Viewing Study NCT01903733

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
Ignite Creation Date: 2025-12-25 @ 2:40 AM
Ignite Modification Date: 2026-03-06 @ 3:00 AM
Study NCT ID: NCT01903733
Status: COMPLETED
Last Update Posted: 2022-07-19
First Post: 2013-07-16
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Bosutinib Treatment Extension Study Only For Subjects With Chronic Myeloid Leukemia (CML) Who Have Previously Participated In Bosutinib Studies B1871006 Or B1871008
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Lithuania']}, 'conditionBrowseModule': {'meshes': [{'id': 'D015464', 'term': 'Leukemia, Myelogenous, Chronic, BCR-ABL Positive'}], 'ancestors': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009196', 'term': 'Myeloproliferative Disorders'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C471992', 'term': 'bosutinib'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From first dose of study drug and up to 30 days after last dose (up to approximately 14 years)', 'description': 'All-cause mortality: The total number of deaths during study, from randomization (B1871008)/first dose (B1871006) and up to the end of the study are reported for all treated participants and includes deaths which occurred after 30 days post last study drug dose. SAEs and other AEs: Analysis performed on safety set. Data from the 2 parent studies was combined with the data from this study for the analysis of safety as planned.', 'eventGroups': [{'id': 'EG000', 'title': 'Bosutinib, CP1L', 'description': 'Participants from B1871008 with Philadelphia chromosome-positive (Ph+) chronic phase 1st line (CP1L) chronic myeloid leukemia (CML).', 'otherNumAtRisk': 248, 'deathsNumAtRisk': 248, 'otherNumAffected': 239, 'seriousNumAtRisk': 248, 'deathsNumAffected': 23, 'seriousNumAffected': 102}, {'id': 'EG001', 'title': 'Bosutinib, CP2L', 'description': 'Participants from B1871006 with Ph+ chronic phase 2nd line (CP2L) CML who were resistant or intolerant to imatinib.', 'otherNumAtRisk': 284, 'deathsNumAtRisk': 284, 'otherNumAffected': 283, 'seriousNumAtRisk': 284, 'deathsNumAffected': 55, 'seriousNumAffected': 124}, {'id': 'EG002', 'title': 'Bosutinib, CP3L/CP4L', 'description': 'Participants from B1871006 with Ph+ chronic phase 3rd line (CP3L)/4th line (CP4L) CML who were resistant or intolerant to imatinib and resistant or intolerant to dasatinib and/or nilotinib.', 'otherNumAtRisk': 119, 'deathsNumAtRisk': 119, 'otherNumAffected': 119, 'seriousNumAtRisk': 119, 'deathsNumAffected': 30, 'seriousNumAffected': 44}, {'id': 'EG003', 'title': 'Bosutinib, ADV', 'description': 'Participants from B1871006 with Ph+ accelerated phase (AP), blast phase (BP) CML or Ph+ acute lymphoblastic leukemia (ALL) and resistant or intolerant to imatinib only or resistant and intolerant to imatinib and at least 1 additional tyrosine kinase inhibitor (TKI) including dasatinib and/or nilotinib.', 'otherNumAtRisk': 167, 'deathsNumAtRisk': 167, 'otherNumAffected': 164, 'seriousNumAtRisk': 167, 'deathsNumAffected': 98, 'seriousNumAffected': 98}, {'id': 'EG004', 'title': 'Bosutinib, Total', 'description': 'Participants from B1871008 CP1L cohort and B1871006 CP2L, CP3L/CP4L and ADV cohorts.', 'otherNumAtRisk': 818, 'deathsNumAtRisk': 818, 'otherNumAffected': 805, 'seriousNumAtRisk': 818, 'deathsNumAffected': 206, 'seriousNumAffected': 368}], 'otherEvents': [{'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 80}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 117}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 45}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 69}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 311}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 72}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 87}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 28}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 64}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 251}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 46}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 23}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 35}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 139}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 37}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 25}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 92}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 177}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 244}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 99}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 124}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 644}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 89}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 132}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 58}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 78}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 357}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 88}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 106}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 47}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 72}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 313}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 77}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 28}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 34}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 178}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 59}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 21}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 16}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 136}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 44}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 28}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 106}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 29}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 12}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 75}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 41}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 50}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 79}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 17}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 59}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 205}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 73}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 27}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 35}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 177}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 45}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 19}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 100}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 32}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 18}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 80}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 12}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 48}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 44}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 11}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 43}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 40}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 93}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 32}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 10}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 93}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 75}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 31}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 55}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 46}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 90}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 67}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 19}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 17}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 193}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 74}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 59}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 17}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 160}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Lipase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 52}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 29}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 98}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 36}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 10}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 85}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 36}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 68}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Amylase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 59}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 46}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 45}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 41}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 21}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 100}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Hypophosphataemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 10}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 51}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 10}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 41}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 55}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 21}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 24}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 132}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 43}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 16}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 100}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 35}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 19}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 87}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 14}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 62}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 11}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 51}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 44}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 43}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 54}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 31}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 30}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 156}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 21}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 90}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 15}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 47}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 70}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 26}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 33}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 161}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 34}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 30}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 102}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 32}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 14}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 92}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 37}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 13}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 76}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 65}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 105}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 34}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 52}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 256}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 29}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 10}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 79}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 44}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 11}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 75}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}], 'seriousEvents': [{'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 20}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 15}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 9}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 8}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Hyperleukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Granulocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Leukostasis syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Splenomegaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 15}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 10}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 9}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 