Viewing Study NCT01981850

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: 2025-12-24 @ 5:13 PM
Ignite Modification Date: 2026-04-18 @ 4:14 AM
Study NCT ID: NCT01981850
Status: COMPLETED
Last Update Posted: 2022-01-05
First Post: 2013-10-29
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: A Phase 2 Study of RO7490677 In Participants With Myelofibrosis
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055728', 'term': 'Primary Myelofibrosis'}, {'id': 'D011087', 'term': 'Polycythemia Vera'}, {'id': 'D005355', 'term': 'Fibrosis'}], 'ancestors': [{'id': 'D009196', 'term': 'Myeloproliferative Disorders'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D019046', 'term': 'Bone Marrow Neoplasms'}, {'id': 'D019337', 'term': 'Hematologic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C540383', 'term': 'ruxolitinib'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'genentech@druginfo.com', 'phone': '800-821-8590', 'title': 'Medical Communications', 'organization': 'Hoffmann-La Roche'}, 'certainAgreement': {'otherDetails': "The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline up until 6.75 years', 'description': 'Treatment-emergent adverse events (TEAEs) were defined as any AE that occurred after the administration of any amount of the study drug, or any event that was present at baseline.', 'eventGroups': [{'id': 'EG000', 'title': 'Main Phase Stage 1: RO7490677 10 mg/kg IV Every Week (QW)', 'description': 'Participants who received no treatment for Myelofibrosis (MF) in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 milligram per kilogram (mg/kg) administered as a 30 minute intravenous (IV) infusion on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 8, 'seriousNumAtRisk': 8, 'deathsNumAffected': 2, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Main Phase Stage 1: RO7490677 10 mg/kg IV Every 4 Weeks (Q4W)', 'description': 'Participants who received no treatment for MF in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 6, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Main Phase Stage 1: RO7490677 10 mg/kg IV QW + Ruxolitinib', 'description': 'Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 1, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'Main Phase Stage 1: RO7490677 10 mg/kg IV Q4W+ Ruxolitinib', 'description': 'Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Main Phase Stage 2: RO7490677 0.3 mg/kg IV Q4W', 'description': 'Participants were treated with single agent PRM-151 at a dose of 0.3 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.', 'otherNumAtRisk': 33, 'deathsNumAtRisk': 33, 'otherNumAffected': 32, 'seriousNumAtRisk': 33, 'deathsNumAffected': 7, 'seriousNumAffected': 11}, {'id': 'EG005', 'title': 'Main Phase Stage 2: RO7490677 3 mg/kg IV Q4W', 'description': 'Participants were treated with single agent PRM-151 at a dose of 3.0 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.', 'otherNumAtRisk': 32, 'deathsNumAtRisk': 32, 'otherNumAffected': 30, 'seriousNumAtRisk': 32, 'deathsNumAffected': 6, 'seriousNumAffected': 14}, {'id': 'EG006', 'title': 'Main Phase Stage 2: RO7490677 10 mg/kg IV Q4W', 'description': 'Participants were treated with single agent PRM-151 at a dose of 10 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.', 'otherNumAtRisk': 32, 'deathsNumAtRisk': 32, 'otherNumAffected': 31, 'seriousNumAtRisk': 32, 'deathsNumAffected': 9, 'seriousNumAffected': 14}, {'id': 'EG007', 'title': 'OLE Stage 1: RO7490677 10 mg/kg IV Q4W', 'description': 'Participants who completed the main phase of treatment moved to the open label extension. They were treated with single agent PRM-151 at a dose of 10 mg/kg administered as an IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle.', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 12, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG008', 'title': 'OLE Stage 1: RO7490677 10 mg/kg IV Q4W + Ruxolitinib', 'description': 'Participants who completed the main phase of treatment moved to the open label extension. They were treated with PRM-151 at a dose of 10 mg/kg administered as an IV infusion in combination with daily oral ruxolitinib on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle.', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 5, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG009', 'title': 'OLE Stage 2: RO7490677 10 mg/kg IV Q4W', 'description': 'Participants who completed 9 cycles of the originally assigned treatment could switch to the open label extension. Participants enrolled received PRM-151 at a dose of 10mg/kg Q4W on days 1, 3, and 5 of first cycle of the open label phase and Day 1 of each subsequent 28 day cycle.', 'otherNumAtRisk': 48, 'deathsNumAtRisk': 48, 'otherNumAffected': 32, 'seriousNumAtRisk': 48, 'deathsNumAffected': 7, 'seriousNumAffected': 22}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 11, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 12, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Splenomegaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 9, 'numAffected': 5}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 5, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Peripheral swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 5, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 7, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 9, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Gout', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Hyperuricaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 9, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 7, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Dyspnoea exertional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 11, 'numAffected': 4}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 16, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Ecchymosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Night sweats', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 7, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Gingival bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Gait disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Folliculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Eye contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 7, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 6, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 6, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Blood sodium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 8, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 11, 'numAffected': 8}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 5, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Cachexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Increased tendency to bruise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Supraventricular extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Abdominal tenderness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Anal incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Aphthous ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Gingival pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Oral disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Oral pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Retching', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Early satiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Extravasation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Ill-defined disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Injection site haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Vessel puncture site bruise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 5, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Hepatomegaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Hepatosplenomegaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Hyperbilirubinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Diarrhoea infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Laryngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Localised infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Lyme disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Respiratory syncytial virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Sialoadenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Subcutaneous abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Tooth infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Arthropod bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Foot fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Post-traumatic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Transfusion reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Wrist fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Blood urea increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Blood uric acid increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Hyperphosphataemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Iron deficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Iron overload', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Type 2 diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Groin pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Joint lock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Joint swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Musculoskeletal stiffness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Lipoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Nerve compression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Sciatic nerve neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Sleep disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Nocturia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Vaginal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Dysphonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Nasal dryness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Paranasal sinus discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Rhinitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Sleep apnoea syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Sneezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Upper-airway cough syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Hyperkeratosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Lichen planus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Petechiae', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Rash erythematous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Rash pruritic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Skin induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Skin lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Blood product transfusion dependent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}], 'seriousEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Bone marrow failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Extramedullary haemopoiesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Aortic valve stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Cardiopulmonary failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Femoral hernia, obstructive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Intestinal ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Melaena', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Oesophageal varices haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Varices oesophageal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Disease progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Peripheral swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Unevaluable event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Anaphylactic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Abscess limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Endocarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Intervertebral discitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Pneumonia fungal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Pseudomonal sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Osteoradionecrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Procedural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Subdural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Eastern Cooperative Oncology Group performance status worsened', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Hepatic enzyme increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Cachexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Hyperuricaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Chondrocalcinosis pyrophosphate', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Haemarthrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Haematoma muscle', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Joint effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Acute myeloid leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Malignant neoplasm progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Myelofibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Primary myelofibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Transformation to acute myeloid leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Hepatic encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Subarachnoid haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Aortic valve replacement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Dry gangrene', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Mouth haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Upper gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Organ failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Portal hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Enterocolitis infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Pneumonia viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Respiratory syncytial virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Sialoadenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Multiple fractures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Post procedural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Hepatic cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Metastatic squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Metabolic encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Urinary bladder haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Urinary bladder rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Stage 1 Main Phase: Overall Response Rate (ORR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Main Phase Stage 1: RO7490677 10 mg/kg IV Every Week (QW)', 'description': 'Participants who received no treatment for Myelofibrosis (MF) in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 milligram per kilogram (mg/kg) administered as a 30 minute intravenous (IV) infusion on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.'