Ignite Creation Date:
2025-12-25 @ 3:16 AM
Ignite Modification Date:
2025-12-26 @ 1:55 AM
Study NCT ID:
NCT00942305
Status:
COMPLETED
Last Update Posted:
2021-07-16
First Post:
2009-07-17
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study of CMX001 to Prevent/Control Cytomegalovirus Infection in R+ Hematopoietic Stem Cell Transplant Recipients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003586', 'term': 'Cytomegalovirus Infections'}], 'ancestors': [{'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C525733', 'term': 'brincidofovir'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dmoore@chimerix.com', 'phone': '919-806-1074', 'title': 'Chief Medical Officer', 'phoneExt': '101', 'organization': 'Chimerix, Inc.'}, 'certainAgreement': {'otherDetails': 'Within 18 months after the end of the Study at all sites, if no publication of the overall multi-center results has been made, institutions are entitled to publish their locally obtained results, provided the Sponsor is given opportunity to review and comment. Institution publication may be delayed up to an additional 45 days to allow Sponsor to seek patent protection.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Cohort 1 BCV', 'description': '40 mg brincidofovir (BCV) administered once weekly (QW)', 'otherNumAtRisk': 25, 'otherNumAffected': 25, 'seriousNumAtRisk': 25, 'seriousNumAffected': 12}, {'id': 'EG001', 'title': 'Cohort 1 Placebo', 'description': 'Placebo administered once weekly (QW)', 'otherNumAtRisk': 8, 'otherNumAffected': 8, 'seriousNumAtRisk': 8, 'seriousNumAffected': 4}, {'id': 'EG002', 'title': 'Cohort 2 BCV', 'description': '100 mg brincidofovir (BCV) administered once weekly (QW)', 'otherNumAtRisk': 27, 'otherNumAffected': 27, 'seriousNumAtRisk': 27, 'seriousNumAffected': 10}, {'id': 'EG003', 'title': 'Cohort 2 Placebo', 'description': 'Placebo administered once weekly (QW)', 'otherNumAtRisk': 10, 'otherNumAffected': 9, 'seriousNumAtRisk': 10, 'seriousNumAffected': 6}, {'id': 'EG004', 'title': 'Cohort 3 BCV', 'description': '200 mg brincidofovir (BCV) administered once weekly (QW)', 'otherNumAtRisk': 39, 'otherNumAffected': 39, 'seriousNumAtRisk': 39, 'seriousNumAffected': 19}, {'id': 'EG005', 'title': 'Cohort 3 Placebo', 'description': 'Placebo administered once weekly (QW)', 'otherNumAtRisk': 14, 'otherNumAffected': 14, 'seriousNumAtRisk': 14, 'seriousNumAffected': 6}, {'id': 'EG006', 'title': 'Cohort 4 BCV', 'description': '200 mg brincidofovir (BCV) administered twice weekly (BIW)\n\nNote: This dose was reduced to 200 mg BCV once weekly for ongoing subjects in this cohort following the recommendation of the Data and Safety Monitoring Board. No new subjects were enrolled into this cohort following the decision to reduce the dose.', 'otherNumAtRisk': 30, 'otherNumAffected': 30, 'seriousNumAtRisk': 30, 'seriousNumAffected': 21}, {'id': 'EG007', 'title': 'Cohort 4 Placebo', 'description': 'Placebo administered twice weekly (BIW)', 'otherNumAtRisk': 10, 'otherNumAffected': 10, 'seriousNumAtRisk': 10, 'seriousNumAffected': 3}, {'id': 'EG008', 'title': 'Cohort 4a BCV', 'description': '100 mg brincidofovir (BCV) administered twice weekly (BIW)', 'otherNumAtRisk': 50, 'otherNumAffected': 50, 'seriousNumAtRisk': 50, 'seriousNumAffected': 30}, {'id': 'EG009', 'title': 'Cohort 4a Placebo', 'description': 'Placebo administered twice weekly (BIW)', 'otherNumAtRisk': 17, 'otherNumAffected': 17, 'seriousNumAtRisk': 17, 'seriousNumAffected': 8}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 3}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 4}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 10}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 5}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 7}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Haemolytic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Aortic valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 3}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Cardiomegaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Left ventricular hypertrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Mitral valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Tricuspid valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Adrenal insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 2}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Eyelid margin crusting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Myodesopsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Vitreous detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 4}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 11}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 13}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Cheilitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 13}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 21}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 26}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 4}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 4}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 3}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Mouth ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 11}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 11}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 3}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 17}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Odynophagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Oral disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Oral pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Tongue coated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 8}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 22}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Adverse drug reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Early satiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 3}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Face oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 