8}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 7}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Pericarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Left ventricular dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Pericardial haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Aortic valve stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Arteriosclerosis coronary artery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Bundle branch block right', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Cardiac disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Cardiac failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Cardiorenal syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Coronary artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Hypertensive cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Pleuropericarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Ventricular fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Cytogenetic abnormality', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Hydrocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Deafness unilateral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Vestibular disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Goitre', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Thyroid mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Glaucoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Visual impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Diplopia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Retinopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Retinopathy hypertensive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Vitreous haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 22}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Gastric ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Gastrointestinal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Haematochezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Abdominal adhesions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Anal fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Colitis ischaemic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Dental caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Duodenal ulcer haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Enteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Epigastric discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Faecaloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Food poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Gastric haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Gastric ulcer haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Gastritis erosive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Gastritis haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Gastrointestinal necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Intestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Intestinal ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Large intestinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Lower gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Melaena', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Mesenteric artery embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Oesophageal perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Proctitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Rectal polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Retroperitoneal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Umbilical hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 11}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 29}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Disease progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'General physical health deterioration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Multiple organ dysfunction syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Adhesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Adverse drug reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Sudden death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 7}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 3}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 3}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Gallbladder disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Bile duct stone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Cholecystitis chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Drug-induced liver injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Gallbladder polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Hepatic function abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Perforation bile duct', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Drug hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 3}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Anaphylactic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 2}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 19}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 44}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Atypical pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Clostridium difficile colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Appendicitis perforated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Device related infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Erysipelas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Infectious pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Large intestine infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Pyelonephritis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Staphylococcal bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Tooth abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Tooth infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Urinary tract infection bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Abscess limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Arthritis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Arthritis infective', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Bacterial sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Brain abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Catheter bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Cellulitis of male external genital organ', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Clostridium difficile infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Dengue fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Dermatitis infected', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Eczema infected', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Enterococcal sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Enterocolitis infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Escherichia bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Escherichia sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Febrile infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Fungal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Gastrointestinal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Gingival abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Hepatitis A', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Infected dermal cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Kidney infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Malaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Meningitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Orchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Perirectal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Pharyngotonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Pneumonia bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Pneumonia fungal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Pneumonia necrotising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Post procedural infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Pseudomembranous colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Pseudomonal sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Pulmonary mycosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Salmonella bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Salmonellosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Staphylococcal sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Streptococcal sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Subcutaneous abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Facial bones fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Subdural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Upper limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Abdominal injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Cervical vertebral fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Clavicle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Exposure during pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Failure to anastomose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Fibula fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Gastrointestinal stoma complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Lower limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Muscle injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Post procedural complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Post procedural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Post procedural haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Post procedural swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Procedural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Seroma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Skin laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Skull fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Subdural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Tooth fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Transfusion reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Traumatic lung injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Vascular pseudoaneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Wound haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Lipase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Amylase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Blood lactate dehydrogenase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Blood pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Hepatic enzyme increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Intraocular pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Liver function test increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Transaminases increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Failure to thrive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Gout', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Fluid retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Hypophosphataemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Hypovolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Gouty arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Intervertebral disc disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Spinal osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Bone cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Groin pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Joint range of motion decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Lumbar spinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Mandibular mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Musculoskeletal stiffness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Myositis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Osteochondrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Osteonecrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Rotator cuff syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Spinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Synovitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Blast cell crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 6}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Adenocarcinoma gastric', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Blast crisis in myelogenous leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Squamous cell carcinoma of skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Chronic myeloid leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Angiomyolipoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Anogenital warts', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Bladder squamous cell carcinoma stage unspecified', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': "Bowen's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Central