Ignite Creation Date:
2025-12-25 @ 12:28 AM
Ignite Modification Date:
2026-01-01 @ 9:56 AM
Study NCT ID:
NCT00805467
Status:
TERMINATED
Last Update Posted:
2014-06-25
First Post:
2008-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Open-Label, Multicenter Extension Study for Patients Completing Treatment Phase of a Rigel-Sponsored R935788 Studies
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': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': '100 MG BID', 'otherNumAtRisk': 381, 'otherNumAffected': 306, 'seriousNumAtRisk': 381, 'seriousNumAffected': 77}, {'id': 'EG001', 'title': '100 MG QD', 'otherNumAtRisk': 59, 'otherNumAffected': 49, 'seriousNumAtRisk': 59, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': '150 MG QD', 'otherNumAtRisk': 183, 'otherNumAffected': 141, 'seriousNumAtRisk': 183, 'seriousNumAffected': 34}, {'id': 'EG003', 'title': '50 MG BID', 'otherNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 381, 'numEvents': 28, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 183, 'numEvents': 17, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'NEUTROPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 381, 'numEvents': 34, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 183, 'numEvents': 13, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'CONJUNCTIVITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 381, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 183, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'ABDOMINAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 381, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 183, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 381, 'numEvents': 151, 'numAffected': 96}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 36, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 183, 'numEvents': 93, 'numAffected': 60}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'DYSPEPSIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 381, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 183, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'GASTRITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 381, 'numEvents': 15, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 183, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'HAEMORRHOIDS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 381, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 183, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 381, 'numEvents': 31, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 183, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'VOMITING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 381, 'numEvents': 27, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 9, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 183, 'numEvents': 11, 'numAffected': 10}, 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disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'BRONCHITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 381, 'numEvents': 38, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 183, 'numEvents': 20, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'INFLUENZA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 381, 'numEvents': 54, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 15, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 183, 'numEvents': 20, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'NASOPHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 381, 'numEvents': 31, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 183, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'PHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 381, 'numEvents': 19, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 183, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'SINUSITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 381, 'numEvents': 37, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 183, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'UPPER RESPIRATORY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 381, 'numEvents': 76, 'numAffected': 51}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 183, 'numEvents': 29, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'URINARY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 381, 'numEvents': 125, 'numAffected': 72}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 32, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 183, 'numEvents': 45, 'numAffected': 28}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'BLOOD PRESSURE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 381, 'numEvents': 35, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 183, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'NEUTROPHIL COUNT DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 381, 'numEvents': 10, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 183, 'numEvents': 5, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'TRANSAMINASES INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 381, 'numEvents': 45, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 183, 'numEvents': 16, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'HYPERLIPIDAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 381, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 183, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'HYPOKALAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 381, 'numEvents': 16, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 183, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'ARTHRALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 381, 'numEvents': 25, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 183, 'numEvents': 16, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'BACK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 381, 'numEvents': 35, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 183, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'BURSITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 381, 'numEvents': 20, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 183, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'OSTEOARTHRITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 381, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 183, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'RHEUMATOID ARTHRITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 381, 'numEvents': 69, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 183, 'numEvents': 16, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'TENDONITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 381, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 183, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 381, 'numEvents': 49, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 7, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 183, 'numEvents': 35, 'numAffected': 23}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'HYPERTONIC BLADDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 381, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 183, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'ASTHMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 381, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 183, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'COUGH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 381, 'numEvents': 18, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 183, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'RASH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 381, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 183, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'SKIN LESION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 381, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 183, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'HYPERTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 381, 'numEvents': 82, 'numAffected': 62}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 13, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 183, 'numEvents': 31, 'numAffected': 26}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}], 'seriousEvents': [{'term': 'ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 381, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 183, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'PANCYTOPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 381, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 183, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'THROMBOTIC THROMBOCYTOPENIC PURPURA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 381, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 183, 'numEvents': 1, 'numAffected': 1}, {'groupId': 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150 mg qd', 'description': 'Oral treatment'}, {'id': 'OG003', 'title': 'Fostamatinib 100 mg Bid', 'description': 'Oral treatment'}], 'classes': [{'title': 'Any AE', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '91.5', 'groupId': 'OG001'}, {'value': '90.7', 'groupId': 'OG002'}, {'value': '88.7', 'groupId': 'OG003'}]}]}, {'title': 'Any fatal AE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}, {'value': '3.8', 'groupId': 'OG002'}, {'value': '1.6', 'groupId': 'OG003'}]}]}, {'title': 'Any SAE (including fatal AEs)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '3.4', 'groupId': 'OG001'}, {'value': '18.6', 'groupId': 'OG002'}, {'value': '20.2', 'groupId': 'OG003'}]}]}, {'title': 'Any AE leading to termination of study therapy', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '22.0', 'groupId': 'OG001'}, {'value': '16.4', 'groupId': 'OG002'}, {'value': '15.2', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Entry in extension to end of study, up to a maximum of 5 years. (Variable by subject - median duration of 3 years)', 'description': 'AE = adverse event, bid = twice daily, IP = investigational product, qd = once daily, SAE = serious adverse event', 'unitOfMeasure': '% of patients', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set includes those patients who received at least 1 dose of investigational product, and were summarised according to treatment first received in this study (intention-to-treat principle).'