Viewing Study NCT00927927

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
Ignite Creation Date: 2025-12-25 @ 5:09 AM
Ignite Modification Date: 2025-12-26 @ 4:13 AM
Study NCT ID: NCT00927927
Status: COMPLETED
Last Update Posted: 2016-10-03
First Post: 2009-06-24
Is NOT Gene Therapy: False
Has Adverse Events: True
Brief Title: First-in-man Trial of NNC0142-0002 in Patients With Rheumatoid Arthritis
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000624132', 'term': 'NNC0142-0002 monoclonal antibody'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'RA-RNDUS-ClinTriDisc@ITS.JNJ.com', 'title': 'Public Access to Clinical Trials', 'organization': 'Novo Nordisk A/S'}, 'certainAgreement': {'otherDetails': 'Novo Nordisk reserves the right to defer data release until specified milestones, e.g. availability of a clinical trial report. Novo Nordisk reserves the right to postpone publication and/or communication for short period to protect intellectual property. Novo Nordisk reserves the right to prior review of site-specific publications and to ask for deferment of publication of individual site results until after the primary manuscript is accepted for publication.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Maximum tolerated dose was not reached.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected for a mean (min; max) of 15.7 (6.4; 42.6) weeks for single-dose subjects, and 30.6 (12.7; 43.1) for multiple-dose subjects. Visits were scheduled until receptor occupancy was below the cut-off level for receptor positivity.', 'description': 'The safety analysis set included all randomised subjects exposed to at least one dose of NNC0142-0002 or placebo.', 'eventGroups': [{'id': 'EG000', 'title': 'SD 0.0002 mg/kg', 'description': 'Subjects were dosed once with NNC0142-0002 at a dose of 0.0002 mg/kg', 'otherNumAtRisk': 3, 'otherNumAffected': 2, 'seriousNumAtRisk': 3, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'MD 0.02 mg/kg', 'description': 'Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.02 mg/kg', 'otherNumAtRisk': 3, 'otherNumAffected': 1, 'seriousNumAtRisk': 3, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'SD 0.0012 mg/kg', 'description': 'Subjects were dosed once with NNC0142-0002 at a dose of 0.0012 mg/kg', 'otherNumAtRisk': 3, 'otherNumAffected': 2, 'seriousNumAtRisk': 3, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'SD 0.007 mg/kg', 'description': 'Subjects were dosed once with NNC0142-0002 at a dose of 0.007 mg/kg', 'otherNumAtRisk': 3, 'otherNumAffected': 1, 'seriousNumAtRisk': 3, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'SD 0.035 mg/kg', 'description': 'Subjects were dosed once with NNC0142-0002 at a dose of 0.035 mg/kg', 'otherNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'SD 0.175 mg/kg', 'description': 'Subjects were dosed once with NNC0142-0002 at a dose of 0.175 mg/kg', 'otherNumAtRisk': 3, 'otherNumAffected': 1, 'seriousNumAtRisk': 3, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'SD 0.7 mg/kg', 'description': 'Subjects were dosed once with NNC0142-0002 at a dose of 0.7 mg/kg', 'otherNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'seriousNumAffected': 1}, {'id': 'EG007', 'title': 'SD 2.5 mg/kg', 'description': 'Subjects were dosed once with NNC0142-0002 at a dose of 2.5 mg/kg', 'otherNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'seriousNumAffected': 0}, {'id': 'EG008', 'title': 'SD 7.5 mg/kg', 'description': 'Subjects were dosed once with NNC0142-0002 at a dose of 7.5 mg/kg', 'otherNumAtRisk': 3, 'otherNumAffected': 1, 'seriousNumAtRisk': 3, 'seriousNumAffected': 1}, {'id': 'EG009', 'title': 'SD Placebo', 'description': 'Subjects were dosed once with placebo', 'otherNumAtRisk': 8, 'otherNumAffected': 6, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}, {'id': 'EG010', 'title': 'MD 0.3 mg/kg', 'description': 'Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.3 mg/kg', 'otherNumAtRisk': 5, 'otherNumAffected': 4, 'seriousNumAtRisk': 5, 'seriousNumAffected': 0}, {'id': 'EG011', 'title': 'MD 1.0 mg/kg', 'description': 'Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.0 mg/kg', 'otherNumAtRisk': 5, 'otherNumAffected': 4, 'seriousNumAtRisk': 5, 'seriousNumAffected': 0}, {'id': 'EG012', 'title': 'MD 1.6 mg/kg', 'description': 'Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.6 mg/kg', 'otherNumAtRisk': 5, 'otherNumAffected': 5, 'seriousNumAtRisk': 5, 'seriousNumAffected': 0}, {'id': 'EG013', 'title': 'MD 4.0 mg/kg', 'description': 'Subjects were injected biweekly four times with NNC0142-0002 at a dose of 4.0 mg/kg', 'otherNumAtRisk': 5, 'otherNumAffected': 3, 'seriousNumAtRisk': 5, 'seriousNumAffected': 0}, {'id': 'EG014', 'title': 'MD Placebo', 'description': 