}, {'id': 'OG001', 'title': 'Main Phase Stage 1: RO7490677 10 mg/kg IV Every 4 Weeks (Q4W)', 'description': 'Participants who received no treatment for MF in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.'}, {'id': 'OG002', 'title': 'Main Phase Stage 1: RO7490677 10 mg/kg IV QW + Ruxolitinib', 'description': 'Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.'}, {'id': 'OG003', 'title': 'Main Phase Stage 1: RO7490677 10 mg/kg IV Q4W+ Ruxolitinib', 'description': 'Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '37.5', 'groupId': 'OG000', 'lowerLimit': '11.11', 'upperLimit': '71.08'}, {'value': '14.3', 'groupId': 'OG001', 'lowerLimit': '0.73', 'upperLimit': '52.07'}, {'value': '33.3', 'groupId': 'OG002', 'lowerLimit': '6.28', 'upperLimit': '72.87'}, {'value': '50.0', 'groupId': 'OG003', 'lowerLimit': '15.32', 'upperLimit': '84.68'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up until and including completion of 6 cycles. Each cycle is 28 days.', 'description': 'ORR was defined as the percent of participants with a response according to the International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) criteria. This was defined as those participants who achieved clinical improvement (CI), partial remission (PR), or complete remission (CR) at a post-baseline assessment of treatment response OR had at least stable disease (SD) for three consecutive end-of-cycle response assessments (e.g. Day 1 of the subsequent cycle) in conjunction with improvement in the bone marrow fibrosis score relative to baseline by at least one grade at any time point during the period of stable disease.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The all treated population included all participants who received at least one dose of RO7490667.'}, {'type': 'PRIMARY', 'title': 'Stage 2 Main Phase: Bone Marrow Response Rate (BMRR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Main Phase Stage 2: RO7490677 0.3 mg/kg IV Q4W', 'description': 'Participants were treated with single agent PRM-151 at a dose of 0.3 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.'}, {'id': 'OG001', 'title': 'Main Phase Stage 2: RO7490677 3 mg/kg IV Q4W', 'description': 'Participants were treated with single agent PRM-151 at a dose of 3.0 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.'}, {'id': 'OG002', 'title': 'Main Phase Stage 2: RO7490677 10 mg/kg IV Q4W', 'description': 'Participants were treated with single agent PRM-151 at a dose of 10 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '30.3', 'groupId': 'OG000', 'lowerLimit': '14.62', 'upperLimit': '45.98'}, {'value': '31.3', 'groupId': 'OG001', 'lowerLimit': '15.19', 'upperLimit': '47.31'}, {'value': '25.0', 'groupId': 'OG002', 'lowerLimit': '10.00', 'upperLimit': '40.00'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up until and including completion of 9 cycles. Each cycle is 28 days.', 'description': 'Response rate was defined as the percent of participants with a reduction in bone marrow fibrosis by at least one grade according to World Health Organization (WHO) criteria from baseline to any time during the study. This was determined by a central adjudication panel of expert hematopathologists, blinded to participant, treatment, and time of biopsy.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The all treated population included all participants randomized and who received at least one administration of the drug.'}, {'type': 'PRIMARY', 'title': 'Stage 1 Main + Open-Label Extension (OLE): ORR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Main Phase Stage 1: RO7490677 10 mg/kg IV QW; OLE: RO7490677 10 mg/kg IV Q4W', 'description': "Participants were followed through their originally assigned treatment. If a participant achieved a clinical benefit in the main phase, they had the opportunity to remain on treatment. Participants who didn't achieve a clinical benefit had the opportunity to switch to a different dosing schedule in the OLE phase. Participants were not allowed to add ruxolitinib if they had been receiving monotherapy during the main phase.\n\nParticipants who received no treatment for Myelofibrosis (MF) in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 milligram per kilogram (mg/kg) administered as a 30 minute intravenous (IV) infusion on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for 6 cycles (main phase) and on Days 1, 3, and 5 of Cycle 7 and Day 1 of each subsequent 28 day cycle for 83 cycles (OLE)."}, {'id': 'OG001', 'title': 'Main Phase Stage 1: RO7490677 10 mg/kg IV Q4W; OLE: RO7490677 10 mg/kg IV Q4W', 'description': "Participants were followed through their originally assigned treatment. If a participant achieved a clinical benefit in the main phase, they had the opportunity to remain on treatment. Participants who didn't achieve a clinical benefit had the opportunity to switch to a different dosing schedule in the OLE phase. Participants were not allowed to add ruxolitinib if they had been receiving monotherapy during the main phase.\n\nParticipants who received no treatment for MF in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for 6 cycles (main phase) and on Days 1, 3, and 5 of Cycle 7 and Day 1 of each subsequent 28 day cycle for 83 cycles (OLE)."}, {'id': 'OG002', 'title': 'Main Phase Stage 1: RO7490677 10 mg/kg IV QW + Ruxolitinib; OLE: RO7490677 10 mg/kg IV Q4W + Ruxo.', 'description': "Participants were followed through their originally assigned treatment. If a participant achieved a clinical benefit in the main phase, they had the opportunity to remain on treatment. Participants who didn't achieve a clinical benefit had the opportunity to switch to a different dosing schedule in the OLE phase. Participants could drop ruxolitinib in the OLE, but were not allowed to add ruxolitinib if they had been receiving monotherapy during the main phase.\n\nParticipants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for 6 cycles (main phase) and on Days 1, 3, and 5 of Cycle 7 and Day 1 of each subsequent 28 day cycle for 83 cycles (OLE)."}, {'id': 'OG003', 'title': 'Main Phase Stage 1: RO7490677 10 mg/kg IV Q4W + Ruxolitinib; OLE: RO7490677 10 mg/kg IV Q4W + Ruxo.', 'description': "Participants were followed through their originally assigned treatment. If a participant achieved a clinical benefit in the main phase, they had the opportunity to remain on treatment. Participants who didn't achieve a clinical benefit had the opportunity to switch to a different dosing schedule in the OLE phase. Participants could drop ruxolitinib in the OLE, but were not allowed to add ruxolitinib if they had been receiving monotherapy during the main phase.\n\nParticipants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for 6 cycles (main phase) and on Days 1, 3, and 5 of Cycle 7 and Day 1 of each subsequent 28 day cycle for 83 cycles (OLE)."}], 'classes': [{'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000', 'lowerLimit': '19.29', 'upperLimit': '80.71'}, {'value': '71.4', 'groupId': 'OG001', 'lowerLimit': '34.13', 'upperLimit': '94.66'}, {'value': '50.0', 'groupId': 'OG002', 'lowerLimit': '15.32', 'upperLimit': '84.68'}, {'value': '66.7', 'groupId': 'OG003', 'lowerLimit': '27.13', 'upperLimit': '93.72'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From cycle 1 day 1 up until cycle 6, day 29 (Main Phase). From cycle 7 day 1 up until study discontinuation or study termination, up to 83 cycles (OLE). Each cycle is 28 days.', 'description': "ORR was defined as the percent of participants with a response according to the IWG-MRT criteria. This was defined as those participants who achieved CI, PR, or CR at a post-baseline assessment of treatment response OR had at least SD for three consecutive end-of-cycle response assessments (e.g. Day 1 of the subsequent cycle) in conjunction with improvement in the bone marrow fibrosis score relative to baseline by at least one grade at any time point during the period of stable disease. Participants who achieved a clinical benefit in the main phase had the opportunity to remain on treatment. The determination of ORR in the main phase is outlined in the arms description below. Participants who didn't achieve a benefit had the opportunity to switch to a different dosing schedule in the OLE phase. The determination of ORR in the OLE phase is outlined in the arms descriptions below.", 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The all treated population (main phase + OLE) included all participants who received at least one dose of RO7490667.'}, {'type': 'PRIMARY', 'title': 'Stage 2 Main + Open-Label Extension (OLE): BMRR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Main Phase Stage 2: RO7490677 0.3 mg/kg IV Q4W; OLE: RO7490677 10 mg/kg IV Q4W', 'description': 'Participants were followed through their originally assigned treatment. Participants in the main phase had the opportunity to remain on treatment. Participants also had the option to switch to the OLE phase after completing 9 cycles of the originally assigned treatment as outlined below.\n\nParticipants were treated with single agent PRM-151 at a dose of 0.3 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for 9 cycles (main phase) and PRM-151 at a dose of 10 mg/kg on Days 1, 3, and 5 of Cycle 10 and Day 1 of each subsequent 28 day cycle for 51 cycles (OLE).'}, {'id': 'OG001', 'title': 'Main Phase Stage 2: RO7490677 3 mg/kg IV Q4W; OLE: RO7490677 10 mg/kg IV Q4W', 'description': 'Participants were followed through their originally assigned treatment. Participants in the main phase had the opportunity to remain on treatment. Participants also had the option to switch to the OLE phase after completing 9 cycles of the originally assigned treatment as outlined below.\n\nParticipants were treated with single agent PRM-151 at a dose of 3.0 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for 9 cycles (main phase) and PRM-151 at a dose of 10 mg/kg on Days 1, 3, and 5 of Cycle 10 and Day 1 of each subsequent 28 day cycle for 51 cycles (OLE).'}, {'id': 'OG002', 'title': 'Main Phase Stage 2: RO7490677 10 mg/kg IV Q4W; OLE: RO7490677 10 mg/kg IV Q4W', 'description': 'Participants were followed through their originally assigned treatment. Participants in the main phase had the opportunity to remain on treatment. Participants also had the option to switch to the OLE phase after completing 9 cycles of the originally assigned treatment as outlined below.\n\nParticipants enrolled received PRM-151 at a dose of 10mg/kg Q4W on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for 9 cycles (main phase) and on Days 1, 3, and 5 of Cycle 10 and Day 1 of each subsequent 28 day cycle for 51 cycles (OLE).'}], 'classes': [{'categories': [{'measurements': [{'value': '30.3', 'groupId': 'OG000', 'lowerLimit': '14.62', 'upperLimit': '45.98'}, {'value': '34.4', 'groupId': 'OG001', 'lowerLimit': '17.92', 'upperLimit': '50.83'}, {'value': '25.0', 'groupId': 'OG002', 'lowerLimit': '10.00', 'upperLimit': '40.00'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From cycle 1 day 1 up until cycle 9 day 29 (main phase). From cycle 10 day 1 up until study discontinuation or study termination, up to 51 cycles (OLE). Each cycle is 28 days.', 'description': 'Defined as the percent of participants with a reduction in bone marrow fibrosis score by at least one grade according to WHO criteria at any time during the study. As determined by a central adjudication panel of expert hematopathologists, blinded to participant, treatment, and time of biopsy. Participants in the main phase had the opportunity to remain on treatment (as outlined in the arms description below). Participants also had the option to switch to the OLE phase after completing 9 cycles of the originally assigned treatment and receive PRM-151 10 mg/kg/Q4W (as outlined in the arms description below).', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The all treated population (main phase + OLE) included all participants randomized and who received at least one administration of the drug.'