nervous system leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Chloroma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Cholangiocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Chronic myelomonocytic leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Colon cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Colon cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Follicle centre lymphoma, follicular grade I, II, III', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Gastric cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Invasive ductal breast carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Keratoacanthoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Laryngeal neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Lipoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Lung adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Malignant melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Melanocytic naevus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Neoplasm prostate', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Neoplasm skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Non-small cell lung cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Paraproteinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Uterine leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 13}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Subarachnoid haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Cerebellar infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Nervous system disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Carotid arteriosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Carpal tunnel syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Encephalitis post varicella', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Hemiparesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Intraventricular haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Loss of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Monoparesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': "Parkinson's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Partial seizures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Radiculopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Speech disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Trigeminal neuralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 2}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Mental status changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Completed suicide', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Disorientation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Dissociative disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Hallucination', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Hallucination, visual', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 15}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 5}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Calculus urinary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Calculus bladder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Chronic kidney disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Cystitis haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'End stage renal disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Prerenal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Renal artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Renal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Renal impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Tubulointerstitial nephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Menorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 2}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Breast hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Cervical dysplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Dysfunctional uterine bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Metrorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Pelvic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Vaginal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 43}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 16}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Pulmonary hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Acute pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Lung disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Pleuritic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Bronchiectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Bronchitis chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Dyspnoea exertional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Lung infiltration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Organising pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Pleurisy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Pulmonary fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Vocal cord polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 11}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Angioedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Circumoral oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Erythema multiforme', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Skin disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Skin lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Pregnancy of partner', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 3}], 'organSystem': 'Social circumstances', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Allogenic bone marrow transplantation therapy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Cyst removal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Knee arthroplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Aortic stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Venous thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 818, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) Based on National Cancer Institute Common Terminology Criteria for AEs (NCI CTCAE) (Version 3.0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}, {'value': '284', 'groupId': 'OG001'}, {'value': '119', 'groupId': 'OG002'}, {'value': '167', 'groupId': 'OG003'}, {'value': '818', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Bosutinib, CP1L', 'description': 'Participants from B1871008 with Philadelphia chromosome-positive (Ph+) chronic phase 1st line (CP1L) chronic myeloid leukemia (CML).'}, {'id': 'OG001', 'title': 'Bosutinib, CP2L', 'description': 'Participants from B1871006 with Ph+ chronic phase 2nd line (CP2L) CML who were resistant or intolerant to imatinib.'}, {'id': 'OG002', 'title': 'Bosutinib, CP3L/CP4L', 'description': 'Participants from B1871006 with Ph+ chronic phase 3rd line (CP3L)/4th line (CP4L) CML who were resistant or intolerant to imatinib and resistant or intolerant to dasatinib and/or nilotinib.'}, {'id': 'OG003', 'title': 'Bosutinib, ADV', 'description': 'Participants from B1871006 with Ph+ accelerated phase (AP), blast phase (BP) CML or Ph+ acute lymphoblastic leukemia (ALL) and resistant or intolerant to imatinib only or resistant and intolerant to imatinib and at least 1 additional tyrosine kinase inhibitor (TKI) including dasatinib and/or nilotinib.'}, {'id': 'OG004', 'title': 'Bosutinib, Total', 'description': 'Participants from B1871008 CP1L cohort and B1871006 CP2L, CP3L/CP4L and ADV cohorts.'}], 'classes': [{'title': 'Treatment-Emergent AEs', 'categories': [{'measurements': [{'value': '241', 'groupId': 'OG000'}, {'value': '283', 'groupId': 'OG001'}, {'value': '119', 'groupId': 'OG002'}, {'value': '165', 'groupId': 'OG003'}, {'value': '808', 'groupId': 'OG004'}]}]}, {'title': 'Treatment-emergent SAEs', 'categories': [{'measurements': [{'value': '102', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '98', 'groupId': 'OG003'}, {'value': '368', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of drug up to 30 days after last dose (up to approximately 14 years)', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Treatment-emergent adverse events were defined as any event increasing in severity from baseline or any new event started during bosutinib therapy or within 30 days of the last dose of study drug.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all dosed participants for both B1871006 and B1871008.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Grade 3 or 4 Treatment-Emergent Adverse Events (AEs) Based on National Cancer Institute Common Terminology Criteria for AEs (NCI CTCAE) (Version 3.0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}, {'value': '284', 'groupId': 'OG001'}, {'value': '119', 'groupId': 'OG002'}, {'value': '167', 'groupId': 'OG003'}, {'value': '818', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Bosutinib, CP1L', 'description': 'Participants from B1871008 with Philadelphia chromosome-positive (Ph+) chronic phase 1st line (CP1L) chronic myeloid leukemia (CML).'}, {'id': 'OG001', 'title': 'Bosutinib, CP2L', 'description': 'Participants from B1871006 with Ph+ chronic phase 2nd line (CP2L) CML who were resistant or intolerant to imatinib.'}, {'id': 'OG002', 'title': 'Bosutinib, CP3L/CP4L', 'description': 'Participants from B1871006 with Ph+ chronic phase 3rd line (CP3L)/4th line (CP4L) CML who were resistant or intolerant to imatinib and resistant or intolerant to dasatinib and/or nilotinib.'}, {'id': 'OG003', 'title': 'Bosutinib, ADV', 'description': 'Participants from B1871006 with Ph+ accelerated phase (AP), blast phase (BP) CML or Ph+ acute lymphoblastic leukemia (ALL) and resistant or intolerant to imatinib only or resistant and intolerant to imatinib and at least 1 additional tyrosine kinase inhibitor (TKI) including dasatinib and/or nilotinib.'}, {'id': 'OG004', 'title': 'Bosutinib, Total', 'description': 'Participants from B1871008 CP1L cohort and B1871006 CP2L, CP3L/CP4L and ADV cohorts.'}], 'classes': [{'categories': [{'measurements': [{'value': '191', 'groupId': 'OG000'}, {'value': '223', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}, {'value': '144', 'groupId': 'OG003'}, {'value': '642', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of drug up to 30 days after last dose (up to approximately 14 years)', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs were assessed according to severity grading based on NCI CTCAE version 3.0. Grade 1 =mild; Grade 2 =moderate; Grade 3 =severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated; Grade 4 =life-threatening or disabling, urgent intervention indicated; Grade 5 =death. Treatment-emergent adverse events were defined as any event increasing in severity from baseline or any new event started during bosutinib therapy or within 30 days of the last dose of study drug.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all dosed participants for both B1871006 and B1871008.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Treatment-Emergent Treatment Related Adverse Events (AEs) Based on National Cancer Institute Common Terminology Criteria for AEs (NCI CTCAE) (Version 3.0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}, {'value': '284', 'groupId': 'OG001'}, {'value': '119', 'groupId': 'OG002'}, {'value': '167', 'groupId': 'OG003'}, {'value': '818', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Bosutinib, CP1L', 'description': 'Participants from B1871008 with Philadelphia chromosome-positive (Ph+) chronic phase 1st line (CP1L) chronic myeloid leukemia (CML).'}, {'id': 'OG001', 'title': 'Bosutinib, CP2L', 'description': 'Participants from B1871006 with Ph+ chronic phase 2nd line (CP2L) CML who were resistant or intolerant to imatinib.'}, {'id': 'OG002', 'title': 'Bosutinib, CP3L/CP4L', 'description': 'Participants from B1871006 with Ph+ chronic phase 3rd line (CP3L)/4th line (CP4L) CML who were resistant or intolerant to imatinib and resistant or intolerant to dasatinib and/or nilotinib.'}, {'id': 'OG003', 'title': 'Bosutinib, ADV', 'description': 'Participants from B1871006 with Ph+ accelerated phase (AP), blast phase (BP) CML or Ph+ acute lymphoblastic leukemia (ALL) and resistant or intolerant to imatinib only or resistant and intolerant to imatinib and at least 1 additional tyrosine kinase inhibitor (TKI) including dasatinib and/or nilotinib.'}, {'id': 'OG004', 'title': 'Bosutinib, Total', 'description': 'Participants from B1871008 CP1L cohort and B1871006 CP2L, CP3L/CP4L and ADV cohorts.'}], 'classes': [{'categories': [{'measurements': [{'value': '235', 'groupId': 'OG000'}, {'value': '282', 'groupId': 'OG001'}, {'value': '119', 'groupId': 'OG002'}, {'value': '161', 'groupId': 'OG003'}, {'value': '797', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of drug up to 30 days after last dose (up to approximately 14 years)', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug. Treatment-emergent adverse events were defined as any event increasing in severity from baseline or any new event started during bosutinib therapy or within 30 days of the last dose of study drug. Related TEAEs were those AEs who were related to the study treatment as judged by the investigator.