Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
Study NCT ID:
NCT01377012
Status:
COMPLETED
Last Update Posted:
2017-03-29
First Post:
2011-06-17
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Efficacy at 24 Weeks and Safety, Tolerability and Long Term Efficacy up to 2 Years of Secukinumab (AIN457) in Patients With Active Rheumatoid Arthritis and an Inadequate Response to Anti-TNFα Agents
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Peru', 'Romania']}, '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': 'C555450', 'term': 'secukinumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '862-778-8300', 'title': 'Study Director', 'organization': 'Novartis'}, 'certainAgreement': {'otherDetails': "The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.', 'eventGroups': [{'id': 'EG000', 'title': 'Any AIN457 75 mg', 'description': 'Group contains all patients who received AIN 75mg during core period of the study. Includes : participants who were randomized to receive AIN457 i.v (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 injected every 4 weeks + participants who were re-randomized to switch from placebo to AIN457 75 mg at week 16 or week 24 of core study', 'otherNumAtRisk': 301, 'otherNumAffected': 184, 'seriousNumAtRisk': 301, 'seriousNumAffected': 33}, {'id': 'EG001', 'title': 'Any AIN457 150 mg', 'description': 'Group contains all patients from the core and the extension that ever received AIN 150mg. This includes : participants who were randomized to AIN457 150 mg arm to receive AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 injected every 4 weeks + participants who were re-randomized to switch from placebo to AIN457 150 mg at week 16 or week 24 + participants who completed core study in any arm and continued in the extension study to receive AIN457 150 mg as open-label study drug', 'otherNumAtRisk': 392, 'otherNumAffected': 225, 'seriousNumAtRisk': 392, 'seriousNumAffected': 48}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (\\>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16 of core. Responders were switched to active treatment in week 24 of core', 'otherNumAtRisk': 214, 'otherNumAffected': 91, 'seriousNumAtRisk': 214, 'seriousNumAffected': 9}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Dental caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 31}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 63}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 39}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 33}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hypercholesterolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Rheumatoid arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 11}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 10}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 6}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 5}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cardiogenic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cardiopulmonary failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Macular degeneration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Abdominal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Lower gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Disease progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Sudden death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Gangrene', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Gastroenteritis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Gastroenteritis norovirus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Helicobacter gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Infected skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Joint tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Laryngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pneumocystis jirovecii pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Psoas abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Soft tissue infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Staphylococcal osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Streptococcal bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Accidental overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Animal bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Jaw fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Joint injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Radius fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Tendon rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Ulna fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Occult blood positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Transaminases increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Diabetes mellitus inadequate control', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hypoalbuminaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Metabolic acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Acquired claw toe', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Foot deformity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Joint range of motion decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Osteonecrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Osteoporosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Rheumatoid arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Spinal osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Diffuse large B-cell lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Carotid artery insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Carotid artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cerebellar embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cerebral artery embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cerebral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cerebrovascular insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Encephalomalacia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hypoxic-ischaemic encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Lumbar radiculopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'VIIth nerve paralysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Acute psychosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Calculus ureteric', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Ovarian cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Ovarian cyst ruptured', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Arteriosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Femoral artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Thrombophlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Core Study: Change From Baseline and Week 24 in Stanford Health Assessment Questionnaire Disability Index (HAQ-DI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'AIN457 10mg/Kg-75mg', 'description': 'Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks'}, {'id': 'OG001', 'title': 'AIN457 10mg/Kg-150mg', 'description': 'Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (\\>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.35', 'spread': '0.039', 'groupId': 'OG000'}, {'value': '-0.35', 'spread': '0.038', 'groupId': 'OG001'}, {'value': '-0.24', 'spread': '0.051', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'The HAQ-DI assesses a subject\'s level of functional ability and includes questions of fine movements of the upper extremity, locomotor activities of the lower extremity, and activities that involve both upper and lower extremities. There are 20 questions in 8 categories of functioning including dressing, rising, eating, walking, hygiene, reach, grip and usual activities. The stem of each item asks \'Over the past week, "are you able to..." perform a particular task\'. Each item is scored on a 4 point scale from 0 - 3, representing normal, no difficulty (0), some difficulty (1), much difficulty (2) and unable to do (3). The disability index score is calculated as the mean of the available category scores, ranging from 0 to 3. A negative change from baseline indicates improvement.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the full analysis set were considered for the analysis. Participants with measurements at both baseline and week 24 were analyzed. The full analysis set was comprised of all randomized participants (excluding mis-randomized participants) who were assigned to study treatment.'}, {'type': 'SECONDARY', 'title': 'Core Study: Change From Baseline at Week 24 in Van Der Heijde Total Modified Sharp Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}, {'value': '83', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'AIN457 10mg/Kg-75mg', 'description': 'Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks'}, {'id': 'OG001', 'title': 'AIN457 10mg/Kg-150mg', 'description': 'Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (\\>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24'}], 'classes': [{'categories': [{'measurements': [{'value': '0.59', 'spread': '0.62', 'groupId': 'OG000'}, {'value': '0.83', 'spread': '0.68', 'groupId': 'OG001'}, {'value': '1.73', 'spread': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 24', 'description': 'Separate radiographs of each hand/wrist and each foot were taken at basline and Week 24. The radiographs were assessed using the van der Heijde modified Sharp score. The change in the Van der Heijde modified Sharp score is calculated against the baseline value. The total van der Heide modified Sharp score goes from 0 to 448, the bigger the change, the worse it is for the patient.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the full analysis set were considered for the analysis. Participants with measurements at both baseline and week 24 were analyzed.'}, {'type': 'SECONDARY', 'title': 'Core Study Percentage of Patients Achieving Major Clinical Response (Continuous Six-month Period of ACR70 Response During the 1 Year Period) at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '210', 'groupId': 'OG000'}, {'value': '213', 'groupId': 'OG001'}, {'value': '214', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'AIN457 10mg/Kg-75mg', 'description': 'Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks'}, {'id': 'OG001', 'title': 'AIN457 10mg/Kg-150mg', 'description': 'Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (\\>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24'}], 'classes': [{'categories': [{'measurements': [{'value': '2.4', 'groupId': 'OG000'}, {'value': '0.9', 'groupId': 'OG001'}, {'value': '1.4', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '52 week', 'description': "The major clinical response is defined as continuous six-month period of ACR70 response during the 1 year period. ACR70 response was defined as having a positive clinical response to treatment (individual improvement) in disease activity if the participant had at least 70% improvement in tender 68-joint count, swollen 66-joint count and at least 3 of the following 5 measures: patient's assessment of RA pain, patient's global assessment of disease activity, physician's global assessment of disease activity, subject self-assessed disability (Health Assessment Questionnaire \\[HAQ-DI\\] score), and/or acute phase reactant (high sensitivity c-reactive protein (hsCRP) or erythrocyte sedimentation rate (ESR). The ACR70 response results at week 24 used non-responder imputation.", 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full analysis set (FAS) comprised all patients who were randomized and to whom study treatment had been assigned. N=The total number of subjects in the treatment groups with evaluation'}, {'type': 'PRIMARY', 'title': 'Core Study: Percentage of Participants Achieving an American College of Rheumatology Response 20 (ACR20) at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '210', 'groupId': 'OG000'}, {'value': '213', 'groupId': 'OG001'}, {'value': '214', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'AIN457 10mg/Kg-75mg', 'description': 'Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks'}, {'id': 'OG001', 'title': 'AIN457 10mg/Kg-150mg', 'description': 'Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (\\>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24'}], 'classes': [{'categories': [{'measurements': [{'value': '35.2', 'groupId': 'OG000'}, {'value': '35.2', 'groupId': 'OG001'}, {'value': '19.6', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0004', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.21', 'ciLowerLimit': '1.4', 'ciUpperLimit': '3.4', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.0004', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.21', 'ciLowerLimit': '1.4', 'ciUpperLimit': '3.4', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'description': "ACR20 response was defined as having a positive clinical response to treatment (individual improvement) in disease activity if the participant had at least 20% improvement in tender 68-joint count, swollen 66-joint count and at least 3 of the following 5 measures: patient's assessment of RA pain, patient's global assessment of disease activity, physician's global assessment of disease activity, subject self-assessed disability (Health Assessment Questionnaire \\[HAQ-DI\\] score), and/or acute phase reactant (high sensitivity c-reactive protein (hsCRP) or erythrocyte sedimentation rate (ESR). The ACR20 response results at week 24 used non-responder imputation.", 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full analysis set (FAS) comprised all patients who were randomized and to whom study treatment had been assigned.'