Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2026-01-02 @ 6:38 AM
Study NCT ID:
NCT00483756
Status:
COMPLETED
Last Update Posted:
2013-03-14
First Post:
2007-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of a JAK3 Inhibitor for the Prevention of Acute Rejection in Kidney Transplant Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016572', 'term': 'Cyclosporine'}, {'id': 'C479163', 'term': 'tofacitinib'}], 'ancestors': [{'id': 'D003524', 'term': 'Cyclosporins'}, {'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Cyclosporine', 'description': 'Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.', 'otherNumAtRisk': 109, 'otherNumAffected': 105, 'seriousNumAtRisk': 109, 'seriousNumAffected': 65}, {'id': 'EG001', 'title': 'CP-690,550 15 mg for Months 1 to 6', 'description': 'CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.', 'otherNumAtRisk': 106, 'otherNumAffected': 102, 'seriousNumAtRisk': 106, 'seriousNumAffected': 76}, {'id': 'EG002', 'title': 'CP-690,550 15 mg for Months 1 to 3', 'description': 'CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.', 'otherNumAtRisk': 107, 'otherNumAffected': 105, 'seriousNumAtRisk': 107, 'seriousNumAffected': 74}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 46}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 38}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 17}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Polycythaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Thrombocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Left ventricular hypertrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 8}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Visual impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Aphthous stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 35}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 38}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 29}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Gingival hypertrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hiatus hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Mouth ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 29}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 25}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 15}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 19}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 15}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Transplant rejection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 5}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'BK virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 15}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Cytomegalovirus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Cytomegalovirus viraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 18}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Epstein-Barr viraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Folliculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Fungal skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Genital herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Herpes simplex', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Oral candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Polyomavirus-associated nephropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 22}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Arteriovenous fistula thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Complications of transplant surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 6}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Complications of transplanted kidney', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Foot fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Graft complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 14}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Incision site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 11}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Post procedural discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Post procedural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Procedural hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 15}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Wound complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Wound dehiscence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Wound secretion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 15}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Cardiac murmur', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hepatic enzyme increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Liver function test abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Urine output decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Viral test positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 12}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'White blood cell count increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Dyslipidaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Fluid overload', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Glucose tolerance impaired', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hypercalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hypercholesterolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 18}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hyperlipidaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 10}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hyperphosphataemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 11}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hypophosphataemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 10}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Metabolic acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Vitamin D deficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 11}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 20}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Lethargy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Sensory disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 6}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 10}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Bladder spasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 8}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 9}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hydronephrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 4}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Nephropathy toxic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Nocturia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pollakiuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 5}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Polyuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 6}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Renal artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Renal impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Renal tubular necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Urinary incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Erectile dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 2}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Penile pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 2}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Testicular swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 3}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Productive cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Rales', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 18}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Ecchymosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hirsutism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hypertrichosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Night sweats', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Skin lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Incisional drainage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 23}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 13}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Lymphocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 8}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Aplastic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Arrhythmia supraventricular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Electromechanical dissociation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Left ventricular hypertrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Congenital cystic kidney disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Adrenal mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Blindness cortical', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Colitis ischaemic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Diarrhoea haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Diverticulum intestinal haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Haemorrhoidal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Intestinal perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Large intestine perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pancreatitis necrotising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Reflux oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Retroperitoneal haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Brain death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Condition aggravated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Drug interaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Multi-organ failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hepatic function abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Kidney transplant rejection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 5}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Serum sickness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Transplant rejection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 10}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Abdominal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Acute sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Arteriovenous fistula site infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'BK virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Bacterial pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Bacterial sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Bacteriuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Bronchopulmonary aspergillosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Cytomegalovirus colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Cytomegalovirus gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Cytomegalovirus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Cytomegalovirus oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Cytomegalovirus viraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Diarrhoea infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Enterococcal bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Escherichia urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Gangrene', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Genital herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Haematoma infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Herpes ophthalmic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Herpes virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Incision site infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Keratitis herpetic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Klebsiella bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Klebsiella sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Localised infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Lung infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Perinephric abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Peritoneal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pneumocystis jiroveci pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pneumonia respiratory syncytial viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Polyomavirus-associated nephropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Postoperative wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Prostatic abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pseudomonas infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pyelonephritis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Retinitis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Staphylococcal bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Tuberculosis gastrointestinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Urinary tract infection bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Urinary tract infection enterococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Urinary tract infection fungal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Abdominal wound dehiscence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Anaemia postoperative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Arteriovenous fistula thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Chronic allograft nephropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Complications of transplanted kidney', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Compression fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Femoral neck fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Graft complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 5}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Graft dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Graft loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Graft thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Patella fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Perirenal haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Post procedural discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Post procedural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Post procedural haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Post procedural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Postoperative wound complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Renal graft loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Renal lymphocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Subdural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Urethral injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Vascular pseudoaneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Wound dehiscence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Wound secretion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Blood creatine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Blood pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Blood urea increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Electroencephalogram abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hepatic enzyme increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Liver function test abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Transaminases increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Troponin I increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'White blood cell count increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Diabetic ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Fluid overload', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hypercreatininaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Type 2 diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Myopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Myositis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Osteonecrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Rhabdomyolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Spinal column stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Epstein-Barr virus associated lymphoproliferative disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': "Hodgkin's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': "Non-Hodgkin's lymphoma", 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Prostate cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Renal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Areflexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Brain oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Embolic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Intracranial pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Loss of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Bladder irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Bladder spasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Haemorrhage urinary tract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hydronephrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Nephropathy toxic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Polyuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Renal artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Renal artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Renal cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Renal impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Renal tubular necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Renal vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Ureteric obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Urethral stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Urinary fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Urinary incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Urinary tract obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Epididymitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Acute respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Sleep apnoea syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Decubitus ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Bladder catheter removal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Arterial haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Lymphocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Malignant hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Superior vena caval occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Vascular insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With First Clinical Biopsy Proven Acute Rejection (BPAR) Episode 6 Months Post-Transplant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cyclosporine', 'description': 'Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.'}, {'id': 'OG001', 'title': 'CP-690,550 15 mg for Months 1 to 6', 'description': 'CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.'}, {'id': 'OG002', 'title': 'CP-690,550 15 mg for Months 1 to 3', 'description': 'CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Month 6', 'description': 'Clinical BPAR was a BPAR (category acute rejection as interpreted by the central blinded pathologist according to the Banff 97 working classification) associated with an increase in serum creatinine of \\>= 0.3 milligram per deciliter (mg/dL) and \\>=20 percent (%) from pre-rejection baseline. The increase in serum creatinine was assessed based on the comparison of baseline and the highest serum creatinine recorded within 24 hours (hrs) of the time of biopsy.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) with last dosing risk set: all randomized participants who received at least 1 dose of study medication, including events occurring up to 7 days after last dose. Here, N (Number of Participants Analyzed) signifies participants evaluable for this measure.'}, {'type': 'PRIMARY', 'title': 'Glomerular Filtration Rate (GFR) at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cyclosporine', 'description': 'Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.'}, {'id': 'OG001', 'title': 'CP-690,550 15 mg for Months 1 to 6', 'description': 'CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.'}, {'id': 'OG002', 'title': 'CP-690,550 15 mg for Months 1 to 3', 'description': 'CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '54.14', 'spread': '19.12', 'groupId': 'OG000'}, {'value': '65.05', 'spread': '18.81', 'groupId': 'OG001'}, {'value': '65.37', 'spread': '20.77', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2, 3, 4, and 5 hrs post iohexol intravenous bolus at Month 12', 'description': 'GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was calculated using iohexol serum clearance. For determination of iohexol serum clearance, iohexol was administered as an intravenous bolus over 5 minutes immediately after morning dosing of CP-690,550 or CsA on day of GFR evaluation. A normal GFR is greater than (\\>) 90 milliliter per minute (mL/min), although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR less than (\\<) 15 mL/min indicated kidney failure.', 'unitOfMeasure': 'mL/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS: all randomized participants who received at least 1 dose of study medication. Here, N (Number of Participants Analyzed) includes only participants with evaluable data for this measure at Month 12.'}, {'type': 'SECONDARY', 'title': 'Glomerular Filtration Rate (GFR) at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cyclosporine', 'description': 'Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.'