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all dosed participants for both B1871006 and B1871008.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Laboratory Test Abnormalities Based on National Cancer Institute Common Terminology Criteria for AEs (NCI CTCAE) (Version 4.03)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}, {'value': '284', 'groupId': 'OG001'}, {'value': '119', 'groupId': 'OG002'}, {'value': '167', 'groupId': 'OG003'}, {'value': '818', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Bosutinib, CP1L', 'description': 'Participants from B1871008 with Philadelphia chromosome-positive (Ph+) chronic phase 1st line (CP1L) chronic myeloid leukemia (CML).'}, {'id': 'OG001', 'title': 'Bosutinib, CP2L', 'description': 'Participants from B1871006 with Ph+ chronic phase 2nd line (CP2L) CML who were resistant or intolerant to imatinib.'}, {'id': 'OG002', 'title': 'Bosutinib, CP3L/CP4L', 'description': 'Participants from B1871006 with Ph+ chronic phase 3rd line (CP3L)/4th line (CP4L) CML who were resistant or intolerant to imatinib and resistant or intolerant to dasatinib and/or nilotinib.'}, {'id': 'OG003', 'title': 'Bosutinib, ADV', 'description': 'Participants from B1871006 with Ph+ accelerated phase (AP), blast phase (BP) CML or Ph+ acute lymphoblastic leukemia (ALL) and resistant or intolerant to imatinib only or resistant and intolerant to imatinib and at least 1 additional tyrosine kinase inhibitor (TKI) including dasatinib and/or nilotinib.'}, {'id': 'OG004', 'title': 'Bosutinib, Total', 'description': 'Participants from B1871008 CP1L cohort and B1871006 CP2L, CP3L/CP4L and ADV cohorts.'}], 'classes': [{'title': 'Grade 1', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '150', 'groupId': 'OG004'}]}]}, {'title': 'Grade 2', 'categories': [{'measurements': [{'value': '86', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '229', 'groupId': 'OG004'}]}]}, {'title': 'Grade 3', 'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}, {'value': '254', 'groupId': 'OG004'}]}]}, {'title': 'Grade 4', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '82', 'groupId': 'OG003'}, {'value': '180', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of drug up to 30 days after last dose (up to approximately 14 years)', 'description': 'Laboratory parameters included Chemistry: high alkaline phosphatase; high alanine aminotransferase; high aspartate aminotransferase; high blood bilirubin; high creatinine. Hematology: absolute neutrophils count decreased; anemia; platelet count decreased; white blood cells (WBC) decreased. Abnormalities in laboratory tests were graded per NCI CTCAE version 4.03 as Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all dosed participants for both B1871006 and B1871008.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Adverse Events as Reason for Treatment Discontinuation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}, {'value': '284', 'groupId': 'OG001'}, {'value': '119', 'groupId': 'OG002'}, {'value': '167', 'groupId': 'OG003'}, {'value': '818', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Bosutinib, CP1L', 'description': 'Participants from B1871008 with Philadelphia chromosome-positive (Ph+) chronic phase 1st line (CP1L) chronic myeloid leukemia (CML).'}, {'id': 'OG001', 'title': 'Bosutinib, CP2L', 'description': 'Participants from B1871006 with Ph+ chronic phase 2nd line (CP2L) CML who were resistant or intolerant to imatinib.'}, {'id': 'OG002', 'title': 'Bosutinib, CP3L/CP4L', 'description': 'Participants from B1871006 with Ph+ chronic phase 3rd line (CP3L)/4th line (CP4L) CML who were resistant or intolerant to imatinib and resistant or intolerant to dasatinib and/or nilotinib.'}, {'id': 'OG003', 'title': 'Bosutinib, ADV', 'description': 'Participants from B1871006 with Ph+ accelerated phase (AP), blast phase (BP) CML or Ph+ acute lymphoblastic leukemia (ALL) and resistant or intolerant to imatinib only or resistant and intolerant to imatinib and at least 1 additional tyrosine kinase inhibitor (TKI) including dasatinib and/or nilotinib.'}, {'id': 'OG004', 'title': 'Bosutinib, Total', 'description': 'Participants from B1871008 CP1L cohort and B1871006 CP2L, CP3L/CP4L and ADV cohorts.'}], 'classes': [{'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '232', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of drug up to 30 days after last dose (up to approximately 14 years)', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all dosed participants for both B1871006 and B1871008.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Diarrhea After Switch From Bosutinib Clinical Formulation to Bosutinib Commercial Formulation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '222', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Bosutinib, CP1L', 'description': 'Participants from B1871008 with Philadelphia chromosome-positive (Ph+) chronic phase 1st line (CP1L) chronic myeloid leukemia (CML).'}, {'id': 'OG001', 'title': 'Bosutinib, CP2L', 'description': 'Participants from B1871006 with Ph+ chronic phase 2nd line (CP2L) CML who were resistant or intolerant to imatinib.'}, {'id': 'OG002', 'title': 'Bosutinib, CP3L/CP4L', 'description': 'Participants from B1871006 with Ph+ chronic phase 3rd line (CP3L)/4th line (CP4L) CML who were resistant or intolerant to imatinib and resistant or intolerant to dasatinib and/or nilotinib.'}, {'id': 'OG003', 'title': 'Bosutinib, ADV', 'description': 'Participants from B1871006 with Ph+ accelerated phase (AP), blast phase (BP) CML or Ph+ acute lymphoblastic leukemia (ALL) and resistant or intolerant to imatinib only or resistant and intolerant to imatinib and at least 1 additional tyrosine kinase inhibitor (TKI) including dasatinib and/or nilotinib.'}, {'id': 'OG004', 'title': 'Bosutinib, Total', 'description': 'Participants from B1871008 CP1L cohort and B1871006 CP2L, CP3L/CP4L and ADV cohorts.'}], 'classes': [{'title': 'Clinical formulation (last 6 months)', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '55', 'groupId': 'OG004'}]}]}, {'title': 'Commercial formulation (first 6 months)', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '70', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Last 6 months on clinical formulation and first 6 months on commercial formulation', 'description': 'The incidence of diarrhea was collected and analyzed before and after the switch from the clinical formulation of bosutinib to the commercial formulation of bosutinib.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Safety analysis set included all dosed participants for both B1871006 and B1871008. Here, 'Overall number of participants analyzed'= participants evaluable for this outcome measure who received commercial formulation."}, {'type': 'PRIMARY', 'title': 'Number of Participants With Breakpoint Cluster Region Abelson Protooncogene (BCR-ABL) Mutations Present at Time of Bosutinib Treatment Discontinuation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '250', 'groupId': 'OG000'}, {'value': '284', 'groupId': 'OG001'}, {'value': '119', 'groupId': 'OG002'}, {'value': '167', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Bosutinib, CP1L', 'description': 'Participants from B1871008 with Philadelphia chromosome-positive (Ph+) chronic phase 1st line (CP1L) chronic myeloid leukemia (CML).'}, {'id': 'OG001', 'title': 'Bosutinib, CP2L', 'description': 'Participants from B1871006 with Ph+ chronic phase 2nd line (CP2L) CML who were resistant or intolerant to imatinib.'}, {'id': 'OG002', 'title': 'Bosutinib, CP3L/CP4L', 'description': 'Participants from B1871006 with Ph+ chronic phase 3rd line (CP3L)/4th line (CP4L) CML who were resistant or intolerant to imatinib and resistant or intolerant to dasatinib and/or nilotinib.'}, {'id': 'OG003', 'title': 'Bosutinib, ADV', 'description': 'Participants from B1871006 with Ph+ accelerated phase (AP), blast phase (BP) CML or Ph+ acute lymphoblastic leukemia (ALL) and resistant or intolerant to imatinib only or resistant and intolerant to imatinib and at least 1 additional tyrosine kinase inhibitor (TKI) including dasatinib and/or nilotinib.'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Post-baseline on Day 1 (maximum up to 14 years)', 'description': 'BCR-ABL is a gene resulting from the 9:22 chromosomal translocation (Philadelphia chromosome). In this outcome measure, the number of participants who had emergent mutation or new BCR-ABL mutations (participants who had a post-baseline mutation which was not present at baseline) were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set included all participants randomized to the bosutinib arm from B1871008 and all dosed participants from B1871006.'}, {'type': 'PRIMARY', 'title': 'Overall Survival (OS) Rate at Year 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '250', 'groupId': 'OG000'}, {'value': '284', 'groupId': 'OG001'}, {'value': '119', 'groupId': 'OG002'}, {'value': '167', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Bosutinib, CP1L', 'description': 'Participants from B1871008 with Philadelphia chromosome-positive (Ph+) chronic phase 1st line (CP1L) chronic myeloid leukemia (CML).'}, {'id': 'OG001', 'title': 'Bosutinib, CP2L', 'description': 'Participants from B1871006 with Ph+ chronic phase 2nd line (CP2L) CML who were resistant or intolerant to imatinib.'}, {'id': 'OG002', 'title': 'Bosutinib, CP3L/CP4L', 'description': 'Participants from B1871006 with Ph+ chronic phase 3rd line (CP3L)/4th line (CP4L) CML who were resistant or intolerant to imatinib and resistant or intolerant to dasatinib and/or nilotinib.'}, {'id': 'OG003', 'title': 'Bosutinib, ADV', 'description': 'Participants from B1871006 with Ph+ accelerated phase (AP), blast phase (BP) CML or Ph+ acute lymphoblastic leukemia (ALL) and resistant or intolerant to imatinib only or resistant and intolerant to imatinib and at least 1 additional tyrosine kinase inhibitor (TKI) including dasatinib and/or nilotinib.'}], 'classes': [{'categories': [{'measurements': [{'value': '88.2', 'groupId': 'OG000', 'lowerLimit': '83.3', 'upperLimit': '93.2'}, {'value': '71.5', 'groupId': 'OG001', 'lowerLimit': '64.4', 'upperLimit': '78.7'}, {'value': '60.4', 'groupId': 'OG002', 'lowerLimit': '47.2', 'upperLimit': '73.7'}, {'value': '34.2', 'groupId': 'OG003', 'lowerLimit': '25.0', 'upperLimit': '43.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Year 10', 'description': 'OS was defined as the time from randomization (B1871008) and time from first dose (B1871006) to the occurrence of death due to any cause or censoring. Kaplan-Meier analysis was used for determination of OS. Percentage of participants who were alive were estimated in this outcome measure.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set included all participants randomized to the bosutinib arm from B1871008 and all dosed participants from B1871006.'}, {'type': 'PRIMARY', 'title': 'Plasma Steady-State Trough Concentrations (Ctrough) of Bosutinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '69', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Bosutinib 200 mg', 'description': 'Participants received uninterrupted once daily oral 200 mg dose of bosutinib for at least 2 weeks in study B1871040.'}, {'id': 'OG001', 'title': 'Bosutinib 300 mg', 'description': 'Participants received uninterrupted once daily oral 300 mg dose of bosutinib for at least 2 weeks in study B1871040.'}, {'id': 'OG002', 'title': 'Bosutinib 400 mg', 'description': 'Participants received uninterrupted once daily oral 400 mg dose of bosutinib for at least 2 weeks in study B1871040.'}, {'id': 'OG003', 'title': 'Bosutinib 500 mg', 'description': 'Participants received uninterrupted once daily oral 500 mg dose of bosutinib for at least 2 weeks in study B1871040.'}, {'id': 'OG004', 'title': 'Bosutinib 600 mg', 'description': 'Participants received uninterrupted once daily oral 600 mg dose of bosutinib for at least 2 weeks in study B1871040.'}], 'classes': [{'categories': [{'measurements': [{'value': '62.2', 'spread': '31.3', 'groupId': 'OG000'}, {'value': '62.0', 'spread': '65.9', 'groupId': 'OG001'}, {'value': '82.2', 'spread': '53.2', 'groupId': 'OG002'}, {'value': '93.3', 'spread': '45.2', 'groupId': 'OG003'}, {'value': '99.4', 'spread': '78.2', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'One pre-dose sample was collected at the first scheduled visit (after approval and implementation of protocol amendment 1) following at least 2 weeks of uninterrupted dosing at the same dose level', 'description': 'Ctrough refers to plasma concentration of bosutinib observed just before treatment administration.', 'unitOfMeasure': 'nanogram per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacokinetic (PK) analysis set included participants who received at least 1 dose of bosutinib and had 1 reported bosutinib concentration.'