}, {'type': 'SECONDARY', 'title': 'Stage 1 Main Phase: BMRR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Main Phase Stage 1: RO7490677 10 mg/kg IV Every Week (QW)', 'description': 'Participants who received no treatment for Myelofibrosis (MF) in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 milligram per kilogram (mg/kg) administered as a 30 minute intravenous (IV) infusion on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.'}, {'id': 'OG001', 'title': 'Main Phase Stage 1: RO7490677 10 mg/kg IV Every 4 Weeks (Q4W)', 'description': 'Participants who received no treatment for MF in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.'}, {'id': 'OG002', 'title': 'Main Phase Stage 1: RO7490677 10 mg/kg IV QW + Ruxolitinib', 'description': 'Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.'}, {'id': 'OG003', 'title': 'Main Phase Stage 1: RO7490677 10 mg/kg IV Q4W+ Ruxolitinib', 'description': 'Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '37.5', 'groupId': 'OG000', 'lowerLimit': '3.95', 'upperLimit': '71.05'}, {'value': '14.3', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '40.21'}, {'value': '16.7', 'groupId': 'OG002', 'lowerLimit': '0.00', 'upperLimit': '46.49'}, {'value': '50.0', 'groupId': 'OG003', 'lowerLimit': '9.99', 'upperLimit': '90.01'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Weeks 12 and 24', 'description': 'Bone marrow response was defined as a reduction in bone marrow fibrosis score by at least one grade from baseline at anytime during the study.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The all treated population included all participants who received at least one dose of RO7490667.'}, {'type': 'SECONDARY', 'title': 'Stage 1 Main Phase: Modified Myeloproliferative Neoplasms Symptom Assessment Form Total Symptom Score (MPN-SAF TSS) Changes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Main Phase Stage 1: RO7490677 10 mg/kg IV Every Week (QW)', 'description': 'Participants who received no treatment for Myelofibrosis (MF) in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 milligram per kilogram (mg/kg) administered as a 30 minute intravenous (IV) infusion on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.'}, {'id': 'OG001', 'title': 'Main Phase Stage 1: RO7490677 10 mg/kg IV Every 4 Weeks (Q4W)', 'description': 'Participants who received no treatment for MF in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.'}, {'id': 'OG002', 'title': 'Main Phase Stage 1: RO7490677 10 mg/kg IV QW + Ruxolitinib', 'description': 'Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.'}, {'id': 'OG003', 'title': 'Main Phase Stage 1: RO7490677 10 mg/kg IV Q4W+ Ruxolitinib', 'description': 'Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '23.1', 'spread': '19.1', 'groupId': 'OG000'}, {'value': '16.9', 'spread': '7.2', 'groupId': 'OG001'}, {'value': '26.8', 'spread': '17.1', 'groupId': 'OG002'}, {'value': '15.3', 'spread': '10.4', 'groupId': 'OG003'}]}]}, {'title': 'Cycle(C)2 Day(D)1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-5.3', 'spread': '12.6', 'groupId': 'OG000'}, {'value': '5.7', 'spread': '11.8', 'groupId': 'OG001'}, {'value': '0.5', 'spread': '8.8', 'groupId': 'OG002'}, {'value': '-2.0', 'spread': '5.0', 'groupId': 'OG003'}]}]}, {'title': 'C3D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-9.1', 'spread': '10.9', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '5.3', 'groupId': 'OG001'}, {'value': '-2.7', 'spread': '14.8', 'groupId': 'OG002'}, {'value': '4.2', 'spread': '8.0', 'groupId': 'OG003'}]}]}, {'title': 'C4D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-8.7', 'spread': '10.7', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '8.0', 'groupId': 'OG001'}, {'value': '-7.5', 'spread': '6.0', 'groupId': 'OG002'}, {'value': '5.7', 'spread': '20.9', 'groupId': 'OG003'}]}]}, {'title': 'C5D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-13.2', 'spread': '13.2', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '6.9', 'groupId': 'OG001'}, {'value': '-6.7', 'spread': '10.6', 'groupId': 'OG002'}, {'value': '1.5', 'spread': '13.6', 'groupId': 'OG003'}]}]}, {'title': 'C6D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-12.2', 'spread': '9.5', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '8.3', 'groupId': 'OG001'}, {'value': '-5.4', 'spread': '6.2', 'groupId': 'OG002'}, {'value': '4.3', 'spread': '11.5', 'groupId': 'OG003'}]}]}, {'title': 'C6D29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-15.0', 'spread': '13.7', 'groupId': 'OG000'}, {'value': '-2.2', 'spread': '5.3', 'groupId': 'OG001'}, {'value': '-5.3', 'spread': '4.6', 'groupId': 'OG002'}, {'value': '2.3', 'spread': '8.8', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, beginning of each cycle (Cycle 2 onward). Each cycle is 28 days.', 'description': 'The MPN-SAF TSS total symptom score was the sum of the following 10 items: Filling up quickly when you eat (early satiety), abdominal discomfort, inactivity, Problems with concentration, Worst fatigue, Night sweats, Itching, Bone pain, Fever and Unintentional weight loss last 6 months. The MPN-SAF Total Symptom Score had a possible range of 0 to 100, where a lower score was more favorable. The values reported are the change from baseline scores.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The all treated population included all participants who received at least one dose of RO7490667.'}, {'type': 'SECONDARY', 'title': 'Stage 2 Main Phase: BMRR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Main Phase Stage 2: RO7490677 0.3 mg/kg IV Q4W', 'description': 'Participants were treated with single agent PRM-151 at a dose of 0.3 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.'}, {'id': 'OG001', 'title': 'Main Phase Stage 2: RO7490677 3 mg/kg IV Q4W', 'description': 'Participants were treated with single agent PRM-151 at a dose of 3.0 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.'}, {'id': 'OG002', 'title': 'Main Phase Stage 2: RO7490677 10 mg/kg IV Q4W', 'description': 'Participants were treated with single agent PRM-151 at a dose of 10 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '30.3', 'groupId': 'OG000', 'lowerLimit': '14.62', 'upperLimit': '45.98'}, {'value': '31.3', 'groupId': 'OG001', 'lowerLimit': '15.19', 'upperLimit': '47.31'}, {'value': '25.0', 'groupId': 'OG002', 'lowerLimit': '10.0', 'upperLimit': '40.00'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up until and including completion of 9 cycles. Each cycle is 28 days.', 'description': 'Response rate was defined as the percent of participants with a reduction in bone marrow fibrosis by at least one grade according to World Health Organization (WHO) criteria at any time during the study. This was determined by a central adjudication panel of expert hematopathologists, blinded to participant, treatment, and time of biopsy.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The all treated population included all participants randomized and who received at least one administration of the drug.'}, {'type': 'SECONDARY', 'title': 'Stage 2 Main Phase: BMRR - Reduction of Bone Marrow Fibrosis by Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Main Phase Stage 2: RO7490677 0.3 mg/kg IV Q4W', 'description': 'Participants were treated with single agent PRM-151 at a dose of 0.3 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.'}, {'id': 'OG001', 'title': 'Main Phase Stage 2: RO7490677 3 mg/kg IV Q4W', 'description': 'Participants were treated with single agent PRM-151 at a dose of 3.0 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.'}, {'id': 'OG002', 'title': 'Main Phase Stage 2: RO7490677 10 mg/kg IV Q4W', 'description': 'Participants were treated with single agent PRM-151 at a dose of 10 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.'}], 'classes': [{'title': 'Cycle(C) 4 Day(D) 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '10.7', 'groupId': 'OG000'}, {'value': '24.0', 'groupId': 'OG001'}, {'value': '19.2', 'groupId': 'OG002'}]}]}, {'title': 'C7D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '23.8', 'groupId': 'OG000'}, {'value': '11.8', 'groupId': 'OG001'}, {'value': '10.5', 'groupId': 'OG002'}]}]}, {'title': 'C9D29/C10D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '30.0', 'groupId': 'OG000'}, {'value': '21.4', 'groupId': 'OG001'}, {'value': '13.3', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 on Cycles 4, 7, 10 and Cycle 9 Day 29. Each cycle is 28 days.', 'description': 'Reduction in bone marrow fibrosis score: Reduction of at least one grade from baseline. Bone marrow fibrosis grades according to WHO criteria (as determined by central adjudication).', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The all treated population included all participants randomized and who received at least one administration of the drug.'}, {'type': 'SECONDARY', 'title': 'Stage 2 Main Phase: Duration of Bone Marrow Improvement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Main Phase Stage 2: RO7490677 0.3 mg/kg IV Q4W', 'description': 'Participants were treated with single agent PRM-151 at a dose of 0.3 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.'}, {'id': 'OG001', 'title': 'Main Phase Stage 2: RO7490677 3 mg/kg IV Q4W', 'description': 'Participants were treated with single agent PRM-151 at a dose of 3.0 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.'}, {'id': 'OG002', 'title': 'Main Phase Stage 2: RO7490677 10 mg/kg IV Q4W', 'description': 'Participants were treated with single agent PRM-151 at a dose of 10 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data was not evaluable as the participants who had bone marrow improvement but did not return to baseline levels at the end of main phase were censored at their last bone marrow assessment in the main phase (the last timepoint in the main phase at which the improvement was still observed).', 'groupId': 'OG000', 'lowerLimit': '12.0', 'upperLimit': 'NA'}, {'value': '12.0', 'comment': 'Data was not evaluable as the participants who had bone marrow improvement but did not return to baseline levels at the end of main phase were censored at their last bone marrow assessment in the main phase (the last timepoint in the main phase at which the improvement was still observed).', 'groupId': 'OG001', 'lowerLimit': '12.0', 'upperLimit': 'NA'}, {'value': '12.1', 'groupId': 'OG002', 'lowerLimit': '11.4', 'upperLimit': '13.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From first decrease from baseline of one grade to time of return to baseline levels, up to cycle 9 of 28-day cycles.', 'description': 'Duration of response was defined as time from first decrease from baseline \\>= 1 grade to time of return to baseline levels.', 'unitOfMeasure': 'Weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The all treated population included all participants randomized and who received at least one administration of the drug.'}, {'type': 'SECONDARY', 'title': 'Stage 2 Main Phase: Hemoglobin Improvement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Main Phase Stage 2: RO7490677 0.3 mg/kg IV Q4W', 'description': 'Participants were treated with single agent PRM-151 at a dose of 0.3 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.'}, {'id': 'OG001', 'title': 'Main Phase Stage 2: RO7490677 3 mg/kg IV Q4W', 'description': 'Participants were treated with single agent PRM-151 at a dose of 3.0 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.'}, {'id': 'OG002', 'title': 'Main Phase Stage 2: RO7490677 10 mg/kg IV Q4W', 'description': 'Participants were treated with single agent PRM-151 at a dose of 10 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.2', 'groupId': 'OG000'}, {'value': '15.6', 'groupId': 'OG001'}, {'value': '6.3', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up until and including completion of 9 cycles. Each cycle is 28 days.', 'description': 'Hemoglobin improvement was measured by the percent of participants with: Red cell transfusion independence (no transfusions for \\>= 12 consecutive weeks) OR 50% reduction in red blood cell (RBC) transfusions for \\>= 12 consecutive weeks OR percent of participants with \\>= 10 g/L and \\>= 20 g/L increase in hemoglobin for \\>= 12 consecutive weeks without transfusions (outcome parameter assessed was dependent on baseline hemoglobin/transfusion status).', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The all treated population included all participants randomized and who received at least one administration of the drug.'}, {'type': 'SECONDARY', 'title': 'Stage 2 Main Phase: Platelet Improvement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Main Phase Stage 2: RO7490677 0.3 mg/kg IV Q4W', 'description': 'Participants were treated with single agent PRM-151 at a dose of 0.3 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.'