9}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Generalised oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Hypothermia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 8}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 10}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Hyperbilirubinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 5}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 3}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Liver injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Acute graft versus host disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 24}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 32}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 6}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Acute graft versus host disease in intestine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Acute graft versus host disease in skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Graft versus host disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Hypogammaglobulinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Aspergillosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'BK virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Clostridium difficile colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 3}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Cytomegalovirus colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Cytomegalovirus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 3}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Cytomegalovirus viraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 5}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 6}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Epstein-Barr virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Escherichia bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Folliculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Oral candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 6}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Parainfluenzae virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 5}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Proctitis herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Pseudomonal bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Staphylococcal bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 6}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Viral haemorrhagic cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Ear abrasion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Excoriation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Spinal fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Therapeutic agent toxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 10}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 9}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 7}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 5}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 3}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 7}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Blood lactate dehydrogenase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 4}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Blood urea increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Blood urine present', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Cytomegalovirus test positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Echocardiogram abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 4}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Hepatic enzyme increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Immunosuppressant drug level increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Liver function test abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Protein total increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Protein urine present', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Transaminases increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 4}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 6}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 5}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 9}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 4}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Electrolyte imbalance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Fluid overload', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 8}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 9}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 3}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Hyperlipidaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Hypertriglyceridaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Hypoalbuminaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 5}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 8}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 3}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Hypophosphataemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 4}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Malnutrition', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Vitamin D deficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 3}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 4}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Bursitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Joint swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 4}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Musculoskeletal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Myopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Osteopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 3}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Rotator cuff syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Acute lymphocytic leukaemia recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Acute myeloid leukaemia recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 3}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Myeloid leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Skin papilloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 4}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 4}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 4}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 3}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Hemiparesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Peropheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Peroneal nerve palsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 3}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 4}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 9}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Mental status changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Mood altered', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Restlessness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Acute prerenal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Cystitis haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Haemorrhage urinary tract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Hypertonic bladder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Nocturia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Pollakiuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Polyuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 3}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Renal failure chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Urinary incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Atelectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 4}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 3}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Dyspnoea exertional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Respiratory disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Sinus congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Wheezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Blister', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Dermal cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 4}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Hyperkeratosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Nail disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Periorbital oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 4}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 5}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Rash erythematous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Rash macular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 3}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Rash pruritic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Skin erosion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Skin exfoliation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Skin hyperpigmentation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Skin irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Skin lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Sinus operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Aortic arteriosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 6}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 6}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 3}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Cholitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Multi-organ failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Acute graft versus host disease in liver', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Escherichia sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Klebsiella bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Serratia bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Staphylococcal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Viral tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Skin laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Transplant failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Failure to thrive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Chronic lymphocytic leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Epstein-Barr virus associated lymphoproliferative disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Central nervous system lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Cognitive disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Depressed level of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Cardiac tamponade', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 10}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 5}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Diverticulum intestinal haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Erosive duodenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 3}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Odynophagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Multi-organ failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Cholecytitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Liver injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Acute graft versus host disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 12}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 15}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 2}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Acute graft versus host disease in intestine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Acute graft versus host disease in liver', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Acute graft versus host disease in skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Graft versus host disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'BK virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Bronchopneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Catheter related infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Citrobacter infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Clostridium difficile colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Cytomegalovirus colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Cytomegalovirus gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Cytomegalovirus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Cytomegalovirus viraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Epstein-Barr virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Escherichia sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Klebsiella bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Metapneumovirus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 4}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Pneumonia cytomegaloviral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Pneumonia legionella', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Pseudomonal bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Serratia bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Staphylococcal bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 4}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Staphylococcal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Staphylococcal sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Stenotrophomonas infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Streptococcal bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Viral haemorrhagic cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Viral sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Viral tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Skin laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Transplant failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Bacteria stool identified', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Liver function test abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Failure to thrive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Hypovolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Chondrocalcinosis pyrophosphate', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Myopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Acute lymphocytic leukaemia recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Acute myeloid leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Acute myeloid leukaemia recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Chronic lymphocytic leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Espstein-Barr virus associated lymphoproliferative disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Myeloid leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': "Non-Hodgkin's lymphoma", 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'T-cell lymphoma recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Teratoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Central nervous system lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Cognitive disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Depressed level of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Clinically Significant CMV Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}, {'value': '30', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '50', 'groupId': 'OG008'}, {'value': '17', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 BCV', 'description': '40 mg brincidofovir (BCV) administered once weekly (QW)'}, {'id': 'OG001', 'title': 'Cohort 1 Placebo', 'description': 'Placebo administered once weekly (QW)'}, {'id': 'OG002', 'title': 'Cohort 2 BCV', 'description': '100 mg brincidofovir (BCV) administered once weekly (QW)'}, {'id': 'OG003', 'title': 'Cohort 2 Placebo', 'description': 'Placebo administered once weekly (QW)'}, {'id': 'OG004', 'title': 'Cohort 3 BCV', 'description': '200 mg brincidofovir (BCV) administered once weekly (QW)'}, {'id': 'OG005', 'title': 'Cohort 3 Placebo', 'description': 'Placebo administered once weekly (QW)'}, {'id': 'OG006', 'title': 'Cohort 4 BCV', 'description': '200 mg brincidofovir (BCV) administered twice weekly (BIW)\n\nNote: This dose was reduced to 200 mg BCV once weekly for ongoing subjects in this cohort following the recommendation of the Data and Safety Monitoring Board. No new subjects were enrolled into this cohort following the decision to reduce the dose.'}, {'id': 'OG007', 'title': 'Cohort 4 Placebo', 'description': 'Placebo administered twice weekly (BIW)'}, {'id': 'OG008', 'title': 'Cohort 4a BCV', 'description': '100 mg brincidofovir (BCV) administered twice weekly (BIW)'}, {'id': 'OG009', 'title': 'Cohort 4a Placebo', 'description': 'Placebo administered twice weekly (BIW)'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Randomization to Week 8 post-treatment (~19 weeks)', 'description': 'The primary efficacy endpoint was a binomial outcome of failure to prevent cytomegalovirus (CMV) infection defined as CMV DNAemia \\>200 copies/mL obtained at the time of the last treatment with study drug or diagnosis of CMV disease at some point during the treatment phase.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat Population, which included all randomized subjects who took at least 1 dose of study treatment and who had at least 1 efficacy evaluation following baseline.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cohort 1 BCV', 'description': '40 mg brincidofovir (BCV) administered once weekly'}, {'id': 'FG001', 'title': 'Cohort 1 Placebo', 'description': 'Placebo administered once weekly (QW)'}, {'id': 'FG002', 'title': 'Cohort 2 BCV', 'description': '100 mg brincidofovir (BCV) administered once weekly'}, {'id': 'FG003', 'title': 'Cohort 2 Placebo', 'description': 'Placebo administered once weekly (QW)'}, {'id': 'FG004', 'title': 'Cohort 3 BCV', 'description': '200 mg brincidofovir (BCV) administered once weekly'}, {'id': 'FG005', 'title': 'Cohort 3 Placebo', 'description': 'Placebo administered once weekly (QW)'}, {'id': 'FG006', 'title': 'Cohort 4 BCV', 'description': '200 mg brincidofovir (BCV) administered twice weekly (BIW)\n\nNote: This dose was reduced to 200 mg BCV once weekly for ongoing subjects in this cohort following the recommendation of the Data and Safety Monitoring Board. No new subjects were enrolled into this cohort following the decision to reduce the dose.'