}, {'type': 'PRIMARY', 'title': 'Kaplan-Meier Estimate of Probability of Maintaining Major Cytogenetic Response (MCyR) at Year 10: B1871006 Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Bosutinib, CP2L', 'description': 'Participants from B1871006 with Ph+ chronic phase 2nd line (CP2L) CML who were resistant or intolerant to imatinib.'}, {'id': 'OG001', 'title': 'Bosutinib, CP3L/CP4L', 'description': 'Participants from B1871006 with Ph+ chronic phase 3rd line (CP3L)/4th line (CP4L) CML who were resistant or intolerant to imatinib and resistant or intolerant to dasatinib and/or nilotinib.'}, {'id': 'OG002', 'title': 'Bosutinib, ADV', 'description': 'Participants from B1871006 with Ph+ accelerated phase (AP), blast phase (BP) CML or Ph+ acute lymphoblastic leukemia (ALL) and resistant or intolerant to imatinib only or resistant and intolerant to imatinib and at least 1 additional tyrosine kinase inhibitor (TKI) including dasatinib and/or nilotinib.'}], 'classes': [{'categories': [{'measurements': [{'value': '65.3', 'groupId': 'OG000', 'lowerLimit': '56.6', 'upperLimit': '74.0'}, {'value': '55.3', 'groupId': 'OG001', 'lowerLimit': '36.3', 'upperLimit': '74.4'}, {'value': '30.6', 'groupId': 'OG002', 'lowerLimit': '16.4', 'upperLimit': '44.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Year 10', 'description': 'Cytogenetic response (CyR) is based on prevalence of Ph+ cells. Duration for MCyR: time from first response to confirmed loss, progression of disease, or on-treatment death due to any cause, or censoring analyzed for responders only. Confirmed loss was defined as 2 consecutive non-responses at least 28 days apart. MCyR was categorized as either complete cytogenetic response (CCyR) or partial cytogenetic response (PCyR). Response was achieved when there was 0% (CCyR) or 1-35% (PCyR) Ph+ cells analyzed from conventional cytogenetics based on the analysis of 20 to 100 metaphases or \\<1% (CCyR) or 1-35% (PCyR) Ph+ cells analyzed from fluorescence in-situ hybridization (FISH) based on analysis of at least 200 nuclei. CCyR may be imputed on a specific date if an MMR or better is achieved and denoted on the CRF on that date for B1871040 study visits. The Kaplan-Meier analysis was used to analyze percentage of participants maintaining MCyR at Year 10.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable analysis set for cytogenetic population were those dosed participants from B1871006 with valid baseline efficacy assessment from B1871006 with \\>=20 metaphases or at least 1 Ph+ metaphase from baseline bone marrow cytogenetic assessment and who achieved MCyR (responders). "N"=evaluable participants. Data for this outcome measure was planned to be collected and analyzed for participants from B1871006 only and not for reporting arm "Bosutinib CP1L" (participants from B1871008).'}, {'type': 'PRIMARY', 'title': 'Kaplan-Meier Estimate of Probability of Maintaining Complete Cytogenetic Response (CCyR) at Year 10: B1871006 Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Bosutinib, CP2L', 'description': 'Participants from B1871006 with Ph+ chronic phase 2nd line (CP2L) CML who were resistant or intolerant to imatinib.'}, {'id': 'OG001', 'title': 'Bosutinib, CP3L/CP4L', 'description': 'Participants from B1871006 with Ph+ chronic phase 3rd line (CP3L)/4th line (CP4L) CML who were resistant or intolerant to imatinib and resistant or intolerant to dasatinib and/or nilotinib.'}, {'id': 'OG002', 'title': 'Bosutinib, ADV', 'description': 'Participants from B1871006 with Ph+ accelerated phase (AP), blast phase (BP) CML or Ph+ acute lymphoblastic leukemia (ALL) and resistant or intolerant to imatinib only or resistant and intolerant to imatinib and at least 1 additional tyrosine kinase inhibitor (TKI) including dasatinib and/or nilotinib.'}], 'classes': [{'categories': [{'measurements': [{'value': '63.4', 'groupId': 'OG000', 'lowerLimit': '54.0', 'upperLimit': '72.8'}, {'value': '40.8', 'groupId': 'OG001', 'lowerLimit': '22.0', 'upperLimit': '59.6'}, {'value': '29.6', 'groupId': 'OG002', 'lowerLimit': '14.6', 'upperLimit': '44.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Year 10', 'description': 'Duration for CCyR was defined as time from first response to confirmed loss, progression of disease, or on-treatment death due to any cause, or censoring analyzed for responders only. Confirmed loss was defined as 2 consecutive assessments with \\>0 Ph+ metaphases or \\>=1% positive cells from FISH at least 28 days apart or progression or death. CCyR was achieved when there was 0% Ph+ cells analysed from conventional cytogenetics with 20 to 100 metaphases or \\<1% Ph+ cells analysed from FISH with at least 200 nuclei. CCyR may be imputed on a specific date if MMR or better is achieved and denoted on the CRF on that date for B1871040 study visits. The Kaplan-Meier analysis was used to analyze percentage of participants maintaining CCyR at Year 10.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable analysis set for cytogenetic population were those dosed participants from B1871006 with a valid baseline efficacy assessment from B1871006 with \\>=20 metaphases or at least 1 Ph+ metaphase from the baseline bone marrow cytogenetic assessment and who achieved CCyR (responders). "N"=evaluable participants. Data for this outcome measure was planned to be collected and analyzed for participants from B1871006 only and not for reporting arm "Bosutinib CP1L" (participants from B1871008).'}, {'type': 'PRIMARY', 'title': 'Kaplan-Meier Estimate of Probability of Maintaining Complete Hematologic Response (CHR) at Year 10: B1871006 Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '245', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Bosutinib, CP2L', 'description': 'Participants from B1871006 with Ph+ chronic phase 2nd line (CP2L) CML who were resistant or intolerant to imatinib.'}, {'id': 'OG001', 'title': 'Bosutinib, CP3L/CP4L', 'description': 'Participants from B1871006 with Ph+ chronic phase 3rd line (CP3L)/4th line (CP4L) CML who were resistant or intolerant to imatinib and resistant or intolerant to dasatinib and/or nilotinib.'}, {'id': 'OG002', 'title': 'Bosutinib, ADV', 'description': 'Participants from B1871006 with Ph+ accelerated phase (AP), blast phase (BP) CML or Ph+ acute lymphoblastic leukemia (ALL) and resistant or intolerant to imatinib only or resistant and intolerant to imatinib and at least 1 additional tyrosine kinase inhibitor (TKI) including dasatinib and/or nilotinib.'}], 'classes': [{'categories': [{'measurements': [{'value': '44.1', 'groupId': 'OG000', 'lowerLimit': '35.2', 'upperLimit': '52.9'}, {'value': '45.1', 'groupId': 'OG001', 'lowerLimit': '29.3', 'upperLimit': '60.9'}, {'value': 'NA', 'comment': 'The percentage and 95% CI was not estimable since BM blasts were not always assessed in later years for ADV participants.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Year 10', 'description': 'Duration for CHR was defined as time from first response to confirmed loss, progression of disease, or on-treatment death due to any cause, or censoring analyzed for responders only. Confirmed loss was defined as 2 consecutive non-responses at least 14 days apart. Complete hematologic response was considered when participants met all of the following criteria: White blood cells equal to or less than (\\<=) institutional upper limit of normal (ULN), no blasts or promyelocytes in blood, \\<20% basophils in blood, no extramedullary involvement (including hepatomegaly or splenomegaly), myelocytes and metamyelocytes \\<5% in blood, platelets \\<450\\*10\\^9 per liter (/L). The following were applicable only to advanced phase: \\<=5% bone marrow blasts, absolute neutrophil count \\>=1.0\\*10\\^9/L, platelets \\>=100\\*10\\^9/L. The Kaplan-Meier analysis was used to analyze percentage of participants maintaining CHR at Year 10.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable analysis set for hematologic population were those dosed participants from B1871006 with a valid baseline efficacy assessment from B1871006 and a valid baseline hematologic assessment and who achieved CHR (responders). "N"=evaluable participants. Data for this outcome measure was planned to be collected and analyzed for participants from B1871006 only and not for reporting arm "Bosutinib CP1L" (participants from B1871008).'}, {'type': 'PRIMARY', 'title': 'Cumulative Incidence of Progression/Death Events at Year 10: B1871006 Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '167', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Bosutinib, CP2L', 'description': 'Participants from B1871006 with Ph+ chronic phase 2nd line (CP2L) CML who were resistant or intolerant to imatinib.'}, {'id': 'OG001', 'title': 'Bosutinib, CP3L/CP4L', 'description': 'Participants from B1871006 with Ph+ chronic phase 3rd line (CP3L)/4th line (CP4L) CML who were resistant or intolerant to imatinib and resistant or intolerant to dasatinib and/or nilotinib.'}, {'id': 'OG002', 'title': 'Bosutinib, ADV', 'description': 'Participants from B1871006 with Ph+ accelerated phase (AP), blast phase (BP) CML or Ph+ acute lymphoblastic leukemia (ALL) and resistant or intolerant to imatinib only or resistant and intolerant to imatinib and at least 1 additional tyrosine kinase inhibitor (TKI) including dasatinib and/or nilotinib.'}], 'classes': [{'categories': [{'measurements': [{'value': '23.9', 'groupId': 'OG000', 'lowerLimit': '19.5', 'upperLimit': '29.5'}, {'value': '26.9', 'groupId': 'OG001', 'lowerLimit': '20.0', 'upperLimit': '36.2'}, {'value': '55.7', 'groupId': 'OG002', 'lowerLimit': '48.6', 'upperLimit': '63.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Year 10', 'description': 'Progression free survival (PFS):interval from date of first dose of bosutinib in parent study until earlier date of progression or death from any cause. Participants without events censored at last evaluation date. PD:evolution from CP (or return to CP for ADV participants) to AP or BP (on 2 consecutive assessments at least 1 week apart), evolution from AP to BP (on 2 consecutive assessments at least 1 week apart) and one of following conditions occurred after dose escalation or presence of AEs prohibiting dose escalation: for 2nd or later line, loss of MCyR (need at least 30% increase); for all lines of treatment, loss of CHR confirmed by 2 assessments \\>=2 weeks apart; for all lines of treatment, increasing WBC defined as doubling of WBC over a period of \\>=1 month with second WBC \\>20\\*10\\^9/L confirmed at least 1 week later. Percentage of participants with PFS/death events based on cumulative incidence method adjusting for competing event of treatment discontinuation without event.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set from B1871006 included all dosed participants from the study B1871006. Data for this outcome measure was planned to be collected and analyzed for participants from B1871006 only and not for reporting arm "Bosutinib CP1L" (participants from B1871008).'}, {'type': 'PRIMARY', 'title': 'Cumulative Incidence of Rate of Transformation to Accelerated Phase (AP) or Blast Phase (BP) at Year 10: B1871006 Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Bosutinib, CP2L', 'description': 'Participants from B1871006 with Ph+ chronic phase 2nd line (CP2L) CML who were resistant or intolerant to imatinib.'}, {'id': 'OG001', 'title': 'Bosutinib, CP3L/CP4L', 'description': 'Participants from B1871006 with Ph+ chronic phase 3rd line (CP3L)/4th line (CP4L) CML who were resistant or intolerant to imatinib and resistant or intolerant to dasatinib and/or nilotinib.'}, {'id': 'OG002', 'title': 'Bosutinib, ADV', 'description': 'Participants from B1871006 with Ph+ accelerated phase (AP), blast phase (BP) CML or Ph+ acute lymphoblastic leukemia (ALL) and resistant or intolerant to imatinib only or resistant and intolerant to imatinib and at least 1 additional tyrosine kinase inhibitor (TKI) including dasatinib and/or nilotinib.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.3', 'groupId': 'OG000', 'lowerLimit': '3.2', 'upperLimit': '8.6'}, {'value': '4.2', 'groupId': 'OG001', 'lowerLimit': '1.8', 'upperLimit': '9.9'}, {'value': '3.8', 'groupId': 'OG002', 'lowerLimit': '1.3', 'upperLimit': '11.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Year 10', 'description': 'Time to transformation was defined as the time from first dose in the parent study to the first date of confirmed transformation to AP or BP. Confirmed transformation was defined as 2 consecutive assessments at least 1 week apart or 1 assessment confirmed by progression of disease or death. For participants without transformation, censorship was at the last evaluation date. Percentage of participants with time to transformation to AP/BP was reported based on cumulative incidence method adjusting for the competing risk of treatment discontinuation without the event.