}, {'type': 'SECONDARY', 'title': 'Extension Phase: Change in Baseline of RA Disease Activity as Measured by Disease Activity Score (DAS28)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'AIN457 10mg/Kg-75mg', 'description': 'Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks'}, {'id': 'OG001', 'title': 'AIN457 10mg/Kg-150mg', 'description': 'Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (\\>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24'}], 'timeFrame': 'week 260', 'description': "The DAS28 score is a measure of RA disease activity calculated using variables such as swollen joint count, the Erythrocyte Sedimentation Rate (ESR) and patient reported assessment of health.\n\nUsing this data, the DAS28 calculation provides a number on a scale from 0-10 indicating the current activity of a patient's RA. A DAS28 score above 5.1 means high disease activity whereas a DAS28 below 3.2 indicates low disease activity. Remission is achieved by a DAS28 score lower than 2.6.", 'reportingStatus': 'POSTED', 'populationDescription': 'The outcome measures were not analyzed, as a result of the lack of efficacy found in study AIN457F2309 and as per changes to the planned analysis plan for CAIN457f2302/E1'}, {'type': 'SECONDARY', 'title': 'Extension Phase: Proportion of Subjects Achieving Low Disease Activity and Good/Moderate European League Against Rheumatism (EULAR) Responses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'AIN457 10mg/Kg-75mg', 'description': 'Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks'}, {'id': 'OG001', 'title': 'AIN457 10mg/Kg-150mg', 'description': 'Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (\\>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24'}], 'timeFrame': 'up to week 260', 'description': 'Low Disease Activity is defined as DAS28 ≤ 3.2. EULAR good response requires an improvement of \\> 1.2 in the DAS28 score with a present score of ≤3.2; EULAR moderate response is defined as an improvement of \\>0.6 to ≤1.2 in DAS28 and a present score of ≤5.1; or an improvement of \\>1.2 and a present score of \\>3.2.', 'reportingStatus': 'POSTED', 'populationDescription': 'The outcome measures were not analyzed, as a result of the lack of efficacy found in study AIN457F2309 and as per changes to the planned analysis plan for CAIN457f2302/E1'}, {'type': 'SECONDARY', 'title': 'Extension Phase: Proportion of Subjects Achieving ACR/(EULAR) Remission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'AIN457 10mg/Kg-75mg', 'description': 'Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks'}, {'id': 'OG001', 'title': 'AIN457 10mg/Kg-150mg', 'description': 'Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (\\>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24'}], 'timeFrame': 'up to week 260', 'description': "ACR/EULAR remission is defined as SDAI ≤ 3.3, where SDAI is a measure of disease activity in RA based on 28 tender and swollen joint counts, CRP, Physician and Patient's Global Assessments of Disease", 'reportingStatus': 'POSTED', 'populationDescription': 'The outcome measures were not analyzed, as a result of the lack of efficacy found in study AIN457F2309 and as per changes to the planned analysis plan for CAIN457f2302/E1'}, {'type': 'SECONDARY', 'title': 'Extension Phase: Changes in Baseline of Quality of Life (Qol) Outcomes Measured by Medical Outcome Short Form SF-36 v2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'AIN457 10mg/Kg-75mg', 'description': 'Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks'}, {'id': 'OG001', 'title': 'AIN457 10mg/Kg-150mg', 'description': 'Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (\\>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24'}], 'timeFrame': 'Baseline, up to week 260', 'description': 'Short Form Health Survey (SF-36) consists of eight subscales that can be scored individually: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. Two overall summary scores, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) also can be computed.', 'reportingStatus': 'POSTED', 'populationDescription': 'The outcome measures were not analyzed, as a result of the lack of efficacy found in study AIN457F2309 and as per changes to the planned analysis plan for CAIN457f2302/E1'}, {'type': 'SECONDARY', 'title': 'Extension Phase: Immunogenicity Against Secukinumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'AIN457 10mg/Kg-75mg', 'description': 'Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks'}, {'id': 'OG001', 'title': 'AIN457 10mg/Kg-150mg', 'description': 'Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (\\>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24'}], 'timeFrame': 'up to week 260', 'reportingStatus': 'POSTED', 'populationDescription': 'The outcome measures were not analyzed, as a result of the lack of efficacy found in study AIN457F2309 and as per changes to the planned analysis plan for CAIN457f2302/E1'}, {'type': 'PRIMARY', 'title': 'Extension Phase: Percentage of Patients Achieving a American College of Rheumatology Response ACR20, ACR50 and ACR70', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'AIN457 10mg/Kg-75mg', 'description': 'Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks'}, {'id': 'OG001', 'title': 'AIN457 10mg/Kg-150mg', 'description': 'Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (\\>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24'}], 'timeFrame': 'up to week 260', 'reportingStatus': 'POSTED', 'populationDescription': 'The outcome measures were not analyzed, as a result of the lack of efficacy found in study AIN457F2309 and as per changes to the planned analysis plan for CAIN457f2302/E1'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'AIN457 10mg/Kg-75mg', 'description': 'Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks up to Week 100, then AIN457 150 mg s.c. starting at week 104'}, {'id': 'FG001', 'title': 'AIN457 10mg/Kg-150mg', 