Ignite Creation Date:
2025-12-24 @ 11:20 PM
Ignite Modification Date:
2026-02-20 @ 8:08 PM
Study NCT ID:
NCT02152956
Status:
TERMINATED
Last Update Posted:
2024-01-30
First Post:
2014-05-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Flotetuzumab in Primary Induction Failure (PIF) or Early Relapse (ER) Acute Myeloid Leukemia (AML)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007938', 'term': 'Leukemia'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C540383', 'term': 'ruxolitinib'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'info@macrogenics.com', 'phone': '301-251-5172', 'title': 'Chief Medical Officer', 'organization': 'MacroGenics, Inc.'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Throughout the study, up to 95 months.', 'description': 'AEs are based on physical exam, patient reports, and significant abnormal laboratory values.\n\nAEs were not collected in survival follow up. Only SAEs were collected in survival follow up if related to study treatment.\n\nOnly patients who received study treatments were assessed for safety. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.\\[', 'eventGroups': [{'id': 'EG000', 'title': 'Cohort 0-a', 'description': 'Flotetuzumab 3 ng/kg/day, 4 days on and 3 days off', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Cohort 0-b', 'description': 'Flotetuzumab 10 ng/kg/day, 4 days on and 3 days off', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'deathsNumAffected': 3, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Cohort 0-c', 'description': 'Flotetuzumab 30 ng/kg/day, 4 days on and 3 days off', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 5, 'seriousNumAtRisk': 5, 'deathsNumAffected': 3, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Cohort 0-d', 'description': 'Flotetuzumab 100 ng/kg/day, 4 days on and 3 days off', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'deathsNumAffected': 4, 'seriousNumAffected': 2}, {'id': 'EG004', 'title': 'Cohort 1', 'description': 'Flotetuzumab 300 ng/kg/day, 4 days on 3 days off, after lead-in dose', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 2, 'seriousNumAffected': 1}, {'id': 'EG005', 'title': 'Cohort 2', 'description': 'Flotetuzumab 500 ng/kg/day, 4 days on 3 days off, after lead-in dose', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'deathsNumAffected': 2, 'seriousNumAffected': 2}, {'id': 'EG006', 'title': 'Cohort 2a', 'description': 'Flotetuzumab 500 ng/kg/day, 4 days on 3 days off, after lead-in dose', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 6, 'seriousNumAffected': 2}, {'id': 'EG007', 'title': 'Cohort 3', 'description': 'Flotetuzumab 700 ng/kg/day, 4 days on 3 days off, after lead-in dose', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 6, 'seriousNumAffected': 1}, {'id': 'EG008', 'title': 'Cohort 6', 'description': 'Flotetuzumab 300 ng/kg/day, continuous infusion, after lead-in dose', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 5, 'seriousNumAffected': 0}, {'id': 'EG009', 'title': 'Cohort 7', 'description': 'Flotetuzumab 500 ng/kg/day, continuous infusion, after lead-in dose', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 5, 'seriousNumAtRisk': 5, 'deathsNumAffected': 5, 'seriousNumAffected': 3}, {'id': 'EG010', 'title': 'Cohort 8', 'description': 'Flotetuzumab 700 ng/kg/day, continuous infusion, after lead-in dose', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 3, 'seriousNumAffected': 1}, {'id': 'EG011', 'title': 'MTD Expansion', 'description': 'Flotetuzumab 500 ng/kg/day, continuous infusion, after lead-in dose', 'otherNumAtRisk': 185, 'deathsNumAtRisk': 185, 'otherNumAffected': 185, 'seriousNumAtRisk': 185, 'deathsNumAffected': 144, 'seriousNumAffected': 100}, {'id': 'EG012', 'title': 'MTD Expansion With Ruxolitinib', 'description': 'Flotetuzumab 500 ng/kg/day, continuous infusion, after lead-in dos Ruxolitinib: Oral inhibitor of JAK kinase', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 12, 'seriousNumAtRisk': 12, 'deathsNumAffected': 12, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 35}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 2}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 35}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 7}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 11}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 28}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 23}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 11}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 4}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 2}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 3}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 83}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 3}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 3}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 75}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 2}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 41}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 42}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 38}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 2}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 22}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 12}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 13}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 12}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 11}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 4}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 2}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 79}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 4}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 43}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 2}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 37}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 16}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 3}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 15}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 7}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Cytokine release syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 95}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 4}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 5}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 6}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 5}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 5}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 70}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 8}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 11}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 34}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 30}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 26}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 26}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 26}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 25}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 2}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 17}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 18}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 16}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 11}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Blood fibrinogen decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 15}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 6}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 5}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 74}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Hypophosphataemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 56}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 45}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Hypoalbuminaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 41}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 4}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 2}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 41}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 4}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 39}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 27}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 21}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Hyperphosphataemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 14}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Fluid retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 16}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Hypervolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 10}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 2}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 57}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 28}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 26}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 23}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 22}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 15}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 52}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 22}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Lethargy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 14}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 32}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 26}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 20}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 10}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 19}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 13}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Urinary incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 10}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 49}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 28}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 26}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 26}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 23}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 15}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 12}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Petechiae', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 34}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 25}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 25}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 18}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 12}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 38}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 24}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 13}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Capillary leak syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 13}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}], 'seriousEvents': [{'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 9}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Disseminated intravascular coagulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Febrile bone marrow aplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 3}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 2}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Left ventricular dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 2}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 2}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 2}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 2}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Enteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Enterocolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Gastric ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Haematemesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Haematochezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Lower gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Upper gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 10}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 5}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Face oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'General physical health deterioration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Generalised oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Localised oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Multiple organ dysfunction syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 2}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Hypertransaminasaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Cytokine release syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 12}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 7}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 6}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Epstein-Barr virus infection reactivation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 4}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Pneumonia fungal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 4}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 4}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Bacterial sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 3}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Neutropenic sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Staphylococcal bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 3}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'COVID-19 pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 2}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 2}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Device related infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 2}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Enterocolitis infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 2}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Clostridium difficile colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Clostridium difficile infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Diverticulitis intestinal perforated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Epstein-Barr viraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Escherichia infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Herpes simplex reactivation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Klebsiella sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Necrotising fasciitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Pneumonia pseudomonal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Pseudomonal bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Pseudomonal sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Scedosporium infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Streptococcal sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Tooth infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Wound infection bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 8}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Accidental overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Subdural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Subdural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Coronavirus test positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Liver function test increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 3}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Failure to thrive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Gout', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Lactic acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 3}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Cancer pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 2}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Depressed level of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Haemorrhage intracranial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Haemorrhagic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Hypercapnic coma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Subarachnoid haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Device infusion issue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 2}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 2}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Mental status changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Azotaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 6}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 3}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 3}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Laryngeal oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 2}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 2}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Acute pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Acute respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Central venous catheter removal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 4}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Capillary leak syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 3}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Efficacy Based on CR or CRh Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '5', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '185', 'groupId': 'OG011'}, {'value': '12', 'groupId': 'OG012'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 0-a', 'description': 'Flotetuzumab 3 ng/kg/day, 4 days on and 3 days off'}, {'id': 'OG001', 'title': 'Cohort 0-b', 'description': 'Flotetuzumab 10 ng/kg/day, 4 days on and 3 days off'}, {'id': 'OG002', 'title': 'Cohort 0-c', 'description': 'Flotetuzumab 30 ng/kg/day, 4 days on and 3 days off'}, {'id': 'OG003', 'title': 'Cohort 0-d', 'description': 'Flotetuzumab 100 ng/kg/day, 4 days on and 3 days off'}, {'id': 'OG004', 'title': 'Cohort 1', 'description': 'Flotetuzumab 300 ng/kg/day, 4 days on 3 days off, after lead-in dose'}, {'id': 'OG005', 'title': 'Cohort 2', 'description': 'Flotetuzumab 500 ng/kg/day, 4 days on 3 days off, after lead-in dose'}, {'id': 'OG006', 'title': 'Cohort 2a', 'description': 'Flotetuzumab 500 ng/kg/day, 4 days on 3 days off, after multistep lead-in dose'}, {'id': 'OG007', 'title': 'Cohort 3', 'description': 'Flotetuzumab 700 ng/kg/day, 4 days on 3 days off, after multistep lead-in dose'}, {'id': 'OG008', 'title': 'Cohort 6', 'description': 'Flotetuzumab 300 ng/kg/day, continuous infusion, after multistep lead-in dose'}, {'id': 'OG009', 'title': 'Cohort 7', 'description': 'Flotetuzumab 500 ng/kg/day, continuous infusion, after lead-in dose'}, {'id': 'OG010', 'title': 'Cohort 8', 'description': 'Flotetuzumab 700 ng/kg/day, continuous infusion, after multistep lead-in dose'}, {'id': 'OG011', 'title': 'MTD Expansion', 'description': 'Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose'}, {'id': 'OG012', 'title': 'MTD Expansion With Ruxolitinib', 'description': 'Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose Ruxolitinib: Oral inhibitor of JAK kinase'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '16', 'groupId': 'OG011'}, {'value': '4', 'groupId': 'OG012'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 14 months', 'description': 'Proportion of patients achieving a best response of CR (morphologic CR \\[mCR\\], cytogenetic CR \\[CRc\\], molecular CR \\[CRm\\], or CRh per Interworking Group AML response criteria.\n\nCR is defined as mCR, CRc, CRm or CRh. mCR is defined as: normal. neutrophil and platelet counts, less than 5% blast cells in a bone marrow (BM) smear and. no extramedullary disease.\n\nCRc is defined as: CR with no evidence of cytogenetic abnormalities in the bone marrow.\n\nCRm is defined as: CR with no evidence of molecular abnormalities in the bone marrow.\n\nCRh is defined as: CR with partial hematologic recovery.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Overall Complete Response Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '5', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '185', 'groupId': 'OG011'}, {'value': '12', 'groupId': 'OG012'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 0-a', 'description': 'Flotetuzumab 3 ng/kg/day, 4 days on and 3 days off'}, {'id': 'OG001', 'title': 'Cohort 0-b', 'description': 'Flotetuzumab 10 ng/kg/day, 4 days on and 3 days off'}, {'id': 'OG002', 'title': 'Cohort 0-c', 'description': 'Flotetuzumab 30 ng/kg/day, 4 days on and 3 days off'}, {'id': 'OG003', 'title': 'Cohort 0-d', 'description': 'Flotetuzumab 100 ng/kg/day, 4 days on and 3 days off'}, {'id': 'OG004', 'title': 'Cohort 1', 'description': 'Flotetuzumab 300 ng/kg/day, 4 days on 3 days off, after lead-in dose:'}, {'id': 'OG005', 'title': 'Cohort 2', 'description': 'Flotetuzumab 500 ng/kg/day, 4 days on 3 days off, after lead-in dose:'}, {'id': 'OG006', 'title': 'Cohort 2a', 'description': 'Flotetuzumab 500 ng/kg/day, 4 days on 3 days off, after multistep lead-in dose:'}, {'id': 'OG007', 'title': 'Cohort 3', 'description': 'Flotetuzumab 700 ng/kg/day, 4 days on 3 days off, after multistep lead-in dose:'}, {'id': 'OG008', 'title': 'Cohort 6', 'description': 'Flotetuzumab 300 ng/kg/day, continuous infusion, after multistep lead-in dose:'}, {'id': 'OG009', 'title': 'Cohort 7', 'description': 'Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose:'}, {'id': 'OG010', 'title': 'Cohort 8', 'description': 'Flotetuzumab 700 ng/kg/day, continuous infusion, after multistep lead-in dose:'}, {'id': 'OG011', 'title': 'MTD Expansion', 'description': 'Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose:'}, {'id': 'OG012', 'title': 'MTD Expansion With Ruxolitinib', 'description': 'Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose:\n\nRuxolitinib: Oral inhibitor of JAK kinase'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '27', 'groupId': 'OG011'}, {'value': '4', 'groupId': 'OG012'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 14 months', 'description': 'Rate of CR + CRh + CRi (CR with incomplete blood cell recovery \\[CR with incomplete neutrophil {CRn}or platelet recovery {CRp}\\]) + MLFS (morphologic leukemia-free state)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'CR Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '5', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '185', 'groupId': 'OG011'}, {'value': '12', 'groupId': 'OG012'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 0-a', 'description': 'Flotetuzumab 3 ng/kg/day, 4 days on and 3 days off'}, {'id': 'OG001', 'title': 'Cohort 0-b', 'description': 'Flotetuzumab 10 ng/kg/day, 4 days on and 3 days off'}, {'id': 'OG002', 'title': 'Cohort 0-c', 'description': 'Flotetuzumab 30 ng/kg/day, 4 days on and 3 days off'}, {'id': 'OG003', 'title': 'Cohort 0-d', 'description': 'Flotetuzumab 100 ng/kg/day, 4 days on and 3 days off'}, {'id': 'OG004', 'title': 'Cohort 1', 'description': 'Flotetuzumab 300 ng/kg/day, 4 days on 3 days off, after lead-in dose'}, {'id': 'OG005', 'title': 'Cohort 2', 'description': 'Flotetuzumab 500 ng/kg/day, 4 days on 3 days off, after lead-in dose'}, {'id': 'OG006', 'title': 'Cohort 2a', 'description': 'Flotetuzumab 500 ng/kg/day, 4 days on 3 days off, after lead-in dose'}, {'id': 'OG007', 'title': 'Cohort 3', 'description': 'Flotetuzumab 700 ng/kg/day, 4 days on 3 days off, after multistep lead-in dose'}, {'id': 'OG008', 'title': 'Cohort 6', 'description': 'Flotetuzumab 300 ng/kg/day, continuous infusion, after multistep lead-in dose'}, {'id': 'OG009', 'title': 'Cohort 7', 'description': 'Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose'}, {'id': 'OG010', 'title': 'Cohort 8', 'description': 'Flotetuzumab 700 ng/kg/day, continuous infusion, after multistep lead-in dose'}, {'id': 'OG011', 'title': 'MTD Expansion', 'description': 'Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose'}, {'id': 'OG012', 'title': 'MTD Expansion With Ruxolitinib', 'description': 'Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose Ruxolitinib: Oral inhibitor of JAK kinase'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '13', 'groupId': 'OG011'}, {'value': '2', 'groupId': 'OG012'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 14 months', 'description': 'Proportion of patients achieving a best response of CR (morphologic CR \\[mCR\\], cytogenetic CR \\[CRc\\], or molecular CR \\[CRm\\] per Interworking Group AML response criteria.\n\nCR is defined as mCR, CRc, CRm or CRh. mCR is defined as: normal. neutrophil and platelet counts, less than 5% blast cells in a bone marrow (BM) smear and. no extramedullary disease.\n\nCRc is defined as: CR with no evidence of cytogenetic abnormalities in the bone marrow.\n\nCRm is defined as: CR with no evidence of molecular abnormalities in the bone marrow.\n\nCRh is defined as: CR with partial hematologic recovery.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'CRh Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '5', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '185', 'groupId': 'OG011'}, {'value': '12', 'groupId': 'OG012'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 0-a', 'description': 'Flotetuzumab 3 ng/kg/day, 4 days on and 3 days off'}, {'id': 'OG001', 'title': 'Cohort 0-b', 'description': 'Flotetuzumab 10 ng/kg/day, 4 days on and 3 days off'}, {'id': 'OG002', 'title': 'Cohort 0-c', 'description': 'Flotetuzumab 30 ng/kg/day, 4 days on and 3 days off'}, {'id': 'OG003', 'title': 'Cohort 0-d', 'description': 'Flotetuzumab 100 ng/kg/day, 4 days on and 3 days off'}, {'id': 'OG004', 'title': 'Cohort 1', 'description': 'Flotetuzumab 300 ng/kg/day, 4 days on 3 days off, after one-step lead-in dose'}, {'id': 'OG005', 'title': 'Cohort 2', 'description': 'Flotetuzumab 500 ng/kg/day, 4 days on 3 days off, after one-step lead-in dose'}, {'id': 'OG006', 'title': 'Cohort 2a', 'description': 'Flotetuzumab 500 ng/kg/day, continuous infusion, after multi-step lead-in dose'}, {'id': 'OG007', 'title': 'Cohort 3', 'description': 'Flotetuzumab 700 ng/kg/day, 4 days on 3 days off, after multi-step lead-in dose'}, {'id': 'OG008', 'title': 'Cohort 6', 'description': 'Flotetuzumab 300 ng/kg/day, continuous infusion, after multi-step lead-in dose'}, {'id': 'OG009', 'title': 'Cohort 7', 'description': 'Flotetuzumab 500 ng/kg/day, continuous infusion, after multi-step lead-in dose'}, {'id': 'OG010', 'title': 'Cohort 8', 'description': 'Flotetuzumab 700 ng/kg/day, continuous infusion, after multi-step lead-in dose'}, {'id': 'OG011', 'title': 'MTD Expansion', 'description': 'Flotetuzumab 500 ng/kg/day, continuous infusion, after multi-step lead-in dose'}, {'id': 'OG012', 'title': 'MTD Expansion With Ruxolitinib', 'description': 'Flotetuzumab 500 ng/kg/day, continuous infusion, after multi-step lead-in dose Ruxolitinib: Oral inhibitor of JAK kinase'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}, {'value': '2', 'groupId': 'OG012'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 14 months', 'description': 'Proportion of patients achieving a best response of CRh per Interworking Group AML response criteria.