}, {'type': 'SECONDARY', 'title': 'DAS28-CRP Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '181', 'groupId': 'OG002'}, {'value': '374', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Fostamatinib 50 mg Bid', 'description': 'Oral treatment'}, {'id': 'OG001', 'title': 'Fostamatinib 100 mg qd', 'description': 'Oral treatment'}, {'id': 'OG002', 'title': 'Fostamatinib 150 mg qd', 'description': 'Oral treatment'}, {'id': 'OG003', 'title': 'Fostamatinib 100 mg Bid', 'description': 'Oral treatment'}], 'classes': [{'title': 'Baseline (n=1, 55, 181, 374)', 'categories': [{'measurements': [{'value': '5.27', 'spread': 'NA', 'comment': 'Standard deviation cannot be defined for a single patient.', 'groupId': 'OG000'}, {'value': '5.34', 'spread': '1.123', 'groupId': 'OG001'}, {'value': '5.31', 'spread': '1.162', 'groupId': 'OG002'}, {'value': '5.36', 'spread': '1.259', 'groupId': 'OG003'}]}]}, {'title': 'Quarter 4 (n=1, 41, 136, 254)', 'categories': [{'measurements': [{'value': '2.00', 'spread': 'NA', 'comment': 'Standard deviation cannot be defined for a single patient.', 'groupId': 'OG000'}, {'value': '3.57', 'spread': '1.408', 'groupId': 'OG001'}, {'value': '3.46', 'spread': '1.282', 'groupId': 'OG002'}, {'value': '3.44', 'spread': '1.453', 'groupId': 'OG003'}]}]}, {'title': 'Quarter 8 (n=1, 33, 114, 201)', 'categories': [{'measurements': [{'value': '2.92', 'spread': 'NA', 'comment': 'Standard deviation cannot be defined for a single patient.', 'groupId': 'OG000'}, {'value': '3.43', 'spread': '1.412', 'groupId': 'OG001'}, {'value': '3.25', 'spread': '1.290', 'groupId': 'OG002'}, {'value': '3.35', 'spread': '1.484', 'groupId': 'OG003'}]}]}, {'title': 'Quarter 12 (n=1, 30, 94, 174)', 'categories': [{'measurements': [{'value': '2.31', 'spread': 'NA', 'comment': 'Standard deviation cannot be defined for a single patient.', 'groupId': 'OG000'}, {'value': '3.36', 'spread': '1.376', 'groupId': 'OG001'}, {'value': '3.07', 'spread': '1.055', 'groupId': 'OG002'}, {'value': '3.27', 'spread': '1.373', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 years', 'description': "The Disease Activity Score 28 using C-Reactive Protein (DAS28-CRP) is a measure of disease activity in rheumatoid arthritis (RA) and assesses the 28 joints RA commonly affects; the score includes the number of tender and swollen joints (out of 28), CRP level (a measure of inflammation in the blood), and the patient's global assessment of health (ranging from very good to very bad). These measures are then fed into a complex mathematical formula to produce the overall DAS on a scale from 1 to 10, where scores greater than 5.1 are considered to indicate active disease, scores less than 3.2 are considered to indicate with well controlled disease, and scores less than 2.6 are considered to indicate remission. bid = twice daily, CRP = C-reactive protein, DAS28 = Disease Activity Score based on a 28 joint count, n/a = not applicable, qd = once daily", 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants are those with baseline data. Baseline defined at entry into qualifying study or at entry into this study if more than 14 days since last dose in qualifying study. As no imputation was applied, the numbers at subsequent visits are lower.'}, {'type': 'SECONDARY', 'title': 'HAQ-DI Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '181', 'groupId': 'OG002'}, {'value': '376', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Fostamatinib 50 mg Bid', 'description': 'Oral treatment'}, {'id': 'OG001', 'title': 'Fostamatinib 100 mg qd', 'description': 'Oral treatment'}, {'id': 'OG002', 'title': 'Fostamatinib 150 mg qd', 'description': 'Oral treatment'}, {'id': 'OG003', 'title': 'Fostamatinib 100 mg Bid', 'description': 'Oral treatment'}], 'classes': [{'title': 'Baseline (n=1, 56, 181, 376)', 'categories': [{'measurements': [{'value': '1.25', 'spread': 'NA', 'comment': 'Standard deviation cannot be defined for a single patient', 'groupId': 'OG000'}, {'value': '1.50', 'spread': '0.735', 'groupId': 'OG001'}, {'value': '1.46', 'spread': '0.707', 'groupId': 'OG002'}, {'value': '1.46', 'spread': '0.715', 'groupId': 'OG003'}]}]}, {'title': 'Quarter 4 (n=1, 41, 138, 254)', 'categories': [{'measurements': [{'value': '0.57', 'spread': 'NA', 'comment': 'Standard deviation cannot be defined for a single patient', 'groupId': 'OG000'}, {'value': '1.00', 'spread': '0.677', 'groupId': 'OG001'}, {'value': '1.07', 'spread': '0.726', 'groupId': 'OG002'}, {'value': '0.99', 'spread': '0.722', 'groupId': 'OG003'}]}]}, {'title': 'Quarter 8 (n=1, 33, 107, 201)', 'categories': [{'measurements': [{'value': '0.43', 'spread': 'NA', 'comment': 'Standard deviation cannot be defined for a single patient', 'groupId': 'OG000'}, {'value': '1.00', 'spread': '0.657', 'groupId': 'OG001'}, {'value': '1.02', 'spread': '0.720', 'groupId': 'OG002'}, {'value': '0.95', 'spread': '0.703', 'groupId': 'OG003'}]}]}, {'title': 'Quarter 12 (n=1, 30, 94, 176)', 'categories': [{'measurements': [{'value': '0.38', 'spread': 'NA', 'comment': 'Standard deviation cannot be defined for a single patient', 'groupId': 'OG000'}, {'value': '1.01', 'spread': '0.651', 'groupId': 'OG001'}, {'value': '0.98', 'spread': '0.718', 'groupId': 'OG002'}, {'value': '0.96', 'spread': '0.687', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 years', 'description': 'Health Assessment Questionnaire - Disability Index, a measure of physical function. The HAQ-DI score is calculated by summing the category scores from 8 sub-categories (ie, scores for patient ability in dressing and grooming, rising, eating, walking, hygeine, 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. A HAQ-DI response is a reduction from baseline in HAQ-DI 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': 'Scores on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants are those with baseline data. Baseline defined at entry into qualifying study or at entry into this study if more than 14 days since last dose in qualifying study. As no imputation was applied, the numbers at subsequent visits are lower.