}, {'id': 'OG001', 'title': 'CP-690,550 15 mg for Months 1 to 6', 'description': 'CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.'}, {'id': 'OG002', 'title': 'CP-690,550 15 mg for Months 1 to 3', 'description': 'CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '57.29', 'spread': '18.52', 'groupId': 'OG000'}, {'value': '67.54', 'spread': '21.86', 'groupId': 'OG001'}, {'value': '73.93', 'spread': '23.72', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2, 3, 4, and 5 hrs post iohexol intravenous bolus at Month 6', 'description': 'GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was calculated using iohexol serum clearance. For determination of iohexol serum clearance, iohexol was administered as an intravenous bolus over 5 minutes immediately after morning dosing of CP-690,550 or CsA on day of GFR evaluation. A normal GFR is \\>90 mL/min, although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR \\<15 mL/min indicated kidney failure.', 'unitOfMeasure': 'mL/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS: all randomized participants who received at least 1 dose of study medication. Here, N (Number of Participants Analyzed) includes only participants with evaluable data for this measure at Month 6.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Progression of Chronic Allograft Lesions at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cyclosporine', 'description': 'Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.'}, {'id': 'OG001', 'title': 'CP-690,550 15 mg for Months 1 to 6', 'description': 'CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.'}, {'id': 'OG002', 'title': 'CP-690,550 15 mg for Months 1 to 3', 'description': 'CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 12', 'description': 'Progression of chronic allograft lesions was defined as an increase in the Banff chronicity score (Banff-CS) in biopsy from the implantation (baseline) biopsy in a given participant. Banff-CS was the sum of the Banff scores for the 4 chronic basic lesions (allograft glomerulopathy \\[cg\\] + interstitial fibrosis \\[ci\\] + tubular atrophy \\[ct\\] + vascular intimal thickening \\[cv\\]).The Banff-CS ranged from 0-12, higher score indicated greater lesions and Month 12 Banff-CS greater than the implantation biopsy score indicated progression of lesions.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol (PP) population: all randomized participants who received at least 1 dose of study treatment; excluding participants who had a protocol deviation thought to affect the analyses. Here, N (Number of Participants Analyzed) includes only participants with evaluable data for this measure at both baseline and Month 12.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With First Clinical Biopsy Proven Acute Rejection (BPAR) 12 Months Post Transplant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cyclosporine', 'description': 'Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.'}, {'id': 'OG001', 'title': 'CP-690,550 15 mg for Months 1 to 6', 'description': 'CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.'}, {'id': 'OG002', 'title': 'CP-690,550 15 mg for Months 1 to 3', 'description': 'CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Month 12', 'description': 'Clinical BPAR was a BPAR (category acute rejection as interpreted by the central blinded pathologist according to the Banff 97 working classification) associated with an increase in serum creatinine of \\>= 0.3 mg/dL and \\>=20% from pre-rejection baseline. The increase in serum creatinine was assessed based on the comparison of baseline and the highest serum creatinine recorded within 24 hrs of the time of biopsy.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS with last dosing risk set: all randomized participants who received at least 1 dose of study medication, including events occurring up to 7 days after last dose. Here, N (Number of Participants Analyzed) signifies participants evaluable for this measure.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treated Clinical Acute Rejection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cyclosporine', 'description': 'Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.'}, {'id': 'OG001', 'title': 'CP-690,550 15 mg for Months 1 to 6', 'description': 'CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.'}, {'id': 'OG002', 'title': 'CP-690,550 15 mg for Months 1 to 3', 'description': 'CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.'}], 'classes': [{'title': 'Month 6 (n=95,86,80)', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}]}, {'title': 'Month 12 (n=92,76,69)', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 6, 12', 'description': 'Treated clinical acute rejection was defined as an acute rejection episode that was diagnosed based on local biopsy readout and received anti-rejection treatment.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS with last dosing risk set: all randomized participants who received at least 1 dose of study medication, including events occurring up to 7 days after last dose. Here, N (Number of Participants Analyzed): participants evaluable for this measure; and n: participants who remained at risk at given time point for each group, respectively.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Combined Banff Rejection Categories (Categories 2, 3, and 4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '83', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cyclosporine', 'description': 'Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.'}, {'id': 'OG001', 'title': 'CP-690,550 15 mg for Months 1 to 6', 'description': 'CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.'}, {'id': 'OG002', 'title': 'CP-690,550 15 mg for Months 1 to 3', 'description': 'CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.'}], 'classes': [{'title': 'Month 6 (n=100,83,83)', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}]}, {'title': 'Month 12 (n=96,74,71)', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 6, 12', 'description': "Banff 97: standard classification for scoring and classifying rejection of kidney transplant biopsies in 6 diagnostic categories: normal, antibody-mediated rejection, borderline changes: 'suspicious' for acute cellular rejection, acute/active cellular rejection, chronic/sclerosing allograft nephropathy, and other. Combined Banff rejection calculated from categories of antibody-mediated rejection (Category 2) plus borderline changes (Category 3) plus acute rejection (Category 4), as interpreted by the central pathologist.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS with last dosing risk set: all randomized participants who received at least 1 dose of study medication, including events occurring up to 7 days after last dose. Here, N (Number of Participants Analyzed): participants evaluable for this measure; and n: participants who were evaluable at given time point for each group, respectively.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Graft Loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cyclosporine', 'description': 'Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.'}, {'id': 'OG001', 'title': 'CP-690,550 15 mg for Months 1 to 6', 'description': 'CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.'}, {'id': 'OG002', 'title': 'CP-690,550 15 mg for Months 1 to 3', 'description': 'CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.'}], 'classes': [{'title': 'Month 6 (n=85,68,72)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Month 12 (n=79,56,58)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 6, 12', 'description': 'Graft loss was defined as graft nephrectomy, participant death, re-transplantation, or return to dialysis for \\>=6 consecutive weeks.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS with last dosing risk set: all randomized participants who received at least 1 dose of study medication, including events occurring up to 7 days after last dose. Here, N (Number of Participants Analyzed): participants evaluable for this measure; and n: participants who remained at risk at given time point for each group, respectively.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Efficacy Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cyclosporine', 'description': 'Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.'}, {'id': 'OG001', 'title': 'CP-690,550 15 mg for Months 1 to 6', 'description': 'CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.'}, {'id': 'OG002', 'title': 'CP-690,550 15 mg for Months 1 to 3', 'description': 'CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.'}], 'classes': [{'title': 'Month 6 (n=98,84,80)', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}]}, {'title': 'Month 12 (n=94,74,67)', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 6, 12', 'description': 'Efficacy failure was the first occurrence of clinical BPAR diagnosed by the central pathologist or graft loss including participant death.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS with last dosing risk set: all randomized participants who received at least 1 dose of study medication, including events occurring up to 7 days after last dose. Here, N (Number of Participants Analyzed): participants evaluable for this measure; and n: participants who remained at risk at given time point for each group, respectively.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Died', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cyclosporine', 'description': 'Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.'}, {'id': 'OG001', 'title': 'CP-690,550 15 mg for Months 1 to 6', 'description': 'CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.'}, {'id': 'OG002', 'title': 'CP-690,550 15 mg for Months 1 to 3', 'description': 'CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.'}], 'classes': [{'title': 'Month 6 (n=86,69,69)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Month 12 (n=80,57,55)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 6, 12', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS with last dosing risk set: all randomized participants who received at least 1 dose of study medication, including events occurring up to 7 days after last dose. Here, N (Number of Participants Analyzed): participants evaluable for this measure; and n: participants who remained at risk at given time point for each group, respectively.'}, {'type': 'SECONDARY', 'title': 'Lymphocyte Subset', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cyclosporine', 'description': 'Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.'}, {'id': 'OG001', 'title': 'CP-690,550 15 mg for Months 1 to 6', 'description': 'CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.'