\n\nCRh is defined as: CR with partial hematologic recovery.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Overall Response Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '5', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '185', 'groupId': 'OG011'}, {'value': '12', 'groupId': 'OG012'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 0-a', 'description': 'Flotetuzumab 3 ng/kg/day, 4 days on and 3 days off'}, {'id': 'OG001', 'title': 'Cohort 0-b', 'description': 'Flotetuzumab 10 ng/kg/day, 4 days on and 3 days off'}, {'id': 'OG002', 'title': 'Cohort 0-c', 'description': 'Flotetuzumab 30 ng/kg/day, 4 days on and 3 days off'}, {'id': 'OG003', 'title': 'Cohort 0-d', 'description': 'Flotetuzumab 100 ng/kg/day, 4 days on and 3 days off'}, {'id': 'OG004', 'title': 'Cohort 1', 'description': 'Flotetuzumab 300 ng/kg/day, 4 days on 3 days off, after lead-in dose'}, {'id': 'OG005', 'title': 'Cohort 2', 'description': 'Flotetuzumab 500 ng/kg/day, 4 days on 3 days off, after lead-in dose'}, {'id': 'OG006', 'title': 'Cohort 2a', 'description': 'Flotetuzumab 500 ng/kg/day, 4 days on 3 days off, after lead-in dose: Flotetuzumab is a CD123 x CD3 bispecific antibody-based molecular construct referred to as a DART® molecule.'}, {'id': 'OG007', 'title': 'Cohort 3', 'description': 'Flotetuzumab 700 ng/kg/day, 4 days on 3 days off, after lead-in dose'}, {'id': 'OG008', 'title': 'Cohort 6', 'description': 'Flotetuzumab 300 ng/kg/day, continuous infusion, after lead-in dose'}, {'id': 'OG009', 'title': 'Cohort 7', 'description': 'Flotetuzumab 500 ng/kg/day, continuous infusion, after lead-in dose'}, {'id': 'OG010', 'title': 'Cohort 8', 'description': 'Flotetuzumab 700 ng/kg/day, continuous infusion, after lead-in dose'}, {'id': 'OG011', 'title': 'MTD Expansion', 'description': 'Flotetuzumab 500 ng/kg/day, continuous infusion, after lead-in dose'}, {'id': 'OG012', 'title': 'MTD Expansion With Ruxolitinib', 'description': 'Flotetuzumab 500 ng/kg/day, continuous infusion, after lead-in dose Ruxolitinib: Oral inhibitor of JAK kinase'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '35', 'groupId': 'OG011'}, {'value': '4', 'groupId': 'OG012'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 14 months', 'description': 'Proportion of patients achieving a best response of CR, CRh, CRi, MLFS or partial response per Interworking Group AML response criteria.\n\nCR is defined as mCR, CRc, CRm or CRh. mCR is defined as: normal. neutrophil and platelet counts, less than 5% blast cells in a bone marrow (BM) smear and. no extramedullary disease.\n\nCRc is defined as: CR with no evidence of cytogenetic abnormalities in the bone marrow.\n\nCRm is defined as: CR with no evidence of molecular abnormalities in the bone marrow.\n\nCRh is defined as: CR with partial hematologic recovery.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'HSCT Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '5', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '185', 'groupId': 'OG011'}, {'value': '12', 'groupId': 'OG012'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 0-a', 'description': 'Flotetuzumab 3 ng/kg/day, 4 days on and 3 days off'}, {'id': 'OG001', 'title': 'Cohort 0-b', 'description': 'Flotetuzumab 10 ng/kg/day, 4 days on and 3 days off'}, {'id': 'OG002', 'title': 'Cohort 0-c', 'description': 'Flotetuzumab 30 ng/kg/day, 4 days on and 3 days off'}, {'id': 'OG003', 'title': 'Cohort 0-d', 'description': 'Flotetuzumab 100 ng/kg/day, 4 days on and 3 days off'}, {'id': 'OG004', 'title': 'Cohort 1', 'description': 'Flotetuzumab 300 ng/kg/day, 4 days on 3 days off, after lead-in dose'}, {'id': 'OG005', 'title': 'Cohort 2', 'description': 'Flotetuzumab 500 ng/kg/day, 4 days on 3 days off, after one-step lead-in dose:'}, {'id': 'OG006', 'title': 'Cohort 2a', 'description': 'Flotetuzumab 500 ng/kg/day, 4 days on 3 days off, after multi-step lead-in dose'}, {'id': 'OG007', 'title': 'Cohort 3', 'description': 'Flotetuzumab 700 ng/kg/day, 4 days on 3 days off, after lead-in dose'}, {'id': 'OG008', 'title': 'Cohort 6', 'description': 'Flotetuzumab 300 ng/kg/day, continuous infusion, after multistep lead-in dose'}, {'id': 'OG009', 'title': 'Cohort 7', 'description': 'Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose'}, {'id': 'OG010', 'title': 'Cohort 8', 'description': 'Flotetuzumab 700 ng/kg/day, continuous infusion, after multistep lead-in dose'}, {'id': 'OG011', 'title': 'MTD Expansion', 'description': 'Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose'}, {'id': 'OG012', 'title': 'MTD Expansion With Ruxolitinib', 'description': 'Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose Ruxolitinib: Oral inhibitor of JAK kinase'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '10', 'groupId': 'OG011'}, {'value': '1', 'groupId': 'OG012'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 8 months', 'description': 'Rate of successful hematopoietic stem cell transplantation (HSCT) after the start flotetuzumab treatment and before subsequent therapy.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Occurrence of Dose Limiting Toxicity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '5', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 0-a', 'description': 'Flotetuzumab 3 ng/kg/day, 4 days on and 3 days off'}, {'id': 'OG001', 'title': 'Cohort 0-b', 'description': 'Flotetuzumab 10 ng/kg/day, 4 days on and 3 days off'}, {'id': 'OG002', 'title': 'Cohort 0-c', 'description': 'Flotetuzumab 30 ng/kg/day, 4 days on and 3 days off'}, {'id': 'OG003', 'title': 'Cohort 0-d', 'description': 'Flotetuzumab 100 ng/kg/day, 4 days on and 3 days off'}, {'id': 'OG004', 'title': 'Cohort 1', 'description': 'Flotetuzumab 300 ng/kg/day, 4 days on 3 days off, after lead-in dose'}, {'id': 'OG005', 'title': 'Cohort 2', 'description': 'Flotetuzumab 500 ng/kg/day, 4 days on 3 days off, after lead-in dose'}, {'id': 'OG006', 'title': 'Cohort 2a', 'description': 'Flotetuzumab 500 ng/kg/day, 4 days on 3 days off, after lead-in dose'}, {'id': 'OG007', 'title': 'Cohort 3', 'description': 'Flotetuzumab 700 ng/kg/day, 4 days on 3 days off, after multistep lead-in dose'}, {'id': 'OG008', 'title': 'Cohort 6', 'description': 'Flotetuzumab 300 ng/kg/day, continuous infusion, after multistep lead-in dose'}, {'id': 'OG009', 'title': 'Cohort 7', 'description': 'Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose'}, {'id': 'OG010', 'title': 'Cohort 8', 'description': 'Flotetuzumab 700 ng/kg/day, continuous infusion, after multistep lead-in dose'}, {'id': 'OG011', 'title': 'MTD Expansion', 'description': 'Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose'}, {'id': 'OG012', 'title': 'MTD Expansion With Ruxolitinib', 'description': 'Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose Ruxolitinib: Oral inhibitor of JAK kinase'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Cycle 1 of a 28 day cycle.', 'description': 'Maximum Tolerated Dose/Schedule: the MTDS is defined as the highest dose/schedule administered during any Cohort in the study at which the incidence of DLT is \\< 33% during the first cycle of MGD006 treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'DLT were reported for dose escalation cohorts only (cohort 0-8)'}, {'type': 'SECONDARY', 'title': 'Occurrence of Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '5', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '185', 'groupId': 'OG011'}, {'value': '12', 'groupId': 'OG012'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 0-a', 'description': 'Flotetuzumab 3 ng/kg/day, 4 days on and 3 days off'}, {'id': 'OG001', 'title': 'Cohort 0-b', 'description': 'Flotetuzumab 10 ng/kg/day, 4 days on and 3 days off'}, {'id': 'OG002', 'title': 'Cohort 0-c', 'description': 'Flotetuzumab 30 ng/kg/day, 4 days on and 3 days off'}, {'id': 'OG003', 'title': 'Cohort 0-d', 'description': 'Flotetuzumab 100 ng/kg/day, 4 days on and 3 days off'}, {'id': 'OG004', 'title': 'Cohort 1', 'description': 'Flotetuzumab 300 ng/kg/day, 4 days on 3 days off, after lead-in dose'}, {'id': 'OG005', 'title': 'Cohort 2', 'description': 'Flotetuzumab 500 ng/kg/day, 4 days on 3 days off, after lead-in dose'}, {'id': 'OG006', 'title': 'Cohort 2a', 'description': 'Flotetuzumab 500 ng/kg/day, 4 days on 3 days off, after lead-in dose'}, {'id': 'OG007', 'title': 'Cohort 3', 'description': 'Flotetuzumab 700 ng/kg/day, 4 days on 3 days off, after multistep lead-in dose'}, {'id': 'OG008', 'title': 'Cohort 6', 'description': 'Flotetuzumab 300 ng/kg/day, continuous infusion, after multistep lead-in dose'}, {'id': 'OG009', 'title': 'Cohort 7', 'description': 'Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose'}, {'id': 'OG010', 'title': 'Cohort 8', 'description': 'Flotetuzumab 700 ng/kg/day, continuous infusion, after multistep lead-in dose'}, {'id': 'OG011', 'title': 'MTD Expansion', 'description': 'Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose'}, {'id': 'OG012', 'title': 'MTD Expansion With Ruxolitinib', 'description': 'Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose Ruxolitinib: Oral inhibitor of JAK kinase'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '5', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '185', 'groupId': 'OG011'}, {'value': '12', 'groupId': 'OG012'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 9 months', 'description': 'Cycle 1 through end of treatment', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Occurrence of Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '5', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '185', 'groupId': 'OG011'}, {'value': '12', 'groupId': 'OG012'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 0-a', 'description': 'Flotetuzumab 3 ng/kg/day, 4 days on and 3 days off'}, {'id': 'OG001', 'title': 'Cohort 0-b', 'description': 'Flotetuzumab 10 ng/kg/day, 4 days on and 3 days off'}, {'id': 'OG002', 'title': 'Cohort 0-c', 'description': 'Flotetuzumab 30 ng/kg/day, 4 days on and 3 days off'}, {'id': 'OG003', 'title': 'Cohort 0-d', 'description': 'Flotetuzumab 100 ng/kg/day, 4 days on and 3 days off'}, {'id': 'OG004', 'title': 'Cohort 1', 'description': 'Flotetuzumab 300 ng/kg/day, 4 days on 3 days off, after lead-in dose'}, {'id': 'OG005', 'title': 'Cohort 2', 'description': 'Flotetuzumab 500 ng/kg/day, 4 days on 3 days off, after lead-in dose'}, {'id': 'OG006', 'title': 'Cohort 2a', 'description': 'Flotetuzumab 500 ng/kg/day, 4 days on 3 days off, after lead-in dose'}, {'id': 'OG007', 'title': 'Cohort 3', 'description': 'Flotetuzumab 700 ng/kg/day, 4 days on 3 days off, after multistep lead-in dose'}, {'id': 'OG008', 'title': 'Cohort 6', 'description': 'Flotetuzumab 300 ng/kg/day, continuous infusion, after multistep lead-in dose'}, {'id': 'OG009', 'title': 'Cohort 7', 'description': 'Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose'}, {'id': 'OG010', 'title': 'Cohort 8', 'description': 'Flotetuzumab 700 ng/kg/day, continuous infusion, after multistep lead-in dose'}, {'id': 'OG011', 'title': 'MTD Expansion', 'description': 'Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose'}, {'id': 'OG012', 'title': 'MTD Expansion With Ruxolitinib', 'description': 'Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose Ruxolitinib: Oral inhibitor of JAK kinase'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '100', 'groupId': 'OG011'}, {'value': '6', 'groupId': 'OG012'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 9 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Participants With Anti-drug Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '244', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Dose Levels', 'description': 'Participants were analyzed for the development of ADA regardless of dose level. Presence or absence of ADA is not related to dose level. The relevant information is the change from one status (positive, negative, or not tested) to a different status.'}], 'classes': [{'categories': [{'title': 'Not tested at baseline, not tested on study', 'measurements': [{'value': '144', 'groupId': 'OG000'}]}, {'title': 'Not tested at baseline, all negative on study', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Not tested at baseline, at least 1 positive on study', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Negative at baseline, not tested on study', 'measurements': [{'value': '25', 'groupId': 'OG000'}]}, {'title': 'Negative at baseline, all negative on study', 'measurements': [{'value': '70', 'groupId': 'OG000'}]}, {'title': 'Negative at baseline, at least 1 positive on study', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Positive at baseline, not tested on study', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Positive at baseline, all negative on study', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Positive at baseline, at least 1 positive on study', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Study Day 1, then every 28 days through 28-days after the last dose (up to 8 months)', 'description': 'Occurrence of anti-drug antibody', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants were analyzed for the development of ADA regardless of dose level. Presence or absence of ADA is not related to dose level. The relevant information is the change from one status (positive, negative, or not tested) to a different status.'