}, {'id': 'OG001', 'title': 'Main Phase Stage 2: RO7490677 3 mg/kg IV Q4W', 'description': 'Participants were treated with single agent PRM-151 at a dose of 3.0 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.'}, {'id': 'OG002', 'title': 'Main Phase Stage 2: RO7490677 10 mg/kg IV Q4W', 'description': 'Participants were treated with single agent PRM-151 at a dose of 10 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '27.3', 'groupId': 'OG000'}, {'value': '34.4', 'groupId': 'OG001'}, {'value': '37.5', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up until and including completion of 9 cycles. Each cycle is 28 days.', 'description': 'Platelet improvement was measured by the percent of participants with: Platelet transfusion independence (no transfusions for \\>= 12 consecutive weeks) OR 50% reduction in platelets transfusions for \\>= 12 consecutive weeks OR doubling of baseline platelet count for \\>= 12 consecutive weeks without platelet transfusions OR platelet count \\> 50 x 10e9/L for \\>=12 consecutive weeks without platelet transfusions OR doubling of baseline platelet count for \\>= 12 consecutive weeks without platelet transfusions OR platelet count \\> 25 x 10e9/L for \\>= 12 consecutive weeks without platelet transfusions (outcome parameter assessed is dependent on baseline platelet status).', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The all treated population included all participants randomized and who received at least one administration of the drug.'}, {'type': 'SECONDARY', 'title': 'Stage 2 Main Phase: Symptom Improvement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Main Phase Stage 2: RO7490677 0.3 mg/kg IV Q4W', 'description': 'Participants were treated with single agent PRM-151 at a dose of 0.3 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.'}, {'id': 'OG001', 'title': 'Main Phase Stage 2: RO7490677 3 mg/kg IV Q4W', 'description': 'Participants were treated with single agent PRM-151 at a dose of 3.0 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.'}, {'id': 'OG002', 'title': 'Main Phase Stage 2: RO7490677 10 mg/kg IV Q4W', 'description': 'Participants were treated with single agent PRM-151 at a dose of 10 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.'}], 'classes': [{'title': 'Cycle(C) 2 Day(D) 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'C3D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'C4D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'C5D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'C6D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'C7D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'C8D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'C9D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'C9D29/C10D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up until and including completion of 9 cycles. Each cycle is 28 days.', 'description': 'Symptom improvement was assessed as the percent of participants with 50% reduction in MPN-SAF TSS from baseline over time. The MPN-SAF TSS total symptom score was the sum of the following 10 items: Filling up quickly when you eat (early satiety), abdominal discomfort, inactivity, Problems with concentration, Worst fatigue, Night sweats, Itching, Bone pain, Fever and Unintentional weight loss last 6 months. The MPN-SAF Total Symptom Score had a possible range of 0 to 100, where a lower score was more favorable.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The all treated population included all participants randomized and who received at least one administration of the drug.'}, {'type': 'SECONDARY', 'title': 'Stage 2 Main Phase: Percentage of Participants With Complete Response (CR), Partial Response (PR), Clinical Improvement (CI), Stable Disease (SD), and Progressive Disease (PD) According to IWG-MRT Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Main Phase Stage 2: RO7490677 0.3 mg/kg IV Q4W', 'description': 'Participants were treated with single agent PRM-151 at a dose of 0.3 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.'}, {'id': 'OG001', 'title': 'Main Phase Stage 2: RO7490677 3 mg/kg IV Q4W', 'description': 'Participants were treated with single agent PRM-151 at a dose of 3.0 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.'}, {'id': 'OG002', 'title': 'Main Phase Stage 2: RO7490677 10 mg/kg IV Q4W', 'description': 'Participants were treated with single agent PRM-151 at a dose of 10 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.'}], 'classes': [{'title': 'CR', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'PR', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'CI', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'SD', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}]}, {'title': 'PD', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Not evaluable', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up until and including completion of 9 cycles. Each cycle is 28 days.', 'description': 'Best Overall Response: (CR, PR, CI), SD and PD according to the IWG-MRT Criteria.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The all treated population included all participants randomized and who received at least one administration of the drug.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Stage 1 Main Phase: Maximum Drug Concentration (Cmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Main Phase Stage 1: RO7490677 10 mg/kg IV Every Week (QW)', 'description': 'Participants who received no treatment for Myelofibrosis (MF) in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 milligram per kilogram (mg/kg) administered as a 30 minute intravenous (IV) infusion on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.'}, {'id': 'OG001', 'title': 'Main Phase Stage 1: RO7490677 10 mg/kg IV Every 4 Weeks (Q4W)', 'description': 'Participants who received no treatment for MF in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.'}, {'id': 'OG002', 'title': 'Main Phase Stage 1: RO7490677 10 mg/kg IV QW + Ruxolitinib', 'description': 'Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.'}, {'id': 'OG003', 'title': 'Main Phase Stage 1: RO7490677 10 mg/kg IV Q4W+ Ruxolitinib', 'description': 'Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.'}], 'classes': [{'title': 'C1D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '133', 'spread': '48.4', 'groupId': 'OG000'}, {'value': '113', 'spread': '28.1', 'groupId': 'OG001'}, {'value': '164', 'spread': '23.9', 'groupId': 'OG002'}, {'value': '112', 'spread': '90.4', 'groupId': 'OG003'}]}]}, {'title': 'C1D15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '127', 'spread': '31.9', 'groupId': 'OG000'}, {'value': '126', 'spread': '27.5', 'groupId': 'OG002'}]}]}, {'title': 'C2D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '107', 'spread': '26.9', 'groupId': 'OG000'}, {'value': '110', 'spread': '20.9', 'groupId': 'OG001'}, {'value': '149', 'spread': '29.1', 'groupId': 'OG002'}, {'value': '130', 'spread': '80.2', 'groupId': 'OG003'}]}]}, {'title': 'C6D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '142', 'spread': '70.0', 'groupId': 'OG000'}, {'value': '111', 'spread': '28.0', 'groupId': 'OG001'}, {'value': '136', 'spread': '34.1', 'groupId': 'OG002'}, {'value': '142', 'spread': '27.4', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose on Cycles(C) 1, 2 and 6, Day(D) 1 and C1 D15. Each cycle is 28 days', 'description': 'Cmax is the maximum observed RO7490677 plasma concentration.', 'unitOfMeasure': 'Micrograms per Milliliter (ug/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK population included all participants who received at least one dose of rhPTX-2 and had at least one post-dose total PTX-2 concentration result.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Stage 1 Main Phase: Time to Maximum Concentration (Tmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Main Phase Stage 1: RO7490677 10 mg/kg IV Every Week (QW)', 'description': 'Participants who received no treatment for Myelofibrosis (MF) in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 milligram per kilogram (mg/kg) administered as a 30 minute intravenous (IV) infusion on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.'}, {'id': 'OG001', 'title': 'Main Phase Stage 1: RO7490677 10 mg/kg IV Every 4 Weeks (Q4W)', 'description': 'Participants who received no treatment for MF in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.'}, {'id': 'OG002', 'title': 'Main Phase Stage 1: RO7490677 10 mg/kg IV QW + Ruxolitinib', 'description': 'Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.'}, {'id': 'OG003', 'title': 'Main Phase Stage 1: RO7490677 10 mg/kg IV Q4W+ Ruxolitinib', 'description': 'Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.'}], 'classes': [{'title': 'C1D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.12', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '2.00'}, {'value': '1.10', 'groupId': 'OG001', 'lowerLimit': '1.00', 'upperLimit': '2.08'}, {'value': '1.14', 'groupId': 'OG002', 'lowerLimit': '1.00', 'upperLimit': '2.25'}, {'value': '1.13', 'groupId': 'OG003', 'lowerLimit': '1.00', 'upperLimit': '5.00'}]}]}, {'title': 'C1D15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.13', 'groupId': 'OG000', 'lowerLimit': '1.03', 'upperLimit': '1.80'}, {'value': '1.65', 'groupId': 'OG002', 'lowerLimit': '1.02', 'upperLimit': '2.50'}]}]}, {'title': 'C2D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.10', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '3.17'}, {'value': '1.08', 'groupId': 'OG001', 'lowerLimit': '1.03', 'upperLimit': '1.08'}, {'value': '1.05', 'groupId': 'OG002', 'lowerLimit': '1.00', 'upperLimit': '1.32'}, {'value': '1.44', 'groupId': 'OG003', 'lowerLimit': '1.00', 'upperLimit': '9.00'}]}]}, {'title': 'C6D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.00', 'groupId': 'OG000', 'lowerLimit': '1.03', 'upperLimit': '5.20'}, {'value': '1.07', 'groupId': 'OG001', 'lowerLimit': '1.00', 'upperLimit': '2.03'}, {'value': '1.17', 'groupId': 'OG002', 'lowerLimit': '1.05', 'upperLimit': '5.00'}, {'value': '1.01', 'groupId': 'OG003', 'lowerLimit': '1.00', 'upperLimit': '1.08'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose on Cycles(C) 1, 2 and 6, Day(D) 1 and C1 D15. Each cycle is 28 days', 'description': 'Time at which the maximum plasma concentration was observed.', 'unitOfMeasure': 'Hour (hr)', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK population included all participants who received at least one dose of rhPTX-2 and had at least one post-dose total PTX-2 concentration result.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Stage 1 Main Phase: Area Under the Curve up to the Last Measurable Concentration (AUC0-last)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Main Phase Stage 1: RO7490677 10 mg/kg IV Every Week (QW)', 'description': 'Participants who received no treatment for Myelofibrosis (MF) in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 milligram per kilogram (mg/kg) administered as a 30 minute intravenous (IV) infusion on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.'}, {'id': 'OG001', 'title': 'Main Phase Stage 1: RO7490677 10 mg/kg IV Every 4 Weeks (Q4W)', 'description': 'Participants who received no treatment for MF in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.'}, {'id': 'OG002', 'title': 'Main Phase Stage 1: RO7490677 10 mg/kg IV QW + Ruxolitinib', 'description': 'Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.'}, {'id': 'OG003', 'title': 'Main Phase Stage 1: RO7490677 10 mg/kg IV Q4W+ Ruxolitinib', 'description': 'Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.'}], 'classes': [{'title': 'C1D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1810', 'spread': '72.0', 'groupId': 'OG000'}, {'value': '1690', 'spread': '26.1', 'groupId': 'OG001'}, {'value': '2590', 'spread': '28.7', 'groupId': 'OG002'}, {'value': '1500', 'spread': '158.3', 'groupId': 'OG003'}]}]}, {'title': 'C1D15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1460', 'spread': '142.0', 'groupId': 'OG000'}, {'value': '2590', 'spread': '187.6', 'groupId': 'OG002'}]}]}, {'title': 'C2D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '127.3', 'spread': '904', 'groupId': 'OG000'}, {'value': '504', 'spread': '84.7', 'groupId': 'OG001'}, {'value': '2990', 'spread': '92.0', 'groupId': 'OG002'}, {'value': '663', 'spread': '79.5', 'groupId': 'OG003'}]}]}, {'title': 'C6D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '698', 'spread': '63.0', 'groupId': 'OG000'}, {'value': '570', 'spread': '44.8', 'groupId': 'OG001'}, {'value': '764', 'spread': '28.9', 'groupId': 'OG002'}, {'value': '703', 'spread': '33.8', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose on Cycles(C) 1, 2 and 6, Day(D) 1 and C1 D15. Each cycle is 28 days', 'description': 'Area under the plasma concentration time curve from time 0 to time of last measurable plasma concentration.', 'unitOfMeasure': 'ug*hour/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK population included all participants who received at least one dose of rhPTX-2 and had at least one post-dose total PTX-2 concentration result.