}, {'id': 'FG007', 'title': 'Cohort 4 Placebo', 'description': 'Placebo administered twice weekly (BIW)'}, {'id': 'FG008', 'title': 'Cohort 4a', 'description': '100 mg brincidofovir (BCV) administered twice weekly (BIW)'}, {'id': 'FG009', 'title': 'Cohort 4a Placebo', 'description': 'Placebo administered twice weekly (BIW)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '29'}, {'groupId': 'FG003', 'numSubjects': '10'}, {'groupId': 'FG004', 'numSubjects': '39'}, {'groupId': 'FG005', 'numSubjects': '14'}, {'groupId': 'FG006', 'numSubjects': '30'}, {'groupId': 'FG007', 'numSubjects': '10'}, {'groupId': 'FG008', 'numSubjects': '50'}, {'groupId': 'FG009', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '14'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '14'}, {'groupId': 'FG005', 'numSubjects': '9'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '5'}, {'groupId': 'FG008', 'numSubjects': '25'}, {'groupId': 'FG009', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '15'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '25'}, {'groupId': 'FG005', 'numSubjects': '5'}, {'groupId': 'FG006', 'numSubjects': '24'}, {'groupId': 'FG007', 'numSubjects': '5'}, {'groupId': 'FG008', 'numSubjects': '25'}, {'groupId': 'FG009', 'numSubjects': '10'}]}]}], 'recruitmentDetails': 'Note: While a total of 239 subjects were enrolled, 1 center was excluded from analysis due to concerns about investigator/site compliance with the study protocol. This center had enrolled 9 subjects: 5 subjects who received brincidofovir (BCV) in Cohort 1, 2 subjects who received placebo in Cohort 1, and 2 subjects who received BCV in Cohort 2.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '39', 'groupId': 'BG004'}, {'value': '14', 'groupId': 'BG005'}, {'value': '30', 'groupId': 'BG006'}, {'value': '10', 'groupId': 'BG007'}, {'value': '50', 'groupId': 'BG008'}, {'value': '17', 'groupId': 'BG009'}, {'value': '230', 'groupId': 'BG010'}]}], 'groups': [{'id': 'BG000', 'title': 'Cohort 1 BCV', 'description': '40 mg brincidofovir (BCV) administered once weekly (QW)'}, {'id': 'BG001', 'title': 'Cohort 1 Placebo', 'description': 'Placebo administered once weekly (QW)'}, {'id': 'BG002', 'title': 'Cohort 2 BCV', 'description': '100 mg brincidofovir (BCV) administered once weekly (QW)'}, {'id': 'BG003', 'title': 'Cohort 2 Placebo', 'description': 'Placebo administered once weekly (QW)'}, {'id': 'BG004', 'title': 'Cohort 3 BCV', 'description': '200 mg brincidofovir (BCV) administered once weekly (QW)'}, {'id': 'BG005', 'title': 'Cohort 3 Placebo', 'description': 'Placebo administered once weekly (QW)'}, {'id': 'BG006', 'title': 'Cohort 4 BCV', 'description': '200 mg brincidofovir (BCV) administered twice weekly (BIW)\n\nNote: This dose was reduced to 200 mg BCV once weekly for ongoing subjects in this cohort following the recommendation of the Data and Safety Monitoring Board. No new subjects were enrolled into this cohort following the decision to reduce the dose.'}, {'id': 'BG007', 'title': 'Cohort 4 Placebo', 'description': 'Placebo administered twice weekly (BIW)'}, {'id': 'BG008', 'title': 'Cohort 4a BCV', 'description': '100 mg brincidofovir (BCV) administered twice weekly (BIW)'}, {'id': 'BG009', 'title': 'Cohort 4a Placebo', 'description': 'Placebo administered twice weekly (BIW)'}, {'id': 'BG010', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.3', 'spread': '10.02', 'groupId': 'BG000'}, {'value': '56.8', 'spread': '10.12', 'groupId': 'BG001'}, {'value': '51.7', 'spread': '10.13', 'groupId': 'BG002'}, {'value': '53.5', 'spread': '11.08', 'groupId': 'BG003'}, {'value': '49.5', 'spread': '12.75', 'groupId': 'BG004'}, {'value': '47.9', 'spread': '14.05', 'groupId': 'BG005'}, {'value': '50.4', 'spread': '11.47', 'groupId': 'BG006'}, {'value': '52.2', 'spread': '14.76', 'groupId': 'BG007'}, {'value': '48.8', 'spread': '12.74', 'groupId': 'BG008'}, {'value': '46.1', 'spread': '12.14', 'groupId': 'BG009'}, {'value': '50.7', 'spread': '12.12', 'groupId': 'BG010'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '12', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '24', 'groupId': 'BG008'}, {'value': '7', 'groupId': 'BG009'}, {'value': '98', 'groupId': 'BG010'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '22', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '18', 'groupId': 'BG006'}, {'value': '7', 'groupId': 'BG007'}, {'value': '26', 'groupId': 'BG008'}, {'value': '10', 'groupId': 'BG009'}, {'value': '132', 'groupId': 'BG010'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Note: While a total of 239 subjects were enrolled, 1 center was excluded from analysis due to concerns about investigator/site compliance with the study protocol. This center had enrolled 9 subjects: 5 subjects who received brincidofovir (BCV) in Cohort 1, 2 subjects who received placebo in Cohort 1, and 2 subjects who received BCV in Cohort 2.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 239}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-28', 'studyFirstSubmitDate': '2009-07-17', 'resultsFirstSubmitDate': '2020-12-09', 'studyFirstSubmitQcDate': '2009-07-17', 'lastUpdatePostDateStruct': {'date': '2021-07-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-06-28', 'studyFirstPostDateStruct': {'date': '2009-07-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-07-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Clinically Significant CMV Infection', 'timeFrame': 'Randomization to Week 8 post-treatment (~19 weeks)', 'description': 'The primary efficacy endpoint was a binomial outcome of failure to prevent cytomegalovirus (CMV) infection defined as CMV DNAemia \\>200 copies/mL obtained at the time of the last treatment with study drug or diagnosis of CMV disease at some point during the treatment phase.