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Infusion Related Reaction (IRR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '5', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '185', 'groupId': 'OG011'}, {'value': '12', 'groupId': 'OG012'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 0-a', 'description': 'Flotetuzumab 3 ng/kg/day, 4 days on and 3 days off'}, {'id': 'OG001', 'title': 'Cohort 0-b', 'description': 'Flotetuzumab 10 ng/kg/day, 4 days on and 3 days off'}, {'id': 'OG002', 'title': 'Cohort 0-c', 'description': 'Flotetuzumab 30 ng/kg/day, 4 days on and 3 days off'}, {'id': 'OG003', 'title': 'Cohort 0-d', 'description': 'Flotetuzumab 100 ng/kg/day, 4 days on and 3 days off'}, {'id': 'OG004', 'title': 'Cohort 1', 'description': 'Flotetuzumab 300 ng/kg/day, 4 days on 3 days off, after lead-in dose'}, {'id': 'OG005', 'title': 'Cohort 2', 'description': 'Flotetuzumab 500 ng/kg/day, 4 days on 3 days off, after lead-in dose'}, {'id': 'OG006', 'title': 'Cohort 2a', 'description': 'Flotetuzumab 500 ng/kg/day, 4 days on 3 days off, after lead-in dose'}, {'id': 'OG007', 'title': 'Cohort 3', 'description': 'Flotetuzumab 700 ng/kg/day, 4 days on 3 days off, after multistep lead-in dose'}, {'id': 'OG008', 'title': 'Cohort 6', 'description': 'Flotetuzumab 300 ng/kg/day, continuous infusion, after multistep lead-in dose'}, {'id': 'OG009', 'title': 'Cohort 7', 'description': 'Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose'}, {'id': 'OG010', 'title': 'Cohort 8', 'description': 'Flotetuzumab 700 ng/kg/day, continuous infusion, after multistep lead-in dose'}, {'id': 'OG011', 'title': 'MTD Expansion', 'description': 'Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose'}, {'id': 'OG012', 'title': 'MTD Expansion With Ruxolitinib', 'description': 'Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose Ruxolitinib: Oral inhibitor of JAK kinase'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '5', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '78', 'groupId': 'OG011'}, {'value': '8', 'groupId': 'OG012'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During study drug administration (up to 8 months)', 'description': 'Determine safety and efficacy of tocilizumab in the treatment of IRR/CRS as measured by incidence of IRR/CRS', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Cytokine Release Syndrome (CRS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '5', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '185', 'groupId': 'OG011'}, {'value': '12', 'groupId': 'OG012'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 0-a', 'description': 'Flotetuzumab 3 ng/kg/day, 4 days on and 3 days off'}, {'id': 'OG001', 'title': 'Cohort 0-b', 'description': 'Flotetuzumab 10 ng/kg/day, 4 days on and 3 days off'}, {'id': 'OG002', 'title': 'Cohort 0-c', 'description': 'Flotetuzumab 30 ng/kg/day, 4 days on and 3 days off'}, {'id': 'OG003', 'title': 'Cohort 0-d', 'description': 'Flotetuzumab 100 ng/kg/day, 4 days on and 3 days off'}, {'id': 'OG004', 'title': 'Cohort 1', 'description': 'Flotetuzumab 300 ng/kg/day, 4 days on 3 days off, after lead-in dose'}, {'id': 'OG005', 'title': 'Cohort 2', 'description': 'Flotetuzumab 500 ng/kg/day, 4 days on 3 days off, after lead-in dose'}, {'id': 'OG006', 'title': 'Cohort 2a', 'description': 'Flotetuzumab 500 ng/kg/day, 4 days on 3 days off, after lead-in dose:'}, {'id': 'OG007', 'title': 'Cohort 3', 'description': 'Flotetuzumab 700 ng/kg/day, 4 days on 3 days off, after multistep lead-in dose'}, {'id': 'OG008', 'title': 'Cohort 6', 'description': 'Flotetuzumab 300 ng/kg/day, continuous infusion, after multistep lead-in dose'}, {'id': 'OG009', 'title': 'Cohort 7', 'description': 'Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose'}, {'id': 'OG010', 'title': 'Cohort 8', 'description': 'Flotetuzumab 700 ng/kg/day, continuous infusion, after multistep lead-in dose'}, {'id': 'OG011', 'title': 'MTD Expansion', 'description': 'Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose'}, {'id': 'OG012', 'title': 'MTD Expansion With Ruxolitinib', 'description': 'Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose Ruxolitinib: Oral inhibitor of JAK kinase'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '107', 'groupId': 'OG011'}, {'value': '4', 'groupId': 'OG012'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 9 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Maximum Serum Concentration of Flotetuzumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '212', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': '10 ng/kg/Day', 'description': 'All patients treated at 10 mg/kg/day'}, {'id': 'OG001', 'title': '30 ng/kg/Day', 'description': 'All patients treated at 30 mg/kg/day'}, {'id': 'OG002', 'title': '100 ng/kg/Day', 'description': 'All patients treated at 100 mg/kg/day'}, {'id': 'OG003', 'title': '300 ng/kg/Day', 'description': 'All patients treated at 300 mg/kg/day wither 4 days on/3 days off or by continuous infusion.'}, {'id': 'OG004', 'title': '500 ng/kg/Day', 'description': 'All patients treated at 500 mg/kg/day wither 4 days on/3 days off or by continuous infusion.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.1', 'groupId': 'OG000', 'lowerLimit': '5.55', 'upperLimit': '25.3'}, {'value': '34.5', 'groupId': 'OG001', 'lowerLimit': '21.0', 'upperLimit': '55.0'}, {'value': '82.8', 'groupId': 'OG002', 'lowerLimit': '68.2', 'upperLimit': '180'}, {'value': '177', 'groupId': 'OG003', 'lowerLimit': '43.6', 'upperLimit': '998'}, {'value': '185', 'groupId': 'OG004', 'lowerLimit': '51.8', 'upperLimit': '754'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Study day 1, then every 28 days and 28 days after the last dose (up to 8 months)', 'description': 'Measure the pharmacokinetics (PK) of flotetuzumab', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis was conducted for patients receiving 10, 30, 100, 300, and 500 ng/kg/day. The study drug was administered as continuous IV dosing. Due to the short half-life, Cmax is not influenced by drug administration schedule. The data for all participants treated at a dose, regardless of schedule, were analyzed together. Specimens were collected and individually analyzed for concentrations only in the 700 ng/kg/day, no PK parameters were derived for this dose group.'}, {'type': 'SECONDARY', 'title': 'Post-baseline Transfusion Independence Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 0-a', 'description': 'Flotetuzumab 3 ng/kg/day, 4 days on and 3 days off'}, {'id': 'OG001', 'title': 'Cohort 0-b', 'description': 'Flotetuzumab 10 ng/kg/day, 4 days on and 3 days off'}, {'id': 'OG002', 'title': 'Cohort 0-c', 'description': 'Flotetuzumab 30 ng/kg/day, 4 days on and 3 days off'}, {'id': 'OG003', 'title': 'Cohort 0-d', 'description': 'Flotetuzumab 100 ng/kg/day, 4 days on and 3 days off'}, {'id': 'OG004', 'title': 'Cohort 1', 'description': 'Flotetuzumab 300 ng/kg/day, 4 days on 3 days off, after lead-in dose'}, {'id': 'OG005', 'title': 'Cohort 2', 'description': 'Flotetuzumab 500 ng/kg/day, 4 days on 3 days off, after lead-in dose'}, {'id': 'OG006', 'title': 'Cohort 2a', 'description': 'Flotetuzumab 500 ng/kg/day, 4 days on 3 days off, after lead-in dose'}, {'id': 'OG007', 'title': 'Cohort 3', 'description': 'Flotetuzumab 700 ng/kg/day, 4 days on 3 days off, after multistep lead-in dose'}, {'id': 'OG008', 'title': 'Cohort 6', 'description': 'Flotetuzumab 300 ng/kg/day, continuous infusion, after multistep lead-in dose'}, {'id': 'OG009', 'title': 'Cohort 7', 'description': 'Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose'}, {'id': 'OG010', 'title': 'Cohort 8', 'description': 'Flotetuzumab 700 ng/kg/day, continuous infusion, after multistep lead-in dose'}, {'id': 'OG011', 'title': 'MTD Expansion', 'description': 'Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose'}, {'id': 'OG012', 'title': 'MTD Expansion With Ruxolitinib', 'description': 'Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose Ruxolitinib: Oral inhibitor of JAK kinase'}], 'timeFrame': '56 days', 'description': 'The number of patients who were transfusion-dependent at baseline and did not receive transfusions during any consecutive 56-day period will be calculated. The number of patients who are transfusion independent at baseline and remain independent during any 56-day post-baseline period will also be calculated.', 'reportingStatus': 'POSTED', 'populationDescription': 'No data was collected regarding transfusion dependency status at baseline or post-baseline.'}, {'type': 'SECONDARY', 'title': 'Number of Patients Alive at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '5', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '185', 'groupId': 'OG011'}, {'value': '12', 'groupId': 'OG012'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 0-a', 'description': 'Flotetuzumab 3 ng/kg/day, 4 days on and 3 days off'}, {'id': 'OG001', 'title': 'Cohort 0-b', 'description': 'Flotetuzumab 10 ng/kg/day, 4 days on and 3 days off'}, {'id': 'OG002', 'title': 'Cohort 0-c', 'description': 'Flotetuzumab 30 ng/kg/day, 4 days on and 3 days off'}, {'id': 'OG003', 'title': 'Cohort 0-d', 'description': 'Flotetuzumab 100 ng/kg/day, 4 days on and 3 days off'}, {'id': 'OG004', 'title': 'Cohort 1', 'description': 'Flotetuzumab 300 ng/kg/day, 4 days on 3 days off, after lead-in dose'}, {'id': 'OG005', 'title': 'Cohort 2', 'description': 'Flotetuzumab 500 ng/kg/day, 4 days on 3 days off, after lead-in dose'}, {'id': 'OG006', 'title': 'Cohort 2a', 'description': 'Flotetuzumab 500 ng/kg/day, 4 days on 3 days off, after lead-in dose'}, {'id': 'OG007', 'title': 'Cohort 3', 'description': 'Flotetuzumab 700 ng/kg/day, 4 days on 3 days off, after multistep lead-in dose'}, {'id': 'OG008', 'title': 'Cohort 6', 'description': 'Flotetuzumab 300 ng/kg/day, continuous infusion, after multistep lead-in dose'}, {'id': 'OG009', 'title': 'Cohort 7', 'description': 'Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose'}, {'id': 'OG010', 'title': 'Cohort 8', 'description': 'Flotetuzumab 700 ng/kg/day, continuous infusion, after multistep lead-in dose'}, {'id': 'OG011', 'title': 'MTD Expansion', 'description': 'Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose'}, {'id': 'OG012', 'title': 'MTD Expansion With Ruxolitinib', 'description': 'Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose Ruxolitinib: Oral inhibitor of JAK kinase'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '42', 'groupId': 'OG011'}, {'value': '6', 'groupId': 'OG012'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Event-free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '5', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '185', 'groupId': 'OG011'}, {'value': '12', 'groupId': 'OG012'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 0-a', 'description': 'Flotetuzumab 3 ng/kg/day, 4 days on and 3 days off'}, {'id': 'OG001', 'title': 'Cohort 0-b', 'description': 'Flotetuzumab 10 ng/kg/day, 4 days on and 3 days off'}, {'id': 'OG002', 'title': 'Cohort 0-c', 'description': 'Flotetuzumab 30 ng/kg/day, 4 days on and 3 days off'}, {'id': 'OG003', 'title': 'Cohort 0-d', 'description': 'Flotetuzumab 100 ng/kg/day, 4 days on and 3 days off'}, {'id': 'OG004', 'title': 'Cohort 1', 'description': 'Flotetuzumab 300 ng/kg/day, 4 days on 3 days off, after lead-in dose'}, {'id': 'OG005', 'title': 'Cohort 2', 'description': 'Flotetuzumab 500 ng/kg/day, 4 days on 3 days off, after lead-in dose'}, {'id': 'OG006', 'title': 'Cohort 2a', 'description': 'Flotetuzumab 500 ng/kg/day, 4 days on 3 days off, after lead-in dose'}, {'id': 'OG007', 'title': 'Cohort 3', 'description': 'Flotetuzumab 700 ng/kg/day, 4 days on 3 days off, after multistep lead-in dose'}, {'id': 'OG008', 'title': 'Cohort 6', 'description': 'Flotetuzumab 300 ng/kg/day, continuous infusion, after multistep lead-in dose'}, {'id': 'OG009', 'title': 'Cohort 7', 'description': 'Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose'}, {'id': 'OG010', 'title': 'Cohort 8', 'description': 'Flotetuzumab 700 ng/kg/day, continuous infusion, after multistep lead-in dose'}, {'id': 'OG011', 'title': 'MTD Expansion', 'description': 'Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose'}, {'id': 'OG012', 'title': 'MTD Expansion With Ruxolitinib', 'description': 'Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose Ruxolitinib: Oral inhibitor of JAK kinase'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not estimable due to an insufficient number of participants with events.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not estimable due to an insufficient number of participants with events.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not estimable due to an insufficient number of participants with events.