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Stage 1 Main Phase: Area Under the Concentration-Time Curve Extrapolated to Infinity (AUC0-inf)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Main Phase Stage 1: RO7490677 10 mg/kg IV Every Week (QW)', 'description': 'Participants who received no treatment for Myelofibrosis (MF) in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 milligram per kilogram (mg/kg) administered as a 30 minute intravenous (IV) infusion on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.'}, {'id': 'OG001', 'title': 'Main Phase Stage 1: RO7490677 10 mg/kg IV Every 4 Weeks (Q4W)', 'description': 'Participants who received no treatment for MF in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.'}, {'id': 'OG002', 'title': 'Main Phase Stage 1: RO7490677 10 mg/kg IV QW + Ruxolitinib', 'description': 'Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.'}, {'id': 'OG003', 'title': 'Main Phase Stage 1: RO7490677 10 mg/kg IV Q4W+ Ruxolitinib', 'description': 'Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.'}], 'classes': [{'title': 'C1D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2830', 'spread': '12.9', 'groupId': 'OG000'}, {'value': '2050', 'spread': '29.5', 'groupId': 'OG001'}, {'value': '2970', 'spread': '34.9', 'groupId': 'OG002'}, {'value': '3130', 'spread': '8.6', 'groupId': 'OG003'}]}]}, {'title': 'C1D15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3450', 'spread': '2.8', 'groupId': 'OG000'}, {'value': '6060', 'spread': '23.2', 'groupId': 'OG002'}]}]}, {'title': 'C2D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2170', 'spread': '170.9', 'groupId': 'OG000'}, {'value': '4230', 'spread': '34.8', 'groupId': 'OG002'}]}]}, {'title': 'C6D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '819', 'spread': 'NA', 'comment': 'Geometric Coefficient of Variation could not be calculated from data for a single participant.', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose on Cycles(C) 1, 2 and 6, Day(D) 1 and C1 D15. Each cycle is 28 days', 'description': 'Area under the plasma concentration-time curve from 0-time extrapolated to infinity.', 'unitOfMeasure': 'ug*hour/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK population included all participants who received at least one dose of rhPTX-2 and had at least one post-dose total PTX-2 concentration result.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Stage 1 Main Phase: Terminal Elimination Half-Life (T1/2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Main Phase Stage 1: RO7490677 10 mg/kg IV Every Week (QW)', 'description': 'Participants who received no treatment for Myelofibrosis (MF) in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 milligram per kilogram (mg/kg) administered as a 30 minute intravenous (IV) infusion on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.'}, {'id': 'OG001', 'title': 'Main Phase Stage 1: RO7490677 10 mg/kg IV Every 4 Weeks (Q4W)', 'description': 'Participants who received no treatment for MF in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.'}, {'id': 'OG002', 'title': 'Main Phase Stage 1: RO7490677 10 mg/kg IV QW + Ruxolitinib', 'description': 'Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.'}, {'id': 'OG003', 'title': 'Main Phase Stage 1: RO7490677 10 mg/kg IV Q4W+ Ruxolitinib', 'description': 'Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.'}], 'classes': [{'title': 'C1D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '14.7', 'spread': '19.2', 'groupId': 'OG000'}, {'value': '17.2', 'spread': '23.7', 'groupId': 'OG001'}, {'value': '16.8', 'spread': '17.7', 'groupId': 'OG002'}, {'value': '18.4', 'spread': '7.9', 'groupId': 'OG003'}]}]}, {'title': 'C1D15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '31.2', 'spread': '45.0', 'groupId': 'OG000'}, {'value': '40.4', 'spread': '12.6', 'groupId': 'OG002'}]}]}, {'title': 'C2D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '18.0', 'spread': '220.6', 'groupId': 'OG000'}, {'value': '30.0', 'spread': '48.6', 'groupId': 'OG002'}]}]}, {'title': 'C6D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.95', 'spread': 'NA', 'comment': 'Geometric Coefficient of Variation could not be calculated from data for a single participant.', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose on Cycles(C) 1, 2 and 6, Day(D) 1 and C1 D15. Each cycle is 28 days', 'description': 'Apparent terminal elimination half-life of RO7490677.', 'unitOfMeasure': 'hr', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK population included all participants who received at least one dose of rhPTX-2 and had at least one post-dose total PTX-2 concentration result.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Stage 1 Main Phase: Clearance (CL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Main Phase Stage 1: RO7490677 10 mg/kg IV Every Week (QW)', 'description': 'Participants who received no treatment for Myelofibrosis (MF) in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 milligram per kilogram (mg/kg) administered as a 30 minute intravenous (IV) infusion on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.'}, {'id': 'OG001', 'title': 'Main Phase Stage 1: RO7490677 10 mg/kg IV Every 4 Weeks (Q4W)', 'description': 'Participants who received no treatment for MF in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.'}, {'id': 'OG002', 'title': 'Main Phase Stage 1: RO7490677 10 mg/kg IV QW + Ruxolitinib', 'description': 'Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.'}, {'id': 'OG003', 'title': 'Main Phase Stage 1: RO7490677 10 mg/kg IV Q4W+ Ruxolitinib', 'description': 'Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.'}], 'classes': [{'title': 'C1D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.258', 'spread': '9.0', 'groupId': 'OG000'}, {'value': '0.362', 'spread': '31.5', 'groupId': 'OG001'}, {'value': '0.269', 'spread': '32.9', 'groupId': 'OG002'}, {'value': '0.233', 'spread': '33.3', 'groupId': 'OG003'}]}]}, {'title': 'C1D15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.233', 'spread': '24.9', 'groupId': 'OG000'}, {'value': '0.147', 'spread': '35.0', 'groupId': 'OG002'}]}]}, {'title': 'C2D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.382', 'spread': '229.9', 'groupId': 'OG000'}, {'value': '0.189', 'spread': '55.5', 'groupId': 'OG002'}]}]}, {'title': 'C6D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.42', 'spread': 'NA', 'comment': 'Geometric Coefficient of Variation could not be calculated from data for a single participant.', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose on Cycles(C) 1, 2 and 6, Day(D) 1 and C1 D15. Each cycle is 28 days', 'unitOfMeasure': 'Litres per hour (L/hr)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK population included all participants who received at least one dose of rhPTX-2 and had at least one post-dose total PTX-2 concentration result.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Stage 1 Main Phase: Volume of Distribution (Vd)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Main Phase Stage 1: RO7490677 10 mg/kg IV Every Week (QW)', 'description': 'Participants who received no treatment for Myelofibrosis (MF) in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 milligram per kilogram (mg/kg) administered as a 30 minute intravenous (IV) infusion on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.'}, {'id': 'OG001', 'title': 'Main Phase Stage 1: RO7490677 10 mg/kg IV Every 4 Weeks (Q4W)', 'description': 'Participants who received no treatment for MF in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.'}, {'id': 'OG002', 'title': 'Main Phase Stage 1: RO7490677 10 mg/kg IV QW + Ruxolitinib', 'description': 'Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.'}, {'id': 'OG003', 'title': 'Main Phase Stage 1: RO7490677 10 mg/kg IV Q4W+ Ruxolitinib', 'description': 'Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.'}], 'classes': [{'title': 'C1D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5.47', 'spread': '10.9', 'groupId': 'OG000'}, {'value': '9.00', 'spread': '28.8', 'groupId': 'OG001'}, {'value': '6.52', 'spread': '26.4', 'groupId': 'OG002'}, {'value': '6.17', 'spread': '38.9', 'groupId': 'OG003'}]}]}, {'title': 'C1D15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '10.5', 'spread': '62.4', 'groupId': 'OG000'}, {'value': '8.57', 'spread': '47.6', 'groupId': 'OG002'}]}]}, {'title': 'C2D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '9.93', 'spread': '63.0', 'groupId': 'OG000'}, {'value': '8.18', 'spread': '24.5', 'groupId': 'OG002'}]}]}, {'title': 'C6D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.01', 'spread': 'NA', 'comment': 'Geometric Coefficient of Variation could not be calculated from data for a single participant.', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose on Cycles(C) 1, 2 and 6, Day(D) 1 and C1 D15. Each cycle is 28 days', 'unitOfMeasure': 'Litres (L)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK population included all participants who received at least one dose of rhPTX-2 and had at least one post-dose total PTX-2 concentration result.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants With Adverse Events (AEs) and Infusion Related Reactions (IRRs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '33', 'groupId': 'OG004'}, {'value': '32', 'groupId': 'OG005'}, {'value': '32', 'groupId': 'OG006'}, {'value': '13', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '48', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Main Phase Stage 1: RO7490677 10 mg/kg IV Every Week (QW)', 'description': 'Participants who received no treatment for Myelofibrosis (MF) in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 milligram per kilogram (mg/kg) administered as a 30 minute intravenous (IV) infusion on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.'}, {'id': 'OG001', 'title': 'Main Phase Stage 1: RO7490677 10 mg/kg IV Every 4 Weeks (Q4W)', 'description': 'Participants who received no treatment for MF in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.'}, {'id': 'OG002', 'title': 'Main Phase Stage 1: RO7490677 10 mg/kg IV QW + Ruxolitinib', 'description': 'Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.'}, {'id': 'OG003', 'title': 'Main Phase Stage 1: RO7490677 10 mg/kg IV Q4W+ Ruxolitinib', 'description': 'Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.'}, {'id': 'OG004', 'title': 'Main Phase Stage 2: RO7490677 0.3 mg/kg IV Q4W', 'description': 'Participants were treated with single agent PRM-151 at a dose of 0.3 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.'}, {'id': 'OG005', 'title': 'Main Phase Stage 2: RO7490677 3 mg/kg IV Q4W', 'description': 'Participants were treated with single agent PRM-151 at a dose of 3.0 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.'}, {'id': 'OG006', 'title': 'Main Phase Stage 2: RO7490677 10 mg/kg IV Q4W', 'description': 'Participants were treated with single agent PRM-151 at a dose of 10 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.'}, {'id': 'OG007', 'title': 'OLE Stage 1: RO7490677 10 mg/kg IV Every 4 Weeks (Q4W)', 'description': 'Participants who received no treatment for MF in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.'}, {'id': 'OG008', 'title': 'OLE Stage 1: RO7490677 10 mg/kg IV Q4W+ Ruxolitinib', 'description': 'Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.'}, {'id': 'OG009', 'title': 'OLE Stage 2: RO7490677 10 mg/kg IV Q4W', 'description': 'Participants who completed 9 cycles of the originally assigned treatment could switch to the open label extension. Participants enrolled received PRM-151 at a dose of 10mg/kg Q4W on days 1, 3, and 5 of first cycle of the open label phase and Day 1 of each subsequent 28 day cycle.'}], 'classes': [{'title': 'AEs', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '85.7', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}, {'value': '100', 'groupId': 'OG004'}, {'value': '100', 'groupId': 'OG005'}, {'value': '100', 'groupId': 'OG006'}, {'value': '92.3', 'groupId': 'OG007'}, {'value': '100', 'groupId': 'OG008'}, {'value': '89.6', 'groupId': 'OG009'}]}]}, {'title': 'IRRs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '16.7', 'groupId': 'OG003'}, {'value': '3.0', 'groupId': 'OG004'}, {'value': '3.1', 'groupId': 'OG005'}, {'value': '6.3', 'groupId': 'OG006'}, {'value': '7.7', 'groupId': 'OG007'}, {'value': '20.0', 'groupId': 'OG008'}, {'value': '2.1', 'groupId': 'OG009'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up until 6.75 years', 'description': 'An AE was defined as any noxious, pathologic, or unintended change in anatomical, physiologic, or metabolic function as indicated by physical signs, symptoms, or laboratory changes occurring in any phase of a clinical study, whether or not considered investigational product-related. Pre-existing conditions which worsened during the study were also considered as adverse events. IRRs were considerd to be Adverse Events of Special Interest (AESI). Grading was completed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 4.0.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population included all participants who received at least one dose of study drug.