Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2025-12-26 @ 3:10 AM
Study NCT ID:
NCT00891020
Status:
COMPLETED
Last Update Posted:
2012-10-25
First Post:
2009-04-29
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study Of Tocilizumab in Patients With Moderate to Severe Active Rheumatoid Arthritis Who Have an Inadequate Response to or Are Unable to Tolerate Biologic and Non-Biologic Disease-modifying Antirheumatic Drugs (DMARDs)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Puerto Rico', 'United Kingdom']}, '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': 'C502936', 'term': 'tocilizumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '800-821-8590', 'title': 'Medical Communications', 'organization': 'Hoffman-LaRoche'}, 'certainAgreement': {'otherDetails': "The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Includes Adverse Events that occurred during the 24-week Treatment Period and the Long-term Extension Period (up to 72 Weeks)', 'description': 'Safety population. Patients were included in the TCZ dose group according to the first infusion they actually received. Patients were assigned as using a nonbiologic DMARD if they took at least 1 dose of nonbiologic DMARD during the treatment period. Patients who did not take at least 1 dose of nonbiologic DMARD were considered as on monotherapy.', 'eventGroups': [{'id': 'EG000', 'title': 'Tocilizumab 8 mg/kg Monotherapy', 'description': 'Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusions for 24 weeks. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.', 'otherNumAtRisk': 138, 'otherNumAffected': 63, 'seriousNumAtRisk': 138, 'seriousNumAffected': 11}, {'id': 'EG001', 'title': 'Tocilizumab 4 mg/kg + DMARD', 'description': "Participants received Tocilizumab (TCZ) 4 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. Participants not achieving a 20% improvement from baseline in tender and swollen joint counts at Week 8 were to have their dosage increased to 8 mg/kg, per protocol. Beginning at Week 12 dosage increase to 8 mg/kg was at the discretion of the investigator. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.", 'otherNumAtRisk': 364, 'otherNumAffected': 185, 'seriousNumAtRisk': 364, 'seriousNumAffected': 45}, {'id': 'EG002', 'title': 'Tocilizumab 8 mg/kg + DMARD', 'description': "Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. The dosage could be decreased to 4 mg/kg for safety reasons at the investigator's discretion. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.", 'otherNumAtRisk': 381, 'otherNumAffected': 189, 'seriousNumAtRisk': 381, 'seriousNumAffected': 40}], 'otherEvents': [{'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 36}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 41}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Rheumatoid arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 40}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 32}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 33}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 36}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 26}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 31}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 19}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 26}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 23}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 19}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 22}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}], 'seriousEvents': [{'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Abscess intestinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Arthritis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Bursitis infective', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Clostridial infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Empyema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Epiglottitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Localised infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Osteomyelitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Pelvic abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Pneumonia streptococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Subcutaneous abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Large intestine perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Aphthous stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Colitis ischaemic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': "Crohn's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Hiatus hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Oesophageal spasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Oesophagitis haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Rectal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Pulmonary fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Sick sinus syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Muscle strain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Patella fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Upper limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Wrist fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Joint destruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Rheumatoid arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Spinal column stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Temporomandibular joint syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Acute prerenal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Vesical fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Malnutrition', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Aortic aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Thrombophlebitis superficial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Adrenal insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Knee arthroplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Cellulitis staphylococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Pneumonia pneumococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Pyothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Staphylococcal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Small intestinal perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Cardiac valve rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Traumatic haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Renal tubular necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Breast cancer in situ', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Lung neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Lung neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Decubitus ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Skin mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Forearm fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Hypercoagulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 364, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 381, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Experiencing at Least One Serious Adverse Event (SAE) During the 24 Week Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '364', 'groupId': 'OG001'}, {'value': '381', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab 8 mg/kg Monotherapy', 'description': 'Participants received Tocilizumab (TCZ) 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusions for 24 weeks. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + DMARD', 'description': "Participants received Tocilizumab (TCZ) 4 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. Participants not achieving a 20% improvement from baseline in tender and swollen joint counts at Week 8 were to have their dosage increased to 8 mg/kg, per protocol. Beginning at Week 12 dosage increase to 8 mg/kg was at the discretion of the investigator. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase."}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + DMARD', 'description': "Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. The dosage could be decreased to 4 mg/kg for safety reasons at the investigator's discretion. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase."}], 'classes': [{'categories': [{'measurements': [{'value': '5.8', 'groupId': 'OG000'}, {'value': '8.0', 'groupId': 'OG001'}, {'value': '8.4', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 Weeks', 'description': 'An SAE was any adverse event that at any dose fulfilled at least one of the following criteria:\n\n* Was fatal (results in death)\n* Was life-threatening\n* Required in-patient hospitalization or prolongation of existing hospitalization\n* Resulted in persistent or significant disability/incapacity\n* Was a congenital anomaly/birth defect\n* Was medically significant or required intervention to prevent one or other of the outcomes listed above.