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not estimable due to an insufficient number of participants with events.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not estimable due to an insufficient number of participants with events.', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not estimable due to an insufficient number of participants with events.', 'groupId': 'OG005', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not estimable due to an insufficient number of participants with events.', 'groupId': 'OG006', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not estimable due to an insufficient number of participants with events.', 'groupId': 'OG007', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not estimable due to an insufficient number of participants with events.', 'groupId': 'OG008', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not estimable due to an insufficient number of participants with events.', 'groupId': 'OG009', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not estimable due to an insufficient number of participants with events.', 'groupId': 'OG010', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not estimable due to an insufficient number of participants with events.', 'groupId': 'OG011', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not estimable due to an insufficient number of participants with events.', 'groupId': 'OG012', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 2 years', 'description': 'Time from the first dose of study drug until date of evidence of primary refractory disease to flotetuzumab, relapse from CR, CRh or CRi, or death from any cause, whichever occurs first.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mortality Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '5', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '185', 'groupId': 'OG011'}, {'value': '12', 'groupId': 'OG012'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 0-a', 'description': 'Flotetuzumab 3 ng/kg/day, 4 days on and 3 days off'}, {'id': 'OG001', 'title': 'Cohort 0-b', 'description': 'Flotetuzumab 10 ng/kg/day, 4 days on and 3 days off'}, {'id': 'OG002', 'title': 'Cohort 0-c', 'description': 'Flotetuzumab 30 ng/kg/day, 4 days on and 3 days off'}, {'id': 'OG003', 'title': 'Cohort 0-d', 'description': 'Flotetuzumab 100 ng/kg/day, 4 days on and 3 days off'}, {'id': 'OG004', 'title': 'Cohort 1', 'description': 'Flotetuzumab 300 ng/kg/day, 4 days on 3 days off, after lead-in dose'}, {'id': 'OG005', 'title': 'Cohort 2', 'description': 'Flotetuzumab 500 ng/kg/day, 4 days on 3 days off, after lead-in dose'}, {'id': 'OG006', 'title': 'Cohort 2a', 'description': 'Flotetuzumab 500 ng/kg/day, 4 days on 3 days off, after lead-in dose'}, {'id': 'OG007', 'title': 'Cohort 3', 'description': 'Flotetuzumab 700 ng/kg/day, 4 days on 3 days off, after multistep lead-in dose'}, {'id': 'OG008', 'title': 'Cohort 6', 'description': 'Flotetuzumab 300 ng/kg/day, continuous infusion, after multistep lead-in dose'}, {'id': 'OG009', 'title': 'Cohort 7', 'description': 'Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose'}, {'id': 'OG010', 'title': 'Cohort 8', 'description': 'Flotetuzumab 700 ng/kg/day, continuous infusion, after multistep lead-in dose'}, {'id': 'OG011', 'title': 'MTD Expansion', 'description': 'Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose:'}, {'id': 'OG012', 'title': 'MTD Expansion With Ruxolitinib', 'description': 'Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose Ruxolitinib: Oral inhibitor of JAK kinase'}], 'classes': [{'categories': [{'title': 'Mortality at 0-30 days', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '23', 'groupId': 'OG011'}, {'value': '2', 'groupId': 'OG012'}]}, {'title': 'Mortality at 31-60 days', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '34', 'groupId': 'OG011'}, {'value': '3', 'groupId': 'OG012'}]}, {'title': 'Mortality at 61-90 days', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '19', 'groupId': 'OG011'}, {'value': '1', 'groupId': 'OG012'}]}, {'title': 'Mortality at 91- >180 days', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '4', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '67', 'groupId': 'OG011'}, {'value': '6', 'groupId': 'OG012'}]}, {'title': 'unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '42', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Throughout the study, up to 3 years.', 'description': 'number of deaths from any cause within 30, 60, 90, or 180 days of first dose of study drug', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Patients Alive at 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '5', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '185', 'groupId': 'OG011'}, {'value': '12', 'groupId': 'OG012'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 0-a', 'description': 'Flotetuzumab 3 ng/kg/day, 4 days on and 3 days off'}, {'id': 'OG001', 'title': 'Cohort 0-b', 'description': 'Flotetuzumab 10 ng/kg/day, 4 days on and 3 days off'}, {'id': 'OG002', 'title': 'Cohort 0-c', 'description': 'Flotetuzumab 30 ng/kg/day, 4 days on and 3 days off'}, {'id': 'OG003', 'title': 'Cohort 0-d', 'description': 'Flotetuzumab 100 ng/kg/day, 4 days on and 3 days off'}, {'id': 'OG004', 'title': 'Cohort 1', 'description': 'Flotetuzumab 300 ng/kg/day, 4 days on 3 days off, after lead-in dose'}, {'id': 'OG005', 'title': 'Cohort 2', 'description': 'Flotetuzumab 500 ng/kg/day, 4 days on 3 days off, after lead-in dose'}, {'id': 'OG006', 'title': 'Cohort 2a', 'description': 'Flotetuzumab 500 ng/kg/day, 4 days on 3 days off, after lead-in dose'}, {'id': 'OG007', 'title': 'Cohort 3', 'description': 'Flotetuzumab 700 ng/kg/day, 4 days on 3 days off, after multistep lead-in dose'}, {'id': 'OG008', 'title': 'Cohort 6', 'description': 'Flotetuzumab 300 ng/kg/day, continuous infusion, after multistep lead-in dose'}, {'id': 'OG009', 'title': 'Cohort 7', 'description': 'Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose'}, {'id': 'OG010', 'title': 'Cohort 8', 'description': 'Flotetuzumab 700 ng/kg/day, continuous infusion, after multistep lead-in dose'}, {'id': 'OG011', 'title': 'MTD Expansion', 'description': 'Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose'}, {'id': 'OG012', 'title': 'MTD Expansion With Ruxolitinib', 'description': 'Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose Ruxolitinib: Oral inhibitor of JAK kinase'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '16', 'groupId': 'OG011'}, {'value': '3', 'groupId': 'OG012'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 year', 'description': 'Number of patients alive at 1 year from first dose of study drug', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Median Time to Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '43', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '5', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '185', 'groupId': 'OG011'}, {'value': '12', 'groupId': 'OG012'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 0-a', 'description': 'Flotetuzumab 3 ng/kg/day, 4 days on and 3 days off'}, {'id': 'OG001', 'title': 'Cohort 0-b', 'description': 'Flotetuzumab 10 ng/kg/day, 4 days on and 3 days off'}, {'id': 'OG002', 'title': 'Cohort 0-c', 'description': 'Flotetuzumab 30 ng/kg/day, 4 days on and 3 days off'}, {'id': 'OG003', 'title': 'Cohort 0-d', 'description': 'Flotetuzumab 100 ng/kg/day, 4 days on and 3 days off'}, {'id': 'OG004', 'title': 'Cohort 1', 'description': 'Flotetuzumab 300 ng/kg/day, 4 days on 3 days off, after lead-in dose'}, {'id': 'OG005', 'title': 'Cohort 2', 'description': 'Flotetuzumab 500 ng/kg/day, 4 days on 3 days off, after lead-in dose'}, {'id': 'OG006', 'title': 'Cohort 2a', 'description': 'Flotetuzumab 500 ng/kg/day, 4 days on 3 days off, after lead-in dose'}, {'id': 'OG007', 'title': 'Cohort 6', 'description': 'Flotetuzumab 300 ng/kg/day, continuous infusion, after multistep lead-in dose'}, {'id': 'OG008', 'title': 'Cohort 3', 'description': 'Flotetuzumab 700 ng/kg/day, 4 days on 3 days off, after multistep lead-in dose'}, {'id': 'OG009', 'title': 'Cohort 7', 'description': 'Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose'}, {'id': 'OG010', 'title': 'Cohort 8', 'description': 'Flotetuzumab 700 ng/kg/day, continuous infusion, after multistep lead-in dose'}, {'id': 'OG011', 'title': 'MTD Expansion', 'description': 'Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose'}, {'id': 'OG012', 'title': 'MTD Expansion With Ruxolitinib', 'description': 'Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose Ruxolitinib: Oral inhibitor of JAK kinase'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not estimable due to an insufficient number of participants with events.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not estimable due to an insufficient number of participants with events.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not estimable due to an insufficient number of participants with events.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not estimable due to an insufficient number of participants with events.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not estimable due to an insufficient number of participants with events.', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not estimable due to an insufficient number of participants with events.', 'groupId': 'OG005', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not estimable due to an insufficient number of participants with events.', 'groupId': 'OG006', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not estimable due to an insufficient number of participants with events.', 'groupId': 'OG007', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not estimable due to an insufficient number of participants with events.', 'groupId': 'OG008', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not estimable due to an insufficient number of participants with events.', 'groupId': 'OG009', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not estimable due to an insufficient number of participants with events.', 'groupId': 'OG010', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not estimable due to an insufficient number of participants with events.', 'groupId': 'OG011', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not estimable due to an insufficient number of participants with events.', 'groupId': 'OG012', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'up to 14 months', 'description': 'Time from first dose of study drug to first CR, CRh, CRi, or MLFS', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Duration of Response of Patients With CR or CRh', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '16', 'groupId': 'OG011'}, {'value': '4', 'groupId': 'OG012'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 0-a', 'description': 'Flotetuzumab 3 ng/kg/day, 4 days on and 3 days off'}, {'id': 'OG001', 'title': 'Cohort 0-b', 'description': 'Flotetuzumab 10 ng/kg/day, 4 days on and 3 days off'}, {'id': 'OG002', 'title': 'Cohort 0-c', 'description': 'Flotetuzumab 30 ng/kg/day, 4 days on and 3 days off'}, {'id': 'OG003', 'title': 'Cohort 0-d', 'description': 'Flotetuzumab 100 ng/kg/day, 4 days on and 3 days off'}, {'id': 'OG004', 'title': 'Cohort 1', 'description': 'Flotetuzumab 300 ng/kg/day, 4 days on 3 days off, after lead-in dose'}, {'id': 'OG005', 'title': 'Cohort 2', 'description': 'Flotetuzumab 500 ng/kg/day, 4 days on 3 days off, after lead-in dose'}, {'id': 'OG006', 'title': 'Cohort 2a', 'description': 'Flotetuzumab 500 ng/kg/day, 4 days on 3 days off, after lead-in dose'}, {'id': 'OG007', 'title': 'Cohort 3', 'description': 'Flotetuzumab 700 ng/kg/day, 4 days on 3 days off, after lead-in dose'}, {'id': 'OG008', 'title': 'Cohort 6', 'description': 'Flotetuzumab 300 ng/kg/day, continuous infusion, after lead-in dose'}, {'id': 'OG009', 'title': 'Cohort 7', 'description': 'Flotetuzumab 500 ng/kg/day, continuous infusion, after lead-in dose'}, {'id': 'OG010', 'title': 'Cohort 8', 'description': 'Flotetuzumab 700 ng/kg/day, continuous infusion, after lead-in dose'}, {'id': 'OG011', 'title': 'MTD Expansion', 'description': 'Flotetuzumab 500 ng/kg/day, continuous infusion, after lead-in dose'}, {'id': 'OG012', 'title': 'MTD Expansion With Ruxolitinib', 'description': 'Flotetuzumab 500 ng/kg/day, continuous infusion, after lead-in dose Ruxolitinib: Oral inhibitor of JAK kinase'}], 'classes': [{'categories': [{'measurements': [{'value': '4.0', 'spread': 'NA', 'comment': 'There was only 1 response in this cohort.', 'groupId': 'OG007'}, {'value': '2.3', 'spread': 'NA', 'comment': 'There was only 1 response in this cohort', 'groupId': 'OG009'}, {'value': '1.4', 'spread': '1.04', 'groupId': 'OG011'}, {'value': '1.1', 'spread': '1.56', 'groupId': 'OG012'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 2 years', 'description': 'Time of initial documentation of response to the time of disease relapse or death due to any cause, whichever occurs first.', 'unitOfMeasure': 'Months', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis is based on the number of participants who had a CR or CRh as reported in Outcome Measure 1'}, {'type': 'SECONDARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '5', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '185', 'groupId': 'OG011'}, {'value': '12', 'groupId': 'OG012'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 0-a', 'description': 'Flotetuzumab 3 ng/kg/day, 4 days on and 3 days off'}, {'id': 'OG001', 'title': 'Cohort 0-b', 'description': 'Flotetuzumab 10 ng/kg/day, 4 days on and 3 days off'}, {'id': 'OG002', 'title': 'Cohort 0-c', 'description': 'Flotetuzumab 30 ng/kg/day, 4 days on and 3 days off'}, {'id': 'OG003', 'title': 'Cohort 0-d', 'description': 'Flotetuzumab 100 ng/kg/day, 4 days on and 3 days off'}, {'id': 'OG004', 'title': 'Cohort 1', 'description': 'Flotetuzumab 300 ng/kg/day, 4 days on 3 days off, after lead-in dose'}, {'id': 'OG005', 'title': 'Cohort 2', 'description': 'Flotetuzumab 500 ng/kg/day, 4 days on 3 days off, after one-step lead-in dose'}, {'id': 'OG006', 'title': 'Cohort 2a', 'description': 'Flotetuzumab 500 ng/kg/day, 4 days on 3 days off, after multi-step lead-in dose'}, {'id': 'OG007', 'title': 'Cohort 3', 'description': 'Flotetuzumab 700 ng/kg/day, 4 days on 3 days off, after lead-in dose'}, {'id': 'OG008', 'title': 'Cohort 6', 'description': 'Flotetuzumab 300 ng/kg/day, continuous infusion, after multistep lead-in dose'}, {'id': 'OG009', 'title': 'Cohort 7', 'description': 'Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose'}, {'id': 'OG010', 'title': 'Cohort 8', 'description': 'Flotetuzumab 700 ng/kg/day, continuous infusion, after multistep lead-in dose'}, {'id': 'OG011', 'title': 'MTD Expansion', 'description': 'Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose'}, {'id': 'OG012', 'title': 'MTD Expansion With Ruxolitinib', 'description': 'Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose Ruxolitinib: Oral inhibitor of JAK kinase'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Not estimable due to an insufficient number of participants with events.', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not estimable due to an insufficient number of participants with events.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not estimable due to an insufficient number of participants with events.', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not estimable due to an insufficient number of participants with events.', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not estimable due to an insufficient number of participants with events.', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not estimable due to an insufficient number of participants with events.', 'groupId': 'OG005'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not estimable due to an insufficient number of participants with events.', 'groupId': 'OG006'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not estimable due to an insufficient number of participants with events.', 'groupId': 'OG007'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not estimable due to an insufficient number of participants with events.', 'groupId': 'OG008'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not estimable due to an insufficient number of participants with events.', 'groupId': 'OG009'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not estimable due to an insufficient number of participants with events.', 'groupId': 'OG010'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not estimable due to an insufficient number of participants with events.', 'groupId': 'OG011'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not estimable due to an insufficient number of participants with events.', 'groupId': 'OG012'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 2 years', 'description': 'Time from first dose to death from any cause', 'unitOfMeasure': 'months', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Rate of Hospitalization for Patients in the Expansion Cohort After Initial Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MTD Expansion', 'description': 'Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not estimable due to an insufficient number of participants with events.', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 8 months', 'description': 'Initial dosing procedures were performed as a hospital inpatient. Incidence rate of hospitalization after discharge from the hospital will be calculated', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Duration of Hospitalization for Patients in the Expansion Cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MTD Expansion', 'description': 'Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not estimable due to an insufficient number of participants with events.', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 8 months', 'description': 'Duration of hospitalization will be characterized after discharge from initial dosing will be characterized', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cohort 0-a', 'description': 'Flotetuzumab 3 ng/kg/day, 4 days on and 3 days off'}, {'id': 'FG001', 'title': 'Cohort 0-b', 'description': 'Flotetuzumab 10 ng/kg/day, 4 days on and 3 days off'}, {'id': 'FG002', 'title': 'Cohort 0-c', 'description': 'Flotetuzumab 30 ng/kg/day, 4 days on and 3 days off'}, {'id': 'FG003', 'title': 'Cohort 0-d', 'description': 'Flotetuzumab 100 ng/kg/day, 4 days on and 3 days off'}, {'id': 'FG004', 'title': 'Cohort 1', 'description': 'Flotetuzumab 300 ng/kg/day, 4 days on 3 days off, after lead-in dose'}, {'id': 'FG005', 'title': 'Cohort 2', 'description': 'Flotetuzumab 500 ng/kg/day, 4 days on 3 days off, after one-step lead-in dose:'}, {'id': 'FG006', 'title': 'Cohort 2a', 'description': 'Flotetuzumab 500 ng/kg/day, 4 days on 3 days off, after multi-step lead-in dose'}, {'id': 'FG007', 'title': 'Cohort 3', 'description': 'Flotetuzumab 700 ng/kg/day, 4 days on 3 days off, after lead-in dose:'}, {'id': 'FG008', 'title': 'Cohort 6', 'description': 'Flotetuzumab 300 ng/kg/day, continuous infusion, after multistep lead-in dose'}, {'id': 'FG009', 'title': 'Cohort 7', 'description': 'Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose'}, {'id': 'FG010', 'title': 'Cohort 8', 'description': 'Flotetuzumab 700 ng/kg/day, continuous infusion, after multistep lead-in dose'}, {'id': 'FG011', 'title': 'MTD Expansion', 'description': 'Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose'}, {'id': 'FG012', 'title': 'MTD Expansion With Ruxolitinib', 'description': 'Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose Ruxolitinib: Oral inhibitor of JAK kinase'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '4'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '6'}, {'groupId': 'FG008', 'numSubjects': '6'}, {'groupId': 'FG009', 'numSubjects': '5'}, {'groupId': 'FG010', 'numSubjects': '3'}, {'groupId': 'FG011', 'numSubjects': '185'}, {'groupId': 'FG012', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'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'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '4'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '6'}, {'groupId': 'FG008', 'numSubjects': '6'}, {'groupId': 'FG009', 'numSubjects': '5'}, {'groupId': 'FG010', 'numSubjects': '3'}, {'groupId': 'FG011', 'numSubjects': '185'}, {'groupId': 'FG012', 'numSubjects': '12'}]}], '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': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '4'}, {'groupId': 'FG012', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '6'}, {'groupId': 'FG008', 'numSubjects': '4'}, {'groupId': 'FG009', 'numSubjects': '5'}, {'groupId': 'FG010', 'numSubjects': '3'}, {'groupId': 'FG011', 'numSubjects': '143'}, {'groupId': 'FG012', 'numSubjects': '12'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'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'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '3'}, {'groupId': 'FG012', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '4'}, {'groupId': 'FG012', 'numSubjects': '0'}]}, {'type': 'Physician Decision', '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': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '1'}, {'groupId': 'FG012', 'numSubjects': '0'}]}, {'type': 'Study terminated by sponsor', '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': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '29'}, {'groupId': 'FG012', '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': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '1'}, {'groupId': 'FG012', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '6', 'groupId': 'BG007'}, {'value': '6', 'groupId': 'BG008'}, {'value': '5', 'groupId': 'BG009'}, {'value': '3', 'groupId': 'BG010'}, {'value': '185', 'groupId': 'BG011'}, {'value': '12', 'groupId': 'BG012'}, {'value': '244', 'groupId': 'BG013'}]}], 'groups': [{'id': 'BG000', 'title': 'Cohort 0-a', 'description': 'Flotetuzumab 3 ng/kg/day, 4 days on and 3 days off'}, {'id': 'BG001', 'title': 'Cohort 0-b', 'description': 'Flotetuzumab 10 ng/kg/day, 4 days on and 3 days off'}, {'id': 'BG002', 'title': 'Cohort 0-c', 'description': 'Flotetuzumab 30 ng/kg/day, 4 days on and 3 days off'}, {'id': 'BG003', 'title': 'Cohort 0-d', 'description': 'Flotetuzumab 100 ng/kg/day, 4 days on and 3 days off'}, {'id': 'BG004', 'title': 'Cohort 1', 'description': 'Flotetuzumab 300 ng/kg/day, 4 days on 3 days off, after lead-in dose'}, {'id': 'BG005', 'title': 'Cohort 2', 'description': 'Flotetuzumab 500 ng/kg/day, 4 days on 3 days off, after lead-in dose'}, {'id': 'BG006', 'title': 'Cohort 2a', 'description': 'Flotetuzumab 500 ng/kg/day, 4 days on 3 days off, after multistep lead-in dose'}, {'id': 'BG007', 'title': 'Cohort 3', 'description': 'Flotetuzumab 700 ng/kg/day, 4 days on 3 days off, after multistep lead-in dose'}, {'id': 'BG008', 'title': 'Cohort 6', 'description': 'Flotetuzumab 300 ng/kg/day, continuous infusion, after multistep lead-in dose'}, {'id': 'BG009', 'title': 'Cohort 7', 'description': 'Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose'}, {'id': 'BG010', 'title': 'Cohort 8', 'description': 'Flotetuzumab 700 ng/kg/day, continuous infusion, after multistep lead-in dose'}, {'id': 'BG011', 'title': 'MTD Expansion', 'description': 'Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose'}, {'id': 'BG012', 'title': 'MTD Expansion With Ruxolitinib', 'description': 'Flotetuzumab 500 ng/kg/day, continuous infusion, after multistep lead-in dose Ruxolitinib: Oral inhibitor of JAK kinase'}, {'id': 'BG013', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52', 'spread': 'NA', 'comment': 'There is only 1 participant in cohort.0-a. Standard deviation is not applicable', 'groupId': 'BG000'}, {'value': '59.3', 'spread': '21.28', 'groupId': 'BG001'}, {'value': '56.4', 'spread': '17.10', 'groupId': 'BG002'}, {'value': '71.8', 'spread': '16.54', 'groupId': 'BG003'}, {'value': '58.3', 'spread': '14.50', 'groupId': 'BG004'}, {'value': '67.3', 'spread': '11.64', 'groupId': 'BG005'}, {'value': '53.0', 'spread': '11.33', 'groupId': 'BG006'}, {'value': '73.5', 'spread': '5.92', 'groupId': 'BG007'}, {'value': '64.0', 'spread': '10.81', 'groupId': 'BG008'}, {'value': '61.2', 'spread': '20.17', 'groupId': 'BG009'}, {'value': '70.0', 'spread': '8.19', 'groupId': 'BG010'}, {'value': '58.3', 'spread': '14.29', 'groupId': 'BG011'}, {'value': '65.7', 'spread': '12.02', 'groupId': 'BG012'}, {'value': '59.5', 'spread': '14.36', 'groupId': 'BG013'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '18 - 65', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '3', 'groupId': 'BG008'}, {'value': '2', 'groupId': 'BG009'}, {'value': '1', 'groupId': 'BG010'}, {'value': '121', 'groupId': 'BG011'}, {'value': '6', 'groupId': 'BG012'}, {'value': '151', 'groupId': 'BG013'}]}]}, {'title': '66 - 75', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}, {'value': '2', 'groupId': 'BG009'}, {'value': '1', 'groupId': 'BG010'}, {'value': '53', 'groupId': 'BG011'}, {'value': '3', 'groupId': 'BG012'}, {'value': '69', 'groupId': 'BG013'}]}]}, {'title': '>75', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '1', 'groupId': 'BG010'}, {'value': '11', 'groupId': 'BG011'}, {'value': '3', 'groupId': 'BG012'}, {'value': '24', 'groupId': 'BG013'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}, {'value': '2', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '85', 'groupId': 'BG011'}, {'value': '4', 'groupId': 'BG012'}, {'value': '109', 'groupId': 'BG013'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '4', 'groupId': 'BG008'}, {'value': '3', 'groupId': 'BG009'}, {'value': '3', 'groupId': 'BG010'}, {'value': '100', 'groupId': 'BG011'}, {'value': '8', 'groupId': 'BG012'}, {'value': '135', 'groupId': 'BG013'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '15', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '15', 'groupId': 'BG013'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '6', 'groupId': 'BG007'}, {'value': '6', 'groupId': 'BG008'}, {'value': '5', 'groupId': 'BG009'}, {'value': '2', 'groupId': 'BG010'}, {'value': '145', 'groupId': 'BG011'}, {'value': '12', 'groupId': 'BG012'}, {'value': '200', 'groupId': 'BG013'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '1', 'groupId': 'BG010'}, {'value': '25', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '29', 'groupId': 