'description': 'Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (\\>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24'}], 'periods': [{'title': 'Core Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '210'}, {'groupId': 'FG001', 'numSubjects': '213'}, {'groupId': 'FG002', 'numSubjects': '214'}]}, {'type': 'wk16 Re-randomized to AIN 75mg NR', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'comment': 'NR=Non-responder', 'groupId': 'FG002', 'numSubjects': '56'}]}, {'type': 'wk16 Re-randomized to AIN 150mg NR', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '53'}]}, {'type': 'wk 24 Re-randomized to AIN 75 mg Res', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'comment': 'Res= responder', 'groupId': 'FG002', 'numSubjects': '38'}]}, {'type': 'wk 24 Re-randomized to AIN 150 mg Res', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '34'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '76'}, {'groupId': 'FG001', 'numSubjects': '81'}, {'groupId': 'FG002', 'numSubjects': '80'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '134'}, {'groupId': 'FG001', 'numSubjects': '132'}, {'groupId': 'FG002', 'numSubjects': '134'}]}], 'dropWithdraws': [{'type': 'Study terminated by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '54'}, {'groupId': 'FG002', 'numSubjects': '46'}]}, {'type': 'Technical problems', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '23'}, {'groupId': 'FG002', 'numSubjects': '18'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '10'}]}, {'type': 'Non-Compliant with study treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'No Longer require treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '28'}, {'groupId': 'FG002', 'numSubjects': '37'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '13'}]}]}, {'title': 'Extension Study, Weeks 104-260', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '57'}, {'groupId': 'FG001', 'numSubjects': '71'}, {'groupId': 'FG002', 'numSubjects': '68'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '57'}, {'groupId': 'FG001', 'numSubjects': '71'}, {'groupId': 'FG002', 'numSubjects': '68'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Study terminated by sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '69'}, {'groupId': 'FG002', 'numSubjects': '63'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'At baseline, participants were randomized to 1 of 3 treatment groups. Placebo non- responders at week 16 were re-randomized to receive AIN457 75mg or AIN457 150mg. Placebo responders at Week16 were re-randomized to receive AIN457 75mg or AIN457 150mg at Week 24.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '210', 'groupId': 'BG000'}, {'value': '213', 'groupId': 'BG001'}, {'value': '214', 'groupId': 'BG002'}, {'value': '637', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'AIN457 10mg/Kg-75mg', 'description': 'Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks'}, {'id': 'BG001', 'title': 'AIN457 10mg/Kg-150mg', 'description': 'Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (\\>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '<65 years', 'categories': [{'measurements': [{'value': '177', 'groupId': 'BG000'}, {'value': '176', 'groupId': 'BG001'}, {'value': '182', 'groupId': 'BG002'}, {'value': '535', 'groupId': 'BG003'}]}]}, {'title': '>=65 years', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '102', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Particpants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '186', 'groupId': 'BG000'}, {'value': '188', 'groupId': 'BG001'}, {'value': '182', 'groupId': 'BG002'}, {'value': '556', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '81', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 637}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2015-09-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-09', 'studyFirstSubmitDate': '2011-06-17', 'resultsFirstSubmitDate': '2016-05-24', 'studyFirstSubmitQcDate': '2011-06-17', 'lastUpdatePostDateStruct': {'date': '2017-03-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-02-09', 'studyFirstPostDateStruct': {'date': '2011-06-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-09-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Core Study: Percentage of Participants Achieving an American College of Rheumatology Response 20 (ACR20) at Week 24', 'timeFrame': 'Week 24', 'description': "ACR20 response was defined as having a positive clinical response to treatment (individual improvement) in disease activity if the participant had at least 20% improvement in tender 68-joint count, swollen 66-joint count and at least 3 of the following 5 measures: patient's assessment of RA pain, patient's global assessment of disease activity, physician's global assessment of disease activity, subject self-assessed disability (Health Assessment Questionnaire \\[HAQ-DI\\] score), and/or acute phase reactant (high sensitivity c-reactive protein (hsCRP) or erythrocyte sedimentation rate (ESR). The ACR20 response results at week 24 used non-responder imputation."}, {'measure': 'Extension Phase: Percentage of Patients Achieving a American College of Rheumatology Response ACR20, ACR50 and ACR70', 'timeFrame': 'up to week 260'}], 'secondaryOutcomes': [{'measure': 'Core Study: Change From Baseline and Week 24 in Stanford Health Assessment Questionnaire Disability Index (HAQ-DI)', 'timeFrame': 'Baseline, Week 24', 'description': 'The HAQ-DI assesses a subject\'s level of functional ability and includes questions of fine movements of the upper extremity, locomotor activities of the lower extremity, and activities that involve both upper and lower extremities. There are 20 questions in 8 categories of functioning including dressing, rising, eating, walking, hygiene, reach, grip and usual activities. The stem of each item asks \'Over the past week, "are you able to..." perform a particular task\'. Each item is scored on a 4 point scale from 0 - 3, representing normal, no difficulty (0), some difficulty (1), much difficulty (2) and unable to do (3). The disability index score is calculated as the mean of the available category scores, ranging from 0 to 3. A negative change from baseline indicates improvement.'}, {'measure': 'Core Study: Change From Baseline at Week 24 in Van Der Heijde Total Modified Sharp Score', 'timeFrame': 'Week 24', 'description': 'Separate radiographs of each hand/wrist and each foot were taken at basline and Week 24. The radiographs were assessed using the van der Heijde modified Sharp score. The change in the Van der Heijde modified Sharp score is calculated against the baseline value. The total van der Heide modified Sharp score goes from 0 to 448, the bigger the change, the worse it is for the patient.'