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Patients were included in the TCZ dose group according to the first infusion they actually received. Patients were assigned as using a nonbiologic DMARD if they took at least 1 dose of nonbiologic DMARD during the treatment period. Patients who did not take at least 1 dose of nonbiologic DMARD were considered as on monotherapy.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Experiencing Serious Adverse Events of Special Interest', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '364', 'groupId': 'OG001'}, {'value': '381', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab 8 mg/kg Monotherapy', 'description': 'Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusions for 24 weeks. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + DMARD', 'description': "Participants received Tocilizumab (TCZ) 4 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. Participants not achieving a 20% improvement from baseline in tender and swollen joint counts at Week 8 were to have their dosage increased to 8 mg/kg, per protocol. Beginning at Week 12 dosage increase to 8 mg/kg was at the discretion of the investigator. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase."}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + DMARD', 'description': "Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. The dosage could be decreased to 4 mg/kg for safety reasons at the investigator's discretion. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase."}], 'classes': [{'title': 'Serious Infections (including opportunistic)', 'categories': [{'measurements': [{'value': '2.9', 'groupId': 'OG000'}, {'value': '3.6', 'groupId': 'OG001'}, {'value': '3.9', 'groupId': 'OG002'}]}]}, {'title': 'Gastrointestinal Perforations and Related Events', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.8', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Myocardial Infarction/Acute Coronary Syndrome', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0.3', 'groupId': 'OG002'}]}]}, {'title': 'Stroke', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Spontaneous/Serious Bleeding', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.3', 'groupId': 'OG001'}, {'value': '0.3', 'groupId': 'OG002'}]}]}, {'title': 'Malignant Neoplasms', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0.3', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 Weeks', 'description': 'Serious Adverse Events of Special interest include:\n\n* Serious infections including opportunistic infections\n* Complications of diverticulitis (including lower gastrointestinal \\[GI\\] perforations)\n* Myocardial infarction/acute coronary syndrome\n* Stroke\n* Spontaneous or serious bleeding\n* Malignant neoplasms', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Patients were included in the TCZ dose group according to the first infusion they actually received. Patients were assigned as using a nonbiologic DMARD if they took at least 1 dose of nonbiologic DMARD during the treatment period. Patients who did not take at least 1 dose of nonbiologic DMARD were considered as on monotherapy.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Experiencing Non-serious Adverse Events of Special Interest', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '364', 'groupId': 'OG001'}, {'value': '381', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab 8 mg/kg Monotherapy', 'description': 'Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusions for 24 weeks. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + DMARD', 'description': "Participants received Tocilizumab (TCZ) 4 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. Participants not achieving a 20% improvement from baseline in tender and swollen joint counts at Week 8 were to have their dosage increased to 8 mg/kg, per protocol. Beginning at Week 12 dosage increase to 8 mg/kg was at the discretion of the investigator. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase."}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + DMARD', 'description': "Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. The dosage could be decreased to 4 mg/kg for safety reasons at the investigator's discretion. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase."}], 'classes': [{'title': 'Serious/Medically Significant Hepatic Events', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0.3', 'groupId': 'OG002'}]}]}, {'title': 'Spontaneous/Serious Bleeding', 'categories': [{'measurements': [{'value': '4.3', 'groupId': 'OG000'}, {'value': '3.3', 'groupId': 'OG001'}, {'value': '7.3', 'groupId': 'OG002'}]}]}, {'title': 'Malignant Neoplasms', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.3', 'groupId': 'OG001'}, {'value': '0.3', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 Weeks', 'description': 'Non-serious adverse Events of Special interest include:\n\n* Serious/Medically Significant Hepatic Events\n* Spontaneous /Serious Bleeding\n* Malignant Neoplasms', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Patients were included in the TCZ dose group according to the first infusion they actually received. Patients were assigned as using a nonbiologic DMARD if they took at least 1 dose of nonbiologic DMARD during the treatment period. Patients who did not take at least 1 dose of nonbiologic DMARD were considered as on monotherapy.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Clinical Remission at Weeks 8, 16, and 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '362', 'groupId': 'OG001'}, {'value': '358', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab 8 mg/kg Monotherapy', 'description': 'Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusions for 24 weeks. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + DMARD', 'description': "Participants received Tocilizumab (TCZ) 4 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. Participants not achieving a 20% improvement from baseline in tender and swollen joint counts at Week 8 were to have their dosage increased to 8 mg/kg, per protocol. Beginning at Week 12 dosage increase to 8 mg/kg was at the discretion of the investigator. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase."}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + DMARD', 'description': "Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. The dosage could be decreased to 4 mg/kg for safety reasons at the investigator's discretion. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase."}], 'classes': [{'title': 'Week 8 (n=147, 337, 334)', 'categories': [{'measurements': [{'value': '8.8', 'groupId': 'OG000'}, {'value': '6.8', 'groupId': 'OG001'}, {'value': '12.9', 'groupId': 'OG002'}]}]}, {'title': 'Week 16 (n=127, 317, 304)', 'categories': [{'measurements': [{'value': '15.7', 'groupId': 'OG000'}, {'value': '17.4', 'groupId': 'OG001'}, {'value': '22.0', 'groupId': 'OG002'}]}]}, {'title': 'Week 24 (n=126, 286, 302)', 'categories': [{'measurements': [{'value': '19.8', 'groupId': 'OG000'}, {'value': '20.6', 'groupId': 'OG001'}, {'value': '25.2', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 8,16,24', 'description': 'Clinical Remission is defined as a Disease Activity Score 28 \\[DAS28\\] \\< 2.6. The DAS28 is a combined index for measuring disease activity in RA. The index includes tender joint count (TJC) -28 joints and swollen joint count (SJC)-28 joints, acute phase response (CRP) and general health status. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population includes participants who received at least one dose of study drug. Patients were included in the treatment group to which they were randomized or assigned, regardless of the treatment actually received. "n" in each of the categories is the number of participants with data available for analysis at the given time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in DAS28 Score at Weeks 8, 16 and 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '362', 'groupId': 'OG001'}, {'value': '358', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab 8 mg/kg Monotherapy', 'description': 'Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusions for 24 weeks. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + DMARD', 'description': "Participants received Tocilizumab (TCZ) 4 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. Participants not achieving a 20% improvement from baseline in tender and swollen joint counts at Week 8 were to have their dosage increased to 8 mg/kg, per protocol. Beginning at Week 12 dosage increase to 8 mg/kg was at the discretion of the investigator. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase."}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + DMARD', 'description': "Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. The dosage could be decreased to 4 mg/kg for safety reasons at the investigator's discretion. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase."}], 'classes': [{'title': 'Week 8 (n=147, 337, 334)', 'categories': [{'measurements': [{'value': '-1.75', 'spread': '1.213', 'groupId': 'OG000'}, {'value': '-1.00', 'spread': '1.189', 'groupId': 'OG001'}, {'value': '-1.54', 'spread': '1.187', 'groupId': 'OG002'}]}]}, {'title': 'Week 16 (n=127, 317, 304)', 'categories': [{'measurements': [{'value': '-2.07', 'spread': '1.406', 'groupId': 'OG000'}, {'value': '-1.66', 'spread': '1.244', 'groupId': 'OG001'}, {'value': '-1.87', 'spread': '1.322', 'groupId': 'OG002'}]}]}, {'title': 'Week 24 (n=126, 286, 302)', 'categories': [{'measurements': [{'value': '-2.03', 'spread': '1.384', 'groupId': 'OG000'}, {'value': '-1.81', 'spread': '1.264', 'groupId': 'OG001'}, {'value': '-1.94', 'spread': '1.380', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 8,16,24', 'description': 'The DAS28 is a combined index for measuring disease activity in rheumatoid arthritis (RA). The index includes tender joint count (TJC) -28 joints and swollen joint count (SJC)-28 joints, acute phase response C-reactive protein (CRP) and general health status. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A score of \\< 2.6 represents clinical remission, a score of ≤ 3.2 represents low disease activity, and a score of \\> 5.1 represents high disease activity.\n\nThe Change from Baseline to Weeks 8, 16 and 24 is reported.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat includes participants who received at least one dose of study drug. Patients were included in the treatment group to which they were randomized or assigned, regardless of the treatment actually received. "n" in each of the categories is the number of participants with data available for analysis at the given time point.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving American College of Rheumatology (ACR) (ACR20/50/70) Responses at Weeks 8, 16, and 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '362', 'groupId': 'OG001'}, {'value': '358', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab 8 mg/kg Monotherapy', 'description': 'Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusions for 24 weeks. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + DMARD', 'description': "Participants received Tocilizumab (TCZ) 4 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. Participants not achieving a 20% improvement from baseline in tender and swollen joint counts at Week 8 were to have their dosage increased to 8 mg/kg, per protocol. Beginning at Week 12 dosage increase to 8 mg/kg was at the discretion of the investigator. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase."}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + DMARD', 'description': "Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. The dosage could be decreased to 4 mg/kg for safety reasons at the investigator's discretion. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase."}], 'classes': [{'title': 'Week 8 ACR20 responders', 'categories': [{'measurements': [{'value': '40.5', 'groupId': 'OG000'}, {'value': '37.8', 'groupId': 'OG001'}, {'value': '40.8', 'groupId': 'OG002'}]}]}, {'title': 'Week 8 ACR50 responders', 'categories': [{'measurements': [{'value': '14.7', 'groupId': 'OG000'}, {'value': '11.9', 'groupId': 'OG001'}, {'value': '16.8', 'groupId': 'OG002'}]}]}, {'title': 'Week 8 ACR70 responders', 'categories': [{'measurements': [{'value': '4.3', 'groupId': 'OG000'}, {'value': '3.3', 'groupId': 'OG001'}, {'value': '5.6', 'groupId': 'OG002'}]}]}, {'title': 'Week 16 ACR20 responders', 'categories': [{'measurements': [{'value': '46.6', 'groupId': 'OG000'}, {'value': '43.9', 'groupId': 'OG001'}, {'value': '45.3', 'groupId': 'OG002'}]}]}, {'title': 'Week 16 ACR50 responders', 'categories': [{'measurements': [{'value': '23.3', 'groupId': 'OG000'}, {'value': '19.9', 'groupId': 'OG001'}, {'value': '22.3', 'groupId': 'OG002'}]}]}, {'title': 'Week 16 ACR70 responders', 'categories': [{'measurements': [{'value': '7.4', 'groupId': 'OG000'}, {'value': '8.6', 'groupId': 'OG001'}, {'value': '9.8', 'groupId': 'OG002'}]}]}, {'title': 'Week 24 ACR20 responders', 'categories': [{'measurements': [{'value': '47.9', 'groupId': 'OG000'}, {'value': '44.8', 'groupId': 'OG001'}, {'value': '49.7', 'groupId': 'OG002'}]}]}, {'title': 'Week 24 ACR50 responders', 'categories': [{'measurements': [{'value': '24.5', 'groupId': 'OG000'}, {'value': '24.3', 'groupId': 'OG001'}, {'value': '27.1', 'groupId': 'OG002'}]}]}, {'title': 'Week 24 ACR70 responders', 'categories': [{'measurements': [{'value': '7.4', 'groupId': 'OG000'}, {'value': '8.8', 'groupId': 'OG001'}, {'value': '10.3', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Weeks 8,16,24', 'description': "The ACR response rates ACR20, ACR50, and ACR70 are defined as ≥20%, ≥50%, and ≥70% improvement from baseline, respectively, in:\n\n1. Swollen Joint Count (66 joints) and Tender Joint Count (68 joints) and\n2. At least 3 of the following 5 assessments:\n\n * Patient's global assessment of pain-Visual Analog Scale (VAS)\n * Patient global assessment of disease activity-(VAS)\n * Physician global assessment of disease activity-(VAS)\n * Patient assessment of disability (physical function scale of the Multidimensional Health Assessment Questionnaire)\n * Acute phase response C-Reactive Protein (CRP)", 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population includes all participants who received at least one dose of study drug. Patients were included in the treatment group to which they were randomized or assigned, regardless of the treatment actually received.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Tocilizumab Dose Increased From 4 mg/kg to 8 mg/kg at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '364', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab 4 mg/kg + DMARD', 'description': "Participants received Tocilizumab (TCZ) 4 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. Participants not achieving a 20% improvement from baseline in tender and swollen joint counts at Week 8 were to have their dosage increased to 8 mg/kg, per protocol. Beginning at Week 12 dosage increase to 8 mg/kg was at the discretion of the investigator. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase."}], 'classes': [{'categories': [{'measurements': [{'value': '39.9', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 8', 'description': 'Dosage could be increased from 4 mg/kg Tocilizumab to 8 mg/kg due to failure to achieve 20% improvement from baseline in swollen and tender joint counts.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Patients were included in the TCZ dose group according to the first infusion they actually received. Patients were assigned as using a nonbiologic DMARD if they took at least 1 dose of nonbiologic DMARD during the treatment period. Patients who did not take at least 1 dose of nonbiologic DMARD were considered as on monotherapy.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Having Their Tocilizumab Dose Increased From 4 mg/kg to 8 mg/kg at Weeks 12, 16, and 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '364', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab 4 mg/kg + DMARD', 'description': "Participants received Tocilizumab (TCZ) 4 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. Participants not achieving a 20% improvement from baseline in tender and swollen joint counts at Week 8 were to have their dosage increased to 8 mg/kg, per protocol. Beginning at Week 12 dosage increase to 8 mg/kg was at the discretion of the investigator. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase."}], 'classes': [{'title': 'Week 12 (n=183)', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}]}]}, {'title': 'Week 16 (n=138)', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}, {'title': 'Week 20 (n=119)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 12,16, 20', 'description': "Dosage of Tocilizumab 4 mg/kg could be increased to 8 mg/kg at the discretion of the investigator based on assessment of the patient's benefit-risk after Week 12.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population includes participants who received at least one dose of study drug. "n" in each of the categories is the number of participants previously on 4mg/kg + DMARD and receiving a dose at the current visit. Patients were assigned as using a nonbiologic DMARD if they took at least 1 dose of nonbiologic DMARD during the treatment period.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Routine Assessment Patient Index Data (RAPID3) Score at Weeks 8, 16, and 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '362', 'groupId': 'OG001'}, {'value': '358', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab 8 mg/kg Monotherapy', 'description': 'Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusions for 24 weeks. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + DMARD', 'description': "Participants received Tocilizumab (TCZ) 4 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. Participants not achieving a 20% improvement from baseline in tender and swollen joint counts at Week 8 were to have their dosage increased to 8 mg/kg, per protocol. Beginning at Week 12 dosage increase to 8 mg/kg was at the discretion of the investigator. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase."}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + DMARD', 'description': "Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. The dosage could be decreased to 4 mg/kg for safety reasons at the investigator's discretion. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase."}], 'classes': [{'title': 'Week 8 (n=156, 348, 343)', 'categories': [{'measurements': [{'value': '-1.60', 'spread': '1.803', 'groupId': 'OG000'}, {'value': '-1.10', 'spread': '1.848', 'groupId': 'OG001'}, {'value': '-1.28', 'spread': '1.733', 'groupId': 'OG002'}]}]}, {'title': 'Week 16 (n=138, 325, 315)', 'categories': [{'measurements': [{'value': '-1.97', 'spread': '2.068', 'groupId': 'OG000'}, {'value': '-1.42', 'spread': '1.896', 'groupId': 'OG001'}, {'value': '-1.46', 'spread': '1.897', 'groupId': 'OG002'}]}]}, {'title': 'Week 24 (n=134, 306, 308)', 'categories': [{'measurements': [{'value': '-1.83', 'spread': '1.978', 'groupId': 'OG000'}, {'value': '-1.61', 'spread': '1.972', 'groupId': 'OG001'}, {'value': '-1.46', 'spread': '1.962', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 8,16,24', 'description': 'The RAPID3 is a combined index derived from the Multidimensional Health Assessment Questionnaire that includes physical function score, pain Visual Analog Scale (VAS), and global assessment of disease activity VAS. The total RAPID3 score ranges from 0 to 10 where higher scores represent worse outcomes. A negative change from baseline indicates improvement.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population includes all participants who received at least 1 dose of study drug. Patients were included in the treatment group to which they were randomized or assigned, regardless of the treatment actually received. "n" in each of the categories is the number of participants with data available for analysis at the given time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fatigue Visual Analogue Scale (VAS) at Weeks 8, 16, and 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '362', 'groupId': 'OG001'}, {'value': '358', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab 8 mg/kg Monotherapy', 'description': 'Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusions for 24 weeks. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.'}, {'id': 'OG001', 'title': 'Tocilizumab 4 mg/kg + DMARD', 'description': "Participants received Tocilizumab (TCZ) 4 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. Participants not achieving a 20% improvement from baseline in tender and swollen joint counts at Week 8 were to have their dosage increased to 8 mg/kg, per protocol. Beginning at Week 12 dosage increase to 8 mg/kg was at the discretion of the investigator. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase."}, {'id': 'OG002', 'title': 'Tocilizumab 8 mg/kg + DMARD', 'description': "Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. The dosage could be decreased to 4 mg/kg for safety reasons at the investigator's discretion. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase."}], 'classes': [{'title': 'Week 8 (n=156, 350, 344)', 'categories': [{'measurements': [{'value': '-13.17', 'spread': '25.584', 'groupId': 'OG000'}, {'value': '-10.06', 'spread': '25.349', 'groupId': 'OG001'}, {'value': '-13.33', 'spread': '24.950', 'groupId': 'OG002'}]}]}, {'title': 'Week 16 (n=138, 329, 317)', 'categories': [{'measurements': [{'value': '-19.38', 'spread': '26.639', 'groupId': 'OG000'}, {'value': '-14.00', 'spread': '26.282', 'groupId': 'OG001'}, {'value': '-15.58', 'spread': '25.802', 'groupId': 'OG002'}]}]}, {'title': 'Week 24 (n=135, 307, 312)', 'categories': [{'measurements': [{'value': '-15.85', 'spread': '26.881', 'groupId': 'OG000'}, {'value': '-16.73', 'spread': '26.261', 'groupId': 'OG001'}, {'value': '-16.07', 'spread': '26.321', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 8,16,24', 'description': 'The fatigue VAS is a single-item, patient-reported outcome that measures the severity of the fatigue over the past week. Patients rate their fatigue on a scale of 0 (fatigue is no problem) to 100 (fatigue is a major problem). Higher scores represent higher disease activity and a negative change from baseline indicates improvement.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population includes all participants who received at least 1 dose of study drug. Patients were included in the treatment group to which they were randomized or assigned, regardless of the treatment actually received. "n" in each of the categories is the number of participants with data available for analysis at the given time point.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tocilizumab 8 mg/kg Monotherapy', 'description': 'Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusions for 24 weeks. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.'}, {'id': 'FG001', 'title': 'Tocilizumab 4 mg/kg + DMARD', 'description': "Participants received Tocilizumab (TCZ) 4 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. Participants not achieving a 20% improvement from baseline in tender and swollen joint counts at Week 8 were to have their dosage increased to 8 mg/kg, per protocol. Beginning at Week 12 dosage increase to 8 mg/kg was at the discretion of the investigator. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase."}, {'id': 'FG002', 'title': 'Tocilizumab 8 mg/kg + DMARD', 'description': "Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. The dosage could be decreased to 4 mg/kg for safety reasons at the investigator's discretion. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase."}], 'periods': [{'title': '24 Week Treatment Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '163'}, {'groupId': 'FG001', 'numSubjects': '363'}, {'groupId': 'FG002', 'numSubjects': '360'}]}, {'type': 'Intent-to-Treat (ITT)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '163'}, {'groupId': 'FG001', 'numSubjects': '362'}, {'groupId': 'FG002', 'numSubjects': '358'}]}, {'type': 'Safety Set', 'achievements': [{'comment': '4 patients from 8 mg/kg +DMARD arm did not receive DMARD, included in Monotherapy arm for safety.', 'groupId': 'FG000', 'numSubjects': '138'}, {'comment': '1 patient from Monotherapy arm and 1 from 8 mg/kg +DMARD, included in 4 mg/kg +DMARD arm for safety.', 'groupId': 'FG001', 'numSubjects': '364'}, {'comment': '28 patients from Monotherapy arm received DMARD, included in 8 mg/kg +DMARD arm for safety.', 'groupId': 'FG002', 'numSubjects': '381'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '126'}, {'groupId': 'FG001', 'numSubjects': '303'}, {'groupId': 'FG002', 'numSubjects': '302'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '60'}, {'groupId': 'FG002', 'numSubjects': '58'}]}], 'dropWithdraws': [{'type': 'Adverse event or intercurrent illness', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '32'}, {'groupId': 'FG002', 'numSubjects': '17'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Insufficient therapeutic response', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '15'}]}, {'type': 'Failure to return', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'Violation of selection criteria at entry', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Other protocol violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Refused treatment/did not cooperate', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Withdrew consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '15'}]}, {'type': 'Administrative/Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}, {'title': 'Long-term Extension Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '55'}, {'groupId': 'FG001', 'numSubjects': '196'}, {'groupId': 'FG002', 'numSubjects': '193'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '172'}, {'groupId': 'FG002', 'numSubjects': '170'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '24'}, {'groupId': 'FG002', 'numSubjects': '23'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '10'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Insufficient therapeutic response', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Refused treatment/did not cooperate', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Failure to return', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Administrative', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}], 'preAssignmentDetails': '1129 patients were screened for the study. Of these 1129 patients, 886 patients were enrolled and 243 patients were screen failures.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'BG000'}, {'value': '364', 'groupId': 'BG001'}, {'value': '381', 'groupId': 'BG002'}, {'value': '883', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Tocilizumab 8 mg/kg Monotherapy', 'description': 'Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusions for 24 weeks. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.'}, {'id': 'BG001', 'title': 'Tocilizumab 4 mg/kg + DMARD', 'description': "Participants received Tocilizumab (TCZ) 4 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. Participants not achieving a 20% improvement from baseline in tender and swollen joint counts at Week 8 were to have their dosage increased to 8 mg/kg, per protocol. Beginning at Week 12 dosage increase to 8 mg/kg was at the discretion of the investigator. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase."}, {'id': 'BG002', 'title': 'Tocilizumab 8 mg/kg + DMARD', 'description': "Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. The dosage could be decreased to 4 mg/kg for safety reasons at the investigator's discretion. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase."}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.5', 'spread': '12.63', 'groupId': 'BG000'}, {'value': '55.6', 'spread': '11.92', 'groupId': 'BG001'}, {'value': '54.0', 'spread': '12.11', 'groupId': 'BG002'}, {'value': '54.6', 'spread': '12.13', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Baseline measures are based on the number of participants in the Safety Population who received at least one dose of study drug and who had at least one post baseline safety assessment.', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '110', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '296', 'groupId': 'BG002'}, {'value': '679', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '91', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}, {'value': '204', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 886}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-10-19', 'studyFirstSubmitDate': '2009-04-29', 'resultsFirstSubmitDate': '2012-02-28', 'studyFirstSubmitQcDate': '2009-04-29', 'lastUpdatePostDateStruct': {'date': '2012-10-25', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-03-23', 'studyFirstPostDateStruct': {'date': '2009-04-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-04-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Experiencing at Least One Serious Adverse Event (SAE) During the 24 Week Treatment Period', 'timeFrame': '24 Weeks', 'description': 'An SAE was any adverse event that at any dose fulfilled at least one of the following criteria:\n\n* Was fatal (results in death)\n* Was life-threatening\n* Required in-patient hospitalization or prolongation of existing hospitalization\n* Resulted in persistent or significant disability/incapacity\n* Was a congenital anomaly/birth defect\n* Was medically significant or required intervention to prevent one or other of the outcomes listed above.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Experiencing Serious Adverse Events of Special Interest', 'timeFrame': '24 Weeks', 'description': 'Serious Adverse Events of Special interest include:\n\n* Serious infections including opportunistic infections\n* Complications of diverticulitis (including lower gastrointestinal \\[GI\\] perforations)\n* Myocardial infarction/acute coronary syndrome\n* Stroke\n* Spontaneous or serious bleeding\n* Malignant neoplasms'}, {'measure': 'Percentage of Participants Experiencing Non-serious Adverse Events of Special Interest', 'timeFrame': '24 Weeks', 'description': 'Non-serious adverse Events of Special interest include:\n\n* Serious/Medically Significant Hepatic Events\n* Spontaneous /Serious Bleeding\n* Malignant Neoplasms'}, {'measure': 'Percentage of Participants Achieving Clinical Remission at Weeks 8, 16, and 24', 'timeFrame': 'Weeks 8,16,24', 'description': 'Clinical Remission is defined as a Disease Activity Score 28 \\[DAS28\\] \\< 2.6. The DAS28 is a combined index for measuring disease activity in RA. The index includes tender joint count (TJC) -28 joints and swollen joint count (SJC)-28 joints, acute phase response (CRP) and general health status. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity.'}, {'measure': 'Change From Baseline in DAS28 Score at Weeks 8, 16 and 24', 'timeFrame': 'Baseline, Weeks 8,16,24', 'description': 'The DAS28 is a combined index for measuring disease activity in rheumatoid arthritis (RA). The index includes tender joint count (TJC) -28 joints and swollen joint count (SJC)-28 joints, acute phase response C-reactive protein (CRP) and general health status. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A score of \\< 2.6 represents clinical remission, a score of ≤ 3.2 represents low disease activity, and a score of \\> 5.1 represents high disease activity.\n\nThe Change from Baseline to Weeks 8, 16 and 24 is reported.'}, {'measure': 'Percentage of Participants Achieving American College of Rheumatology (ACR) (ACR20/50/70) Responses at Weeks 8, 16, and 24', 'timeFrame': 'Baseline, Weeks 8,16,24', 'description': "The ACR response rates ACR20, ACR50, and ACR70 are defined as ≥20%, ≥50%, and ≥70% improvement from baseline, respectively, in:\n\n1. Swollen Joint Count (66 joints) and Tender Joint Count (68 joints) and\n2. At least 3 of the following 5 assessments:\n\n * Patient's global assessment of pain-Visual Analog Scale (VAS)\n * Patient global assessment of disease activity-(VAS)\n * Physician global assessment of disease activity-(VAS)\n * Patient assessment of disability (physical function scale of the Multidimensional Health Assessment Questionnaire)\n * Acute phase response C-Reactive Protein (CRP)"}, {'measure': 'Percentage of Participants With Tocilizumab Dose Increased From 4 mg/kg to 8 mg/kg at Week 8', 'timeFrame': 'Baseline, Week 8', 'description': 'Dosage could be increased from 4 mg/kg Tocilizumab to 8 mg/kg due to failure to achieve 20% improvement from baseline in swollen and tender joint counts.'}, {'measure': 'Number of Participants Having Their Tocilizumab Dose Increased From 4 mg/kg to 8 mg/kg at Weeks 12, 16, and 20', 'timeFrame': 'Weeks 12,16, 20', 'description': "Dosage of Tocilizumab 4 mg/kg could be increased to 8 mg/kg at the discretion of the investigator based on assessment of the patient's benefit-risk after Week 12."}, {'measure': 'Change From Baseline in Routine Assessment Patient Index Data (RAPID3) Score at Weeks 8, 16, and 24', 'timeFrame': 'Baseline, Weeks 8,16,24', 'description': 'The RAPID3 is a combined index derived from the Multidimensional Health Assessment Questionnaire that includes physical function score, pain Visual Analog Scale (VAS), and global assessment of disease activity VAS. The total RAPID3 score ranges from 0 to 10 where higher scores represent worse outcomes. A negative change from baseline indicates improvement.'}, {'measure': 'Change From Baseline in Fatigue Visual Analogue Scale (VAS) at Weeks 8, 16, and 24', 'timeFrame': 'Baseline, Weeks 8,16,24', 'description': 'The fatigue VAS is a single-item, patient-reported outcome that measures the severity of the fatigue over the past week. Patients rate their fatigue on a scale of 0 (fatigue is no problem) to 100 (fatigue is a major problem). Higher scores represent higher disease activity and a negative change from baseline indicates improvement.'}]}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'referencesModule': {'references': [{'pmid': '22972745', 'type': 'DERIVED', 'citation': 'Weinblatt ME, Kremer J, Cush J, Rigby W, Teng LL, Devenport J, Singh N, Lepley D, Genovese MC. Tocilizumab as monotherapy or in combination with nonbiologic disease-modifying antirheumatic drugs: twenty-four-week results of an open-label, clinical practice study. Arthritis Care Res (Hoboken). 2013 Mar;65(3):362-71. doi: 10.1002/acr.21847.'}]}, 'descriptionModule': {'briefSummary': 'This 3 arm randomized open label study will evaluate the safety, tolerability and efficacy of tocilizumab in patients with moderate to severe active rheumatoid arthritis, who have had inadequate response to or are unable to tolerate DMARDs. The protocol incorporates risk mitigation strategies developed in partnership with the FDA to manage known and potential risks associated with the treatment of tocilizumab. Patients will be randomized to receive tocilizumab either 4 mg/kg intravenous (iv) or 8 mg/kg iv with concomitant non-biologic DMARDs, or 8 mg/kg iv without concomitant non-biologic DMARDs, every 4 weeks, for a total of 6 infusions. The anticipated time on study treatment is 3-12 months, and the target sample size is 500-1000 individuals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients, \\>=18 years of age;\n* moderate to severe active rheumatoid arthritis for \\>6 months;\n* inadequate clinical response or unable to tolerate current or prior biologic or non-biologic Disease-modifying antirheumatic drug (DMARD) therapy;\n* Swollen joint count (SJC) \\>/=4 and Tender joint count (TJC) \\>/=4\n* body weight \\</=150kg\n* current permitted non-biologic DMARDs must be on stable dose for \\>/= 7 weeks prior to baseline;\n\nExclusion Criteria:\n\n* history of autoimmune disease or inflammatory joint disease other than rheumatoid arthritis;\n* functional class IV as defined by the American College of Rheumatology (ACR) Classification of Functional Status in rheumatoid arthritis;\n* treatment with rituximab within 6 months before screening;\n* intraarticular corticosteroids within 8 weeks or intramuscular (im)/ intravenous (iv) corticosteroids within 12 weeks prior to screening;\n* known active current or history of recurrent infections, or any major episode of infection requiring hospitalization or treatment with iv antibiotics within 4 weeks of screening, or oral antibiotics within 2 weeks prior to screening.'