'BG013'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '12', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '12', 'groupId': 'BG013'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '14', 'groupId': 'BG011'}, {'value': '3', 'groupId': 'BG012'}, {'value': '22', 'groupId': 'BG013'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}, {'value': '6', 'groupId': 'BG007'}, {'value': '4', 'groupId': 'BG008'}, {'value': '5', 'groupId': 'BG009'}, {'value': '3', 'groupId': 'BG010'}, {'value': '133', 'groupId': 'BG011'}, {'value': '9', 'groupId': 'BG012'}, {'value': '183', 'groupId': 'BG013'}]}]}, {'title': 'Not Reported', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '21', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '21', 'groupId': 'BG013'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '5', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '6', 'groupId': 'BG013'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Netherlands', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '1', 'groupId': 'BG010'}, {'value': '9', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '10', 'groupId': 'BG013'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}, {'value': '4', 'groupId': 'BG007'}, {'value': '5', 'groupId': 'BG008'}, {'value': '3', 'groupId': 'BG009'}, {'value': '1', 'groupId': 'BG010'}, {'value': '120', 'groupId': 'BG011'}, {'value': '12', 'groupId': 'BG012'}, {'value': '170', 'groupId': 'BG013'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '1', 'groupId': 'BG010'}, {'value': '8', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '12', 'groupId': 'BG013'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '5', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '5', 'groupId': 'BG013'}]}]}, {'title': 'France', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '26', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '28', 'groupId': 'BG013'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '15', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '17', 'groupId': 'BG013'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '2', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '2', 'groupId': 'BG013'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-04-26', 'size': 5842577, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-04-27T11:43', 'hasProtocol': True}, {'date': '2021-04-19', 'size': 3948886, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-04-27T11:42', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 244}}, 'statusModule': {'whyStopped': 'Business decision', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-06-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'nctId': 'NCT04678466', 'statusForNctId': 'NO_LONGER_AVAILABLE', 'hasExpandedAccess': True}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2022-07-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-24', 'studyFirstSubmitDate': '2014-05-28', 'resultsFirstSubmitDate': '2023-05-05', 'studyFirstSubmitQcDate': '2014-05-28', 'lastUpdatePostDateStruct': {'date': '2024-01-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-01-24', 'studyFirstPostDateStruct': {'date': '2014-06-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy Based on CR or CRh Rate', 'timeFrame': 'up to 14 months', 'description': 'Proportion of patients achieving a best response of CR (morphologic CR \\[mCR\\], cytogenetic CR \\[CRc\\], molecular CR \\[CRm\\], or CRh per Interworking Group AML response criteria.\n\nCR is defined as mCR, CRc, CRm or CRh. mCR is defined as: normal. neutrophil and platelet counts, less than 5% blast cells in a bone marrow (BM) smear and. no extramedullary disease.\n\nCRc is defined as: CR with no evidence of cytogenetic abnormalities in the bone marrow.\n\nCRm is defined as: CR with no evidence of molecular abnormalities in the bone marrow.\n\nCRh is defined as: CR with partial hematologic recovery.'}], 'secondaryOutcomes': [{'measure': 'Overall Complete Response Rate', 'timeFrame': 'up to 14 months', 'description': 'Rate of CR + CRh + CRi (CR with incomplete blood cell recovery \\[CR with incomplete neutrophil {CRn}or platelet recovery {CRp}\\]) + MLFS (morphologic leukemia-free state)'}, {'measure': 'CR Rate', 'timeFrame': 'up to 14 months', 'description': 'Proportion of patients achieving a best response of CR (morphologic CR \\[mCR\\], cytogenetic CR \\[CRc\\], or molecular CR \\[CRm\\] per Interworking Group AML response criteria.\n\nCR is defined as mCR, CRc, CRm or CRh. mCR is defined as: normal. neutrophil and platelet counts, less than 5% blast cells in a bone marrow (BM) smear and. no extramedullary disease.\n\nCRc is defined as: CR with no evidence of cytogenetic abnormalities in the bone marrow.\n\nCRm is defined as: CR with no evidence of molecular abnormalities in the bone marrow.\n\nCRh is defined as: CR with partial hematologic recovery.'}, {'measure': 'CRh Rate', 'timeFrame': 'up to 14 months', 'description': 'Proportion of patients achieving a best response of CRh per Interworking Group AML response criteria.\n\nCRh is defined as: CR with partial hematologic recovery.'}, {'measure': 'Overall Response Rate', 'timeFrame': 'up to 14 months', 'description': 'Proportion of patients achieving a best response of CR, CRh, CRi, MLFS or partial response per Interworking Group AML response criteria.\n\nCR is defined as mCR, CRc, CRm or CRh. mCR is defined as: normal. neutrophil and platelet counts, less than 5% blast cells in a bone marrow (BM) smear and. no extramedullary disease.\n\nCRc is defined as: CR with no evidence of cytogenetic abnormalities in the bone marrow.\n\nCRm is defined as: CR with no evidence of molecular abnormalities in the bone marrow.\n\nCRh is defined as: CR with partial hematologic recovery.'}, {'measure': 'HSCT Rate', 'timeFrame': 'up to 8 months', 'description': 'Rate of successful hematopoietic stem cell transplantation (HSCT) after the start flotetuzumab treatment and before subsequent therapy.'}, {'measure': 'Occurrence of Dose Limiting Toxicity', 'timeFrame': 'Cycle 1 of a 28 day cycle.', 'description': 'Maximum Tolerated Dose/Schedule: the MTDS is defined as the highest dose/schedule administered during any Cohort in the study at which the incidence of DLT is \\< 33% during the first cycle of MGD006 treatment.'}, {'measure': 'Occurrence of Adverse Events (AEs)', 'timeFrame': 'up to 9 months', 'description': 'Cycle 1 through end of treatment'}, {'measure': 'Occurrence of Serious Adverse Events (SAEs)', 'timeFrame': 'up to 9 months'}, {'measure': 'Participants With Anti-drug Antibodies', 'timeFrame': 'Study Day 1, then every 28 days through 28-days after the last dose (up to 8 months)', 'description': 'Occurrence of anti-drug antibody'}, {'measure': 'Number of Patients With Infusion Related Reaction (IRR)', 'timeFrame': 'During study drug administration (up to 8 months)', 'description': 'Determine safety and efficacy of tocilizumab in the treatment of IRR/CRS as measured by incidence of IRR/CRS'}, {'measure': 'Number of Patients With Cytokine Release Syndrome (CRS)', 'timeFrame': 'up to 9 months'}, {'measure': 'Maximum Serum Concentration of Flotetuzumab', 'timeFrame': 'Study day 1, then every 28 days and 28 days after the last dose (up to 8 months)', 'description': 'Measure the pharmacokinetics (PK) of flotetuzumab'}, {'measure': 'Post-baseline Transfusion Independence Rate', 'timeFrame': '56 days', 'description': 'The number of patients who were transfusion-dependent at baseline and did not receive transfusions during any consecutive 56-day period will be calculated. The number of patients who are transfusion independent at baseline and remain independent during any 56-day post-baseline period will also be calculated.'}, {'measure': 'Number of Patients Alive at 6 Months', 'timeFrame': '6 months'}, {'measure': 'Event-free Survival', 'timeFrame': 'Up to 2 years', 'description': 'Time from the first dose of study drug until date of evidence of primary refractory disease to flotetuzumab, relapse from CR, CRh or CRi, or death from any cause, whichever occurs first.'}, {'measure': 'Mortality Rate', 'timeFrame': 'Throughout the study, up to 3 years.', 'description': 'number of deaths from any cause within 30, 60, 90, or 180 days of first dose of study drug'}, {'measure': 'Number of Patients Alive at 12 Months', 'timeFrame': '1 year', 'description': 'Number of patients alive at 1 year from first dose of study drug'}, {'measure': 'Median Time to Response', 'timeFrame': 'up to 14 months', 'description': 'Time from first dose of study drug to first CR, CRh, CRi, or MLFS'}, {'measure': 'Duration of Response of Patients With CR or CRh', 'timeFrame': 'Up to 2 years', 'description': 'Time of initial documentation of response to the time of disease relapse or death due to any cause, whichever occurs first.'}, {'measure': 'Overall Survival', 'timeFrame': 'Up to 2 years', 'description': 'Time from first dose to death from any cause'}, {'measure': 'Rate of Hospitalization for Patients in the Expansion Cohort After Initial Discharge', 'timeFrame': 'up to 8 months', 'description': 'Initial dosing procedures were performed as a hospital inpatient. Incidence rate of hospitalization after discharge from the hospital will be calculated'}, {'measure': 'Duration of Hospitalization for Patients in the Expansion Cohort', 'timeFrame': 'up to 8 months', 'description': 'Duration of hospitalization will be characterized after discharge from initial dosing will be characterized'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['AML', 'leukemia', 'myelogenous', 'myeloid', 'refractory'], 'conditions': ['AML']}, 'referencesModule': {'references': [{'pmid': '32929488', 'type': 'DERIVED', 'citation': 'Uy GL, Aldoss I, Foster MC, Sayre PH, Wieduwilt MJ, Advani AS, Godwin JE, Arellano ML, Sweet KL, Emadi A, Ravandi F, Erba HP, Byrne M, Michaelis L, Topp MS, Vey N, Ciceri F, Carrabba MG, Paolini S, Huls GA, Jongen-Lavrencic M, Wermke M, Chevallier P, Gyan E, Recher C, Stiff PJ, Pettit KM, Lowenberg B, Church SE, Anderson E, Vadakekolathu J, Santaguida M, Rettig MP, Muth J, Curtis T, Fehr E, Guo K, Zhao J, Bakkacha O, Jacobs K, Tran K, Kaminker P, Kostova M, Bonvini E, Walter RB, Davidson-Moncada JK, Rutella S, DiPersio JF. Flotetuzumab as salvage immunotherapy for refractory acute myeloid leukemia. Blood. 2021 Feb 11;137(6):751-762. doi: 10.1182/blood.2020007732.'}]}, 'descriptionModule': {'briefSummary': 'Open-label, multi-dose, single-arm, multi-center, Phase 1/2 study conducted in three segments: the Single Patient Dose Escalation Segment (complete), followed by the Multi-Patient Dose Escalation Segment (complete) and the Maximum Tolerated Dose and Schedule (MTDS) Expansion Cohort Segment (closed). Having characterized safety and determined the maximum tolerated dose and schedule, the primary objective of this study now is to assess the anti-neoplastic activity of flotetuzumab in patients with PIF/ER AML, as determined by the proportion of patients who achieve CR or CRh. Starting with Cycle 2, patients who are benefiting from flotetuzumab may receive up to a maximum of 8 cycles of treatment.\n\nPatients will receive daily increasing doses of flotetuzumab for the first week of Cycle 1 (Lead-In Dosing) followed by 3 weeks of continuous intravenous infusion at a the assigned dose. Subsequent cycles are each 4 weeks of continuous infusion at the assigned dose. Dosing may continue for up to 8 cycles. Follow up visits may continue for 6 months after treatment is discontinued.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Confirmed diagnosis of primary or secondary AML \\[any subtype except acute promyelocytic leukemia (APL)\\] according to World Health Organization (WHO) classification\n* Patients with AML must meet one of the following criteria, a or b:\n\n 1. Primary Induction Failure (PIF) AML, defined as disease refractory to either, i or ii:\n\n * i. An intensive induction attempt, per institution. Induction attempts include high-dose and/or standard-dose cytarabine ± an anthracyclines/anthracenedione ± an anti-metabolite, with or without growth factor or targeted therapy containing regimens. Examples include but are not limited to: 1 cycle of high dose cytarabine (HiDAC) containing regimen, 1 cycle of liposomal cytarabine and daunorubicin, 2 cycles of standard dose cytarabine containing regimen\n * ii. For adults who are age 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy; PIF is defined as AML refractory to one of the following less intensive regimens: i ≥ 2 but ≤ 4 cycles of Bcl-2 inhibitors in combination with azacitidine, decitabine, or low dose cytarabine, or ii ≥ 2 but ≤ 4 cycles of gemtuzumab ozogamicin monotherapy\n 2. Early relapse (ER) AML, defined as AML in first relapse with initial CR1 duration \\< 6 months\n* Limit of 3 prior lines of therapy (excluding focal radiation therapy for palliative purposes): up to 2 induction (induction, re-induction) or 1 induction plus/minus 1 consolidation attempt, followed by a maximum of 1 salvage/re-induction attempt.