}, {'id': 'OG002', 'title': 'CP-690,550 15 mg for Months 1 to 3', 'description': 'CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.'}], 'classes': [{'title': 'CD3: Month 1 (n=60,54,47)', 'categories': [{'measurements': [{'value': '1555.0', 'spread': '925.45', 'groupId': 'OG000'}, {'value': '1256.7', 'spread': '708.47', 'groupId': 'OG001'}, {'value': '1327.2', 'spread': '627.74', 'groupId': 'OG002'}]}]}, {'title': 'CD3: Month 3 (n=59,44,34)', 'categories': [{'measurements': [{'value': '1273.2', 'spread': '742.82', 'groupId': 'OG000'}, {'value': '894.20', 'spread': '527.87', 'groupId': 'OG001'}, {'value': '1007.1', 'spread': '447.91', 'groupId': 'OG002'}]}]}, {'title': 'CD3: Month 6 (n=47,34,31)', 'categories': [{'measurements': [{'value': '1267.9', 'spread': '693.20', 'groupId': 'OG000'}, {'value': '811.74', 'spread': '379.16', 'groupId': 'OG001'}, {'value': '970.39', 'spread': '410.28', 'groupId': 'OG002'}]}]}, {'title': 'CD3: Month 12 (n=45,29,26)', 'categories': [{'measurements': [{'value': '1352.5', 'spread': '647.60', 'groupId': 'OG000'}, {'value': '796.76', 'spread': '368.51', 'groupId': 'OG001'}, {'value': '956.04', 'spread': '522.08', 'groupId': 'OG002'}]}]}, {'title': 'CD19: Month 1 (n=60,54,47)', 'categories': [{'measurements': [{'value': '280.58', 'spread': '220.96', 'groupId': 'OG000'}, {'value': '409.39', 'spread': '339.45', 'groupId': 'OG001'}, {'value': '416.70', 'spread': '304.95', 'groupId': 'OG002'}]}]}, {'title': 'CD19: Month 3 (n=58,44,34)', 'categories': [{'measurements': [{'value': '154.47', 'spread': '208.07', 'groupId': 'OG000'}, {'value': '189.41', 'spread': '190.23', 'groupId': 'OG001'}, {'value': '185.68', 'spread': '139.24', 'groupId': 'OG002'}]}]}, {'title': 'CD19: Month 6 (n=47,34,31)', 'categories': [{'measurements': [{'value': '125.26', 'spread': '164.65', 'groupId': 'OG000'}, {'value': '151.03', 'spread': '129.52', 'groupId': 'OG001'}, {'value': '173.10', 'spread': '136.53', 'groupId': 'OG002'}]}]}, {'title': 'CD19: Month 12 (n=45,29,26)', 'categories': [{'measurements': [{'value': '120.18', 'spread': '117.14', 'groupId': 'OG000'}, {'value': '180.03', 'spread': '235.85', 'groupId': 'OG001'}, {'value': '181.46', 'spread': '141.45', 'groupId': 'OG002'}]}]}, {'title': 'CD56: Month 1 (n=60,54,47)', 'categories': [{'measurements': [{'value': '166.47', 'spread': '93.95', 'groupId': 'OG000'}, {'value': '116.65', 'spread': '110.62', 'groupId': 'OG001'}, {'value': '112.23', 'spread': '110.25', 'groupId': 'OG002'}]}]}, {'title': 'CD56: Month 3 (n=58,44,34)', 'categories': [{'measurements': [{'value': '143.14', 'spread': '86.42', 'groupId': 'OG000'}, {'value': '86.86', 'spread': '97.80', 'groupId': 'OG001'}, {'value': '65.38', 'spread': '38.91', 'groupId': 'OG002'}]}]}, {'title': 'CD56: Month 6 (n=47,34,31)', 'categories': [{'measurements': [{'value': '170.23', 'spread': '123.27', 'groupId': 'OG000'}, {'value': '68.06', 'spread': '63.85', 'groupId': 'OG001'}, {'value': '65.00', 'spread': '48.86', 'groupId': 'OG002'}]}]}, {'title': 'CD56: Month 12 (n=45,29,26)', 'categories': [{'measurements': [{'value': '168.91', 'spread': '122.80', 'groupId': 'OG000'}, {'value': '96.00', 'spread': '100.85', 'groupId': 'OG001'}, {'value': '77.23', 'spread': '57.74', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 1, 3, 6, 12', 'description': 'The absolute cell counts of cluster of differentiation 3 (CD3): T-lymphocytes, cluster of differentiation 19 (CD19): B-lymphocytes, and cluster of differentiation 56 (CD56): assumed natural killer cells, were determined using flow cytometry.', 'unitOfMeasure': 'cells per microliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS: all randomized participants who received at least 1 dose of study medication. Here, N (Number of Participants Analyzed) signifies participants evaluable for this measure; and 'n' signifies those participants who were evaluable at given time point for each group, respectively."}, {'type': 'SECONDARY', 'title': 'Population Pharmacokinetics (PK)', 'paramType': 'MEAN', 'timeFrame': 'Pre-dose-2(P-2), Pre-dose(P), 0.5,1,2 hr post-dose(PD) on Day14, Month(M) 3; P,1,2 hr PD on M1; P, 0.5, 2, 4 hr PD on M6; P-2, P, 0.5 hr PD on M9, M12 as per randomization in CP-690,550 treated; P on M3 and P, 2, 4 hr PD on M6 in CsA treated participants', 'description': 'Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.', 'unitOfMeasure': 'nanogram*hour per milliliter (ng*hr/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Glomerular Filtration Rate (GFR) by The Nankivell Equation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cyclosporine', 'description': 'Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.'}, {'id': 'OG001', 'title': 'CP-690,550 15 mg for Months 1 to 6', 'description': 'CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.'}, {'id': 'OG002', 'title': 'CP-690,550 15 mg for Months 1 to 3', 'description': 'CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.'}], 'classes': [{'title': 'Month 1', 'categories': [{'measurements': [{'value': '65.85', 'spread': '19.73', 'groupId': 'OG000'}, {'value': '71.53', 'spread': '17.72', 'groupId': 'OG001'}, {'value': '73.66', 'spread': '16.53', 'groupId': 'OG002'}]}]}, {'title': 'Month 3', 'categories': [{'measurements': [{'value': '65.80', 'spread': '17.88', 'groupId': 'OG000'}, {'value': '73.58', 'spread': '18.46', 'groupId': 'OG001'}, {'value': '72.91', 'spread': '16.90', 'groupId': 'OG002'}]}]}, {'title': 'Month 6', 'categories': [{'measurements': [{'value': '66.75', 'spread': '18.75', 'groupId': 'OG000'}, {'value': '73.23', 'spread': '18.26', 'groupId': 'OG001'}, {'value': '74.49', 'spread': '16.81', 'groupId': 'OG002'}]}]}, {'title': 'Month 9', 'categories': [{'measurements': [{'value': '66.85', 'spread': '20.33', 'groupId': 'OG000'}, {'value': '74.29', 'spread': '18.23', 'groupId': 'OG001'}, {'value': '74.22', 'spread': '16.78', 'groupId': 'OG002'}]}]}, {'title': 'Month 12', 'categories': [{'measurements': [{'value': '66.88', 'spread': '21.87', 'groupId': 'OG000'}, {'value': '75.58', 'spread': '18.54', 'groupId': 'OG001'}, {'value': '75.41', 'spread': '17.50', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 1, 3, 6, 9, 12', 'description': 'GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was measured directly or estimated using established formulas. GFR was calculated was estimated by creatinine clearance (CLcr) using Nankivell equation. CLcr by Nankivell equation= (6.7 per serum creatinine) plus (0.25\\*body weight) minus (0.5\\*serum urea) minus (100 per height square) plus (35 for male/25 for female). A normal GFR is \\>90 mL/min, although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR \\<15 mL/min indicated kidney failure.', 'unitOfMeasure': 'mL/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS: all randomized participants who received at least 1 dose of study medication. Here, N (Number of Participants Analyzed) signifies participants evaluable for this measure. Missing data were imputed using Last Observation Carried Forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Glomerular Filtration Rate (GFR) by The Cockcroft-Gault Equation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cyclosporine', 'description': 'Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.'}, {'id': 'OG001', 'title': 'CP-690,550 15 mg for Months 1 to 6', 'description': 'CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.'}, {'id': 'OG002', 'title': 'CP-690,550 15 mg for Months 1 to 3', 'description': 'CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.'}], 'classes': [{'title': 'Month 1', 'categories': [{'measurements': [{'value': '67.23', 'spread': '23.84', 'groupId': 'OG000'}, {'value': '71.12', 'spread': '23.31', 'groupId': 'OG001'}, {'value': '73.55', 'spread': '20.62', 'groupId': 'OG002'}]}]}, {'title': 'Month 3', 'categories': [{'measurements': [{'value': '68.08', 'spread': '23.19', 'groupId': 'OG000'}, {'value': '74.41', 'spread': '25.76', 'groupId': 'OG001'}, {'value': '74.16', 'spread': '22.45', 'groupId': 'OG002'}]}]}, {'title': 'Month 6', 'categories': [{'measurements': [{'value': '69.21', 'spread': '23.66', 'groupId': 'OG000'}, {'value': '74.71', 'spread': '25.87', 'groupId': 'OG001'}, {'value': '76.30', 'spread': '23.11', 'groupId': 'OG002'}]}]}, {'title': 'Month 9', 'categories': [{'measurements': [{'value': '70.05', 'spread': '25.15', 'groupId': 'OG000'}, {'value': '76.41', 'spread': '25.62', 'groupId': 'OG001'}, {'value': '76.40', 'spread': '24.20', 'groupId': 'OG002'}]}]}, {'title': 'Month 12', 'categories': [{'measurements': [{'value': '69.67', 'spread': '25.64', 'groupId': 'OG000'}, {'value': '78.41', 'spread': '27.62', 'groupId': 'OG001'}, {'value': '78.09', 'spread': '24.69', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 1, 3, 6, 9, 12', 'description': 'GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was measured directly or estimated using established formulas. GFR was calculated using Cockcroft-Gault equation. GFR by Cockcroft-Gault equation= body weight\\*(140 minus age in years) divided by (72\\*serum creatinine). For females value obtained was multiplied by 0.85. A normal GFR is \\>90 mL/min, although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR \\<15 mL/min indicated kidney failure.', 'unitOfMeasure': 'mL/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS: all randomized participants who received at least 1 dose of study medication. Here, N (Number of Participants Analyzed) signifies participants evaluable for this measure. Missing data were imputed using LOCF.'}, {'type': 'SECONDARY', 'title': 'Glomerular Filtration Rate (GFR) by The Modification of Diet in Renal Disease (MDRD) Equation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cyclosporine', 'description': 'Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.'}, {'id': 'OG001', 'title': 'CP-690,550 15 mg for Months 1 to 6', 'description': 'CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.'}, {'id': 'OG002', 'title': 'CP-690,550 15 mg for Months 1 to 3', 'description': 'CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.'