}, {'measure': 'Core Study Percentage of Patients Achieving Major Clinical Response (Continuous Six-month Period of ACR70 Response During the 1 Year Period) at Week 52', 'timeFrame': '52 week', 'description': "The major clinical response is defined as continuous six-month period of ACR70 response during the 1 year period. ACR70 response was defined as having a positive clinical response to treatment (individual improvement) in disease activity if the participant had at least 70% improvement in tender 68-joint count, swollen 66-joint count and at least 3 of the following 5 measures: patient's assessment of RA pain, patient's global assessment of disease activity, physician's global assessment of disease activity, subject self-assessed disability (Health Assessment Questionnaire \\[HAQ-DI\\] score), and/or acute phase reactant (high sensitivity c-reactive protein (hsCRP) or erythrocyte sedimentation rate (ESR). The ACR70 response results at week 24 used non-responder imputation."}, {'measure': 'Extension Phase: Change in Baseline of RA Disease Activity as Measured by Disease Activity Score (DAS28)', 'timeFrame': 'week 260', 'description': "The DAS28 score is a measure of RA disease activity calculated using variables such as swollen joint count, the Erythrocyte Sedimentation Rate (ESR) and patient reported assessment of health.\n\nUsing this data, the DAS28 calculation provides a number on a scale from 0-10 indicating the current activity of a patient's RA. A DAS28 score above 5.1 means high disease activity whereas a DAS28 below 3.2 indicates low disease activity. Remission is achieved by a DAS28 score lower than 2.6."}, {'measure': 'Extension Phase: Proportion of Subjects Achieving Low Disease Activity and Good/Moderate European League Against Rheumatism (EULAR) Responses', 'timeFrame': 'up to week 260', 'description': 'Low Disease Activity is defined as DAS28 ≤ 3.2. EULAR good response requires an improvement of \\> 1.2 in the DAS28 score with a present score of ≤3.2; EULAR moderate response is defined as an improvement of \\>0.6 to ≤1.2 in DAS28 and a present score of ≤5.1; or an improvement of \\>1.2 and a present score of \\>3.2.'}, {'measure': 'Extension Phase: Proportion of Subjects Achieving ACR/(EULAR) Remission', 'timeFrame': 'up to week 260', 'description': "ACR/EULAR remission is defined as SDAI ≤ 3.3, where SDAI is a measure of disease activity in RA based on 28 tender and swollen joint counts, CRP, Physician and Patient's Global Assessments of Disease"}, {'measure': 'Extension Phase: Changes in Baseline of Quality of Life (Qol) Outcomes Measured by Medical Outcome Short Form SF-36 v2', 'timeFrame': 'Baseline, up to week 260', 'description': 'Short Form Health Survey (SF-36) consists of eight subscales that can be scored individually: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. Two overall summary scores, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) also can be computed.'}, {'measure': 'Extension Phase: Immunogenicity Against Secukinumab', 'timeFrame': 'up to week 260'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Rheumatoid Arthritis', 'RA', 'ACR', 'inflammatory joints'], 'conditions': ['Rheumatoid Arthritis']}, 'referencesModule': {'references': [{'pmid': '31087226', 'type': 'DERIVED', 'citation': 'Huang Y, Fan Y, Liu Y, Xie W, Zhang Z. Efficacy and safety of secukinumab in active rheumatoid arthritis with an inadequate response to tumor necrosis factor inhibitors: a meta-analysis of phase III randomized controlled trials. Clin Rheumatol. 2019 Oct;38(10):2765-2776. doi: 10.1007/s10067-019-04595-1. Epub 2019 May 14.'}, {'pmid': '29138986', 'type': 'DERIVED', 'citation': 'Tahir H, Deodhar A, Genovese M, Takeuchi T, Aelion J, Van den Bosch F, Haemmerle S, Richards HB. Secukinumab in Active Rheumatoid Arthritis after Anti-TNFalpha Therapy: A Randomized, Double-Blind Placebo-Controlled Phase 3 Study. Rheumatol Ther. 2017 Dec;4(2):475-488. doi: 10.1007/s40744-017-0086-y. Epub 2017 Nov 14.'}]}, 'descriptionModule': {'briefSummary': 'The core and extension studies assessed the safety and efficacy of secukinumab when added to a background therapy in patients with active rheumatoid arthritis who are intolerant to or have had an inadequate response to anti-TNF-α agents. Patients received either secukinumab, placebo. The core study was completed. However, the extension study was terminated early (unrelated to safety) due to the results of study AIN457F2309, which indicated the efficacy of AIN457 was not comparable to the currently available RA treatment, abatacept, thus leading to closing of the AIN457 RA program.', 'detailedDescription': 'CAIN457F2302 (Core Study): Completed Sep 9 2015\n\nCAIN457F2302E1 (Extension study): terminated early May 26 2015, ((unrelated to safety) due to the results of study AIN457F2309, which indicated the efficacy of AIN457 was not comparable to the currently available RA treatment, abatacept, thus leading to closing of the AIN457 RA program.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Male or non-pregnant, non-lactating female patients\n* Presence of RA classified by American College of Rheumatology (ACR) 2010 revised criteria for at least 3 months before screening\n* At Baseline: Disease activity criteria defined by ≥ 6 tender joints out of 68 and ≥6 swollen joints out of 66 with at least 1 of the following at screening:\n* Anti-Cyclic Citrullinated Peptide (CCP) antibodies positive OR\n\nRheumatoid Factor positive and with at least 1 of the following at screening:\n\n* High sensitivity C-reactive protein (hsCRP) ≥ 10 mg/L OR Erythrocyte sedimentation rate (ESR) ≥ 28 mm/1st hr\n* Patients must have been taking at least one anti-TNF-α agent given at an approved dose for at least 3 months before randomization and have experienced an inadequate response to treatment or have been intolerant to at least one administration of an anti-TNF-α agent\n* Patients must be taking MTX for at least 3 months before randomization and have to be on a stable dose at least 4 weeks before randomization (7.5 to 25 mg/week For Japan only: 6 to 25 mg/week)\n\nExclusion criteria:\n\n* Chest x-ray with evidence of ongoing infectious or malignant process, obtained within 3 months prior to screening and evaluated by a qualified physician RA patients functional status class IV according to the ACR 1991 revised criteria\n* Patients who have ever received biologic