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set from B1871006 included all dosed participants from the study B1871006. Data for this outcome measure was planned to be collected and analyzed for participants from B1871006 only and not for reporting arm "Bosutinib, CP1L" (participants from B1871008). For "Bosutinib ADV" reporting arm, data was analyzed for participants with AP who had BP transformation only.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Bosutinib, CP1L', 'description': 'Participants from B1871008 with Philadelphia chromosome-positive (Ph+) chronic phase 1st line (CP1L) chronic myeloid leukemia (CML) who either continued to receive the same bosutinib dose as at the time of completion of B1871008 or continued to be followed for survival. Dose for bosutinib was 500 milligram (mg) orally once daily (adjusted dose varied from 200 mg to 600 mg once daily). Treatment continued until the end of the study, disease progression, unacceptable toxicity, death, withdrawal of consent or study discontinuation whichever occurred first. Follow-up continued till end of the study or death due to any cause whichever occurred first. Participants remained in this study, either for treatment or for follow-up, until the last participant enrolled in 1 of the parent studies reached 10 years of follow-up, as calculated from the date of his/her first dose of bosutinib administered in parent study.'}, {'id': 'FG001', 'title': 'Bosutinib, CP2L', 'description': 'Participants from B1871006 with Ph+ chronic phase 2nd line (CP2L) CML who were resistant or intolerant to imatinib either continued to receive the same bosutinib dose as at the time of completion of B1871006 or continued to be followed for survival. Dose for bosutinib was 500 mg orally once daily (adjusted dose varied from 200 mg to 600 mg once daily). Treatment continued until the end of the study, disease progression, unacceptable toxicity, death, withdrawal of consent or study discontinuation whichever occurred first. Follow-up continued till end of the study or death due to any cause whichever occurred first. Participants remained in this study, either for treatment or for follow-up, until the last participant enrolled in 1 of the parent studies reached 10 years of follow-up, as calculated from the date of his/her first dose of bosutinib administered in parent study.'}, {'id': 'FG002', 'title': 'Bosutinib, CP3L/CP4L', 'description': 'Participants from B1871006 with Ph+ chronic phase 3rd line (CP3L)/4th line (CP4L) CML who were resistant or intolerant to imatinib and resistant or intolerant to dasatinib and/or nilotinib either continued to receive the same bosutinib dose as at the time of completion of B1871006 or continued to be followed for survival. Dose for bosutinib was 500 mg orally once daily (adjusted dose varied from 200 mg to 600 mg once daily). Treatment continued until the end of the study, disease progression, unacceptable toxicity, death, withdrawal of consent or study discontinuation whichever occurred first. Follow-up continued till end of the study or death due to any cause whichever occurred first. Participants remained in this study, either for treatment or for follow-up, until the last participant enrolled in 1 of the parent studies reached 10 years of follow-up, as calculated from the date of his/her first dose of bosutinib administered in parent study.'}, {'id': 'FG003', 'title': 'Bosutinib, ADV', 'description': 'Advanced (ADV) participants from B1871006 with Ph+ accelerated phase (AP), blast phase (BP) CML, Ph+ acute lymphoblastic leukemia (ALL) and resistant or intolerant to imatinib only or resistant or intolerant to imatinib and at least 1 additional tyrosine kinase inhibitor (TKI) including dasatinib and/or nilotinib who either continued to receive the same bosutinib dose as at the time of completion of B1871008 or continued to be followed for survival. Dose for bosutinib was 500 mg orally once daily (adjusted dose varied from 200 mg to 600 mg once daily). Treatment continued until the end of the study, disease progression, unacceptable toxicity, death, withdrawal of consent or study discontinuation whichever occurred first. Follow-up continued till end of the study or death due to any cause whichever occurred first. Participants remained in this study, either for treatment or for follow-up, until the last participant enrolled in 1 of the parent studies reached 10 years of follow-up, as calculated from the date of his/her first dose of bosutinib administered in parent study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '250'}, {'groupId': 'FG001', 'numSubjects': '284'}, {'groupId': 'FG002', 'numSubjects': '119'}, {'groupId': 'FG003', 'numSubjects': '167'}]}, {'type': 'Full Analysis Set', 'comment': '(participants randomized to bosutinib arm in B1871008 and all dosed participants in B1871006)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '250'}, {'groupId': 'FG001', 'numSubjects': '284'}, {'groupId': 'FG002', 'numSubjects': '119'}, {'groupId': 'FG003', 'numSubjects': '167'}]}, {'type': 'Safety Analysis Set', 'comment': '(all dosed participants in B1871008 and B1871006)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '248'}, {'groupId': 'FG001', 'numSubjects': '284'}, {'groupId': 'FG002', 'numSubjects': '119'}, {'groupId': 'FG003', 'numSubjects': '167'}]}, {'type': 'Enrolled in B1871040', 'achievements': [{'groupId': 'FG000', 'numSubjects': '124'}, {'groupId': 'FG001', 'numSubjects': '90'}, {'groupId': 'FG002', 'numSubjects': '28'}, {'groupId': 'FG003', 'numSubjects': '18'}]}, {'type': 'Treated in B1871040', 'achievements': [{'groupId': 'FG000', 'numSubjects': '98'}, {'groupId': 'FG001', 'numSubjects': '69'}, {'groupId': 'FG002', 'numSubjects': '13'}, {'groupId': 'FG003', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '144'}, {'groupId': 'FG001', 'numSubjects': '158'}, {'groupId': 'FG002', 'numSubjects': '58'}, {'groupId': 'FG003', 'numSubjects': '48'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '106'}, {'groupId': 'FG001', 'numSubjects': '126'}, {'groupId': 'FG002', 'numSubjects': '61'}, {'groupId': 'FG003', 'numSubjects': '119'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '54'}, {'groupId': 'FG002', 'numSubjects': '30'}, {'groupId': 'FG003', 'numSubjects': '98'}]}, {'type': 'Participant refused further follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '38'}, {'groupId': 'FG002', 'numSubjects': '13'}, {'groupId': 'FG003', 'numSubjects': '9'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '9'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Missing', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Investigator request', 'reasons': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This study was offered to participants randomized to bosutinib arm in B1871008 (NCT00574873) or dosed with bosutinib in B1871006 (NCT00261846). Participants enrolled in this study were who in any of the parent studies (B1871008 or B1871006) at time of protocol approval 1) receiving bosutinib, benefiting per investigator, 2) discontinued bosutinib, being followed-up,3) completed parent study. Per enrolment criteria, 281 participants were enrolled in this study and 21 participants were from China.', 'preAssignmentDetails': 'Per protocol data from 2 parent studies were combined with data from this study (B1871040) for all analyses. Reporting arms were based on parent study, disease phase and line of therapy (CP1L,CP2L,CP3L/CP4L,ADV).The B1871040 data from 21 participants enrolled in China were not included in results because the Human Genetics Resources Administration of China did not approve the use of the data in accordance with its regulations. This data has been excluded from all our analyses.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '250', 'groupId': 'BG000'}, {'value': '284', 'groupId': 'BG001'}, {'value': '119', 'groupId': 'BG002'}, {'value': '167', 'groupId': 'BG003'}, {'value': '820', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Bosutinib, CP1L', 'description': 'Participants from B1871008 with Philadelphia chromosome-positive (Ph+) chronic phase 1st line (CP1L) chronic myeloid leukemia (CML).'}, {'id': 'BG001', 'title': 'Bosutinib, CP2L', 'description': 'Participants from B1871006 with Ph+ chronic phase 2nd line (CP2L) CML who were resistant or intolerant to imatinib.'}, {'id': 'BG002', 'title': 'Bosutinib, CP3L/CP4L', 'description': 'Participants from B1871006 with Ph+ chronic phase 3rd line (CP3L)/4th line (CP4L) CML who were resistant or intolerant to imatinib and resistant or intolerant to dasatinib and/or nilotinib.'}, {'id': 'BG003', 'title': 'Bosutinib, ADV', 'description': 'Participants from B1871006 with Ph+ accelerated phase (AP), blast phase (BP) CML or Ph+ acute lymphoblastic leukemia (ALL) and resistant or intolerant to imatinib only or resistant and intolerant to imatinib and at least 1 additional tyrosine kinase inhibitor (TKI) including dasatinib and/or nilotinib.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '47.9', 'spread': '14.4', 'groupId': 'BG000'}, {'value': '51.9', 'spread': '15.1', 'groupId': 'BG001'}, {'value': '55.1', 'spread': '13.0', 'groupId': 'BG002'}, {'value': '50.1', 'spread': '15.4', 'groupId': 'BG003'}, {'value': '50.8', 'spread': '14.8', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '101', 'groupId': 'BG000'}, {'value': '135', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}, {'value': '69', 'groupId': 'BG003'}, {'value': '371', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '149', 'groupId': 'BG000'}, {'value': '149', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}, {'value': '98', 'groupId': 'BG003'}, {'value': '449', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '83', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}, {'value': '196', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}, {'value': '43', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '160', 'groupId': 'BG000'}, {'value': '186', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}, {'value': '102', 'groupId': 'BG003'}, {'value': '535', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '45', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The full analysis set included all participants randomized to the bosutinib arm from B1871008 and all dosed participants from B1871006.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-11-07', 'size': 1909082, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-06-07T13:09', 'hasProtocol': True}, {'date': '2020-08-11', 'size': 2321298, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-06-07T13:09', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 281}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2020-06-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-28', 'studyFirstSubmitDate': '2013-07-16', 'resultsFirstSubmitDate': '2021-06-07', 'studyFirstSubmitQcDate': '2013-07-16', 'lastUpdatePostDateStruct': {'date': '2022-07-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-07-23', 'studyFirstPostDateStruct': {'date': '2013-07-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-08-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) Based on National Cancer Institute Common Terminology Criteria for AEs (NCI CTCAE) (Version 3.0)', 'timeFrame': 'From first dose of drug up to 30 days after last dose (up to approximately 14 years)', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Treatment-emergent adverse events were defined as any event increasing in severity from baseline or any new event started during bosutinib therapy or within 30 days of the last dose of study drug.'}, {'measure': 'Number of Participants With Grade 3 or 4 Treatment-Emergent Adverse Events (AEs) Based on National Cancer Institute Common Terminology Criteria for AEs (NCI CTCAE) (Version 3.0)', 'timeFrame': 'From first dose of drug up to 30 days after last dose (up to approximately 14 years)', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs were assessed according to severity grading based on NCI CTCAE version 3.0. Grade 1 =mild; Grade 2 =moderate; Grade 3 =severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated; Grade 4 =life-threatening or disabling, urgent intervention indicated; Grade 5 =death. Treatment-emergent adverse events were defined as any event increasing in severity from baseline or any new event started during bosutinib therapy or within 30 days of the last dose of study drug.'}, {'measure': 'Number of Participants With Treatment-Emergent Treatment Related Adverse Events (AEs) Based on National Cancer Institute Common Terminology Criteria for AEs (NCI CTCAE) (Version 3.0)', 'timeFrame': 'From first dose of drug up to 30 days after last dose (up to approximately 14 years)', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug. Treatment-emergent adverse events were defined as any event increasing in severity from baseline or any new event started during bosutinib therapy or within 30 days of the last dose of study drug. Related TEAEs were those AEs who were related to the study treatment as judged by the investigator.'