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Fostamatinib 50 mg Bid', 'description': 'Oral treatment'}, {'id': 'FG001', 'title': 'Fostamatinib 100 mg qd', 'description': 'Oral treatment'}, {'id': 'FG002', 'title': 'Fostamatinib 150 mg qd', 'description': 'Oral treatment'}, {'id': 'FG003', 'title': 'Fostamatinib 100 mg Bid', 'description': 'Oral treatment'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Patients who received treatment', 'groupId': 'FG000', 'numSubjects': '1'}, {'comment': 'Patients who received treatment', 'groupId': 'FG001', 'numSubjects': '59'}, {'comment': 'Patients who received treatment', 'groupId': 'FG002', 'numSubjects': '183'}, {'comment': 'Patients who received treatment', 'groupId': 'FG003', 'numSubjects': '381'}]}, {'type': 'Enrolled But Did Not Receive Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Ongoing when study terminated', 'groupId': 'FG000', 'numSubjects': '1'}, {'comment': 'Ongoing when study terminated', 'groupId': 'FG001', 'numSubjects': '25'}, {'comment': 'Ongoing when study terminated', 'groupId': 'FG002', 'numSubjects': '80'}, {'comment': 'Ongoing when study terminated', 'groupId': 'FG003', 'numSubjects': '144'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '34'}, {'groupId': 'FG002', 'numSubjects': '103'}, {'groupId': 'FG003', 'numSubjects': '237'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '13'}, {'groupId': 'FG003', 'numSubjects': '86'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '21'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '45'}, {'groupId': 'FG003', 'numSubjects': '50'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '26'}, {'groupId': 'FG003', 'numSubjects': '57'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '6'}]}, {'type': 'Not reported', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '7'}]}]}], 'recruitmentDetails': 'A total of 624 patients were enrolled: 1, 59, 183 \\& 381 were allocated to the 50mg twice daily (bid), 100 mg once daily (qd), 150 mg qd and 100 mg bid groups, respectively. As this was a long-term extension study no specific end date was given. Patients who were ongoing when the study was terminated are shown as completers.', 'preAssignmentDetails': 'Treatments were assigned according to those given in the qualifying studies. All patients received investigational product.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '183', 'groupId': 'BG002'}, {'value': '381', 'groupId': 'BG003'}, {'value': '624', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Fostamatinib 50 mg Bid', 'description': 'Oral treatment'}, {'id': 'BG001', 'title': 'Fostamatinib 100 mg qd', 'description': 'Oral treatment'}, {'id': 'BG002', 'title': 'Fostamatinib 150 mg qd', 'description': 'Oral treatment'}, {'id': 'BG003', 'title': 'Fostamatinib 100 mg Bid', 'description': 'Oral treatment'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '70', 'spread': 'NA', 'comment': 'Standard deviation cannot be defined for a single patient.', 'groupId': 'BG000'}, {'value': '51.4', 'spread': '11.15', 'groupId': 'BG001'}, {'value': '51.7', 'spread': '13.32', 'groupId': 'BG002'}, {'value': '53.8', 'spread': '12.36', 'groupId': 'BG003'}, {'value': '53.0', 'spread': '12.58', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '157', 'groupId': 'BG002'}, {'value': '324', 'groupId': 'BG003'}, {'value': '535', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '57', 'groupId': 'BG003'}, {'value': '89', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}, {'value': '184', 'groupId': 'BG003'}, {'value': '290', 'groupId': 'BG004'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '22', 'groupId': 'BG004'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}, {'value': '179', 'groupId': 'BG003'}, {'value': '307', 'groupId': 'BG004'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 624}}, 'statusModule': {'whyStopped': 'AZ decision to discontinue fostamatinib development in RA; rights to fostamatinib returned to Rigel Pharmaceuticals.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-23', 'studyFirstSubmitDate': '2008-12-05', 'resultsFirstSubmitDate': '2014-01-22', 'studyFirstSubmitQcDate': '2008-12-05', 'lastUpdatePostDateStruct': {'date': '2014-06-25', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-05-23', 'studyFirstPostDateStruct': {'date': '2008-12-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-06-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Patients Who Had at Least 1 Treatment Emergent Adverse Event in Any Category', 'timeFrame': 'Entry in extension to end of study, up to a maximum of 5 years. (Variable by subject - median duration of 3 years)', 'description': 'AE = adverse event, bid = twice daily, IP = investigational product, qd = once daily, SAE = serious adverse event'}], 'secondaryOutcomes': [{'measure': 'DAS28-CRP Score', 'timeFrame': '3 years', 'description': "The Disease Activity Score 28 using C-Reactive Protein (DAS28-CRP) is a measure of disease activity in rheumatoid arthritis (RA) and assesses the 28 joints RA commonly affects; the score includes the number of tender and swollen joints (out of 28), CRP level (a measure of inflammation in the blood), and the patient's global assessment of health (ranging from very good to very bad). These measures are then fed into a complex mathematical formula to produce the overall DAS on a scale from 1 to 10, where scores greater than 5.1 are considered to indicate active disease, scores less than 3.2 are considered to indicate with well controlled disease, and scores less than 2.6 are considered to indicate remission. bid = twice daily, CRP = C-reactive protein, DAS28 = Disease Activity Score based on a 28 joint count, n/a = not applicable, qd = once daily"}, {'measure': 'HAQ-DI Score', 'timeFrame': '3 years', 'description': 'Health Assessment Questionnaire - Disability Index, a measure of physical function. The HAQ-DI score is calculated by summing the category scores from 8 sub-categories (ie, scores for patient ability in dressing and grooming, rising, eating, walking, hygeine, 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. A HAQ-DI response is a reduction from baseline in HAQ-DI 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.