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants With Serious Adverse Events (SAEs) and AEs Leading to Study Drug Discontinuation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '33', 'groupId': 'OG004'}, {'value': '32', 'groupId': 'OG005'}, {'value': '32', 'groupId': 'OG006'}, {'value': '13', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '48', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Main Phase Stage 1: RO7490677 10 mg/kg IV Every Week (QW)', 'description': 'Participants who received no treatment for Myelofibrosis (MF) in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 milligram per kilogram (mg/kg) administered as a 30 minute intravenous (IV) infusion on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.'}, {'id': 'OG001', 'title': 'Main Phase Stage 1: RO7490677 10 mg/kg IV Every 4 Weeks (Q4W)', 'description': 'Participants who received no treatment for MF in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.'}, {'id': 'OG002', 'title': 'Main Phase Stage 1: RO7490677 10 mg/kg IV QW + Ruxolitinib', 'description': 'Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.'}, {'id': 'OG003', 'title': 'Main Phase Stage 1: RO7490677 10 mg/kg IV Q4W+ Ruxolitinib', 'description': 'Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.'}, {'id': 'OG004', 'title': 'Main Phase Stage 2: RO7490677 0.3 mg/kg IV Q4W', 'description': 'Participants were treated with single agent PRM-151 at a dose of 0.3 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.'}, {'id': 'OG005', 'title': 'Main Phase Stage 2: RO7490677 3 mg/kg IV Q4W', 'description': 'Participants were treated with single agent PRM-151 at a dose of 3.0 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.'}, {'id': 'OG006', 'title': 'Main Phase Stage 2: RO7490677 10 mg/kg IV Q4W', 'description': 'Participants were treated with single agent PRM-151 at a dose of 10 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.'}, {'id': 'OG007', 'title': 'OLE Stage 1: RO7490677 10 mg/kg IV Every 4 Weeks (Q4W)', 'description': 'Participants who received no treatment for MF in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.'}, {'id': 'OG008', 'title': 'OLE Stage 1: RO7490677 10 mg/kg IV Q4W+ Ruxolitinib', 'description': 'Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.'}, {'id': 'OG009', 'title': 'OLE Stage 2: RO7490677 10 mg/kg IV Q4W', 'description': 'Participants who completed 9 cycles of the originally assigned treatment could switch to the open label extension. Participants enrolled received PRM-151 at a dose of 10mg/kg Q4W on days 1, 3, and 5 of first cycle of the open label phase and Day 1 of each subsequent 28 day cycle.'}], 'classes': [{'title': 'SAEs', 'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '15.2', 'groupId': 'OG004'}, {'value': '15.6', 'groupId': 'OG005'}, {'value': '28.1', 'groupId': 'OG006'}, {'value': '7.7', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '22.9', 'groupId': 'OG009'}]}]}, {'title': 'AEs', 'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '21.2', 'groupId': 'OG004'}, {'value': '34.4', 'groupId': 'OG005'}, {'value': '37.5', 'groupId': 'OG006'}, {'value': '30.8', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '27.1', 'groupId': 'OG009'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up until 6.75 years', 'description': 'An SAE was defined as any AE that occurred at any dose the resulted in death; was life-threatening; required hospitalization or prolongation of existing hospitalizations; a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions; a congenital anomaly or birth defect. An AE was defined as any noxious, pathologic, or unintended change in anatomical, physiologic, or metabolic function as indicated by physical signs, symptoms, or laboratory changes occurring in any phase of a clinical study, whether or not considered investigational product-related. Pre-existing conditions which worsened during the study were also considered as adverse events. Grading was completed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 4.0.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population included all participants who received at least one dose of study drug.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Main Phase Stage 1: RO7490677 10 mg/kg IV Every Week (QW)', 'description': 'Participants who received no treatment for Myelofibrosis (MF) in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 milligram per kilogram (mg/kg) administered as a 30 minute intravenous (IV) infusion on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.'}, {'id': 'FG001', 'title': 'Main Phase Stage 1: RO7490677 10 mg/kg IV Every 4 Weeks (Q4W)', 'description': 'Participants who received no treatment for MF in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.'}, {'id': 'FG002', 'title': 'Main Phase Stage 1: RO7490677 10 mg/kg IV QW + Ruxolitinib', 'description': 'Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.'}, {'id': 'FG003', 'title': 'Main Phase Stage 1: RO7490677 10 mg/kg IV Q4W+ Ruxolitinib', 'description': 'Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.'}, {'id': 'FG004', 'title': 'Main Phase Stage 2: RO7490677 0.3 mg/kg IV Q4W', 'description': 'Participants were treated with single agent PRM-151 at a dose of 0.3 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.'}, {'id': 'FG005', 'title': 'Main Phase Stage 2: RO7490677 3 mg/kg IV Q4W', 'description': 'Participants were treated with single agent PRM-151 at a dose of 3.0 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.'}, {'id': 'FG006', 'title': 'Main Phase Stage 2: RO7490677 10 mg/kg IV Q4W', 'description': 'Participants were treated with single agent PRM-151 at a dose of 10 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.'}, {'id': 'FG007', 'title': 'OLE Stage 1: RO7490677 10 mg/kg IV Q4W', 'description': 'Participants who completed the main phase of treatment moved to the open label extension. They were treated with single agent PRM-151 at a dose of 10 mg/kg administered as an IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle.'}, {'id': 'FG008', 'title': 'OLE Stage 1: RO7490677 10 mg/kg IV Q4W + Ruxolitinib', 'description': 'Participants who completed the main phase of treatment moved to the open label extension. They were treated with PRM-151 at a dose of 10 mg/kg administered as an IV infusion in combination with daily oral ruxolitinib on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle.'}, {'id': 'FG009', 'title': 'OLE Stage 2: RO7490677 10 mg/kg IV Q4W', 'description': 'Participants who completed 9 cycles of the originally assigned treatment could switch to the open label extension. Participants enrolled received PRM-151 at a dose of 10mg/kg Q4W on days 1, 3, and 5 of first cycle of the open label phase and Day 1 of each subsequent 28 day cycle.'}], 'periods': [{'title': 'Main Phase Stage 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'comment': 'Main Study', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'Informed Consent Withdrawn', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'Various reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}]}, {'title': 'Main Phase Stage 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '33'}, {'groupId': 'FG005', 'numSubjects': '32'}, {'groupId': 'FG006', 'numSubjects': '32'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'comment': 'Main Study', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '20'}, {'groupId': 'FG005', 'numSubjects': '16'}, {'groupId': 'FG006', 'numSubjects': '15'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '13'}, {'groupId': 'FG005', 'numSubjects': '16'}, {'groupId': 'FG006', 'numSubjects': '17'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '5'}, {'groupId': 'FG006', 'numSubjects': '7'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'Informed Consent Withdrawn', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '3'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'Various reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'Progressive Disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '6'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}]}, {'title': 'Open Label Extension (OLE)', 'milestones': [{'type': 'STARTED', 'comment': 'Continued in OLE', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '13'}, {'groupId': 'FG008', 'numSubjects': '5'}, {'groupId': 'FG009', 'numSubjects': '48'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '12'}, {'groupId': 'FG008', 'numSubjects': '5'}, {'groupId': 'FG009', 'numSubjects': '48'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '2'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '8'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '4'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '19'}]}, {'type': 'Various reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '3'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '3'}]}, {'type': 'Progressive Disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '3'}, {'groupId': 'FG008', 'numSubjects': '2'}, {'groupId': 'FG009', 'numSubjects': '9'}]}, {'type': 'Informed Consent Withdrawn', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '8'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'A total of 125 participants were enrolled at sites in 8 different countries.', 'preAssignmentDetails': 'One randomized participant in Stage 2 did not receive the study treatment, bringing the total number of treated participants to 124.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '33', 'groupId': 'BG004'}, {'value': '32', 'groupId': 'BG005'}, {'value': '32', 'groupId': 'BG006'}, {'value': '124', 'groupId': 'BG007'}]}], 'groups': [{'id': 'BG000', 'title': 'Main Phase Stage 1: RO7490677 10 mg/kg IV Every Week (QW)', 'description': 'Participants who received no treatment for Myelofibrosis (MF) in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 milligram per kilogram (mg/kg) administered as a 30 minute intravenous (IV) infusion on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.'}, {'id': 'BG001', 'title': 'Main Phase Stage 1: RO7490677 10 mg/kg IV Every 4 Weeks (Q4W)', 'description': 'Participants who received no treatment for MF in at least two weeks were assigned to treatment with single agent PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.'}, {'id': 'BG002', 'title': 'Main Phase Stage 1: RO7490677 10 mg/kg IV QW + Ruxolitinib', 'description': 'Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.'}, {'id': 'BG003', 'title': 'Main Phase Stage 1: RO7490677 10 mg/kg IV Q4W+ Ruxolitinib', 'description': 'Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks were assigned to receive PRM-151 at a dose of 10 mg/kg administered as a 30 minute IV infusion in combination with daily oral ruxolitinib on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.'}, {'id': 'BG004', 'title': 'Main Phase Stage 2: RO7490677 0.3 mg/kg IV Q4W', 'description': 'Participants were treated with single agent PRM-151 at a dose of 0.3 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.'}, {'id': 'BG005', 'title': 'Main Phase Stage 2: RO7490677 3 mg/kg IV Q4W', 'description': 'Participants were treated with single agent PRM-151 at a dose of 3.0 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.'}, {'id': 'BG006', 'title': 'Main Phase Stage 2: RO7490677 10 mg/kg IV Q4W', 'description': 'Participants were treated with single agent PRM-151 at a dose of 10 mg/kg administered as a 60 minute IV infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.'}, {'id': 'BG007', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '27', 'groupId': 'BG007'}]}], 'categories': [{'measurements': [{'value': '64.3', 'spread': '11.4', 'groupId': 'BG000'}, {'value': '70.7', 'spread': '6.3', 'groupId': 'BG001'}, {'value': '66.0', 'spread': '7.3', 'groupId': 'BG002'}, {'value': '66.2', 'spread': '8.6', 'groupId': 'BG003'}, {'value': '66.7', 'spread': '8.7', 'groupId': 'BG007'}]}]}], 'paramType': 'MEAN', 'description': 'Participants in the Main Phase Stage 1 part of the study', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Main Phase Stage 1 reported separately from Main Phase Stage 2.'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '33', 'groupId': 'BG004'}, {'value': '32', 'groupId': 'BG005'}, {'value': '32', 'groupId': 'BG006'}, {'value': '97', 'groupId': 'BG007'}]}], 'categories': [{'measurements': [{'value': '70.6', 'spread': '7.1', 'groupId': 'BG004'}, {'value': '70.2', 'spread': '6.5', 'groupId': 'BG005'}, {'value': '69.4', 'spread': '8.9', 'groupId': 'BG006'}, {'value': '70.1', 'spread': '7.5', 'groupId': 'BG007'}]}]}], 'paramType': 'MEAN', 'description': 'Participants in the Main Phase Stage 2 part of the study', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Main Phase Stage 2 reported separately from Main Phase Stage 1.'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '27', 'groupId': 'BG007'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '15', 'groupId': 'BG007'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Participants in the Main Phase Stage 1 part of the study', 'unitOfMeasure': 'Participants', 'populationDescription': 'Main Phase Stage 1 reported separately from Main Phase Stage 2.'