mental component scores (PCS and MCS) are derived by multiplying each of these 8 scores by a constant, summing them and standardising against a population with mean of 50+/- 10. Higher scores represent a better quality of life. Mean changes from baseline score are presented as increases from baseline (defined as post-baseline minus baseline); larger changes indicate a better clinical condition. ANCOVA = analysis of covariance, BID = twice daily, DMARD = disease modifying antirheumatic drugs, PO = orally, QD = once a day.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Rheumatoid Arthritis'], 'conditions': ['Rheumatoid Arthritis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=421&filename=CSR-D8480C00039.pdf', 'label': 'Related Info'}, {'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=1202&filename=CSR-D1700C00004.pdf', 'label': 'Related Info'}, {'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=2264&filename=CSR-1939IL-0551.pdf', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate the effectiveness of two dosing regimens of fostamatinib compared to placebo, in patients with rheumatoid arthritis (RA) who are taking disease modifying anti-rheumatic drug (DMARD) but not responding. The study will last for 1 year.', 'detailedDescription': 'Sub-study:\n\nFull title: Optional Genetic Research\n\nDate: 18 June 2010\n\nVersion: 1\n\nObjectives: To collect and store, with appropriate consent ,DNA samples for future exploratory research into genes/genetic variation that may influence response (ie, absorption, distribution, metabolism and excretion, safety, tolerability and efficacy) to fostamatinib disodium and/or methotrexate; and/or susceptibility to, progression of and prognosis of RA'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Active rheumatoid arthritis (RA) diagnosed after the age of 16\n* Treatment with one the following disease modifying anti-rheumatic drug: methotrexate, sulfasalazine, hydroxychloroquine or chloroquine\n* 4 or more swollen joints and 4 or more tender/painful joints (from 28 joint count)and either Erythrocyte Sedimentation Rate (ESR) blood result of 28mm/h or more, or C-Reactive Protein (CRP) blood result of 10mg/L or more\n* At least one of the following: documented history of positive rheumatoid factor (blood test), current presence of rheumatoid factor (blood test), radiographic erosion within 12 months prior to study enrolment, presence of serum anti-cyclic citrullinated peptide antibodies (blood test)\n\nExclusion Criteria:\n\n* Females who are pregnant or breast feeding\n* Poorly controlled hypertension\n* Liver disease or significant liver function test abnormalities\n* Certain inflammatory conditions (other than rheumatoid arthritis), connective tissue diseases or chronic pain disorders\n* Recent or significant cardiovascular disease\n* Significant active or recent infection including tuberculosis\n* Previous failure to respond to a TNF alpha antagonist, anakinra or previous treatment with other biological agent\n* Severe renal impairment\n* Neutropenia'}, 'identificationModule': {'nctId': 'NCT01197534', 'acronym': 'OSKIRA - 2', 'briefTitle': 'Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Disease Modifying Anti-rheumatic Drug (DMARD) But Not Responding.', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': '(OSKIRA-2): A Phase III, Multi-centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients With an Inadequate Response to DMARDs', 'orgStudyIdInfo': {'id': 'D4300C00002'}, 'secondaryIdInfos': [{'id': '2010-020744-35', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dosing Regimen A', 'description': 'Oral Treatment', 'interventionNames': ['Drug: fostamatinib']}, {'type': 'EXPERIMENTAL', 'label': 'Dosing Regimen B', 'description': 'Oral Treatment', 'interventionNames': ['Drug: fostamatinib']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Dosing Regimen C', 'description': 'Oral Treatment', 'interventionNames': ['Drug: placebo, fostamatinib']}], 'interventions': [{'name': 'fostamatinib', 'type': 'DRUG', 'description': 'fostamatinib 100 mg twice daily', 'armGroupLabels': ['Dosing Regimen A']}, {'name': 'fostamatinib', 'type': 'DRUG', 'description': 'fostamatinib 100 mg twice daily/ 150 mg once daily', 'armGroupLabels': ['Dosing Regimen B']}, {'name': 'placebo, fostamatinib', 'type': 'DRUG', 'description': 'Placebo for 24 weeks followed by fostamatinib 100 mg twice daily.', 'armGroupLabels': ['Dosing Regimen C']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'city': 'Glendale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.53865, 'lon': -112.18599}}, {'city': 'Mesa', 'state': 'Arizona', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.42227, 'lon': -111.82264}}, {'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'city': 'Hot Springs', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.5037, 'lon': -93.05518}}, {'city': 'Huntington Beach', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.6603, 'lon': -117.99923}}, {'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 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'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'city': 'Venice', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 27.09978, 'lon': -82.45426}}, {'city': 'Zephyrhills', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 28.23362, 'lon': -82.18119}}, {'city': 'Canton', 'state': 'Georgia', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.23676, 'lon': -84.49076}}, {'city': 'Decatur', 'state': 'Georgia', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.77483, 'lon': -84.29631}}, {'city': 'Macon', 'state': 'Georgia', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 32.84069, 'lon': -83.6324}}, {'city': 'Boise', 'state': 'Idaho', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 43.6135, 'lon': -116.20345}}, {'city': 'South Bend', 'state': 'Indiana', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 41.68338, 'lon': -86.25001}}, {'city': 'Elizabethtown', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 37.69395, 'lon': -85.85913}}, {'city': 'Crofton', 'state': 'Maryland', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.00178, 'lon': -76.68747}}, {'city': 'Cumberland', 'state': 'Maryland', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.65287, 'lon': -78.76252}}, {'city': 'Hagerstown', 'state': 'Maryland', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.64176, 'lon': -77.71999}}, {'city': 'Kalamazoo', 'state': 'Michigan', 'country': 'United States', 'facility': 'Research Site', 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'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}, {'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'city': 'Roslyn', 'state': 'New York', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 40.79982, 'lon': -73.65096}}, {'city': 'Syracuse', 'state': 'New York', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 43.04812, 'lon': -76.14742}}, {'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'city': 'Dayton', 'state': 'Ohio', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.75895, 'lon': 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'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 35.222, 'lon': -101.8313}}, {'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'city': 'Lubbock', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.57786, 'lon': -101.85517}}, {'city': 'Mesquite', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 32.7668, 'lon': -96.59916}}, {'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'city': 'Chesapeake', 'state': 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