immunomodulating agents except for those targeting TNFα\n* Previous treatment with any cell-depleting therapies including but not limited to anti-CD20, investigational agents (e.g., CAMPATH, anti-CD4, anti-CD5, anti-CD3, anti-CD19)\n* Other protocol-defined inclusion/exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT01377012', 'acronym': 'REASSURE', 'briefTitle': 'Efficacy at 24 Weeks and Safety, Tolerability and Long Term Efficacy up to 2 Years of Secukinumab (AIN457) in Patients With Active Rheumatoid Arthritis and an Inadequate Response to Anti-TNFα Agents', 'nctIdAliases': ['NCT01901900'], 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled Study of Secukinumab to Demonstrate the Efficacy at 24 Weeks and to Assess the Safety, Tolerability and Long Term Efficacy up to 2 Years in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Anti-TNFα Agents (CAIN457F2302) and a Three Year Extension Study to Evaluate the Long Term Efficacy, Safety and Tolerability of Secukinumab in Patients With Active Rheumatoid Arthritis (CAIN457F2302E1)', 'orgStudyIdInfo': {'id': 'CAIN457F2302/E1'}, 'secondaryIdInfos': [{'id': '2011-000275-13', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AIN457 10mg/kg-75mg', 'description': 'Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks', 'interventionNames': ['Biological: Secukinumab (AIN457)']}, {'type': 'EXPERIMENTAL', 'label': 'AIN457 10mg/kg-150mg', 'description': 'Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks', 'interventionNames': ['Biological: Secukinumab (AIN457)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (\\>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24', 'interventionNames': ['Biological: Placebo']}], 'interventions': [{'name': 'Secukinumab (AIN457)', 'type': 'BIOLOGICAL', 'otherNames': ['AIN457'], 'description': 'AIN457 (Secukinumab) is a human monoclonal antibody. Secukinumab binds and reduces the activity of Interleukin 17 (IL- 17). AIN457 was given as i.v. (10mg/kg) at baseline, week 2 and week 4, and then s.c. (75 or 150mg) every 4 weeks starting at week 8.', 'armGroupLabels': ['AIN457 10mg/kg-150mg', 'AIN457 10mg/kg-75mg']}, {'name': 'Placebo', 'type': 'BIOLOGICAL', 'description': 'Placebo was given as i.v. at baseline, week 2 and week 4, and then s.c. every 4 weeks starting at week 8.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85202', 'city': 'Mesa', 'state': 'Arizona', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 33.42227, 'lon': -111.82264}}, {'zip': '85253', 'city': 'Paradise Valley', 'state': 'Arizona', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 33.53115, 'lon': -111.94265}}, {'zip': '85381', 'city': 'Peoria', 'state': 'Arizona', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 33.5806, 'lon': -112.23738}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '90502', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '91786', 'city': 'Upland', 'state': 'California', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 34.09751, 'lon': -117.64839}}, {'zip': '33016', 'city': 'Hialeah', 'state': 'Florida', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 25.8576, 'lon': -80.27811}}, {'zip': '33773', 'city': 'Largo', 'state': 'Florida', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 27.90979, 'lon': -82.78842}}, {'zip': '33169', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '34684', 'city': 'Palm Harbor', 'state': 'Florida', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 28.07807, 'lon': -82.76371}}, {'zip': '33143', 'city': 'South Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 25.7076, 'lon': -80.29338}}, {'zip': '33321', 'city': 'Tamarac', 'state': 'Florida', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 26.21286, 'lon': -80.24977}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '33614-7118', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30114', 'city': 'Canton', 'state': 'Georgia', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 34.23676, 'lon': -84.49076}}, {'zip': '42101', 'city': 'Bowling Green', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 36.99032, 'lon': -86.4436}}, {'zip': '20902', 'city': 'Wheaton', 'state': 'Maryland', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 39.03983, 'lon': -77.05526}}, {'zip': '55121', 'city': 'Eagan', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 44.80413, 'lon': -93.16689}}, {'zip': '66160-7330', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '89119', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '28801', 'city': 'Asheville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.60095, 'lon': -82.55402}}, {'zip': '28210', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '27704', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '45631', 'city': 'Gallipolis', 'state': 'Ohio', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 38.8098, 'lon': -82.20237}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '15237', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '29204', 'city': 'Columbia', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 34.00071, 'lon': -81.03481}}, {'zip': '29601', 'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'zip': '38305', 'city': 'Jackson', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.61452, 'lon': -88.81395}}, {'zip': '37604', 'city': 'Johnson City', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 36.31344, 'lon': -82.35347}}, {'zip': '37205', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77034', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77074', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '75150', 'city': 'Mesquite', 'state': 'Texas', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 32.7668, 'lon': -96.59916}}, {'zip': '84132', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': 'C1114AAP', 'city': 'Buenos Aires', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Novartis Investigative Site'}, {'zip': 'C1417EYG', 'city': 'Buenos Aires', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Novartis Investigative Site'}, {'zip': 'C1181ACH', 'city': 'Caba', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Novartis Investigative Site'}, {'zip': 'B8000XAV', 'city': 'Lanús', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': -34.70757, 'lon': -58.39132}}, {'zip': 'C1419AHN', 'city': 'Caba', 'state': 'Buenos Aires F.D.', 'country': 'Argentina', 'facility': 'Novartis Investigative Site'}, {'zip': 'C1428AZF', 'city': 'Ciudad Autonoma de Bs As', 'state': 'Ciudad Autonoma de Bs As', 'country': 'Argentina', 'facility': 'Novartis