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '33', 'groupId': 'BG004'}, {'value': '32', 'groupId': 'BG005'}, {'value': '32', 'groupId': 'BG006'}, {'value': '97', 'groupId': 'BG007'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}, {'value': '11', 'groupId': 'BG006'}, {'value': '35', 'groupId': 'BG007'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG004'}, {'value': '24', 'groupId': 'BG005'}, {'value': '21', 'groupId': 'BG006'}, {'value': '62', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Participants in the Main Phase Stage 2 part of the study', 'unitOfMeasure': 'Participants', 'populationDescription': 'Main Phase Stage 2 reported separately from Main Phase Stage 1.'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '27', 'groupId': 'BG007'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG007'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '25', 'groupId': 'BG007'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Participants in the Main Phase Stage 1 part of the study', 'unitOfMeasure': 'Participants', 'populationDescription': 'Main Phase Stage 1 reported separately from Main Phase Stage 2.'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '27', 'groupId': 'BG007'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG007'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG007'}]}, {'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': 'BG007'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG007'}]}, {'title': 'White', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '23', 'groupId': 'BG007'}]}, {'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': 'BG007'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Participants in the Main Phase Stage 1 part of the study', 'unitOfMeasure': 'Participants', 'populationDescription': 'Main Phase Stage 1 reported separately from Main Phase Stage 2.'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '33', 'groupId': 'BG004'}, {'value': '32', 'groupId': 'BG005'}, {'value': '32', 'groupId': 'BG006'}, {'value': '97', 'groupId': 'BG007'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}]}, {'title': 'White', 'measurements': [{'value': '33', 'groupId': 'BG004'}, {'value': '29', 'groupId': 'BG005'}, {'value': '29', 'groupId': 'BG006'}, {'value': '91', 'groupId': 'BG007'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Participants in the Main Phase Stage 2 part of the study', 'unitOfMeasure': 'Participants', 'populationDescription': 'Main Phase Stage 2 reported separately from Main Phase Stage 1.'}], 'populationDescription': 'Stage 1 \\& Stage 2 reported separately.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-12-15', 'size': 1732130, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-06-30T15:24', 'hasProtocol': True}, {'date': '2020-07-22', 'size': 2060615, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-06-30T15:24', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 125}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2020-07-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-07', 'studyFirstSubmitDate': '2013-10-29', 'resultsFirstSubmitDate': '2021-06-30', 'studyFirstSubmitQcDate': '2013-11-05', 'lastUpdatePostDateStruct': {'date': '2022-01-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-12-07', 'studyFirstPostDateStruct': {'date': '2013-11-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Stage 1 Main Phase: Maximum Drug Concentration (Cmax)', 'timeFrame': 'Pre-dose on Cycles(C) 1, 2 and 6, Day(D) 1 and C1 D15. Each cycle is 28 days', 'description': 'Cmax is the maximum observed RO7490677 plasma concentration.'}, {'measure': 'Stage 1 Main Phase: Time to Maximum Concentration (Tmax)', 'timeFrame': 'Pre-dose on Cycles(C) 1, 2 and 6, Day(D) 1 and C1 D15. Each cycle is 28 days', 'description': 'Time at which the maximum plasma concentration was observed.'}, {'measure': 'Stage 1 Main Phase: Area Under the Curve up to the Last Measurable Concentration (AUC0-last)', 'timeFrame': 'Pre-dose on Cycles(C) 1, 2 and 6, Day(D) 1 and C1 D15. Each cycle is 28 days', 'description': 'Area under the plasma concentration time curve from time 0 to time of last measurable plasma concentration.'}, {'measure': 'Stage 1 Main Phase: Area Under the Concentration-Time Curve Extrapolated to Infinity (AUC0-inf)', 'timeFrame': 'Pre-dose on Cycles(C) 1, 2 and 6, Day(D) 1 and C1 D15. Each cycle is 28 days', 'description': 'Area under the plasma concentration-time curve from 0-time extrapolated to infinity.'}, {'measure': 'Stage 1 Main Phase: Terminal Elimination Half-Life (T1/2)', 'timeFrame': 'Pre-dose on Cycles(C) 1, 2 and 6, Day(D) 1 and C1 D15. Each cycle is 28 days', 'description': 'Apparent terminal elimination half-life of RO7490677.'}, {'measure': 'Stage 1 Main Phase: Clearance (CL)', 'timeFrame': 'Pre-dose on Cycles(C) 1, 2 and 6, Day(D) 1 and C1 D15. Each cycle is 28 days'}, {'measure': 'Stage 1 Main Phase: Volume of Distribution (Vd)', 'timeFrame': 'Pre-dose on Cycles(C) 1, 2 and 6, Day(D) 1 and C1 D15. Each cycle is 28 days'}, {'measure': 'Percentage of Participants With Adverse Events (AEs) and Infusion Related Reactions (IRRs)', 'timeFrame': 'Baseline up until 6.75 years', 'description': 'An AE was defined as any noxious, pathologic, or unintended change in anatomical, physiologic, or metabolic function as indicated by physical signs, symptoms, or laboratory changes occurring in any phase of a clinical study, whether or not considered investigational product-related. Pre-existing conditions which worsened during the study were also considered as adverse events. IRRs were considerd to be Adverse Events of Special Interest (AESI). Grading was completed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 4.0.'}, {'measure': 'Percentage of Participants With Serious Adverse Events (SAEs) and AEs Leading to Study Drug Discontinuation', 'timeFrame': 'Baseline up until 6.75 years', 'description': 'An SAE was defined as any AE that occurred at any dose the resulted in death; was life-threatening; required hospitalization or prolongation of existing hospitalizations; a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions; a congenital anomaly or birth defect. An AE was defined as any noxious, pathologic, or unintended change in anatomical, physiologic, or metabolic function as indicated by physical signs, symptoms, or laboratory changes occurring in any phase of a clinical study, whether or not considered investigational product-related. Pre-existing conditions which worsened during the study were also considered as adverse events. Grading was completed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 4.0.'}], 'primaryOutcomes': [{'measure': 'Stage 1 Main Phase: Overall Response Rate (ORR)', 'timeFrame': 'Up until and including completion of 6 cycles. Each cycle is 28 days.', 'description': 'ORR was defined as the percent of participants with a response according to the International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) criteria. This was defined as those participants who achieved clinical improvement (CI), partial remission (PR), or complete remission (CR) at a post-baseline assessment of treatment response OR had at least stable disease (SD) for three consecutive end-of-cycle response assessments (e.g. Day 1 of the subsequent cycle) in conjunction with improvement in the bone marrow fibrosis score relative to baseline by at least one grade at any time point during the period of stable disease.'}, {'measure': 'Stage 2 Main Phase: Bone Marrow Response Rate (BMRR)', 'timeFrame': 'Up until and including completion of 9 cycles. Each cycle is 28 days.', 'description': 'Response rate was defined as the percent of participants with a reduction in bone marrow fibrosis by at least one grade according to World Health Organization (WHO) criteria from baseline to any time during the study. This was determined by a central adjudication panel of expert hematopathologists, blinded to participant, treatment, and time of biopsy.'}, {'measure': 'Stage 1 Main + Open-Label Extension (OLE): ORR', 'timeFrame': 'From cycle 1 day 1 up until cycle 6, day 29 (Main Phase). From cycle 7 day 1 up until study discontinuation or study termination, up to 83 cycles (OLE). Each cycle is 28 days.', 'description': "ORR was defined as the percent of participants with a response according to the IWG-MRT criteria. This was defined as those participants who achieved CI, PR, or CR at a post-baseline assessment of treatment response OR had at least SD for three consecutive end-of-cycle response assessments (e.g. Day 1 of the subsequent cycle) in conjunction with improvement in the bone marrow fibrosis score relative to baseline by at least one grade at any time point during the period of stable disease. Participants who achieved a clinical benefit in the main phase had the opportunity to remain on treatment. The determination of ORR in the main phase is outlined in the arms description below. Participants who didn't achieve a benefit had the opportunity to switch to a different dosing schedule in the OLE phase. The determination of ORR in the OLE phase is outlined in the arms descriptions below."}, {'measure': 'Stage 2 Main + Open-Label Extension (OLE): BMRR', 'timeFrame': 'From cycle 1 day 1 up until cycle 9 day 29 (main phase). From cycle 10 day 1 up until study discontinuation or study termination, up to 51 cycles (OLE). Each cycle is 28 days.', 'description': 'Defined as the percent of participants with a reduction in bone marrow fibrosis score by at least one grade according to WHO criteria at any time during the study. As determined by a central adjudication panel of expert hematopathologists, blinded to participant, treatment, and time of biopsy. Participants in the main phase had the opportunity to remain on treatment (as outlined in the arms description below). Participants also had the option to switch to the OLE phase after completing 9 cycles of the originally assigned treatment and receive PRM-151 10 mg/kg/Q4W (as outlined in the arms description below).'}], 'secondaryOutcomes': [{'measure': 'Stage 1 Main Phase: BMRR', 'timeFrame': 'Baseline, Weeks 12 and 24', 'description': 'Bone marrow response was defined as a reduction in bone marrow fibrosis score by at least one grade from baseline at anytime during the study.'}, {'measure': 'Stage 1 Main Phase: Modified Myeloproliferative Neoplasms Symptom Assessment Form Total Symptom Score (MPN-SAF TSS) Changes', 'timeFrame': 'Baseline, beginning of each cycle (Cycle 2 onward). Each cycle is 28 days.', 'description': 'The MPN-SAF TSS total symptom score was the sum of the following 10 items: Filling up quickly when you eat (early satiety), abdominal discomfort, inactivity, Problems with concentration, Worst fatigue, Night sweats, Itching, Bone pain, Fever and Unintentional weight loss last 6 months. The MPN-SAF Total Symptom Score had a possible range of 0 to 100, where a lower score was more favorable. The values reported are the change from baseline scores.'}, {'measure': 'Stage 2 Main Phase: BMRR', 'timeFrame': 'Up until and including completion of 9 cycles. Each cycle is 28 days.', 'description': 'Response rate was defined as the percent of participants with a reduction in bone marrow fibrosis by at least one grade according to World Health Organization (WHO) criteria at any time during the study. This was determined by a central adjudication panel of expert hematopathologists, blinded to participant, treatment, and time of biopsy.'}, {'measure': 'Stage 2 Main Phase: BMRR - Reduction of Bone Marrow Fibrosis by Visit', 'timeFrame': 'Day 1 on Cycles 4, 7, 10 and Cycle 9 Day 29. Each cycle is 28 days.', 'description': 'Reduction in bone marrow fibrosis score: Reduction of at least one grade from baseline. Bone marrow fibrosis grades according to WHO criteria (as determined by central adjudication).'}, {'measure': 'Stage 2 Main Phase: Duration of Bone Marrow Improvement', 'timeFrame': 'From first decrease from baseline of one grade to time of return to baseline levels, up to cycle 9 of 28-day cycles.', 'description': 'Duration of response was defined as time from first decrease from baseline \\>= 1 grade to time of return to baseline levels.'}, {'measure': 'Stage 2 Main Phase: Hemoglobin Improvement', 'timeFrame': 'Up until and including completion of 9 cycles. Each cycle is 28 days.', 'description': 'Hemoglobin improvement was measured by the percent of participants with: Red cell transfusion independence (no transfusions for \\>= 12 consecutive weeks) OR 50% reduction in red blood cell (RBC) transfusions for \\>= 12 consecutive weeks OR percent of participants with \\>= 10 g/L and \\>= 20 g/L increase in hemoglobin for \\>= 12 consecutive weeks without transfusions (outcome parameter assessed was dependent on baseline hemoglobin/transfusion status).'}, {'measure': 'Stage 2 Main Phase: Platelet Improvement', 'timeFrame': 'Up until and including completion of 9 cycles. Each cycle is 28 days.', 'description': 'Platelet improvement was measured by the percent of participants with: Platelet transfusion independence (no transfusions for \\>= 12 consecutive weeks) OR 50% reduction in platelets transfusions for \\>= 12 consecutive weeks OR doubling of baseline platelet count for \\>= 12 consecutive weeks without platelet transfusions OR platelet count \\> 50 x 10e9/L for \\>=12 consecutive weeks without platelet transfusions OR doubling of baseline platelet count for \\>= 12 consecutive weeks without platelet transfusions OR platelet count \\> 25 x 10e9/L for \\>= 12 consecutive weeks without platelet transfusions (outcome parameter assessed is dependent on baseline platelet status).'