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Allogeneic stem cell transplant', 'CMV seropositive (R+)', 'transplant'], 'conditions': ['Cytomegalovirus Infection']}, 'referencesModule': {'references': [{'pmid': '26941282', 'type': 'BACKGROUND', 'citation': 'Lanier ER, Foster S, Brundage T, Chou S, Prichard MN, Kleiboeker S, Wilson C, Colville D, Mommeja-Marin H. Analysis of Mutations in the Gene Encoding Cytomegalovirus DNA Polymerase in a Phase 2 Clinical Trial of Brincidofovir Prophylaxis. J Infect Dis. 2016 Jul 1;214(1):32-5. doi: 10.1093/infdis/jiw073. Epub 2016 Mar 3.'}, {'pmid': '24066743', 'type': 'RESULT', 'citation': 'Marty FM, Winston DJ, Rowley SD, Vance E, Papanicolaou GA, Mullane KM, Brundage TM, Robertson AT, Godkin S, Mommeja-Marin H, Boeckh M; CMX001-201 Clinical Study Group. CMX001 to prevent cytomegalovirus disease in hematopoietic-cell transplantation. N Engl J Med. 2013 Sep 26;369(13):1227-36. doi: 10.1056/NEJMoa1303688.'}, {'pmid': '27851688', 'type': 'DERIVED', 'citation': 'Tippin TK, Morrison ME, Brundage TM, Mommeja-Marin H. Brincidofovir Is Not a Substrate for the Human Organic Anion Transporter 1: A Mechanistic Explanation for the Lack of Nephrotoxicity Observed in Clinical Studies. Ther Drug Monit. 2016 Dec;38(6):777-786. doi: 10.1097/FTD.0000000000000353.'}], 'seeAlsoLinks': [{'url': 'http://pubmed.ncbi.nlm.nih.gov/26941282/', 'label': 'Analysis of Mutations in Gene Encoding Cytomegalovirus DNA Polymerase in a Phase 2 Clinical Trial of Brincidofovir Prophylaxis'}]}, 'descriptionModule': {'briefSummary': 'This was a multicenter, randomized, double-blind, placebo-controlled, dose-escalation study of brincidofovir (BCV) administered orally once or twice weekly for up to 11 weeks. Dosing was initiated immediately following engraftment (between Days 14-30 post-transplant) to prevent/control cytomegalovirus (CMV) infection or prevent disease in R+ hematopoietic stem cell transplant (HCT) recipients.', 'detailedDescription': 'This was to be a 2-part study. Part 1 was a randomized, double-blind, placebo-controlled, dose-escalation study of multiple doses of oral brincidofovir (BCV) in R+ hematopoietic stem cell transplant (HCT) recipients. In Part 2, one of the dose levels administered in Part 1 was to be tested against placebo to evaluate the statistical significance of BCV as a therapy for preventing progression of cytomegalovirus (CMV) infection or preventing CMV disease. The first 3 dose-escalating cohorts in Part 1 were to include 32 subjects within each cohort (24 randomized to receive oral BCV and 8 randomized to receive placebo in a 3:1 ratio) for a total of 96 planned subjects. Following completion of the first 3 cohorts and subsequent safety review of the data, up to an additional 3 cohorts of 32 subjects each could have been enrolled. Two additional cohorts (labeled Cohort 4 and Cohort 4A) beyond the initial 3 cohorts were actually enrolled in Part 1 of the study. Following the safety and antiviral activity analyses of the 5 cohorts in Part 1 and the number of subjects enrolled in each of those cohorts, Part 2 of the study was not conducted.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\nFor inclusion into the study, all prospective subjects were required to fulfill all of the following criteria (as applicable):\n\n1. Were aged ≥18 years. Males must have been able and willing to use adequate contraceptive methods throughout the treatment and follow-up phases of the study.\n2. Were cytomegalovirus (CMV) seropositive before allogeneic hematopoietic stem cell transplantation (HCT) (i.e., R+ subjects).\n3. Were less than 30 days post qualifying transplant.\n4. Had evidence of engraftment before randomization and receiving their first dose of study drug.\n5. Were able to ingest and absorb oral medication (in the judgment of the investigator and based on lack of significant gastrointestinal \\[GI\\] events).\n6. Were willing and able to understand and provide written informed consent.\n7. To the best of his or her knowledge, were willing and able to participate in all required study activities for the duration of the study.\n\nExclusion Criteria\n\nSubjects meeting any of the following exclusion criteria were to be excluded from participation in the study:\n\n1. Females who were pregnant or currently nursing.\n2. Had a body mass index \\>35 kg/m2. \\[Note: This criterion was removed per Protocol Amendment 2 dated 27 August 2010.\\]\n3. Had hypersensitivity to cidofovir (CDV) or brincidofovir.\n4. Recipients for whom the current, predose clinical course of CMV infection suggested that the investigator would not be able to withhold treatment for CMV for a minimum of 5, but preferably 7 days following the subject\'s first dose of study drug.\n5. Received any of the following:\n\n * Ganciclovir, valganciclovir, foscarnet or CDV within 14 days prior to enrollment;\n * Any anti-CMV therapy following transplantation (including Cytogam®1);\n * Any CMV vaccine;\n * Any investigational drug with antiviral activity against double-stranded DNA (dsDNA) viruses within 14 days prior to enrollment. \\[Note: An investigational drug was defined as a drug that was not approved for any indication by the Food and Drug Administration.\\]; or\n * Any other investigational drug (i.e., those without any "anti-dsDNA virus" activity; e.g., anti-influenza compounds) within 14 days prior to enrollment without the prior written consent of the medical monitor. The use of investigational drugs in certain circumstances was added per Protocol Amendment 1 dated 15 January 2010.\n6. Received high dose acyclovir (\\>2000 mg total oral daily dose or \\>5 mg/kg intravenously 3 times daily) or valacyclovir (Valtrex; \\>3000 mg total daily dose) at the time of dosing.\n7. Were diagnosed with active CMV disease within 6 months prior to enrollment; patients with CMV DNAemia requiring intervention with antiviral therapy at the time of enrollment.\n8. Were HIV positive; patients with active hepatitis C virus (HCV) or hepatitis B virus (HBV) infection as evidenced by plasma levels of HCV RNA or HBV DNA, respectively.\n9. Received another allogeneic HCT within the past 2 years, other than the qualifying HCT.