}], 'classes': [{'title': 'Month 1', 'categories': [{'measurements': [{'value': '52.89', 'spread': '20.05', 'groupId': 'OG000'}, {'value': '59.93', 'spread': '17.54', 'groupId': 'OG001'}, {'value': '63.61', 'spread': '21.00', 'groupId': 'OG002'}]}]}, {'title': 'Month 3', 'categories': [{'measurements': [{'value': '53.55', 'spread': '18.83', 'groupId': 'OG000'}, {'value': '62.20', 'spread': '17.16', 'groupId': 'OG001'}, {'value': '62.81', 'spread': '20.04', 'groupId': 'OG002'}]}]}, {'title': 'Month 6', 'categories': [{'measurements': [{'value': '54.16', 'spread': '19.21', 'groupId': 'OG000'}, {'value': '61.84', 'spread': '17.71', 'groupId': 'OG001'}, {'value': '64.04', 'spread': '19.63', 'groupId': 'OG002'}]}]}, {'title': 'Month 9', 'categories': [{'measurements': [{'value': '54.11', 'spread': '20.45', 'groupId': 'OG000'}, {'value': '62.98', 'spread': '17.50', 'groupId': 'OG001'}, {'value': '63.61', 'spread': '18.82', 'groupId': 'OG002'}]}]}, {'title': 'Month 12', 'categories': [{'measurements': [{'value': '53.94', 'spread': '21.36', 'groupId': 'OG000'}, {'value': '64.25', 'spread': '18.28', 'groupId': 'OG001'}, {'value': '64.59', 'spread': '20.35', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 1, 3, 6, 9, 12', 'description': 'GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was calculated using MDRD equation. GFR by MDRD equation = 170 \\* (serum creatinine)\\^(-0.999) \\* (age in years)\\^(-0.176) \\* (0.762 if female) \\* (1.18 if black) \\* (blood urea nitrogen concentration)\\^(-0.170) \\* (serum albumin concentration)\\^(0.318).A normal GFR is \\>90 mL/min/1.73 square meter (m\\^2), although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR \\<15 mL/min/1.73 m\\^2 indicated kidney failure.', 'unitOfMeasure': 'mL/min/1.73 m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS: all randomized participants who received at least 1 dose of study medication. Here, N (Number of Participants Analyzed) signifies participants evaluable for this measure. Missing data were imputed using LOCF.'}, {'type': 'SECONDARY', 'title': 'Glomerular Filtration Rate (GFR) by The Abbreviated Modification of Diet in Renal Disease (MDRD) Equation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cyclosporine', 'description': 'Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.'}, {'id': 'OG001', 'title': 'CP-690,550 15 mg for Months 1 to 6', 'description': 'CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.'}, {'id': 'OG002', 'title': 'CP-690,550 15 mg for Months 1 to 3', 'description': 'CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.'}], 'classes': [{'title': 'Month 1', 'categories': [{'measurements': [{'value': '55.29', 'spread': '21.96', 'groupId': 'OG000'}, {'value': '61.49', 'spread': '18.66', 'groupId': 'OG001'}, {'value': '64.81', 'spread': '21.15', 'groupId': 'OG002'}]}]}, {'title': 'Month 3', 'categories': [{'measurements': [{'value': '54.36', 'spread': '19.28', 'groupId': 'OG000'}, {'value': '62.45', 'spread': '18.39', 'groupId': 'OG001'}, {'value': '62.27', 'spread': '19.71', 'groupId': 'OG002'}]}]}, {'title': 'Month 6', 'categories': [{'measurements': [{'value': '55.01', 'spread': '20.22', 'groupId': 'OG000'}, {'value': '61.49', 'spread': '18.10', 'groupId': 'OG001'}, {'value': '63.33', 'spread': '19.74', 'groupId': 'OG002'}]}]}, {'title': 'Month 9', 'categories': [{'measurements': [{'value': '55.39', 'spread': '22.09', 'groupId': 'OG000'}, {'value': '62.52', 'spread': '17.86', 'groupId': 'OG001'}, {'value': '62.76', 'spread': '18.55', 'groupId': 'OG002'}]}]}, {'title': 'Month 12', 'categories': [{'measurements': [{'value': '54.99', 'spread': '24.15', 'groupId': 'OG000'}, {'value': '63.88', 'spread': '18.40', 'groupId': 'OG001'}, {'value': '64.17', 'spread': '19.94', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 1, 3, 6, 9, 12', 'description': 'GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was measured directly or estimated using established formulas. GFR was calculated using abbreviated MDRD equation. GFR by abbreviated MDRD equation= 186 \\* (serum creatinine)\\^(-1.154) \\* (age in years)\\^(-0.203) \\* (0.742 if female) \\* (1.210 if black). A normal GFR is \\>90 mL/min/1.73 m\\^2, although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR \\<15 mL/min/1.73 m\\^2 indicated kidney failure.', 'unitOfMeasure': 'mL/min per 1.73 m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS: all randomized participants who received at least 1 dose of study medication. Here, N (Number of Participants Analyzed) signifies participants evaluable for this measure. Missing data were imputed using LOCF.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinically Significant Infections', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}, {'value': '107', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cyclosporine', 'description': 'Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.'}, {'id': 'OG001', 'title': 'CP-690,550 15 mg for Months 1 to 6', 'description': 'CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.'}, {'id': 'OG002', 'title': 'CP-690,550 15 mg for Months 1 to 3', 'description': 'CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '83', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Month 12', 'description': 'Clinically significant infection was defined as the presence of documented infection confirmed by culture, biopsy, genomic, or serologic findings post-randomization and requiring hospitalization or parenteral anti-infective treatment, or otherwise deemed significant by the investigator.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS: all randomized participants who received at least 1 dose of study medication.'}, {'type': 'SECONDARY', 'title': '36-Item Short-Form Health Survey (SF-36)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cyclosporine', 'description': 'Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.'}, {'id': 'OG001', 'title': 'CP-690,550 15 mg for Months 1 to 6', 'description': 'CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.'}, {'id': 'OG002', 'title': 'CP-690,550 15 mg for Months 1 to 3', 'description': 'CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.'}], 'classes': [{'title': 'Baseline: Bodily Pain (n=79,68,71)', 'categories': [{'measurements': [{'value': '52.89', 'spread': '9.45', 'groupId': 'OG000'}, {'value': '51.43', 'spread': '10.56', 'groupId': 'OG001'}, {'value': '49.56', 'spread': '10.59', 'groupId': 'OG002'}]}]}, {'title': 'Baseline: General Health (n=79,68,72)', 'categories': [{'measurements': [{'value': '44.77', 'spread': '9.28', 'groupId': 'OG000'}, {'value': '42.46', 'spread': '10.63', 'groupId': 'OG001'}, {'value': '42.39', 'spread': '9.68', 'groupId': 'OG002'}]}]}, {'title': 'Baseline: Mental Health (n=78,68,72)', 'categories': [{'measurements': [{'value': '49.15', 'spread': '9.13', 'groupId': 'OG000'}, {'value': '44.85', 'spread': '12.75', 'groupId': 'OG001'}, {'value': '48.69', 'spread': '11.33', 'groupId': 'OG002'}]}]}, {'title': 'Baseline: Physical Functioning (n=79,68,72)', 'categories': [{'measurements': [{'value': '44.03', 'spread': '10.03', 'groupId': 'OG000'}, {'value': '44.46', 'spread': '9.58', 'groupId': 'OG001'}, {'value': '45.88', 'spread': '9.52', 'groupId': 'OG002'}]}]}, {'title': 'Baseline: Role Emotional (n=79,68,71)', 'categories': [{'measurements': [{'value': '46.19', 'spread': '11.75', 'groupId': 'OG000'}, {'value': '43.82', 'spread': '13.80', 'groupId': 'OG001'}, {'value': '43.79', 'spread': '13.62', 'groupId': 'OG002'}]}]}, {'title': 'Baseline: Role Physical (n=79,68,71)', 'categories': [{'measurements': [{'value': '41.26', 'spread': '11.86', 'groupId': 'OG000'}, {'value': '42.28', 'spread': '12.56', 'groupId': 'OG001'}, {'value': '42.51', 'spread': '12.32', 'groupId': 'OG002'}]}]}, {'title': 'Baseline: Social Functioning (n=79,68,72)', 'categories': [{'measurements': [{'value': '47.42', 'spread': '8.98', 'groupId': 'OG000'}, {'value': '41.14', 'spread': '12.42', 'groupId': 'OG001'}, {'value': '44.38', 'spread': '11.54', 'groupId': 'OG002'}]}]}, {'title': 'Baseline: Vitality (n=78,68,72)', 'categories': [{'measurements': [{'value': '49.77', 'spread': '10.81', 'groupId': 'OG000'}, {'value': '48.04', 'spread': '12.38', 'groupId': 'OG001'}, {'value': '50.29', 'spread': '10.57', 'groupId': 'OG002'}]}]}, {'title': 'Baseline: Physical Component (n=78,68,71)', 'categories': [{'measurements': [{'value': '44.85', 'spread': '9.38', 'groupId': 'OG000'}, {'value': '45.85', 'spread': '8.35', 'groupId': 'OG001'}, {'value': '45.05', 'spread': '8.58', 'groupId': 'OG002'}]}]}, {'title': 'Baseline: Mental Component (n=78,68,71)', 'categories': [{'measurements': [{'value': '49.41', 'spread': '9.66', 'groupId': 'OG000'}, {'value': '44.18', 'spread': '13.27', 'groupId': 'OG001'}, {'value': '47.13', 'spread': '11.54', 'groupId': 'OG002'}]}]}, {'title': 'Baseline: Q2-Health in General Now (n=80,68,72)', 'categories': [{'measurements': [{'value': '2.78', 'spread': '0.62', 'groupId': 'OG000'}, {'value': '2.57', 'spread': '0.78', 'groupId': 'OG001'}, {'value': '2.63', 'spread': '0.74', 'groupId': 'OG002'}]}]}, {'title': 'Month 6: Bodily Pain (n=78,63,65)', 'categories': [{'measurements': [{'value': '51.87', 'spread': '9.55', 'groupId': 'OG000'}, {'value': '49.76', 'spread': '11.49', 'groupId': 'OG001'}, {'value': '50.88', 'spread': '10.10', 'groupId': 'OG002'}]}]}, {'title': 'Month 6: General Health (n=78,63,65)', 'categories': [{'measurements': [{'value': '47.87', 'spread': '9.00', 'groupId': 'OG000'}, {'value': '46.70', 'spread': '10.31', 'groupId': 'OG001'}, {'value': '47.36', 'spread': '9.79', 'groupId': 'OG002'}]}]}, {'title': 'Month 6: Mental Health (n=78,63,65)', 'categories': [{'measurements': [{'value': '50.47', 'spread': '10.69', 'groupId': 'OG000'}, {'value': '48.35', 'spread': '12.48', 'groupId': 'OG001'}, {'value': '48.81', 'spread': '10.97', 'groupId': 'OG002'}]}]}, {'title': 'Month 6: Physical Functioning (n=77,63,65)', 'categories': [{'measurements': [{'value': '47.06', 'spread': '9.96', 'groupId': 'OG000'}, {'value': '45.74', 'spread': '11.08', 'groupId': 'OG001'}, {'value': '46.91', 'spread': '10.50', 'groupId': 'OG002'}]}]}, {'title': 'Month 6: Role Emotional (n=77,63,65)', 'categories': [{'measurements': [{'value': '48.06', 'spread': '11.15', 'groupId': 'OG000'}, {'value': '45.40', 'spread': '11.82', 'groupId': 'OG001'}, {'value': '46.77', 'spread': '11.87', 'groupId': 'OG002'}]}]}, {'title': 'Month 6: Role Physical (n=77,63,65)', 'categories': [{'measurements': [{'value': '46.48', 'spread': '10.44', 'groupId': 'OG000'}, {'value': '43.11', 'spread': '12.14', 'groupId': 'OG001'}, {'value': '45.87', 'spread': '10.80', 'groupId': 'OG002'}]}]}, {'title': 'Month 6: Social Functioning (n=78,63,65)', 'categories': [{'measurements': [{'value': '50.34', 'spread': '8.64', 'groupId': 'OG000'}, {'value': '45.14', 'spread': '12.21', 'groupId': 'OG001'}, {'value': '47.88', 'spread': '10.15', 'groupId': 'OG002'}]}]}, {'title': 'Month 6: Vitality (n=78,63,65)', 'categories': [{'measurements': [{'value': '54.22', 'spread': '9.70', 'groupId': 'OG000'}, {'value': '52.13', 'spread': '11.14', 'groupId': 'OG001'}, {'value': '51.95', 'spread': '10.49', 'groupId': 'OG002'}]}]}, {'title': 'Month 6: Physical Component (n=77,63,65)', 'categories': [{'measurements': [{'value': '47.93', 'spread': '8.27', 'groupId': 'OG000'}, {'value': '46.22', 'spread': '10.76', 'groupId': 'OG001'}, {'value': '47.82', 'spread': '9.24', 'groupId': 'OG002'}]}]}, {'title': 'Month 6: Mental Component (n=77,63,65)', 'categories': [{'measurements': [{'value': '51.60', 