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['RA'], 'conditions': ['Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': 'The purpose of this new research study is to gain additional information about how safe and effective R935788 is over a longer period of time.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients must give written informed consent by signing an IRB/EC-approved Informed Consent Form (ICF) prior to admission to this study\n* Patients who are being treated in Study C-788-006X\n* Patients who completed Studies C-788-010 or C-788-011 and did not withdraw due to adverse events\n* Patients who withdrew from Study C-788-010 at Month 4 or Month 5 because of a pre-defined lack of efficacy\n* Females of childbearing potential must be fully informed of the potential for R788 to adversely affect the fetus and, if sexually active, must agree to use a well established method of birth control during the study (oral contraceptive, mechanical barrier, long acting hormonal agent). These patients must not be lactating and must have a negative pregnancy test at the time of entry and at each laboratory determination.\n\nExclusion Criteria:\n\n* The patient has a history of, or a concurrent, clinically significant illness, medical condition (other than arthritis) or laboratory abnormality that, in the Investigator's opinion, could affect the conduct of the study. Specifically, excluded are patients with the following:\n\n 1. unresolved Grade 2 or greater toxicity in a RA protocol studying R788\n 2. uncontrolled or poorly controlled hypertension;\n 3. recent (within past 2 months) serious surgery or infectious disease;\n 4. recent history (since enrollment in prior R788 study) of, or treatment for, a malignancy other than non-melanomatous skin cancer, or any history of lymphoma;\n 5. known to be positive for Hepatitis B, Hepatitis C, HIV or Tuberculosis;\n 6. interstitial pneumonitis or active pulmonary infection;\n 7. known laboratory abnormalities: ALT \\> 1.2 x ULN, creatinine \\>1.5x ULN, an ANC \\<2,500/mm3 or 2.5 x 109/L, lymphocyte count \\< 600/mm3 or 0.6 x 109L, Hgb \\< 9 g/dL or 5 mmol/L, platelet count \\<125,000/mm3 or 125 x 109/L are excluded.\n* The patient has a history of substance abuse, drug addiction or alcoholism. Patients may consume up to 4 units of alcohol per week; however, alcohol should be avoided in the 72 hours prior to lab assessments. Patients who cannot reliably comply with this should be excluded. A unit of alcohol is defined as the following: Beer = 12 oz or 355 mL; wine = 5 oz or 148 mL; sweet dessert wine = 3 oz or 89 mL; 80 proof distilled spirits = 1.5 oz or 44 mL.\n* The patient is unable to report for clinical and laboratory monitoring as per protocol."}, 'identificationModule': {'nctId': 'NCT00805467', 'briefTitle': 'Open-Label, Multicenter Extension Study for Patients Completing Treatment Phase of a Rigel-Sponsored R935788 Studies', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'An Open-Label, Multicenter Extension Study to Evaluate the Safety of R935788 in Patients With Rheumatoid Arthritis Who Have Completed the Treatment Phase of a Rigel-Sponsored R935788 Study', 'orgStudyIdInfo': {'id': 'C-935788-012'}, 'secondaryIdInfos': [{'id': 'D4300C00021'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'R935788 50 mg tablet, orally, twice-a-day', 'interventionNames': ['Drug: Fostamatinib Disodium (R935788)']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'R935788 100 mg tablet, orally, twice-a-day', 'interventionNames': ['Drug: Fostamatinib Disodium (R935788)']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': 'R935788 100 mg tablet, orally, once-a-day', 'interventionNames': ['Drug: Fostamatinib Disodium (R935788)']}, {'type': 'EXPERIMENTAL', 'label': '4', 'description': 'R935788 150 mg tablet, orally, once-a-day', 'interventionNames': ['Drug: Fostamatinib Disodium (R935788)']}], 'interventions': [{'name': 'Fostamatinib Disodium (R935788)', 'type': 'DRUG', 'otherNames': ['R935788'], 'description': '50 mg PO BID; 100 mg PO BID; 100 mg PO QD; 150 mg tablet PO QD', 'armGroupLabels': ['1', '2', '3', '4']}]}, 'contactsLocationsModule': {'locations': [{'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'city': 'Palm Desert', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.72255, 'lon': -116.37697}}, {'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'city': 'Santa Maria', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.95303, 'lon': -120.43572}}, {'city': 'Hamden', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 41.39593, 'lon': -72.89677}}, {'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'city': 'Aventura', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 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