}, 'identificationModule': {'nctId': 'NCT00891020', 'briefTitle': 'A Study Of Tocilizumab in Patients With Moderate to Severe Active Rheumatoid Arthritis Who Have an Inadequate Response to or Are Unable to Tolerate Biologic and Non-Biologic Disease-modifying Antirheumatic Drugs (DMARDs)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis on Background Non-biologic DMARDs and Monotherapy Who Have an Inadequate Response to Current Non-Biologic or Biologic DMARDs', 'orgStudyIdInfo': {'id': 'ML22533'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tocilizumab 8 mg/kg Monotherapy', 'description': "Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusions for 24 weeks. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase at the investigator's discretion.", 'interventionNames': ['Drug: tocilizumab [RoActemra/Actemra]']}, {'type': 'EXPERIMENTAL', 'label': 'Tocilizumab 4 mg/kg + DMARD', 'description': "Participants received Tocilizumab (TCZ) 4 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusions plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. Participants not achieving a 20% improvement from baseline in tender and swollen joint counts at Week 8 were to have their dosage increased to 8 mg/kg, per protocol. Beginning at Week 12 dosage increase to 8 mg/kg was at the discretion of the investigator. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase at the investigator's discretion.", 'interventionNames': ['Drug: tocilizumab [RoActemra/Actemra]', "Drug: Nonbiologic DMARDs of investigator's choice"]}, {'type': 'EXPERIMENTAL', 'label': 'Tocilizumab 8 mg/kg + DMARD', 'description': "Participants received Tocilizumab (TCZ) 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusions plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase at the investigator's discretion.", 'interventionNames': ['Drug: tocilizumab [RoActemra/Actemra]', "Drug: Nonbiologic DMARDs of investigator's choice"]}], 'interventions': [{'name': 'tocilizumab [RoActemra/Actemra]', 'type': 'DRUG', 'description': '8 mg/kg intravenous every 4 weeks for 24 weeks', 'armGroupLabels': ['Tocilizumab 4 mg/kg + DMARD', 'Tocilizumab 8 mg/kg + DMARD', 'Tocilizumab 8 mg/kg Monotherapy']}, {'name': 'tocilizumab [RoActemra/Actemra]', 'type': 'DRUG', 'description': '4 mg/kg every 4 weeks for 24 weeks', 'armGroupLabels': ['Tocilizumab 4 mg/kg + DMARD']}, {'name': "Nonbiologic DMARDs of investigator's choice", 'type': 'DRUG', 'description': 'Nonbiologic disease-modifying antirheumatic drugs (DMARDs) As prescribed', 'armGroupLabels': ['Tocilizumab 4 mg/kg + DMARD', 'Tocilizumab 8 mg/kg + DMARD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36207', 'city': 'Anniston', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 33.65983, 'lon': -85.83163}}, {'zip': '35205', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35801', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '36608', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '36111', 'city': 'Montgomery', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 32.36681, 'lon': -86.29997}}, {'zip': '35406', 'city': 'Tuscaloosa', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 33.20984, 'lon': -87.56917}}, {'zip': '71913', 'city': 'Hot Springs', 'state': 'Arizona', 'country': 'United States'}, {'zip': '85253', 'city': 'Paradise Valley', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.53115, 'lon': -111.94265}}, {'zip': '85381', 'city': 'Peoria', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.5806, 'lon': -112.23738}}, {'zip': '85251', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '85258', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '85704', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '27203', 'city': 'Fayetteville', 'state': 'Arkansas', 'country': 'United States', 'geoPoint': {'lat': 36.06258, 'lon': -94.15743}}, {'zip': '72903', 'city': 'Fort Smith', 'state': 'Arkansas', 'country': 'United States', 'geoPoint': {'lat': 35.38592, 'lon': -94.39855}}, {'zip': '72401', 'city': 'Jonesboro', 'state': 'Arkansas', 'country': 'United States', 'geoPoint': {'lat': 35.8423, 'lon': -90.70428}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '91723', 'city': 'Covina', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.09001, 'lon': -117.89034}}, {'zip': '92025', 'city': 'Escondido', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.11921, 'lon': -117.08642}}, {'zip': '92835', 'city': 'Fullerton', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.87029, 'lon': -117.92534}}, {'zip': '92646', 'city': 'Huntington Beach', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.6603, 'lon': -117.99923}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '90712', 'city': 'Lakewood', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.85363, 'lon': -118.13396}}, {'zip': '90808', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92563', 'city': 'Murrieta', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.55391, 'lon': -117.21392}}, {'zip': '92663', 'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '91107', 'city': 'Pasadena', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.14778, 'lon': -118.14452}}, {'zip': '95825', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '92108', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '94578', 'city': 'San Leandro', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 37.72493, 'lon': -122.15608}}, {'zip': '93108', 'city': 'Santa Barbara', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.42083, 'lon': -119.69819}}, {'zip': '93454', 'city': 'Santa Maria', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.95303, 'lon': -120.43572}}, {'zip': '91423', 'city': 'Sherman Oaks', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.15112, 'lon': -118.44925}}, {'zip': '91405', 'city': 'Van Nuys', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.18667, 'lon': -118.44897}}, {'zip': '92295', 'city': 'Victorville', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.53611, 'lon': -117.29116}}, {'zip': '91361', 'city': 'Westlake Village', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.14584, 'lon': -118.80565}}, {'zip': '90606', 'city': 'Whittier', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.97918, 'lon': -118.03284}}, {'zip': '80910', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '80230', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '06606', 'city': 'Bridgeport', 'state': 'Connecticut', 'country': 'United States', 'geoPoint': {'lat': 41.17923, 'lon': -73.18945}}, {'zip': '06810', 'city': 'Danbury', 'state': 'Connecticut', 'country': 'United States', 'geoPoint': {'lat': 41.39482, 'lon': -73.45401}}, {'zip': '06518', 'city': 'Hamden', 'state': 'Connecticut', 'country': 'United States', 'geoPoint': {'lat': 41.39593, 'lon': -72.89677}}, {'zip': '06611', 'city': 'Trumbull', 'state': 'Connecticut', 'country': 'United States', 'geoPoint': {'lat': 41.24287, 'lon': -73.20067}}, {'zip': '19958', 'city': 'Lewes', 'state': 'Delaware', 'country': 'United States', 'geoPoint': {'lat': 38.77456, 'lon': -75.13935}}, {'zip': '33180', 'city': 'Aventura', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 25.95648, 'lon': -80.13921}}, {'zip': '33486', 'city': 'Boca Raton', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.35869, 'lon': -80.0831}}, {'zip': '33761', 'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '34698', 'city': 'Dunedin', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 28.0199, 'lon': -82.77323}}, {'zip': '33334', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '30501', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '32608', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '32209', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '32746', 'city': 'Lake Mary', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 28.75888, 'lon': -81.31784}}, {'zip': '32901', 'city': 'Melbourne', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 28.08363, 'lon': -80.60811}}, {'zip': '33126', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33133', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '34102', 'city': 'Naples', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.14234, 'lon': -81.79596}}, {'zip': '34474', 'city': 'Ocala', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 29.1872, 'lon': -82.14009}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '34684', 'city': 'Palm Harbor', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 