'spread': '9.43', 'groupId': 'OG000'}, {'value': '48.30', 'spread': '11.82', 'groupId': 'OG001'}, {'value': '49.09', 'spread': '10.91', 'groupId': 'OG002'}]}]}, {'title': 'Month 6: Q2-Health in General Now (n=78,63,65)', 'categories': [{'measurements': [{'value': '2.74', 'spread': '0.73', 'groupId': 'OG000'}, {'value': '2.65', 'spread': '0.77', 'groupId': 'OG001'}, {'value': '2.72', 'spread': '0.63', 'groupId': 'OG002'}]}]}, {'title': 'Month 12: Bodily Pain (n=73,58,56)', 'categories': [{'measurements': [{'value': '51.12', 'spread': '9.23', 'groupId': 'OG000'}, {'value': '51.07', 'spread': '10.24', 'groupId': 'OG001'}, {'value': '49.48', 'spread': '10.95', 'groupId': 'OG002'}]}]}, {'title': 'Month 12: General Health (n=73,57,56)', 'categories': [{'measurements': [{'value': '48.94', 'spread': '8.74', 'groupId': 'OG000'}, {'value': '46.79', 'spread': '8.71', 'groupId': 'OG001'}, {'value': '44.71', 'spread': '10.02', 'groupId': 'OG002'}]}]}, {'title': 'Month 12: Mental Health (n=73,57,56)', 'categories': [{'measurements': [{'value': '51.93', 'spread': '9.24', 'groupId': 'OG000'}, {'value': '49.43', 'spread': '10.98', 'groupId': 'OG001'}, {'value': '46.91', 'spread': '10.77', 'groupId': 'OG002'}]}]}, {'title': 'Month 12: Physical Functioning (n=73,58,56)', 'categories': [{'measurements': [{'value': '47.19', 'spread': '10.26', 'groupId': 'OG000'}, {'value': '46.88', 'spread': '10.16', 'groupId': 'OG001'}, {'value': '46.99', 'spread': '11.01', 'groupId': 'OG002'}]}]}, {'title': 'Month 12: Role Emotional (n=71,57,56)', 'categories': [{'measurements': [{'value': '46.13', 'spread': '12.36', 'groupId': 'OG000'}, {'value': '47.31', 'spread': '9.15', 'groupId': 'OG001'}, {'value': '46.21', 'spread': '12.27', 'groupId': 'OG002'}]}]}, {'title': 'Month 12: Role Physical (n=71,57,56)', 'categories': [{'measurements': [{'value': '46.57', 'spread': '9.68', 'groupId': 'OG000'}, {'value': '44.19', 'spread': '10.73', 'groupId': 'OG001'}, {'value': '45.20', 'spread': '11.47', 'groupId': 'OG002'}]}]}, {'title': 'Month 12: Social Functioning (n=73,57,56)', 'categories': [{'measurements': [{'value': '49.63', 'spread': '8.41', 'groupId': 'OG000'}, {'value': '46.87', 'spread': '10.06', 'groupId': 'OG001'}, {'value': '47.18', 'spread': '10.84', 'groupId': 'OG002'}]}]}, {'title': 'Month 12: Vitality (n=73,57,56)', 'categories': [{'measurements': [{'value': '54.25', 'spread': '8.31', 'groupId': 'OG000'}, {'value': '51.45', 'spread': '11.20', 'groupId': 'OG001'}, {'value': '51.69', 'spread': '10.23', 'groupId': 'OG002'}]}]}, {'title': 'Month 12: Physical Component (n=71,57,56)', 'categories': [{'measurements': [{'value': '47.98', 'spread': '8.02', 'groupId': 'OG000'}, {'value': '46.84', 'spread': '8.80', 'groupId': 'OG001'}, {'value': '47.03', 'spread': '10.23', 'groupId': 'OG002'}]}]}, {'title': 'Month 12: Mental Component (n=71,57,56)', 'categories': [{'measurements': [{'value': '51.12', 'spread': '9.34', 'groupId': 'OG000'}, {'value': '49.47', 'spread': '9.36', 'groupId': 'OG001'}, {'value': '47.91', 'spread': '12.17', 'groupId': 'OG002'}]}]}, {'title': 'Month 12: Q2-Health in General Now (n=73,58,56)', 'categories': [{'measurements': [{'value': '2.75', 'spread': '0.62', 'groupId': 'OG000'}, {'value': '2.69', 'spread': '0.71', 'groupId': 'OG001'}, {'value': '2.84', 'spread': '0.56', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 6, 12', 'description': 'SF-36: standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as physical and mental component scores. Total of 11 variables were analyzed (8 subscales,2 composite subscales and Question(Q) 2 "how would you rate your health in general now?"(range 1=better, 5=worst). The score for a section (except Q2) is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS: all randomized participants who received at least 1 dose of study medication. Here, N (Number of Participants Analyzed) signifies participants evaluable for this measure; and 'n' signifies those participants who were evaluable at given time point for each group, respectively."}, {'type': 'SECONDARY', 'title': 'End-Stage Renal Disease Symptom Checklist Transplantation Module (ESRD-SCL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cyclosporine', 'description': 'Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.'}, {'id': 'OG001', 'title': 'CP-690,550 15 mg for Months 1 to 6', 'description': 'CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.'}, {'id': 'OG002', 'title': 'CP-690,550 15 mg for Months 1 to 3', 'description': 'CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.'}], 'classes': [{'title': 'Baseline:Cardiac and Renal Dysfunction(n=76,61,71)', 'categories': [{'measurements': [{'value': '0.76', 'spread': '0.55', 'groupId': 'OG000'}, {'value': '0.70', 'spread': '0.59', 'groupId': 'OG001'}, {'value': '0.64', 'spread': '0.61', 'groupId': 'OG002'}]}]}, {'title': 'Baseline: In Growth of Gum and Hair (n=76,61,70)', 'categories': [{'measurements': [{'value': '0.19', 'spread': '0.36', 'groupId': 'OG000'}, {'value': '0.16', 'spread': '0.31', 'groupId': 'OG001'}, {'value': '0.18', 'spread': '0.32', 'groupId': 'OG002'}]}]}, {'title': 'Baseline: Limited Cognitive Capacity (n=77,62,71)', 'categories': [{'measurements': [{'value': '0.67', 'spread': '0.63', 'groupId': 'OG000'}, {'value': '0.76', 'spread': '0.74', 'groupId': 'OG001'}, {'value': '0.64', 'spread': '0.61', 'groupId': 'OG002'}]}]}, {'title': 'Baseline: Limited Physical Capacity (n=76,61,71)', 'categories': [{'measurements': [{'value': '0.80', 'spread': '0.59', 'groupId': 'OG000'}, {'value': '0.79', 'spread': '0.65', 'groupId': 'OG001'}, {'value': '0.72', 'spread': '0.56', 'groupId': 'OG002'}]}]}, {'title': 'Baseline: SEs of Corticosteroids (n=76,61,71)', 'categories': [{'measurements': [{'value': '0.45', 'spread': '0.53', 'groupId': 'OG000'}, {'value': '0.56', 'spread': '0.64', 'groupId': 'OG001'}, {'value': '0.48', 'spread': '0.52', 'groupId': 'OG002'}]}]}, {'title': 'Baseline: TAPD (n=77,62,71)', 'categories': [{'measurements': [{'value': '0.98', 'spread': '0.68', 'groupId': 'OG000'}, {'value': '1.21', 'spread': '0.82', 'groupId': 'OG001'}, {'value': '1.16', 'spread': '0.74', 'groupId': 'OG002'}]}]}, {'title': 'Month 6:Cardiac and Renal Dysfunction(n=77,63,64)', 'categories': [{'measurements': [{'value': '0.59', 'spread': '0.63', 'groupId': 'OG000'}, {'value': '0.40', 'spread': '0.50', 'groupId': 'OG001'}, {'value': '0.50', 'spread': '0.48', 'groupId': 'OG002'}]}]}, {'title': 'Month 6: In Growth of Gum and Hair (n=77,63,64)', 'categories': [{'measurements': [{'value': '0.67', 'spread': '0.61', 'groupId': 'OG000'}, {'value': '0.23', 'spread': '0.47', 'groupId': 'OG001'}, {'value': '0.24', 'spread': '0.35', 'groupId': 'OG002'}]}]}, {'title': 'Month 6: Limited Cognitive Capacity (n=77,64,65)', 'categories': [{'measurements': [{'value': '0.64', 'spread': '0.68', 'groupId': 'OG000'}, {'value': '0.70', 'spread': '0.74', 'groupId': 'OG001'}, {'value': '0.68', 'spread': '0.50', 'groupId': 'OG002'}]}]}, {'title': 'Month 6: Limited Physical Capacity (n=77,63,64)', 'categories': [{'measurements': [{'value': '0.69', 'spread': '0.60', 'groupId': 'OG000'}, {'value': '0.67', 'spread': '0.61', 'groupId': 'OG001'}, {'value': '0.62', 'spread': '0.49', 'groupId': 'OG002'}]}]}, {'title': 'Month 6: SEs of Corticosteroids (n=77,63,64)', 'categories': [{'measurements': [{'value': '0.65', 'spread': '0.70', 'groupId': 'OG000'}, {'value': '0.54', 'spread': '0.56', 'groupId': 'OG001'}, {'value': '0.69', 'spread': '0.63', 'groupId': 'OG002'}]}]}, {'title': 'Month 6: TAPD (n=77,64,65)', 'categories': [{'measurements': [{'value': '0.62', 'spread': '0.60', 'groupId': 'OG000'}, {'value': '0.78', 'spread': '0.65', 'groupId': 'OG001'}, {'value': '0.85', 'spread': '0.62', 'groupId': 'OG002'}]}]}, {'title': 'Month 12:Cardiac and Renal Dysfunction(n=70,57,55)', 'categories': [{'measurements': [{'value': '0.51', 'spread': '0.46', 'groupId': 'OG000'}, {'value': '0.51', 'spread': '0.48', 'groupId': 'OG001'}, {'value': '0.49', 'spread': '0.50', 'groupId': 'OG002'}]}]}, {'title': 'Month 12: In Growth of Gum and Hair (n=70,57,55)', 'categories': [{'measurements': [{'value': '0.58', 'spread': '0.52', 'groupId': 'OG000'}, {'value': '0.19', 'spread': '0.30', 'groupId': 'OG001'}, {'value': '0.29', 'spread': '0.51', 'groupId': 'OG002'}]}]}, {'title': 'Month 12: Limited Cognitive Capacity (n=71,58,55)', 'categories': [{'measurements': [{'value': '0.68', 'spread': '0.60', 'groupId': 'OG000'}, {'value': '0.79', 'spread': '0.70', 'groupId': 'OG001'}, {'value': '0.85', 'spread': '0.67', 'groupId': 'OG002'}]}]}, {'title': 'Month 12: Limited Physical Capacity (n=70,57,55)', 'categories': [{'measurements': [{'value': '0.63', 'spread': '0.46', 'groupId': 'OG000'}, {'value': '0.69', 'spread': '0.50', 'groupId': 'OG001'}, {'value': '0.73', 'spread': '0.65', 'groupId': 'OG002'}]}]}, {'title': 'Month 12: SEs of Corticosteroids (n=70,56,55)', 'categories': [{'measurements': [{'value': '0.50', 'spread': '0.48', 'groupId': 'OG000'}, {'value': '0.56', 'spread': '0.63', 'groupId': 'OG001'}, {'value': '0.72', 'spread': '0.78', 'groupId': 'OG002'}]}]}, {'title': 'Month 12: TAPD (n=71,57,55)', 'categories': [{'measurements': [{'value': '0.58', 'spread': '0.53', 'groupId': 'OG000'}, {'value': '0.90', 'spread': '0.66', 'groupId': 'OG001'}, {'value': '0.96', 'spread': '0.73', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 6, 12', 'description': 'ESRD-SCL:43-item disease specific self-administered questionnaire. Participants\' rated question"At the moment,how much do you suffer?"for each item on 5 point scale,ranged (Ra) 0(not at all)to 4(extremely).Consisted of 6 subscales:cardiac and renal dysfunction;Ra 0-28,increased(In) growth of gum and hair;Ra 0-20,limited cognitive capacity;Ra 0-32,limited physical capacity;Ra 0 - 40,side effects (SEs) of corticosteroids;Ra 0-20,transplantation associated psychological distress(TAPD);Ra 0-32(higher scores=greater dysfunction for each subscale).Total score:0-172,higher scores=greater dysfunction.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS: all randomized participants who received at least 1 dose of study medication. Here, N (Number of Participants Analyzed) signifies participants evaluable for this measure; and 'n' signifies those participants who were evaluable at given time point for each group, respectively."}, {'type': 'SECONDARY', 'title': 'Severity of Dyspepsia Assessment (SODA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cyclosporine', 'description': 'Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.'}, {'id': 'OG001', 'title': 'CP-690,550 15 mg for Months 1 to 6', 'description': 'CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.'}, {'id': 'OG002', 'title': 'CP-690,550 15 mg for Months 1 to 3', 'description': 'CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.'