}, {'measure': 'Number of Participants With Laboratory Test Abnormalities Based on National Cancer Institute Common Terminology Criteria for AEs (NCI CTCAE) (Version 4.03)', 'timeFrame': 'From first dose of drug up to 30 days after last dose (up to approximately 14 years)', 'description': 'Laboratory parameters included Chemistry: high alkaline phosphatase; high alanine aminotransferase; high aspartate aminotransferase; high blood bilirubin; high creatinine. Hematology: absolute neutrophils count decreased; anemia; platelet count decreased; white blood cells (WBC) decreased. Abnormalities in laboratory tests were graded per NCI CTCAE version 4.03 as Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling.'}, {'measure': 'Number of Participants With Adverse Events as Reason for Treatment Discontinuation', 'timeFrame': 'From first dose of drug up to 30 days after last dose (up to approximately 14 years)', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.'}, {'measure': 'Number of Participants With Diarrhea After Switch From Bosutinib Clinical Formulation to Bosutinib Commercial Formulation', 'timeFrame': 'Last 6 months on clinical formulation and first 6 months on commercial formulation', 'description': 'The incidence of diarrhea was collected and analyzed before and after the switch from the clinical formulation of bosutinib to the commercial formulation of bosutinib.'}, {'measure': 'Number of Participants With Breakpoint Cluster Region Abelson Protooncogene (BCR-ABL) Mutations Present at Time of Bosutinib Treatment Discontinuation', 'timeFrame': 'Post-baseline on Day 1 (maximum up to 14 years)', 'description': 'BCR-ABL is a gene resulting from the 9:22 chromosomal translocation (Philadelphia chromosome). In this outcome measure, the number of participants who had emergent mutation or new BCR-ABL mutations (participants who had a post-baseline mutation which was not present at baseline) were reported.'}, {'measure': 'Overall Survival (OS) Rate at Year 10', 'timeFrame': 'Year 10', 'description': 'OS was defined as the time from randomization (B1871008) and time from first dose (B1871006) to the occurrence of death due to any cause or censoring. Kaplan-Meier analysis was used for determination of OS. Percentage of participants who were alive were estimated in this outcome measure.'}, {'measure': 'Plasma Steady-State Trough Concentrations (Ctrough) of Bosutinib', 'timeFrame': 'One pre-dose sample was collected at the first scheduled visit (after approval and implementation of protocol amendment 1) following at least 2 weeks of uninterrupted dosing at the same dose level', 'description': 'Ctrough refers to plasma concentration of bosutinib observed just before treatment administration.'}, {'measure': 'Kaplan-Meier Estimate of Probability of Maintaining Major Cytogenetic Response (MCyR) at Year 10: B1871006 Participants', 'timeFrame': 'Year 10', 'description': 'Cytogenetic response (CyR) is based on prevalence of Ph+ cells. Duration for MCyR: time from first response to confirmed loss, progression of disease, or on-treatment death due to any cause, or censoring analyzed for responders only. Confirmed loss was defined as 2 consecutive non-responses at least 28 days apart. MCyR was categorized as either complete cytogenetic response (CCyR) or partial cytogenetic response (PCyR). Response was achieved when there was 0% (CCyR) or 1-35% (PCyR) Ph+ cells analyzed from conventional cytogenetics based on the analysis of 20 to 100 metaphases or \\<1% (CCyR) or 1-35% (PCyR) Ph+ cells analyzed from fluorescence in-situ hybridization (FISH) based on analysis of at least 200 nuclei. CCyR may be imputed on a specific date if an MMR or better is achieved and denoted on the CRF on that date for B1871040 study visits. The Kaplan-Meier analysis was used to analyze percentage of participants maintaining MCyR at Year 10.'}, {'measure': 'Kaplan-Meier Estimate of Probability of Maintaining Complete Cytogenetic Response (CCyR) at Year 10: B1871006 Participants', 'timeFrame': 'Year 10', 'description': 'Duration for CCyR was defined as time from first response to confirmed loss, progression of disease, or on-treatment death due to any cause, or censoring analyzed for responders only. Confirmed loss was defined as 2 consecutive assessments with \\>0 Ph+ metaphases or \\>=1% positive cells from FISH at least 28 days apart or progression or death. CCyR was achieved when there was 0% Ph+ cells analysed from conventional cytogenetics with 20 to 100 metaphases or \\<1% Ph+ cells analysed from FISH with at least 200 nuclei. CCyR may be imputed on a specific date if MMR or better is achieved and denoted on the CRF on that date for B1871040 study visits. The Kaplan-Meier analysis was used to analyze percentage of participants maintaining CCyR at Year 10.'}, {'measure': 'Kaplan-Meier Estimate of Probability of Maintaining Complete Hematologic Response (CHR) at Year 10: B1871006 Participants', 'timeFrame': 'Year 10', 'description': 'Duration for CHR was defined as time from first response to confirmed loss, progression of disease, or on-treatment death due to any cause, or censoring analyzed for responders only. Confirmed loss was defined as 2 consecutive non-responses at least 14 days apart. Complete hematologic response was considered when participants met all of the following criteria: White blood cells equal to or less than (\\<=) institutional upper limit of normal (ULN), no blasts or promyelocytes in blood, \\<20% basophils in blood, no extramedullary involvement (including hepatomegaly or splenomegaly), myelocytes and metamyelocytes \\<5% in blood, platelets \\<450\\*10\\^9 per liter (/L). The following were applicable only to advanced phase: \\<=5% bone marrow blasts, absolute neutrophil count \\>=1.0\\*10\\^9/L, platelets \\>=100\\*10\\^9/L. The Kaplan-Meier analysis was used to analyze percentage of participants maintaining CHR at Year 10.'}, {'measure': 'Cumulative Incidence of Progression/Death Events at Year 10: B1871006 Participants', 'timeFrame': 'Year 10', 'description': 'Progression free survival (PFS):interval from date of first dose of bosutinib in parent study until earlier date of progression or death from any cause. Participants without events censored at last evaluation date. PD:evolution from CP (or return to CP for ADV participants) to AP or BP (on 2 consecutive assessments at least 1 week apart), evolution from AP to BP (on 2 consecutive assessments at least 1 week apart) and one of following conditions occurred after dose escalation or presence of AEs prohibiting dose escalation: for 2nd or later line, loss of MCyR (need at least 30% increase); for all lines of treatment, loss of CHR confirmed by 2 assessments \\>=2 weeks apart; for all lines of treatment, increasing WBC defined as doubling of WBC over a period of \\>=1 month with second WBC \\>20\\*10\\^9/L confirmed at least 1 week later. Percentage of participants with PFS/death events based on cumulative incidence method adjusting for competing event of treatment discontinuation without event.'}, {'measure': 'Cumulative Incidence of Rate of Transformation to Accelerated Phase (AP) or Blast Phase (BP) at Year 10: B1871006 Participants', 'timeFrame': 'Year 10', 'description': 'Time to transformation was defined as the time from first dose in the parent study to the first date of confirmed transformation to AP or BP. Confirmed transformation was defined as 2 consecutive assessments at least 1 week apart or 1 assessment confirmed by progression of disease or death. For participants without transformation, censorship was at the last evaluation date. Percentage of participants with time to transformation to AP/BP was reported based on cumulative incidence method adjusting for the competing risk of treatment discontinuation without the event.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Subjects', 'Chronic Myeloid Leukemia', 'CML', 'Bosutinib', 'Extension'], 'conditions': ['Chronic Myeloid Leukemia']}, 'referencesModule': {'references': [{'pmid': '35235189', 'type': 'DERIVED', 'citation': 'Takahashi N, Cortes JE, Sakaida E, Ishizawa K, Ono T, Doki N, Matsumura I, Garcia-Gutierrez V, Rosti G, Ono C, Ohkura M, Tanetsugu Y, Viqueira A, Brummendorf TH. Safety profile of bosutinib in Japanese versus non-Japanese patients with chronic myeloid leukemia: a pooled analysis. Int J Hematol. 2022 Jun;115(6):838-851. doi: 10.1007/s12185-022-03314-y. Epub 2022 Mar 2.'}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1871040&StudyName=An%20Open-label%20Bosutinib%20Treatment%20Extension%20Study%20For%20Subjects%20With%20Chronic%20Myeloid%20Leukemia%20%28cml%29%20Who%20Have%20Previously%20Participated%20In%20Bosutinib%20Studies%20B1871006%20Or%20B1871008', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The objective of the study is to provide long term access to bosutinib treatment and assess long term safety, tolerability and duration of clinical benefit, without any formal hypothesis testing; therefore, there is no formal primary endpoint.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Only subjects previously participating in two specific studies are eligible to enroll into this study. Enrollment is not open to subjects if not previously enrolled in studies B1871006 or B1871008.\n\nExclusion Criteria:\n\n* All subjects are excluded unless previously participating in studies B1871006 or B1871008.'}, 'identificationModule': {'nctId': 'NCT01903733', 'briefTitle': 'Bosutinib Treatment Extension Study Only For Subjects With Chronic Myeloid Leukemia (CML) Who Have Previously Participated In Bosutinib Studies B1871006 Or B1871008', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'AN OPEN-LABEL BOSUTINIB TREATMENT EXTENSION STUDY FOR SUBJECTS WITH CHRONIC MYELOID LEUKEMIA (CML) WHO HAVE PREVIOUSLY PARTICIPATED IN BOSUTINIB STUDIES B1871006 OR B1871008', 'orgStudyIdInfo': {'id': 'B1871040'}, 'secondaryIdInfos': [{'id': '2013-000691-15', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'bosutinib', 'type': 'DRUG', 'description': 'The starting bosutinib dose is 500 mg once daily, however the dose can vary from 300 mg to 600 mg.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Orlando Health, Inc', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University Hospital', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'The Emory Clinic', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Winship Cancer Institute, Emory University', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30342', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Northside Hospital Inc., - GCS/Northside', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30342', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Northside Hospital, Inc. - Central Research Department', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '46237', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana Blood and Marrow Transplantation', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '51101', 'city': 'Sioux City', 'state': 'Iowa', 'country': 'United States', 'facility': 'Siouxland Hematology-Oncology Associates, LLP', 'geoPoint': {'lat': 42.49999, 'lon': -96.40031}}, {'zip': '20817', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'Rcca Md,Llc', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}, {'zip': '10532', 'city': 'Hawthorne', 'state': 'New York', 'country': 'United States', 'facility': 'Hudson Valley Hematology and Oncology Associates', 'geoPoint': {'lat': 41.10732, 'lon': -73.79597}}, {'zip': '17033-0850', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Penn State Milton S. Hershey Medical Center', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'The University of Texas MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'The University of Texas, MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': 'C1426ANZ', 'city': 'Cd. Autonoma de Buenos Aires', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Instituto Medico Especializado Alexander Fleming'}, {'zip': '1900', 'city': 'La Plata', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Hospital Italiano de la Plata', 'geoPoint': {'lat': -34.92126, 'lon': -57.95442}}, {'zip': '3400', 'city': 'Corrientes', 'country': 'Argentina', 'facility': 'Hospital Dr. Jose Ramon Vidal', 'geoPoint': {'lat': -27.46784, 'lon': -58.8344}}, {'zip': '4029', 'city': 'Herston', 'state': 'Queensland', 'country': 'Australia', 'facility': "Royal Brisbane & Women's Hospital", 'geoPoint': {'lat': -27.44453, 'lon': 153.01852}}, {'zip': '5000', 'city': 'Adelaide', 'state': 'South Australia', 'country': 'Australia', 'facility': 'Royal