28.07807, 'lon': -82.76371}}, {'zip': '34239', 'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '33143', 'city': 'South Miami', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 25.7076, 'lon': -80.29338}}, {'zip': '33710', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '33614', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '33618', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30342', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30501', 'city': 'Gainesville', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 34.29788, 'lon': -83.82407}}, {'zip': '83702', 'city': 'Boise', 'state': 'Idaho', 'country': 'United States', 'geoPoint': {'lat': 43.6135, 'lon': -116.20345}}, {'zip': '83404', 'city': 'Idaho Falls', 'state': 'Idaho', 'country': 'United States', 'geoPoint': {'lat': 43.46658, 'lon': -112.03414}}, {'zip': '83686', 'city': 'Nampa', 'state': 'Idaho', 'country': 'United States', 'geoPoint': {'lat': 43.54072, 'lon': -116.56346}}, {'zip': '60616', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60153', 'city': 'Maywood', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 41.8792, 'lon': -87.84312}}, {'zip': '61265', 'city': 'Moline', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 41.5067, 'lon': -90.51513}}, {'zip': '60053', 'city': 'Morton Grove', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 42.04059, 'lon': -87.78256}}, {'zip': '61602', 'city': 'Peoria', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 40.69365, 'lon': -89.58899}}, {'zip': '60195', 'city': 'Schaumburg', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 42.03336, 'lon': -88.08341}}, {'zip': '62704', 'city': 'Springfield', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 39.80172, 'lon': -89.64371}}, {'zip': '60061', 'city': 'Vernon Hills', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 42.21947, 'lon': -87.97952}}, {'zip': '47714', 'city': 'Evansville', 'state': 'Indiana', 'country': 'United States', 'geoPoint': {'lat': 37.97476, 'lon': -87.55585}}, {'zip': '46804', 'city': 'Fort Wayne', 'state': 'Indiana', 'country': 'United States', 'geoPoint': {'lat': 41.1306, 'lon': -85.12886}}, {'zip': '46601', 'city': 'South Bend', 'state': 'Indiana', 'country': 'United States', 'geoPoint': {'lat': 41.68338, 'lon': -86.25001}}, {'zip': '52401', 'city': 'Cedar Rapids', 'state': 'Iowa', 'country': 'United States', 'geoPoint': {'lat': 42.00833, 'lon': -91.64407}}, {'zip': '64086', 'city': 'Lees Summit', 'state': 'Kansas', 'country': 'United States'}, {'zip': '67208', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '40515', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '70808', 'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}, {'zip': '70810', 'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}, {'zip': '71203', 'city': 'Monroe', 'state': 'Louisiana', 'country': 'United States', 'geoPoint': {'lat': 32.50931, 'lon': -92.1193}}, {'zip': '70121', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '21045', 'city': 'Columbia', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 39.24038, 'lon': -76.83942}}, {'zip': '21042', 'city': 'Ellicott City', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 39.26733, 'lon': -76.79831}}, {'zip': '21702', 'city': 'Frederick', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 39.41427, 'lon': -77.41054}}, {'zip': '20902', 'city': 'Wheaton', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 39.03983, 'lon': -77.05526}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02720', 'city': 'Fall River', 'state': 'Massachusetts', 'country': 'United States', 'geoPoint': {'lat': 41.70149, 'lon': -71.15505}}, {'zip': '39581', 'city': 'Pascagoula', 'state': 'Massachusetts', 'country': 'United States'}, {'zip': '01960', 'city': 'Peabody', 'state': 'Massachusetts', 'country': 'United States', 'geoPoint': {'lat': 42.52787, 'lon': -70.92866}}, {'zip': '02360', 'city': 'Plymouth', 'state': 'Massachusetts', 'country': 'United States', 'geoPoint': {'lat': 41.95844, 'lon': -70.66726}}, {'zip': '01605', 'city': 'Worcester', 'state': 'Massachusetts', 'country': 'United States', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}, {'zip': '01610', 'city': 'Worcester', 'state': 'Massachusetts', 'country': 'United States', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}, {'zip': '49015', 'city': 'Battle Creek', 'state': 'Michigan', 'country': 'United States', 'geoPoint': {'lat': 42.3173, 'lon': -85.17816}}, {'zip': '49048', 'city': 'Kalamazoo', 'state': 'Michigan', 'country': 'United States', 'geoPoint': {'lat': 42.29171, 'lon': -85.58723}}, {'zip': '48910', 'city': 'Lansing', 'state': 'Michigan', 'country': 'United States', 'geoPoint': {'lat': 42.73253, 'lon': -84.55553}}, {'zip': '49770', 'city': 'Petoskey', 'state': 'Michigan', 'country': 'United States', 'geoPoint': {'lat': 45.37334, 'lon': -84.95533}}, {'zip': '48080', 'city': 'Saint Clair Shores', 'state': 'Michigan', 'country': 'United States', 'geoPoint': {'lat': 42.49698, 'lon': -82.88881}}, {'zip': '55805', 'city': 'Duluth', 'state': 'Minnesota', 'country': 'United States', 'geoPoint': {'lat': 46.78327, 'lon': -92.10658}}, {'zip': '55121', 'city': 'Eagan', 'state': 'Minnesota', 'country': 'United States', 'geoPoint': {'lat': 44.80413, 'lon': -93.16689}}, {'zip': '55435', 'city': 'Edina', 'state': 'Minnesota', 'country': 'United States', 'geoPoint': {'lat': 44.88969, 'lon': -93.34995}}, {'zip': '55426', 'city': 'Saint Louis Park', 'state': 'Minnesota', 'country': 'United States', 'geoPoint': {'lat': 44.9483, 'lon': -93.34801}}, {'zip': '39232', 'city': 'Flowood', 'state': 'Mississippi', 'country': 'United States', 'geoPoint': {'lat': 32.30959, 'lon': -90.13898}}, {'zip': '39402', 'city': 'Hattiesburg', 'state': 'Mississippi', 'country': 'United States', 'geoPoint': {'lat': 31.32712, 'lon': -89.29034}}, {'zip': '39202', 'city': 'Jackson', 'state': 'Mississippi', 'country': 'United States', 'geoPoint': {'lat': 32.29876, 'lon': -90.18481}}, {'zip': '38802', 'city': 'Tupelo', 'state': 'Mississippi', 'country': 'United States', 'geoPoint': {'lat': 34.25807, 'lon': -88.70464}}, {'zip': '63031', 'city': 'Florissant', 'state': 'Missouri', 'country': 'United States', 'geoPoint': {'lat': 38.78922, 'lon': -90.32261}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '63117', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '63128', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '63141', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '59901', 'city': 'Kalispell', 'state': 'Montana', 'country': 'United States', 'geoPoint': {'lat': 48.19579, 'lon': -114.31291}}, {'zip': '68803', 'city': 'Grand Island', 'state': 'Nebraska', 'country': 'United States', 'geoPoint': {'lat': 40.92501, 'lon': -98.34201}}, {'zip': '68516', 'city': 'Lincoln', 'state': 'Nebraska', 'country': 'United States', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}, {'zip': '89502', 'city': 'Reno', 'state': 'Nevada', 'country': 'United States', 'geoPoint': {'lat': 39.52963, 'lon': -119.8138}}, {'zip': '03820', 'city': 'Dover', 'state': 'New Hampshire', 'country': 'United States', 'geoPoint': {'lat': 43.19786, 'lon': -70.87367}}, {'zip': '03756', 'city': 'Lebanon', 'state': 'New Hampshire', 'country': 'United States', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}, {'zip': '07012', 'city': 'Clifton', 'state': 'New Jersey', 'country': 'United States', 'geoPoint': {'lat': 40.85843, 'lon': -74.16376}}, {'zip': '08035', 'city': 'Haddon Heights', 'state': 'New Jersey', 'country': 'United States', 'geoPoint': {'lat': 39.87734, 'lon': -75.06462}}, {'zip': '07726', 'city': 'Manalapan', 'state': 'New Jersey', 'country': 'United States', 'geoPoint': {'lat': 40.25733, 'lon': -74.39571}}, {'zip': '07962', 'city': 'Morristown', 'state': 'New Jersey', 'country': 'United States', 'geoPoint': {'lat': 40.79677, 'lon': -74.48154}}, {'zip': '08903', 'city': 'New Brunswick', 'state': 'New Jersey', 'country': 'United States', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}, {'zip': '08360', 'city': 'Trenton', 'state': 'New Jersey', 'country': 'United States', 'geoPoint': {'lat': 40.21705, 'lon': -74.74294}}, {'zip': '08043', 'city': 'Voorhees Township', 'state': 'New Jersey', 'country': 'United States', 'geoPoint': {'lat': 40.4795, 'lon': -74.49062}}, {'zip': '88011', 'city': 'Las Cruces', 'state': 'New Mexico', 'country': 'United States', 'geoPoint': {'lat': 32.31232, 'lon': -106.77834}}, {'zip': '12206', 'city': 'Albany', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}, {'zip': '13905', 'city': 'Binghamton', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 42.09869, 'lon': -75.91797}}, {'zip': '11201', 'city': 'Brooklyn', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}, {'zip': '13326', 'city': 'Cooperstown', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 42.70048, 'lon': -74.92426}}, {'zip': '11557', 'city': 'Hewlett', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.64316, 'lon': -73.69569}}, {'zip': '11042', 