}], 'timeFrame': 'Baseline, Month 6, 12', 'description': 'SODA:17-item health scale, assessed participant-reported perceptions of dyspepsia;consists of 3 subscales:Pain Intensity (6-items to assess pain and intensity of abdominal \\[Ab\\] discomfort; Range (Ra):2-47, higher score= greater pain and Ab discomfort), Non-Pain Symptoms (7-items to assess severity and impact of non-pain symptoms:burping/belching,heartburn,bloating,flatulence,sour taste,nausea,and bad breath; Ra:7-35,higher scores = increased symptom severity and influence), and Satisfaction (4-items to assess degree of satisfaction with Ab discomfort; Ra:2-23,higher scores= more satisfaction).', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not analyzed since the SODA instrument was found irrelevant in the treated population.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cyclosporine', 'description': 'Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.'}, {'id': 'FG001', 'title': 'CP-690,550 15 mg for Months 1 to 6', 'description': 'CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.'}, {'id': 'FG002', 'title': 'CP-690,550 15 mg for Months 1 to 3', 'description': 'CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '110'}, {'groupId': 'FG001', 'numSubjects': '110'}, {'groupId': 'FG002', 'numSubjects': '111'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '109'}, {'groupId': 'FG001', 'numSubjects': '106'}, {'groupId': 'FG002', 'numSubjects': '107'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '77'}, {'groupId': 'FG001', 'numSubjects': '60'}, {'groupId': 'FG002', 'numSubjects': '59'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '50'}, {'groupId': 'FG002', 'numSubjects': '52'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '38'}, {'groupId': 'FG002', 'numSubjects': '40'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Randomized, Not Treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}]}]}], 'preAssignmentDetails': 'Initially 7 participants were enrolled and randomized under original protocol but enrollment was terminated because 2 participants developed Grade 2B rejection. Protocol amendment 1 was implemented to increase aggregate level of immunosuppression and 331 participants were enrolled. Results of participants enrolled under amendment 1 are reported.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'BG000'}, {'value': '106', 'groupId': 'BG001'}, {'value': '107', 'groupId': 'BG002'}, {'value': '322', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Cyclosporine', 'description': 'Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.'}, {'id': 'BG001', 'title': 'CP-690,550 15 mg for Months 1 to 6', 'description': 'CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.'}, {'id': 'BG002', 'title': 'CP-690,550 15 mg for Months 1 to 3', 'description': 'CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '18 to 44 Years', 'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}, {'value': '134', 'groupId': 'BG003'}]}]}, {'title': '45 to 64 Years', 'categories': [{'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}, {'value': '167', 'groupId': 'BG003'}]}]}, {'title': 'Greater Than or Equal to (>=) 65 Years', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '90', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '82', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}, {'value': '232', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 338}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'dispFirstSubmitDate': '2011-03-24', 'completionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-08', 'studyFirstSubmitDate': '2007-06-06', 'dispFirstSubmitQcDate': '2011-03-24', 'resultsFirstSubmitDate': '2012-12-03', 'studyFirstSubmitQcDate': '2007-06-06', 'dispFirstPostDateStruct': {'date': '2011-04-01', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2013-03-14', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-02-08', 'studyFirstPostDateStruct': {'date': '2007-06-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-03-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With First Clinical Biopsy Proven Acute Rejection (BPAR) Episode 6 Months Post-Transplant', 'timeFrame': 'Baseline up to Month 6', 'description': 'Clinical BPAR was a BPAR (category acute rejection as interpreted by the central blinded pathologist according to the Banff 97 working classification) associated with an increase in serum creatinine of \\>= 0.3 milligram per deciliter (mg/dL) and \\>=20 percent (%) from pre-rejection baseline. The increase in serum creatinine was assessed based on the comparison of baseline and the highest serum creatinine recorded within 24 hours (hrs) of the time of biopsy.'}, {'measure': 'Glomerular Filtration Rate (GFR) at Month 12', 'timeFrame': '2, 3, 4, and 5 hrs post iohexol intravenous bolus at Month 12', 'description': 'GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was calculated using iohexol serum clearance. For determination of iohexol serum clearance, iohexol was administered as an intravenous bolus over 5 minutes immediately after morning dosing of CP-690,550 or CsA on day of GFR evaluation. A normal GFR is greater than (\\>) 90 milliliter per minute (mL/min), although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR less than (\\<) 15 mL/min indicated kidney failure.'}], 'secondaryOutcomes': [{'measure': 'Glomerular Filtration Rate (GFR) at Month 6', 'timeFrame': '2, 3, 4, and 5 hrs post iohexol intravenous bolus at Month 6', 'description': 'GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was calculated using iohexol serum clearance. For determination of iohexol serum clearance, iohexol was administered as an intravenous bolus over 5 minutes immediately after morning dosing of CP-690,550 or CsA on day of GFR evaluation. A normal GFR is \\>90 mL/min, although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR \\<15 mL/min indicated kidney failure.'}, {'measure': 'Number of Participants With Progression of Chronic Allograft Lesions at Month 12', 'timeFrame': 'Month 12', 'description': 'Progression of chronic allograft lesions was defined as an increase in the Banff chronicity score (Banff-CS) in biopsy from the implantation (baseline) biopsy in a given participant. Banff-CS was the sum of the Banff scores for the 4 chronic basic lesions (allograft glomerulopathy \\[cg\\] + interstitial fibrosis \\[ci\\] + tubular atrophy \\[ct\\] + vascular intimal thickening \\[cv\\]).The Banff-CS ranged from 0-12, higher score indicated greater lesions and Month 12 Banff-CS greater than the implantation biopsy score indicated progression of lesions.'}, {'measure': 'Number of Participants With First Clinical Biopsy Proven Acute Rejection (BPAR) 12 Months Post Transplant', 'timeFrame': 'Baseline up to Month 12', 'description': 'Clinical BPAR was a BPAR (category acute rejection as interpreted by the central blinded pathologist according to the Banff 97 working classification) associated with an increase in serum creatinine of \\>= 0.3 mg/dL and \\>=20% from pre-rejection baseline. The increase in serum creatinine was assessed based on the comparison of baseline and the highest serum creatinine recorded within 24 hrs of the time of biopsy.'}, {'measure': 'Number of Participants With Treated Clinical Acute Rejection', 'timeFrame': 'Month 6, 12', 'description': 'Treated clinical acute rejection was defined as an acute rejection episode that was diagnosed based on local biopsy readout and received anti-rejection treatment.'}, {'measure': 'Number of Participants With Combined Banff Rejection Categories (Categories 2, 3, and 4)', 'timeFrame': 'Month 6, 12', 'description': "Banff 97: standard classification for scoring and classifying rejection of kidney transplant biopsies in 6 diagnostic categories: normal, antibody-mediated rejection, borderline changes: 'suspicious' for acute cellular rejection, acute/active cellular rejection, chronic/sclerosing allograft nephropathy, and other. Combined Banff rejection calculated from categories of antibody-mediated rejection (Category 2) plus borderline changes (Category 3) plus acute rejection (Category 4), as interpreted by the central pathologist."}, {'measure': 'Number of Participants With Graft Loss', 'timeFrame': 'Month 6, 12', 'description': 'Graft loss was defined as graft nephrectomy, participant death, re-transplantation, or return to dialysis for \\>=6 consecutive weeks.'}, {'measure': 'Number of Participants With Efficacy Failure', 'timeFrame': 'Month 6, 12', 'description': 'Efficacy failure was the first occurrence of clinical BPAR diagnosed by the central pathologist or graft loss including participant death.'}, {'measure': 'Number of Participants Who Died', 'timeFrame': 'Month 6, 12'}, {'measure': 'Lymphocyte Subset', 'timeFrame': 'Month 1, 3, 6, 12', 'description': 'The absolute cell counts of cluster of differentiation 3 (CD3): T-lymphocytes, cluster of differentiation 19 (CD19): B-lymphocytes, and cluster of differentiation 56 (CD56): assumed natural killer cells, were determined using flow cytometry.'}, {'measure': 'Population Pharmacokinetics (PK)', 'timeFrame': 'Pre-dose-2(P-2), Pre-dose(P), 0.5,1,2 hr post-dose(PD) on Day14, Month(M) 3; P,1,2 hr PD on M1; P, 0.5, 2, 4 hr PD on M6; P-2, P, 0.5 hr PD on M9, M12 as per randomization in CP-690,550 treated; P on M3 and P, 2, 4 hr PD on M6 in CsA treated participants', 'description': 'Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.'}, {'measure': 'Glomerular Filtration Rate (GFR) by The Nankivell Equation', 'timeFrame': 'Month 1, 3, 6, 9, 12', 'description': 'GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was measured directly or estimated using established formulas. GFR was calculated was estimated by creatinine clearance (CLcr) using Nankivell equation. CLcr by Nankivell equation= (6.7 per serum creatinine) plus (0.25\\*body weight) minus (0.5\\*serum urea) minus (100 per height square) plus (35 for male/25 for female). A normal GFR is \\>90 mL/min, although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR \\<15 mL/min indicated kidney failure.'}, {'measure': 'Glomerular Filtration Rate (GFR) by The Cockcroft-Gault Equation', 'timeFrame': 'Month 1, 3, 6, 9, 12', 'description': 'GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was measured directly or estimated using established formulas. GFR was calculated using Cockcroft-Gault equation. GFR by Cockcroft-Gault equation= body weight\\*(140 minus age in years) divided by (72\\*serum creatinine). For females value obtained was multiplied by 0.85. A normal GFR is \\>90 mL/min, although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR \\<15 mL/min indicated kidney failure.'