Investigative Site'}, {'zip': 'X5016KEH', 'city': 'Córdoba', 'state': 'Córdoba Province', 'country': 'Argentina', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': -31.40648, 'lon': -64.18853}}, {'zip': 'S2000CFJ', 'city': 'Rosario', 'state': 'Santa Fe Province', 'country': 'Argentina', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': -32.94682, 'lon': -60.63932}}, {'zip': 'S200BHD', 'city': 'Rosario', 'state': 'Santa Fe Province', 'country': 'Argentina', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': -32.94682, 'lon': -60.63932}}, {'zip': '4000', 'city': 'San Miguel de Tucumán', 'state': 'Tucumán Province', 'country': 'Argentina', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': -26.81601, 'lon': -65.21051}}, {'zip': '1200', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '3600', 'city': 'Genk', 'country': 'Belgium', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 50.965, 'lon': 5.50082}}, {'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': 'R3A 1M3', 'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}, {'zip': 'L2N 7E4', 'city': 'St. Catharines', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 43.17126, 'lon': -79.24267}}, {'zip': 'G1v 3M7', 'city': 'Sainte-Foy', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 46.78139, 'lon': -71.29217}}, {'city': 'Bucaramanga', 'state': 'Colombia', 'country': 'Colombia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 7.125, 'lon': -73.11895}}, {'city': 'Bogotá', 'country': 'Colombia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 4.60971, 'lon': -74.08175}}, {'city': 'Medellín', 'country': 'Colombia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 6.245, 'lon': -75.57151}}, {'zip': '01010', 'city': 'Guatemala City', 'state': 'Departamento de Guatemala', 'country': 'Guatemala', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 14.64072, 'lon': -90.51327}}, {'zip': '01011', 'city': 'Guatemala City', 'state': 'Departamento de Guatemala', 'country': 'Guatemala', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 14.64072, 'lon': -90.51327}}, {'zip': '01015', 'city': 'Guatemala City', 'state': 'Departamento de Guatemala', 'country': 'Guatemala', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 14.64072, 'lon': -90.51327}}, {'zip': '1023', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '1062', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '3300', 'city': 'Eger', 'country': 'Hungary', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 47.90265, 'lon': 20.37329}}, {'zip': '5700', 'city': 'Gyula', 'country': 'Hungary', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 46.65, 'lon': 21.28333}}, {'zip': 'H-8000', 'city': 'Székesfehérvár', 'country': 'Hungary', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 47.18995, 'lon': 18.41034}}, {'zip': '5000', 'city': 'Szolnok', 'country': 'Hungary', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 47.18066, 'lon': 20.19835}}, {'zip': 'H-8200', 'city': 'Veszprém', 'country': 'Hungary', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 47.09327, 'lon': 17.91149}}, {'zip': '500004', 'city': 'Hyderabad', 'state': 'Andhra Pradesh', 'country': 'India', 'facility': 'Novartis Investigative Site'}, {'zip': '560043', 'city': 'Bangalore', 'state': 'Karnataka', 'country': 'India', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}, {'zip': '560054', 'city': 'Bangalore', 'state': 'Karnataka', 'country': 'India', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}, {'zip': '444606', 'city': 'Amravati', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 20.93333, 'lon': 77.75}}, {'zip': '400 053', 'city': 'Mumbai', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 19.07283, 'lon': 72.88261}}, {'zip': '411 007', 'city': 'Pune', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 18.51957, 'lon': 73.85535}}, {'zip': '110 060', 'city': 'New Delhi', 'state': 'National Capital Territory of Delhi', 'country': 'India', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 28.62137, 'lon': 77.2148}}, {'zip': '305 001', 'city': 'Ajmer', 'state': 'Rajasthan', 'country': 'India', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 26.4521, 'lon': 74.63867}}, {'zip': '320013', 'city': 'Jaipur', 'state': 'Rajasthan', 'country': 'India', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 26.91962, 'lon': 75.78781}}, {'zip': '500003', 'city': 'Secunderabad', 'state': 'Telangana', 'country': 'India', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 17.50427, 'lon': 78.54263}}, {'zip': '95100', 'city': 'Catania', 'state': 'CT', 'country': 'Italy', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 37.49223, 'lon': 15.07041}}, {'zip': '50134', 'city': 'Florence', 'state': 'FI', 'country': 'Italy', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'zip': '46020', 'city': 'Pieve di Coriano', 'state': 'MN', 'country': 'Italy', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 45.03388, 'lon': 11.1078}}, {'zip': '53100', 'city': 'Siena', 'state': 'SI', 'country': 'Italy', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 43.31822, 'lon': 11.33064}}, {'zip': '37100', 'city': 'Verona', 'state': 'VR', 'country': 'Italy', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 45.43854, 'lon': 10.9938}}, {'zip': '460-0001', 'city': 'Nagoya', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'zip': '466-8560', 'city': 'Nagoya', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'zip': '260-0801', 'city': 'Chiba', 'state': 'Chiba', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.6, 'lon': 140.11667}}, {'zip': '284-0003', 'city': 'Yotsukaidō', 'state': 'Chiba', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.65, 'lon': 140.16667}}, {'zip': '810-8563', 'city': 'Fukuoka', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'zip': '813-0017', 'city': 'Fukuoka', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'zip': '820-8505', 'city': 'Iizuka', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 33.63654, 'lon': 130.68678}}, {'zip': '807-8556', 'city': 'Kitakyushu', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 33.85181, 'lon': 130.85034}}, {'zip': '370-0053', 'city': 'Takasaki', 'state': 'Gunma', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 36.33333, 'lon': 139.01667}}, {'zip': '733-0032', 'city': 'Hiroshima', 'state': 'Hiroshima', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 34.4, 'lon': 132.45}}, {'zip': '060-0001', 'city': 'Sapporo', 'state': 'Hokkaido', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'zip': '063-0811', 'city': 'Sapporo', 