'city': 'Lake Success', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.77066, 'lon': -73.71763}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '14760', 'city': 'Olean', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 42.07756, 'lon': -78.42974}}, {'zip': '14127', 'city': 'Orchard Park', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 42.76756, 'lon': -78.74392}}, {'zip': '11803', 'city': 'Plainview', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.77649, 'lon': -73.46735}}, {'zip': '14618', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '11576', 'city': 'Roslyn', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.79982, 'lon': -73.65096}}, {'zip': '11787', 'city': 'Smithtown', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.85593, 'lon': -73.20067}}, {'zip': '13210', 'city': 'Syracuse', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 43.04812, 'lon': -76.14742}}, {'zip': '13504', 'city': 'Utica', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 43.1009, 'lon': -75.23266}}, {'zip': '28803', 'city': 'Asheville', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.60095, 'lon': -82.55402}}, {'zip': '28012', 'city': 'Belmont', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.24292, 'lon': -81.0373}}, {'zip': '28204', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '28207', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '28210', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '27704', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '27834', 'city': 'Greenville', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.61266, 'lon': -77.36635}}, {'zip': '27609', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '29732', 'city': 'Rock Hill', 'state': 'North Carolina', 'country': 'United States'}, {'zip': '28401', 'city': 'Wilmington', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 34.23556, 'lon': -77.94604}}, {'zip': '58501', 'city': 'Bismarck', 'state': 'North Dakota', 'country': 'United States', 'geoPoint': {'lat': 46.80833, 'lon': -100.78374}}, {'zip': '44333', 'city': 'Akron', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 41.08144, 'lon': -81.51901}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '45255', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '43215', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '45402', 'city': 'Dayton', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.75895, 'lon': -84.19161}}, {'zip': '45631', 'city': 'Gallipolis', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 38.8098, 'lon': -82.20237}}, {'zip': '44143', 'city': 'Mayfield', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 41.552, 'lon': -81.43928}}, {'zip': '44130', 'city': 'Middleburg Heights', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 41.36144, 'lon': -81.81291}}, {'zip': '43551', 'city': 'Perryburg', 'state': 'Ohio', 'country': 'United States'}, {'zip': '43701', 'city': 'Zanesville', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.94035, 'lon': -82.01319}}, {'zip': '73103', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '73109', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '74135', 'city': 'Tulsa', 'state': 'Oklahoma', 'country': 'United States', 'geoPoint': {'lat': 36.15398, 'lon': -95.99277}}, {'zip': '97035', 'city': 'Lake Oswego', 'state': 'Oregon', 'country': 'United States', 'geoPoint': {'lat': 45.42067, 'lon': -122.67065}}, {'zip': '18015', 'city': 'Bethlehem', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 40.62593, 'lon': -75.37046}}, {'zip': '17011', 'city': 'Camp Hill', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 40.23981, 'lon': -76.91997}}, {'zip': '16635', 'city': 'Duncansville', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 40.42341, 'lon': -78.4339}}, {'zip': '17042', 'city': 'Lebanon', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 40.34093, 'lon': -76.41135}}, {'zip': '19141', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19152', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19464', 'city': 'Pottstown', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 40.24537, 'lon': -75.64963}}, {'zip': '19611', 'city': 'West Reading', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 40.3337, 'lon': -75.94743}}, {'zip': '15090', 'city': 'Wexford', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 40.62646, 'lon': -80.05589}}, {'zip': '19090', 'city': 'Willow Grove', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 40.144, 'lon': -75.11573}}, {'zip': '29406', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '29204', 'city': 'Columbia', 'state': 'South Carolina', 'country': 'United States', 'geoPoint': {'lat': 34.00071, 'lon': -81.03481}}, {'zip': '28602', 'city': 'Hickory Grove', 'state': 'South Carolina', 'country': 'United States', 'geoPoint': {'lat': 34.98319, 'lon': -81.41648}}, {'zip': '29572', 'city': 'Myrtle Beach', 'state': 'South Carolina', 'country': 'United States', 'geoPoint': {'lat': 33.68906, 'lon': -78.88669}}, {'zip': '37073', 'city': 'Hendersonville', 'state': 'Tennessee', 'country': 'United States', 'geoPoint': {'lat': 36.30477, 'lon': -86.62}}, {'zip': '37343', 'city': 'Hixson', 'state': 'Tennessee', 'country': 'United States', 'geoPoint': {'lat': 35.14063, 'lon': -85.23273}}, {'zip': '38305', 'city': 'Jackson', 'state': 'Tennessee', 'country': 'United States', 'geoPoint': {'lat': 35.61452, 'lon': -88.81395}}, {'zip': '37909', 'city': 'Knoxville', 'state': 'Tennessee', 'country': 'United States', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}, {'zip': '37027', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '79106', 'city': 'Amarillo', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 35.222, 'lon': -101.8313}}, {'zip': '79124', 'city': 'Amarillo', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 35.222, 'lon': -101.8313}}, {'zip': '78705', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '78749', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '75007', 'city': 'Carrollton', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 32.95373, 'lon': -96.89028}}, {'zip': '75231-4406', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75246', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '76107', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '77074', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77090', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '79424', 'city': 'Lubbock', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 33.57786, 'lon': -101.85517}}, {'zip': '75150', 'city': 'Mesquite', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 32.7668, 'lon': -96.59916}}, {'zip': '77058', 'city': 'Nassau Bay', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.54468, 'lon': -95.09104}}, {'zip': '78217', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78258', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '75701', 'city': 'Tyler', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 32.35126, 'lon': -95.30106}}, {'zip': '76708', 'city': 'Waco', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 31.54933, 'lon': -97.14667}}, {'zip': '05401', 'city': 'Burlington', 'state': 'Vermont', 'country': 'United States', 'geoPoint': {'lat': 44.47588, 'lon': -73.21207}}, {'zip': '22205', 'city': 'Arlington', 'state': 'Virginia', 'country': 'United States', 'geoPoint': {'lat': 38.88101, 'lon': -77.10428}}, {'zip': '22015', 'city': 'Burke', 'state': 'Virginia', 'country': 'United States', 'geoPoint': {'lat': 38.79345, 'lon': -77.27165}}, {'zip': '23294', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '23454', 'city': 'Virginia Beach', 'state': 'Virginia', 'country': 'United States', 'geoPoint': {'lat': 36.85293, 'lon': -75.97799}}, {'zip': '98502', 'city': 'Olympia', 'state': 'Washington', 'country': 'United States', 'geoPoint': {'lat': 47.04491, 'lon': -122.90169}}, {'zip': '99204', 'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}, {'zip': '98405', 'city': 'Tacoma', 'state': 'Washington', 'country': 'United States', 'geoPoint': {'lat': 47.25288, 'lon': -122.44429}}, {'zip': '25801', 'city': 'Beckley', 'state': 'West Virginia', 'country': 'United States', 'geoPoint': {'lat': 37.77817, 'lon': -81.18816}}, {'zip': '26301', 'city': 'Clarksburg', 'state': 'West Virginia', 'country': 'United States', 'geoPoint': {'lat': 39.28065, 'lon': -80.34453}}, {'zip': '53045', 'city': 'Brookfield', 'state': 'Wisconsin', 'country': 'United States', 'geoPoint': {'lat': 43.06057, 'lon': -88.10648}}, {'zip': '53132', 'city': 'Franklin', 'state': 'Wisconsin', 'country': 'United States', 'geoPoint': {'lat': 42.88863, 'lon': -88.03842}}, {'zip': '53217', 'city': 'Glendale', 'state': 'Wisconsin', 'country': 'United States', 'geoPoint': {'lat': 43.13529, 'lon': -87.93564}}, {'zip': '53209', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'zip': '54605', 'city': 'Onalaska', 'state': 'Wisconsin', 'country': 'United States', 'geoPoint': {'lat': 43.88441, 'lon': -91.23514}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}