}, {'measure': 'Stage 2 Main Phase: Symptom Improvement', 'timeFrame': 'Up until and including completion of 9 cycles. Each cycle is 28 days.', 'description': 'Symptom improvement was assessed as the percent of participants with 50% reduction in MPN-SAF TSS from baseline over time. The MPN-SAF TSS total symptom score was the sum of the following 10 items: Filling up quickly when you eat (early satiety), abdominal discomfort, inactivity, Problems with concentration, Worst fatigue, Night sweats, Itching, Bone pain, Fever and Unintentional weight loss last 6 months. The MPN-SAF Total Symptom Score had a possible range of 0 to 100, where a lower score was more favorable.'}, {'measure': 'Stage 2 Main Phase: Percentage of Participants With Complete Response (CR), Partial Response (PR), Clinical Improvement (CI), Stable Disease (SD), and Progressive Disease (PD) According to IWG-MRT Criteria', 'timeFrame': 'Up until and including completion of 9 cycles. Each cycle is 28 days.', 'description': 'Best Overall Response: (CR, PR, CI), SD and PD according to the IWG-MRT Criteria.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['fibrosis'], 'conditions': ['Primary Myelofibrosis', 'Polycythemia Vera', 'Post-Essential Thrombocythemia Myelofibrosis']}, 'referencesModule': {'references': [{'pmid': '37165840', 'type': 'DERIVED', 'citation': 'Verstovsek S, Foltz L, Gupta V, Hasserjian R, Manshouri T, Mascarenhas J, Mesa R, Pozdnyakova O, Ritchie E, Veletic I, Gamel K, Hamidi H, Han L, Higgins B, Trunzer K, Uguen M, Wang D, El-Galaly TC, Todorov B, Gotlib J. Safety and efficacy of zinpentraxin alfa as monotherapy or in combination with ruxolitinib in myelofibrosis: stage I of a phase II trial. Haematologica. 2023 Oct 1;108(10):2730-2742. doi: 10.3324/haematol.2022.282411.'}]}, 'descriptionModule': {'briefSummary': 'RO7490677 is an investigational drug that is being developed for possible use in the treatment of myelofibrosis (MF), a disease in which the bone marrow, which is the organ in the body that makes blood cells, is replaced by fibrosis, or excess scar tissue.\n\nThe purpose of this study is to gather information on whether RO7490677 has an effect on the MF disease, whether it is safe in patients with MF, and how well it is tolerated.', 'detailedDescription': 'Stage 1 of this study has completed. Stage 1 was an open-label, Simon two stage, Phase 2 study to determine the efficacy and safety of two different dose schedules of RO7490677 in participants with PMF and post ET/PV MF. There were two treatment cohorts, each assigned to one of two dose schedules receiving either single-agent RO7490677 or RO7490677 in combination with ruxolitinib. Participants were assigned to a weekly or every four week dosing schedule by the investigator.\n\nStage 2 is a randomized, double-blind Phase 2 study to determine the efficacy and safety of three different doses of RO7490677 in participants with PMF and post ET/PV MF. Participants will be randomized to one of three doses: 0.3 mg/kg, 3.0 mg/kg or 10 mg/kg of RO7490677. This is the second stage of an adaptive design study as defined in FDA Draft Guidance for Industry: Adaptive Design Clinical Trials for Drugs and Biologics, February 2010. Modifications to dose levels, schedule, and regimen have been made in Stage 2 based on data from Stage 1.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Participants must be ≥18 years of age at the time of signing the Informed Consent Form (ICF);\n2. Participants must voluntarily sign an ICF;\n3. Participants must have a pathologically confirmed diagnosis of PMF as per the WHO diagnostic criteria or post ET/PV MF;\n4. At least Grade 2 marrow fibrosis according to the WHO Grading of Bone Marrow Fibrosis;\n5. Intermediate-1, intermediate -2, or high risk disease according to the IWG -MRT Dynamic International Prognostic Scoring System\n6. A bone marrow biopsy must be performed within four weeks prior to Cycle 1 Day 1 treatment to establish the baseline fibrosis score;\n7. Participants must not be candidates for ruxolitinib based on EITHER:\n\n 1. Platelet count \\< 50 x 10e9/L, OR\n 2. Hgb \\< 100 g/L, have received ≥ 2 units PRBC in the 12 weeks prior to study entry, and be intolerant of or had inadequate response to ruxolitinib;\n8. Participants must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2. (Appendix F);\n9. Life expectancy of at least twelve months;\n10. At least four weeks must have elapsed between the last dose of any MF- directed drug treatments for myelofibrosis (including investigational therapies) and study enrollment;\n11. Recovery to ≤ Grade 1 or baseline of any toxicities due to prior systemic treatments, excluding alopecia;\n12. Women of child bearing potential (WCBP), defined as a sexually mature woman not surgically sterilized or not post-menopausal for at least 24 consecutive months if ≤55 years or 12 months if \\>55 years, must have a negative serum pregnancy test within four weeks prior to the first dose of study drug and must agree to use adequate methods of birth control throughout the study. Adequate methods of contraception are outlined in the protocol.\n13. Ability to adhere to the study visit schedule and all protocol requirements;\n14. Must have adequate organ function as demonstrated by the following:\n\n * ALT (SGPT) and/or AST (SGOT) ≤ 3x upper limit of normal (ULN), or ≤ 4 x ULN (if upon judgment of the treating physician, it is believed to be due to extramedullary hematopoiesis \\[EMH\\] related to MF);\n * Direct bilirubin ≤ 1.5 x ULN; or ≤ 2x ULN (if upon judgment of the treating physician, it is believed to be due to EMH related to MF);\n * Serum creatinine ≤ 2.5 mg/dL x ULN.\n\nExclusion Criteria:\n\n1. White blood cell count \\> 25 x 10e9/L or \\> 10% peripheral blood blasts;\n2. Other invasive malignancies within the last 3 years, except non- melanoma skin cancer and localized cured prostate and cervical cancer;\n3. History of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within the last 6 months;\n4. Presence of active serious infection;\n5. Any serious, unstable medical or psychiatric condition that would prevent, (as judged by the Investigator) the participant from signing the informed consent form or any condition, including the presence of laboratory abnormalities, which places the participant at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study;\n6. Known history of human immunodeficiency virus (HIV), or known active hepatitis A, B, or C infection;\n7. Organ transplant recipients other than bone marrow transplant;\n8. Women who are pregnant or lactating.'}, 'identificationModule': {'nctId': 'NCT01981850', 'briefTitle': 'A Phase 2 Study of RO7490677 In Participants With Myelofibrosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Phase 2, Prospective Study Of PRM-151 In Subjects With Primary Myelofibrosis (PMF), Post-Polycythemia Vera MF (Post-PV MF), Or Post-Essential Thrombocythemia MF (Post-ET MF)', 'orgStudyIdInfo': {'id': 'BO42355'}, 'secondaryIdInfos': [{'id': 'PRM-151G-101', 'type': 'OTHER', 'domain': 'Promedior, Inc.'}, {'id': '2015-001718-80', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Stage 1: Cohort 1 Weekly', 'description': 'Participants who received no treatment for MF in at least two weeks will be assigned to treatment with single agent RO7490677 at a dose of 10 mg/kg IV on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.', 'interventionNames': ['Biological: RO7490677']}, {'type': 'EXPERIMENTAL', 'label': 'Stage 1: Cohort 1 Every 4 Weeks', 'description': 'Paricipants who received no treatment for MF in at least two weeks will be assigned to treatment with single agent RO7490677 at a dose of 10 mg/kg administered IV on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.', 'interventionNames': ['Biological: RO7490677']}, {'type': 'EXPERIMENTAL', 'label': 'Stage 1: Cohort 2 Weekly', 'description': 'Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks will be assigned to receive RO7490677 in combination with ruxolitinib at a dose of 10 mg/kg administered IV on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles.', 'interventionNames': ['Biological: RO7490677', 'Drug: Ruxolitinib']}, {'type': 'EXPERIMENTAL', 'label': 'Stage 1: Cohort 2 Every 4 Weeks', 'description': 'Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks will be assigned to receive RO7490677 in combination with ruxolitinib at a dose of 10 mg/kg administered IV on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles.', 'interventionNames': ['Biological: RO7490677', 'Drug: Ruxolitinib']}, {'type': 'EXPERIMENTAL', 'label': 'Stage 2: Cohort 1 0.3mg/kg Every 4 Weeks', 'description': 'Participants will be treated with single agent RO7490677 at a dose of 0.3 mg/kg IV administered as a 60 minute intravenous infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.', 'interventionNames': ['Biological: RO7490677']}, {'type': 'EXPERIMENTAL', 'label': 'Stage 2: Cohort 2 3mg/kg Every 4 Weeks', 'description': 'Participants will be treated with single agent RO7490677 at a dose of 3.0 mg/kg IV administered as a 60 minute intravenous infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.', 'interventionNames': ['Biological: RO7490677']}, {'type': 'EXPERIMENTAL', 'label': 'Stage 2: Cohort 3 10mg /kg Every 4 Weeks', 'description': 'Participants will be treated with single agent RO7490677 at a dose of 10 mg/kg IV administered as a 60 minute intravenous infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles.', 'interventionNames': ['Biological: RO7490677']}], 'interventions': [{'name': 'RO7490677', 'type': 'BIOLOGICAL', 'otherNames': ['originally called PRM-151, and also known as rhPTX-2'], 'description': 'IV infusion', 'armGroupLabels': ['Stage 1: Cohort 1 Every 4 Weeks', 'Stage 1: Cohort 1 Weekly', 'Stage 1: Cohort 2 Every 4 Weeks', 'Stage 1: Cohort 2 Weekly', 'Stage 2: Cohort 1 0.3mg/kg Every 4 Weeks', 'Stage 2: Cohort 2 3mg/kg Every 4 Weeks', 'Stage 2: Cohort 3 10mg /kg Every 4 Weeks']}, {'name': 'Ruxolitinib', 'type': 'DRUG', 'otherNames': ['Jakafi'], 'description': 'IV infusion', 'armGroupLabels': ['Stage 1: Cohort 2 Every 4 Weeks', 'Stage 1: Cohort 2 Weekly']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85054', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic Cancer Center', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stanford Cancer Institute', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory Hospital', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'University of Maryland Medical Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana-Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48109-2800', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mount Sinai Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Weill Cornell Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest Baptist Medical Center', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': 'V6Z 2A5', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Providence Health Care', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'M5T 2M9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The Princess Margaret Cancer Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': '75475', 'city': 'Paris', 'country': 'France', 'facility': 'Hospital Saint-Louis', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': 'D-52074', 'city': 'Aachen', 'country': 'Germany', 'facility': 'University Medical Center RWTH Aachen', 'geoPoint': {'lat': 50.77664, 'lon': 6.08342}}, {'zip': '32429', 'city': 'Minden', 'country': 'Germany', 'facility': 'Johannes Wesling Academic Medical Center', 'geoPoint': {'lat': 52.28953, 'lon': 8.91455}}, {'zip': '91120', 'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Hadassah Medical Centre', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}, {'zip': '4428164', 'city': 'Kfar Saba', 'country': 'Israel', 'facility': 'Meir Medical Centre', 'geoPoint': {'lat': 32.175, 'lon': 34.90694}}, {'zip': '27100', 'city': 'Pavia', 'country': 'Italy', 'facility': 'Fondazione IRCCS Policlinico San Matteo', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}, {'zip': '61122', 'city': 'Pesaro', 'country': 'Italy', 'facility': 'Marche Nord Hospital', 'geoPoint': {'lat': 43.90921, 'lon': 12.9164}}, {'zip': '3015 CE', 'city': 'Rotterdam', 'state': 'South Holland', 'country': 'Netherlands', 'facility': 'Erasmus Medical Center', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'zip': '6525 GA', 'city': 'Nijmegen', 'country': 'Netherlands', 'facility': 'Radboud University Medical Center', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'city': 'London', 'country': 'United Kingdom', 'facility': "Guy's and St. Thomas' Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': "Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\\_and\\_development/who\\_we\\_are\\_how\\_we\\_work/clinical\\_trials/our\\_commitment\\_to\\_data\\_sharing.htm)."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}