'state': 'Hokkaido', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'zip': '247-8533', 'city': 'Kamakura', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.31085, 'lon': 139.54698}}, {'zip': '210-0013', 'city': 'Kawasaki', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.52056, 'lon': 139.71722}}, {'zip': '228-8522', 'city': 'Sagamihara', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.56707, 'lon': 139.24167}}, {'zip': '231-8682', 'city': 'Yokohama', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}, {'zip': '862-0976', 'city': 'Kumamoto', 'state': 'Kumamoto', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 32.80589, 'lon': 130.69181}}, {'zip': '982-0032', 'city': 'Taihaku-ku', 'state': 'Miyagi', 'country': 'Japan', 'facility': 'Novartis Investigative Site'}, {'zip': '380-8582', 'city': 'Nagano', 'state': 'Nagano', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 36.65, 'lon': 138.18333}}, {'zip': '852-8501', 'city': 'Nagasaki', 'state': 'Nagasaki', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 32.75, 'lon': 129.88333}}, {'zip': '857-1165', 'city': 'Sasebo', 'state': 'Nagasaki', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 33.16834, 'lon': 129.72502}}, {'zip': '710-0016', 'city': 'Kurashiki', 'state': 'Okayama-ken', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 34.58333, 'lon': 133.76667}}, {'zip': '700-8511', 'city': 'Okayama', 'state': 'Okayama-ken', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 34.65, 'lon': 133.93333}}, {'zip': '701-0304', 'city': 'Tsukubo-gun', 'state': 'Okayama-ken', 'country': 'Japan', 'facility': 'Novartis Investigative Site'}, {'zip': '599-0212', 'city': 'Hannan', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 34.33333, 'lon': 135.25}}, {'zip': '586-8521', 'city': 'Kawachi-Nagano', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 34.44108, 'lon': 135.58283}}, {'zip': '545-8586', 'city': 'Osaka', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '350-1103', 'city': 'Kawagoe', 'state': 'Saitama', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.90861, 'lon': 139.48528}}, {'zip': '359-1111', 'city': 'Tokorozawa', 'state': 'Saitama', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.79916, 'lon': 139.46903}}, {'zip': '417-0045', 'city': 'Fuji', 'state': 'Shizuoka', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.16667, 'lon': 138.68333}}, {'zip': '430-8558', 'city': 'Hamamatsu', 'state': 'Shizuoka', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 34.7, 'lon': 137.73333}}, {'zip': '183-8524', 'city': 'Fuchū', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.67452, 'lon': 139.48216}}, {'zip': '174-0071', 'city': 'Itabashi-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Novartis Investigative Site'}, {'zip': '156-0052', 'city': 'Setagaya-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Novartis Investigative Site'}, {'zip': '160-0054', 'city': 'Shinjuku-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Novartis Investigative Site'}, {'zip': '160-8582', 'city': 'Shinjuku-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Novartis Investigative Site'}, {'zip': '933-0874', 'city': 'Takaoka', 'state': 'Toyama', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 36.75, 'lon': 137.01667}}, {'zip': '930-0138', 'city': 'Toyama', 'state': 'Toyama', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 36.7, 'lon': 137.21667}}, {'zip': '752-0976', 'city': 'Shimonoseki', 'state': 'Yamaguchi', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 33.95548, 'lon': 130.93713}}, {'zip': '21100', 'city': 'Mexicali', 'state': 'Estado de Baja California', 'country': 'Mexico', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 32.62781, 'lon': -115.45446}}, {'zip': '21200', 'city': 'Mexicali', 'state': 'Estado de Baja California', 'country': 'Mexico', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 32.62781, 'lon': -115.45446}}, {'zip': '44160', 'city': 'Guadalajara', 'state': 'Jalisco', 'country': 'Mexico', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 20.67738, 'lon': -103.34749}}, {'zip': '06700', 'city': 'Mexico City', 'state': 'Mexico City', 'country': 'Mexico', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'zip': '11850', 'city': 'Mexico City', 'state': 'Mexico City', 'country': 'Mexico', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'zip': '80000', 'city': 'Culiacán', 'state': 'Sinaloa', 'country': 'Mexico', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 24.80209, 'lon': -107.39421}}, {'zip': '0823-01510', 'city': 'Panama City', 'state': 'Provincia de Panamá', 'country': 'Panama', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 8.9936, 'lon': -79.51973}}, {'city': 'Panama City', 'state': 'Provincia de Panamá', 'country': 'Panama', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 8.9936, 'lon': -79.51973}}, {'zip': '00716', 'city': 'Ponce', 'country': 'Puerto Rico', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 18.01031, 'lon': -66.62398}}, {'zip': '00909', 'city': 'San Juan', 'country': 'Puerto Rico', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}, {'zip': '10400', 'city': 'Bangkok', 'state': 'Bangkok', 'country': 'Thailand', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'zip': '10330', 'city': 'Bangkok', 'state': 'THA', 'country': 'Thailand', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'zip': '40002', 'city': 'Khon Kaen', 'state': 'THA', 'country': 'Thailand', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 16.44671, 'lon': 102.833}}, {'zip': '10400', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'zip': '50200', 'city': 'Chiang Mai', 'country': 'Thailand', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 18.79038, 'lon': 98.98468}}, {'zip': '90110', 'city': 'Songkhla', 'country': 'Thailand', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 7.19882, 'lon': 100.5951}}, {'zip': '06100', 'city': 'Ankara', 'state': 'Turkey', 'country': 'Turkey (Türkiye)', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}, {'zip': 'E11 1NR', 'city': 'Leytonstone', 'state': 'London', 'country': 'United Kingdom', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.56856, 'lon': 0.00768}}, {'zip': 'WS11 2XY', 'city': 'Cannock', 'state': 'Staffordshire', 'country': 'United Kingdom', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 52.69045, 'lon': -2.03085}}, {'zip': 'SP2 8BJ', 'city': 'Salisbury', 'country': 'United Kingdom', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.06931, 'lon': -1.79569}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}