}, {'measure': 'Glomerular Filtration Rate (GFR) by The Modification of Diet in Renal Disease (MDRD) Equation', 'timeFrame': 'Month 1, 3, 6, 9, 12', 'description': 'GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was calculated using MDRD equation. GFR by MDRD equation = 170 \\* (serum creatinine)\\^(-0.999) \\* (age in years)\\^(-0.176) \\* (0.762 if female) \\* (1.18 if black) \\* (blood urea nitrogen concentration)\\^(-0.170) \\* (serum albumin concentration)\\^(0.318).A normal GFR is \\>90 mL/min/1.73 square meter (m\\^2), although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR \\<15 mL/min/1.73 m\\^2 indicated kidney failure.'}, {'measure': 'Glomerular Filtration Rate (GFR) by The Abbreviated Modification of Diet in Renal Disease (MDRD) Equation', 'timeFrame': 'Month 1, 3, 6, 9, 12', 'description': 'GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was measured directly or estimated using established formulas. GFR was calculated using abbreviated MDRD equation. GFR by abbreviated MDRD equation= 186 \\* (serum creatinine)\\^(-1.154) \\* (age in years)\\^(-0.203) \\* (0.742 if female) \\* (1.210 if black). A normal GFR is \\>90 mL/min/1.73 m\\^2, although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR \\<15 mL/min/1.73 m\\^2 indicated kidney failure.'}, {'measure': 'Number of Participants With Clinically Significant Infections', 'timeFrame': 'Baseline up to Month 12', 'description': 'Clinically significant infection was defined as the presence of documented infection confirmed by culture, biopsy, genomic, or serologic findings post-randomization and requiring hospitalization or parenteral anti-infective treatment, or otherwise deemed significant by the investigator.'}, {'measure': '36-Item Short-Form Health Survey (SF-36)', 'timeFrame': 'Baseline, Month 6, 12', 'description': 'SF-36: standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as physical and mental component scores. Total of 11 variables were analyzed (8 subscales,2 composite subscales and Question(Q) 2 "how would you rate your health in general now?"(range 1=better, 5=worst). The score for a section (except Q2) is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).'}, {'measure': 'End-Stage Renal Disease Symptom Checklist Transplantation Module (ESRD-SCL)', 'timeFrame': 'Baseline, Month 6, 12', 'description': 'ESRD-SCL:43-item disease specific self-administered questionnaire. Participants\' rated question"At the moment,how much do you suffer?"for each item on 5 point scale,ranged (Ra) 0(not at all)to 4(extremely).Consisted of 6 subscales:cardiac and renal dysfunction;Ra 0-28,increased(In) growth of gum and hair;Ra 0-20,limited cognitive capacity;Ra 0-32,limited physical capacity;Ra 0 - 40,side effects (SEs) of corticosteroids;Ra 0-20,transplantation associated psychological distress(TAPD);Ra 0-32(higher scores=greater dysfunction for each subscale).Total score:0-172,higher scores=greater dysfunction.'}, {'measure': 'Severity of Dyspepsia Assessment (SODA)', 'timeFrame': 'Baseline, Month 6, 12', 'description': 'SODA:17-item health scale, assessed participant-reported perceptions of dyspepsia;consists of 3 subscales:Pain Intensity (6-items to assess pain and intensity of abdominal \\[Ab\\] discomfort; Range (Ra):2-47, higher score= greater pain and Ab discomfort), Non-Pain Symptoms (7-items to assess severity and impact of non-pain symptoms:burping/belching,heartburn,bloating,flatulence,sour taste,nausea,and bad breath; Ra:7-35,higher scores = increased symptom severity and influence), and Satisfaction (4-items to assess degree of satisfaction with Ab discomfort; Ra:2-23,higher scores= more satisfaction).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Immunosuppression', 'JAK3 inhibitor', 'kidney transplantation.'], 'conditions': ['Kidney Transplantation']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3921030&StudyName=Study%20of%20a%20JAK3%20Inhibitor%20for%20the%20Prevention%20of%20Acute%20Rejection%20in%20Kidney%20Transplant%20Patients', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'A new immunosuppressive drug, based on the inhibition of an important enzyme in the immune system called JAK3, is being developed by Pfizer to prevent transplant rejection. In this research study, a JAK3 inhibitor or cyclosporine will be given to new kidney transplant patients for 12 months. Patients will be assigned to one of three treatment groups after receiving a kidney transplant. Two of the treatment groups will receive 2 different dosing regimens of the JAK3 inhibitor that will be taken by mouth. The third treatment group will be a standard-of-care control arm. Patients will continue to take the assigned study medication for 12 months as well as other standard transplant medications such as prednisone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Recipient of a first-time kidney transplant\n* Between the ages of 18 and 70 years, inclusive\n\nExclusion Criteria:\n\n* Recipient of any non-kidney transplant'}, 'identificationModule': {'nctId': 'NCT00483756', 'briefTitle': 'Study of a JAK3 Inhibitor for the Prevention of Acute Rejection in Kidney Transplant Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Phase 2 Randomized, Multicenter, Active Comparator-Controlled Trial to Evaluate the Safety and Efficacy of Co-administration of CP-690,550 and Mycophenolate Mofetil / Mycophenolate Sodium in De Novo Renal Allograft Recipients', 'orgStudyIdInfo': {'id': 'A3921030'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Treatment Arm 1 will also receive standard of care medications', 'interventionNames': ['Drug: Cyclosporine']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Treatment Arm 2 will also receive standard of care medications', 'interventionNames': ['Drug: CP-690,550']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': 'Treatment Arm 3 will also receive standard of care medications', 'interventionNames': ['Drug: CP-690,550']}], 'interventions': [{'name': 'Cyclosporine', 'type': 'DRUG', 'description': 'Standard of care', 'armGroupLabels': ['1']}, {'name': 'CP-690,550', 'type': 'DRUG', 'description': 'CP-690,550 15 mg BID for Months 1-6, then 10 mg BID for Months 7-12', 'armGroupLabels': ['2']}, {'name': 'CP-690,550', 'type': 'DRUG', 'description': 'CP-690,550 15 mg BID for Months 1-3, then 10 mg BID for Months 4-12', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '06504', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '32610', 'city': 'Gainsville', 'state': 'Florida', 'country': 'United States', 'facility': 'Pfizer Investigational Site'}, {'zip': '33606', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '01107', 'city': 'Springfield', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 42.10148, 'lon': -72.58981}}, {'zip': '01199', 'city': 'Springfield', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 42.10148, 'lon': -72.58981}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '07039', 'city': 'Livingston', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 40.79593, 'lon': -74.31487}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10595', 'city': 'Valhalla', 'state': 'New York', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 41.07482, 'lon': -73.77513}}, {'zip': '27514', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '27599-7155', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '27599-7211', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '27599-7360', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '19102', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '75204', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75246', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '76104', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '2050', 'city': 'Camperdown', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': -33.88965, 'lon': 151.17642}}, {'zip': '2145', 'city': 'Westmead', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': -33.80383, 'lon': 150.98768}}, {'zip': '5000', 'city': 'Adelaide', 'state': 'South Australia', 'country': 'Australia', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}, {'zip': '5011', 'city': 'Woodville', 'state': 'South Australia', 'country': 'Australia', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': -34.877, 'lon': 138.54291}}, {'zip': '3168', 'city': 'Clayton', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': -37.91667, 'lon': 145.11667}}, {'zip': '3050', 'city': 'Parkville', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': -37.78333, 'lon': 144.95}}, {'zip': '1070', 'city': 'Anderlecht', 'country': 'Belgium', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 50.83619, 'lon': 4.31454}}, {'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '90020-090', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'zip': '04038-002', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '04039-050', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': 'T6G 2B7', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': '140 21', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '44093', 'city': 'Nantes', 'country': 'France', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '75743', 'city': 'Paris', 'country': 'France', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '31059', 'city': 'Toulouse', 'country': 'France', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '54500', 'city': 'Vandœuvre-lès-Nancy', 'country': 'France', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}, {'zip': '10117', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '20246', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '40138', 'city': 'Bologna', 'country': 'Italy', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'zip': '00168', 'city': 'Roma', 'country': 'Italy', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '3015 GD', 'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'zip': '0027', 'city': 'Oslo', 'country': 'Norway', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}, {'zip': '02-006', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '50-417', 'city': 'Wroclaw', 'country': 'Poland', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'zip': '3000-075', 'city': 'Coimbra', 'country': 'Portugal', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 40.20686, 'lon': -8.41996}}, {'zip': '1069-166', 'city': 'Lisbon', 'country': 'Portugal', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}, {'zip': '110-744', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '120-752', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '138-736', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '08036', 'city': 'Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08907', 'city': "L'Hospitalet de Llobregat", 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 41.35967, 'lon': 2.10028}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}