Adelaide Hospital', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}, {'zip': '6000', 'city': 'Charleroi', 'country': 'Belgium', 'facility': 'GHDC (Grand Hopital de Charleroi)', 'geoPoint': {'lat': 50.41136, 'lon': 4.44448}}, {'zip': '13083-878', 'city': 'Campinas', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Universidade Estadual de Campinas / Centro de Hematologia e Hemoterapia', 'geoPoint': {'lat': -22.90556, 'lon': -47.06083}}, {'zip': '09060-650', 'city': 'Santo André', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Faculdade de Medicina do ABC - Centro de Estudos e Pesquisa em Hematologia e Oncologia (CEPHO)', 'geoPoint': {'lat': -23.66389, 'lon': -46.53833}}, {'zip': 'T6G 1Z2', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Alberta Health Services - Department of Medical Oncology - Cross Cancer Institute', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'V5Z1M9', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Vancouver General Hospital', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'M5G 2M9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Princess Margaret Cancer Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H3T 1E2', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Sir Mortimer B. Davis-Jewish General Hospital', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': '2540364', 'city': 'Reñaca', 'state': 'Región de Valparaíso', 'country': 'Chile', 'facility': 'Instituto Oncologico, Clinica Renaca', 'geoPoint': {'lat': -32.98298, 'lon': -71.54374}}, {'zip': '2540488', 'city': 'Reñaca', 'state': 'Región de Valparaíso', 'country': 'Chile', 'facility': 'Instituto Oncologico', 'geoPoint': {'lat': -32.98298, 'lon': -71.54374}}, {'zip': '100730', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Peking Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '310003', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'The First affiliated Hospital of College of Medicine, Zhejiang University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'zip': '100853', 'city': 'Beijing', 'country': 'China', 'facility': "Chinese People's Liberation Army General Hospital", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '200025', 'city': 'Shanghai', 'country': 'China', 'facility': 'Ruijin Hospital- Shanghai Jiaotong University School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '300020', 'city': 'Tianjin', 'country': 'China', 'facility': 'Blood Disease Hospital, Chinese Academy of Medical Science & Peking Union Medical College', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'zip': '110111', 'city': 'Bogota', 'state': 'Cundinamarca', 'country': 'Colombia', 'facility': 'Fundacion Santa Fe de Bogota'}, {'zip': '00290', 'city': 'Helsinki', 'country': 'Finland', 'facility': 'Helsingin Yliopistollinen Keskussairaala, Hematologian poliklinikka', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}, {'zip': '14033', 'city': 'Caen', 'country': 'France', 'facility': 'CHU de CAEN', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'zip': '44093', 'city': 'Nantes', 'country': 'France', 'facility': 'CHU Hotel Dieu - Service Hematologie', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '86021', 'city': 'Poitiers', 'country': 'France', 'facility': 'CHU de Poitiers', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'zip': '86021', 'city': 'Poitiers', 'country': 'France', 'facility': 'CHU Poitiers', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'zip': '67000', 'city': 'Strasbourg', 'country': 'France', 'facility': 'Strasbourg Oncologie Liberale -Centre de Radiotherapie, Clinique Ste Anne', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'city': 'Chai Wan', 'country': 'Hong Kong', 'facility': 'Pamela Youde Nethersole Eastern Hospital', 'geoPoint': {'lat': 22.26718, 'lon': 114.24051}}, {'city': 'Shatin, New Territories', 'country': 'Hong Kong', 'facility': 'Department of Medicine & Therapeutics, Prince of Wales Hospital'}, {'zip': '1097', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Egyesitett Szent Istvan es Szent Laszlo Korhaz-Rendelointezet', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '7400', 'city': 'Kaposvár', 'country': 'Hungary', 'facility': 'Somogy Megyei Kaposi Mor Oktato Korhaz, Belgyogyaszati Osztaly', 'geoPoint': {'lat': 46.36667, 'lon': 17.8}}, {'zip': '632004', 'city': 'Vellore', 'state': 'Tamil Nadu', 'country': 'India', 'facility': 'Christian Medical College. Vellore', 'geoPoint': {'lat': 12.9184, 'lon': 79.13255}}, {'zip': '40138', 'city': 'Bologna', 'state': 'BO', 'country': 'Italy', 'facility': 'A.O.U. Policlinico S.Orsola Malpighi', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'zip': '20090', 'city': 'Monza', 'state': 'Monza and Brianza', 'country': 'Italy', 'facility': 'ASST Monza - Ospedale san Gerardo', 'geoPoint': {'lat': 45.58005, 'lon': 9.27246}}, {'zip': '10043', 'city': 'Orbassano', 'state': 'TO', 'country': 'Italy', 'facility': 'A.O.U. San Luigi Gonzaga di Orbassano', 'geoPoint': {'lat': 45.00547, 'lon': 7.53813}}, {'zip': '00144', 'city': 'Roma', 'country': 'Italy', 'facility': 'Ospedale S. Eugenio - UOC Ematologia', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '4418570', 'city': 'Toyohashi', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Toyohashi Municipal Hospital', 'geoPoint': {'lat': 34.76667, 'lon': 137.38333}}, {'zip': '010-8543', 'city': 'Akita', 'state': 'Akita', 'country': 'Japan', 'facility': 'Akita University Hospital', 'geoPoint': {'lat': 39.71667, 'lon': 140.11667}}, {'zip': '811-1395', 'city': 'Fukuoka', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'National Hospital Organization Kyushu Cancer Center', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'zip': '920-8641', 'city': 'Kanazawa', 'state': 'Ishikawa-ken', 'country': 'Japan', 'facility': 'Kanazawa University Hospital', 'geoPoint': {'lat': 36.6, 'lon': 136.61667}}, {'zip': '589-8511', 'city': 'Sayama', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Kindai University Hospital', 'geoPoint': {'lat': 34.51685, 'lon': 135.56298}}, {'zip': '565-0871', 'city': 'Suita', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Osaka University Hospital', 'geoPoint': {'lat': 34.76143, 'lon': 135.51567}}, {'zip': '431-3192', 'city': 'Hamamatsu', 'state': 'Shizuoka', 'country': 'Japan', 'facility': 'Hamamatsu University School of Medicine University Hospital', 'geoPoint': {'lat': 34.7, 'lon': 137.73333}}, {'zip': '113-8677', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': 'LV-1079', 'city': 'Riga', 'country': 'Latvia', 'facility': 'Riga East Clinical University Hospital', 'geoPoint': {'lat': 56.946, 'lon': 24.10589}}, {'zip': '1081 HV', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'VU University Medical Center', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '9713 GZ', 'city': 'Groningen', 'country': 'Netherlands', 'facility': 'University Medical Center Groningen, Department of Hematology', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}, {'zip': '11', 'city': 'Lima', 'country': 'Peru', 'facility': 'Unidad de Investigacion de Hematologia - Hospital Nacional Edgardo Rebagliati Martins', 'geoPoint': {'lat': -12.04318, 'lon': -77.02824}}, {'zip': '80-214', 'city': 'Gdansk', 'country': 'Poland', 'facility': 'Uniwersyteckie Centrum Kliniczne', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}, {'zip': '80-952', 'city': 'Gdansk', 'country': 'Poland', 'facility': 'Uniwersyteckie Centrum Kliniczne', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}, {'zip': '31-501', 'city': 'Krakow', 'country': 'Poland', 'facility': 'SP ZOZ Szpital Uniwersytecki w Krakowie', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '20-081', 'city': 'Lublin', 'country': 'Poland', 'facility': 'Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie', 'geoPoint': {'lat': 51.25058, 'lon': 22.57009}}, {'zip': '620102', 'city': 'Yekaterinburg', 'state': 'Sverdlovsk Oblast', 'country': 'Russia', 'facility': 'State Budgetary Institution of Healthcare of Sverdlovsk Region', 'geoPoint': {'lat': 56.85733, 'lon': 60.61529}}, {'zip': '125167', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Federal State-Funded Institution National Research Center of Hematology of the Ministry of', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '344015', 'city': 'Rostov-on-Don', 'country': 'Russia', 'facility': 'State Budgetary Institution of Rostov Region - Rostov Regional Clinical Hospital', 'geoPoint': {'lat': 47.21997, 'lon': 39.70769}}, {'zip': '344022', 'city': 'Rostov-on-Don', 'country': 'Russia', 'facility': 'State Budgetary Educational Institution of Higher Professional Education', 'geoPoint': {'lat': 47.21997, 'lon': 39.70769}}, {'zip': '194291', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'State Budgetary Institution of Healthcare - Leningrad Regional Clinical Hospital', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '197022', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Clinic "Institute of Pediatric Oncology, Hematology and Transplantation n.a. R.M. Gorbachova"', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '197341', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Federal State Budgetary Institution "Federal Almazov Medical Research Centre"', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '443095', 'city': 'Samara', 'country': 'Russia', 'facility': 'State Budgetary Institution of Healthcare Samara Regional Clinical Hospital n.a. V.D. Seredavin', 'geoPoint': {'lat': 53.20767, 'lon': 50.13553}}, {'zip': '169608', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'Singapore General Hospital', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'zip': '2013', 'city': 'Soweto', 'state': 'Gauteng', 'country': 'South Africa', 'facility': 'Wits Clinical Research-Chris Hani Baragwanath Hospital', 'geoPoint': {'lat': -26.26781, 'lon': 27.85849}}, {'zip': '06591', 'city': 'Seoul', 'country': 'South Korea', 'facility': "The Catholic University of Korea, Seoul St. Mary's Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '08036', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Clinic Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28006', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario La Princesa', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28046', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario La Paz', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28050', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario Madrid Sanchinarro, Centro Integral Oncologico Clara Campal', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '45004', 'city': 'Toledo', 'country': 'Spain', 'facility': 'Hospital Virgen de la Salud', 'geoPoint': {'lat': 39.8581, 'lon': -4.02263}}, {'zip': '46010', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Hospital Clinico Universitario De Valencia (CHUV)', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '10700', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Division of Hematology, Department of Medicine, Faculty of Medicine, Siriraj Hospital,', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'zip': '27310', 'city': 'Gaziantep', 'state': 'Sehit Kamil', 'country': 'Turkey (Türkiye)', 'facility': 'Gaziantep Universitesi Tip Fakultesi Sahinbey Uygulama ve Arastirma Hastanesi', 'geoPoint': {'lat': 37.05944, 'lon': 37.3825}}, {'zip': '06100', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Hacettepe Universitesi Tip Fakultesi', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}, {'zip': '18009', 'city': 'Cherkasy', 'country': 'Ukraine', 'facility': 'Municipal Institution "Cherkasy Regional Oncology Dispensary"', 'geoPoint': {'lat': 49.44452, 'lon': 32.05738}}, {'zip': '49102', 'city': 'Dnipropetrovsk', 'country': 'Ukraine', 'facility': 'MI "Dnipropetrovsk City Multi-field Clinical Hospital #4" of DRC Hematology Center', 'geoPoint': {'lat': 48.46664, 'lon': 35.04066}}, {'zip': '03115', 'city': 'Kyiv', 'country': 'Ukraine', 'facility': 'State Institution "National Research Center for Radiation Medicine of the National Academy of', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}, {'zip': '04112', 'city': 'Kyiv', 'country': 'Ukraine', 'facility': 'Kyiv City Clinical Hospital #9, SI "Institute of Hematology and Transfusiology of NAMS of Ukraine"', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}, {'zip': '79044', 'city': 'Lviv', 'country': 'Ukraine', 'facility': 'State Institution "Institute of Blood Pathology and Transfusion Medicine of', 'geoPoint': {'lat': 49.83826, 'lon': 24.02324}}, {'zip': 'NE7 7DN', 'city': 'Newcastle upon Tyne', 'country': 'United Kingdom', 'facility': 'Freeman Hospital', 'geoPoint': {'lat': 54.97328, 'lon': -1.61396}}, {'zip': 'NG5 1PB', 'city': 'Nottinhgam', 'country': 'United Kingdom', 'facility': 'Nottingham University Hospitals NHS Trust'}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\\_trials/trial\\_data\\_and\\_results/data\\_requests."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}