\n10. Had renal insufficiency as evidenced by glomerular filtration rate (GFR) \\<30 mL/min.\n11. Had a current diagnosis of hypotony, uveitis, or retinitis or any intraocular pathology that would predispose the subject to any one of these conditions.\n12. Had hepatic dysfunction as evidenced by alanine aminotransferase or aspartate aminotransferase \\>5 x the upper limit of normal (ULN) or direct bilirubin \\>2.5 x the ULN.\n13. Had any of the following active autoimmune disorders: myasthenia gravis, Addison\'s disease, Wegener\'s granulomatosis, primary biliary cirrhosis, bullous pemphigoid, autoimmune hemolytic anemia, autoimmune hepatitis, multiple sclerosis, Goodpasture\'s syndrome, idiopathic thrombocytopenic purpura, lupus erythematosus, dermatomyositis, polymyositis, or vasculitis.\n14. Had active solid tumor malignancies with the exception of basal cell carcinoma or the condition under treatment (e.g., lymphomas).\n15. Had 1 or more episode of hyperglycemic coma or diabetic ketoacidosis within the 6 months prior to enrollment.\n16. Had cardiovascular disease which, in the opinion of the investigator, would interfere with the conduct of the study.\n17. Had Grade 3 or 4 graft versus host disease of the GI tract; subjects with any GI disease that would, in the judgment of the investigator, preclude the subject from taking or absorbing oral medication (e.g. clinically active Crohn\'s disease, ischemic colitis, moderate or severe ulcerative colitis, or any condition expected to require abdominal surgery during the course of study participation).\n18. Any other condition including abnormal laboratory values that would have, in the judgment of the investigator, put the subject at increased risk for participating in the trial, or interferes with the conduct of the trial.'}, 'identificationModule': {'nctId': 'NCT00942305', 'briefTitle': 'Study of CMX001 to Prevent/Control Cytomegalovirus Infection in R+ Hematopoietic Stem Cell Transplant Recipients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jazz Pharmaceuticals'}, 'officialTitle': 'A Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-escalation Study of the Safety, Tolerability and Ability of CMX001 to Prevent or Control CMV Infection in R+ Hematopoietic Stem Cell Transplant Recipients', 'orgStudyIdInfo': {'id': 'CMX001-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '* Cohort 1 = 40 mg of matching placebo administered once weekly (QW)\n* Cohort 2 = 100 mg of matching placebo administered QW\n* Cohort 3 = 200 mg of matching placebo administered QW\n* Cohort 4 = 200 mg of matching placebo administered twice weekly (BIW)\n* Cohort 4A = 100 mg of matching placebo administered BIW', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Brincidofovir', 'description': '* Cohort 1 = 40 mg brincidofovir (BCV) administered once weekly (QW)\n* Cohort 2 = 100 mg BCV administered QW\n* Cohort 3 = 200 mg BCV administered QW\n* Cohort 4 = 200 mg BCV administered twice weekly (BIW)\n* Cohort 4A = 100 mg BCV administered BIW', 'interventionNames': ['Drug: Brincidofovir']}], 'interventions': [{'name': 'Brincidofovir', 'type': 'DRUG', 'otherNames': ['BCV', 'CMX001'], 'description': 'Subjects received their first dose of study drug of brincidofovir (BCV) within 30 (+5) days post-transplant and were treated through Week 13 post-transplant.', 'armGroupLabels': ['Brincidofovir']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Subjects received their first dose of study drug within 30 (+5) days post-transplant and were treated through Week 13 post-transplant.\n\nMatching placebo administered for each cohort.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'The University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '92093', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Moores UCSD Cancer Center', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Denver', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Winship Cancer Institute at Emory University', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Brigham and Womens Hospital, Division of Infectious Disease', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan Medical School', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Harper University Hospital', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota Medical Center', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '68198-5130', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Nebraska Medical Center', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '07601', 'city': 'Hackensack', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Hackensack University Medical Center', 'geoPoint': {'lat': 40.88593, 'lon': -74.04347}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mt. Sinai School of Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'University of Rochester Medical Center', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '10467', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Montefiore Medical Center Oncology', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'UNC Health Care Center', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '27517', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest University School of Medicine', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health and Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '75246', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor University Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75390-8565', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'UT Southwestern Medical Center at Dallas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas, MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '84088', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Utah Cancer Specialists - Intermountain Healthcare', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '98109', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Fred Hutchinson Cancer Research Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jazz Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}