\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤2\n* Life expectancy of at least 4 weeks\n* Peripheral blast count \\</= 20,000/mm3 at the time of first dose\n* Acceptable laboratory parameters and adequate organ reserve\n\nExclusion Criteria:\n\n* History of allogeneic stem cell transplantation\n* Prior treatment with an anti-CD123-directed agent\n* Need for concurrent other cytoreductive chemotherapy\n* Any active untreated autoimmune disorders (with the exception of vitiligo, resolved childhood atopic dermatitis, prior Grave's disease now euthyroid clinically and with stable supplementation)\n* Second primary malignancy that requires active therapy. Adjuvant hormonal therapy is allowed.\n* Antitumor therapy or investigational agent within 14 days or 5 half-lives of Cycle 1 Day 1.\n* Requirement, at the time of study entry, for concurrent steroids \\> 10 mg/day of oral prednisone or the equivalent, except steroid inhaler, otic preparations, nasal spray or ophthalmic solution\n* Use of immunosuppressant medications in the 2 weeks prior to Cycle 1 Day 1\n* Use of granulocyte colony stimulating or granulocyte-macrophage colony stimulating factor in the 2 weeks prior to Cycle 1 Day 1\n* Known central nervous system (CNS) leukemia\n* Active uncontrolled infection (including, but not limited to viral, bacterial, fungal, or mycobacterial infection),\n* Known human immunodeficiency virus infection, unless all of the following criteria are met: CD4+ count ≥ 350 cells/μL, undetectable viral load, and receiving highly active antiretroviral therapy.\n* Known, active, history of or current acute or chronic hepatitis B or C virus (HBV) infection (as evidenced by detectable HBV surface antigen and HBV DNA ≥ 500 IU/mL),\n* History of hepatitis C virus (HCV) infection, unless the infection has been treated and cured,\n* Active SARS-CoV-2 infection. While SARS-CoV-2 testing is not mandatory for study entry, testing for ongoing infection should follow local clinical practice guidelines/standards. Participants with a positive test result for ongoing SARS-CoV-2 infection, known asymptomatic infection, or suspected infection are excluded unless or until asymptomatic and with subsequent negative SARS-CoV-2 laboratory test."}, 'identificationModule': {'nctId': 'NCT02152956', 'acronym': 'VOYAGE', 'briefTitle': 'Flotetuzumab in Primary Induction Failure (PIF) or Early Relapse (ER) Acute Myeloid Leukemia (AML)', 'organization': {'class': 'INDUSTRY', 'fullName': 'MacroGenics'}, 'officialTitle': 'A Phase 1/2, First in Human, Dose Escalation Study of MGD006, a CD123 x CD3 DART® Bi-Specific Antibody Based Molecule, in Patients With Relapsed or Refractory AML or Intermediate-2/High Risk Myelodysplastic Syndrome (MDS)', 'orgStudyIdInfo': {'id': 'CP-MGD006-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 0-a', 'interventionNames': ['Biological: Flotetuzumab 3 ng/kg/day, 4 days on and 3 days off']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 0-b', 'interventionNames': ['Biological: Flotetuzumab 10 ng/kg/day, 4 days on and 3 days off']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 0-c', 'interventionNames': ['Biological: Flotetuzumab 30 ng/kg/day, 4 days on and 3 days off']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 0-d', 'interventionNames': ['Biological: Flotetuzumab 100 ng/kg/day, 4 days on and 3 days off']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 1', 'interventionNames': ['Biological: Flotetuzumab 300 ng/kg/day, 4 days on 3 days off, after one-step lead-in dose']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2', 'interventionNames': ['Biological: Flotetuzumab 500 ng/kg/day, 4 days on 3 days off, after one-step lead-in dose']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2a', 'interventionNames': ['Biological: Flotetuzumab 500 ng/kg/day, continuous infusion, after multi-step lead-in dose']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 3', 'interventionNames': ['Biological: Flotetuzumab 700 ng/kg/day, 4 days on 3 days off, after multi-step lead-in dose']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 6', 'interventionNames': ['Biological: Flotetuzumab 300 ng/kg/day, continuous infusion, after multi-step lead-in dose']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 7', 'interventionNames': ['Biological: Flotetuzumab 500 ng/kg/day, continuous infusion, after multi-step lead-in dose']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 8', 'interventionNames': ['Biological: Flotetuzumab 700 ng/kg/day, continuous infusion, after multi-step lead-in dose']}, {'type': 'EXPERIMENTAL', 'label': 'MTD Expansion', 'interventionNames': ['Biological: Flotetuzumab 500 ng/kg/day, continuous infusion, after multi-step lead-in dose']}, {'type': 'EXPERIMENTAL', 'label': 'MTD expansion with Ruxolitinib', 'interventionNames': ['Biological: Flotetuzumab 500 ng/kg/day, continuous infusion, after multi-step lead-in dose', 'Drug: Ruxolitinib']}], 'interventions': [{'name': 'Flotetuzumab 3 ng/kg/day, 4 days on and 3 days off', 'type': 'BIOLOGICAL', 'otherNames': ['MGD006'], 'description': 'Flotetuzumab is a CD123 x CD3 bispecific antibody-based molecular construct referred to as a DART® molecule.', 'armGroupLabels': ['Cohort 0-a']}, {'name': 'Flotetuzumab 10 ng/kg/day, 4 days on and 3 days off', 'type': 'BIOLOGICAL', 'otherNames': ['MGD006'], 'description': 'Flotetuzumab is a CD123 x CD3 bispecific antibody-based molecular construct referred to as a DART molecule.', 'armGroupLabels': ['Cohort 0-b']}, {'name': 'Flotetuzumab 30 ng/kg/day, 4 days on and 3 days off', 'type': 'BIOLOGICAL', 'otherNames': ['MGD006'], 'description': 'Flotetuzumab is a CD123 x CD3 bispecific antibody-based molecular construct referred to as a DART molecule.', 'armGroupLabels': ['Cohort 0-c']}, {'name': 'Flotetuzumab 100 ng/kg/day, 4 days on and 3 days off', 'type': 'BIOLOGICAL', 'otherNames': ['MGD006'], 'description': 'Flotetuzumab is a CD123 x CD3 bispecific antibody-based molecular construct referred to as a DART molecule.', 'armGroupLabels': ['Cohort 0-d']}, {'name': 'Flotetuzumab 300 ng/kg/day, 4 days on 3 days off, after one-step lead-in dose', 'type': 'BIOLOGICAL', 'otherNames': ['MGD006'], 'description': 'Flotetuzumab is a CD123 x CD3 bispecific antibody-based molecular construct referred to as a DART molecule.', 'armGroupLabels': ['Cohort 1']}, {'name': 'Flotetuzumab 500 ng/kg/day, 4 days on 3 days off, after one-step lead-in dose', 'type': 'BIOLOGICAL', 'otherNames': ['MGD006'], 'description': 'Flotetuzumab is a CD123 x CD3 bispecific antibody-based molecular construct referred to as a DART® molecule.', 'armGroupLabels': ['Cohort 2']}, {'name': 'Flotetuzumab 500 ng/kg/day, continuous infusion, after multi-step lead-in dose', 'type': 'BIOLOGICAL', 'otherNames': ['MGD006'], 'description': 'Flotetuzumab is a CD123 x CD3 bispecific antibody-based molecular construct referred to as a DART molecule.', 'armGroupLabels': ['Cohort 2a', 'Cohort 7', 'MTD Expansion', 'MTD expansion with Ruxolitinib']}, {'name': 'Flotetuzumab 700 ng/kg/day, 4 days on 3 days off, after multi-step lead-in dose', 'type': 'BIOLOGICAL', 'otherNames': ['MGD006'], 'description': 'Flotetuzumab is a CD123 x CD3 bispecific antibody-based molecular construct referred to as a DART molecule.', 'armGroupLabels': ['Cohort 3']}, {'name': 'Flotetuzumab 700 ng/kg/day, continuous infusion, after multi-step lead-in dose', 'type': 'BIOLOGICAL', 'otherNames': ['MGD006'], 'description': 'Flotetuzumab is a CD123 x CD3 bispecific antibody-based molecular construct referred to as a DART molecule.', 'armGroupLabels': ['Cohort 8']}, {'name': 'Ruxolitinib', 'type': 'DRUG', 'otherNames': ['Jakafi'], 'description': 'Oral inhibitor of JAK kinase', 'armGroupLabels': ['MTD expansion with Ruxolitinib']}, {'name': 'Flotetuzumab 300 ng/kg/day, continuous infusion, after multi-step lead-in dose', 'type': 'BIOLOGICAL', 'description': 'Flotetuzumab is a CD123 x CD3 bispecific antibody-based molecular construct referred to as a DART molecule.', 'armGroupLabels': ['Cohort 6']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91010', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope National Medical Center', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '92093', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'UCSD Moores Cancer Center', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF - Helen Diller Family Comprehensive Cancer Center', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '20057', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Georgetown University - Lombardi Cancer Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Moffitt Cancer Center', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60153', 'city': 'Maywood', 'state': 'Illinois', 'country': 'United States', 'facility': 'Loyola University Chicago - Cardinal Bernadin Cancer Center', 'geoPoint': {'lat': 41.8792, 'lon': -87.84312}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'University of Maryland', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '11794', 'city': 'Stony Brook', 'state': 'New York', 'country': 'United States', 'facility': 'Stony Brook Medicine', 'geoPoint': {'lat': 40.92565, 'lon': -73.14094}}, {'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina Lineberger Comprehensive Cancer Center', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '97213', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Providence Portland Medical Center', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt-Ingram Cancer Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'The University of Texas MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '98109', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Fred Hutchinson Cancer Research Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Medical College of Wisconsin', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'zip': '13002', 'city': 'Marseille', 'country': 'France', 'facility': 'Institut Paoli-Calmettes', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '44093', 'city': 'Nantes', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire de Nantes', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '31059', 'city': 'Toulouse', 'country': 'France', 'facility': 'Institut Universitaire du Cancer de Toulouse-Oncopole', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '37044', 'city': 'Tours', 'country': 'France', 'facility': 'CHRU de Tours - Hôpital Bretonneau', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}, {'zip': '13353', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Charité - Universitätsmedizin Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '01307', 'city': 'Dresden', 'country': 'Germany', 'facility': 'Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '20246', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Universitätsklinik Hamburg-Eppendorf', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '04103', 'city': 'Leipzig', 'country': 'Germany', 'facility': 'Universitätsklinikum Leipzig', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': '55131', 'city': 'Mainz', 'country': 'Germany', 'facility': 'Universitätsmedizin der Johannes Gutenberg-Universität Mainz', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'zip': '81675', 'city': 'Munich', 'country': 'Germany', 'facility': 'III. Med. Klinik-Klinikum rechts der Isar-Technische Universität München', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}, {'zip': '97080', 'city': 'Würzbur', 'country': 'Germany', 'facility': 'Medizinische Klinik und II, Universitätsklinikum Würzburg'}, {'city': 'Haifa', 'country': 'Israel', 'facility': 'Rambam Health Care Campus', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Shaare Zedek Medical Center', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}, {'zip': '40138', 'city': 'Bologna', 'country': 'Italy', 'facility': "Policlinico Sant'Orsola Malpighi", 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'zip': '74014', 'city': 'Meldola', 'country': 'Italy', 'facility': 'Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)', 'geoPoint': {'lat': 44.12775, 'lon': 12.0626}}, {'zip': '20132', 'city': 'Milan', 'country': 'Italy', 'facility': 'University Vita-Salute San Raffaele', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '48123', 'city': 'Ravenna', 'country': 'Italy', 'facility': 'Unità Operativa di Ematologia Ospedale Santa Maria delle Croci', 'geoPoint': {'lat': 44.41344, 'lon': 12.20121}}, {'zip': '9713', 'city': 'Groningen', 'country': 'Netherlands', 'facility': 'University Medical Center Groningen', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}, {'zip': '3075', 'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Erasmus University Medical Center', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'Universitat Autonomaa de Barcelona (UAB) - Hospital de la Santa Creu i de Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario 12 de Octubre', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'London', 'country': 'United Kingdom', 'facility': "King's Health Partners", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'M20 4BX', 'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'The Christie NHS Foundation Trust', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}], 'overallOfficials': [{'name': 'Ashley L. Ward, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'MacroGenics'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MacroGenics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}