'Subjects were injected biweekly four times with placebo', 'otherNumAtRisk': 9, 'otherNumAffected': 8, 'seriousNumAtRisk': 9, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Lacrimation increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG014', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG014', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 5, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG012', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG010', 'numAtRisk': 5, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG011', 'numAtRisk': 5, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG012', 'numAtRisk': 5, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG013', 'numAtRisk': 5, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG014', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Paronychia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Incorrect dose administered', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Epstein-Barr virus antibody positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Rheumatoid arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 5, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG014', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG014', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 5, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG014', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Skin irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG014', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}], 'seriousEvents': [{'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Femoral neck fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Frequency of Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '8', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '5', 'groupId': 'OG010'}, {'value': '5', 'groupId': 'OG011'}, {'value': '5', 'groupId': 'OG012'}, {'value': '5', 'groupId': 'OG013'}, {'value': '9', 'groupId': 'OG014'}]}], 'groups': [{'id': 'OG000', 'title': 'SD 0.0002 mg/kg', 'description': 'Subjects were dosed once with NNC0142-0002 at a dose of 0.0002 mg/kg'}, {'id': 'OG001', 'title': 'SD 0.0012 mg/kg', 'description': 'Subjects were dosed once with NNC0142-0002 at a dose of 0.0012 mg/kg'}, {'id': 'OG002', 'title': 'SD 0.007 mg/kg', 'description': 'Subjects were dosed once with NNC0142-0002 at a dose of 0.007 mg/kg'}, {'id': 'OG003', 'title': 'SD 0.035 mg/kg', 'description': 'Subjects were dosed once with NNC0142-0002 at a dose of 0.035 mg/kg'}, {'id': 'OG004', 'title': 'SD 0.175 mg/kg', 'description': 'Subjects were dosed once with NNC0142-0002 at a dose of 0.175 mg/kg'}, {'id': 'OG005', 'title': 'SD 0.7 mg/kg', 'description': 'Subjects were dosed once with NNC0142-0002 at a dose of 0.7 mg/kg'}, {'id': 'OG006', 'title': 'SD 2.5 mg/kg', 'description': 'Subjects were dosed once with NNC0142-0002 at a dose of 2.5 mg/kg'}, {'id': 'OG007', 'title': 'SD 7.5 mg/kg', 'description': 'Subjects were dosed once with NNC0142-0002 at a dose of 7.5 mg/kg'}, {'id': 'OG008', 'title': 'SD Placebo', 'description': 'Subjects were dosed once with placebo'}, {'id': 'OG009', 'title': 'MD 0.02 mg/kg', 'description': 'Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.02 mg/kg'}, {'id': 'OG010', 'title': 'MD 0.3 mg/kg', 'description': 'Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.3 mg/kg'}, {'id': 'OG011', 'title': 'MD 1.0 mg/kg', 'description': 'Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.0 mg/kg'}, {'id': 'OG012', 'title': 'MD 1.6 mg/kg', 'description': 'Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.6 mg/kg'}, {'id': 'OG013', 'title': 'MD 4.0 mg/kg', 'description': 'Subjects were injected biweekly four times with NNC0142-0002 at a dose of 4.0 mg/kg'}, {'id': 'OG014', 'title': 'MD Placebo', 'description': 'Subjects were injected biweekly four times with placebo'}], 'classes': [{'title': 'Adverse events', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '9', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}, {'value': '8', 'groupId': 'OG010'}, {'value': '13', 'groupId': 'OG011'}, {'value': '10', 'groupId': 'OG012'}, {'value': '14', 'groupId': 'OG013'}, {'value': '9', 'groupId': 'OG014'}]}]}, {'title': 'Serious AE', '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': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Adverse events were collected for a mean (min; max) of 15.7 (6.4; 42.6) weeks for single-dose subjects, and 30.6 (12.7; 43.1) for multiple-dose subjects. Visits were scheduled until receptor occupancy was below the cut-off level for receptor positivity.', 'description': 'Adverse event: any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have a causal relationship with this treatment. Serious AE: AE that at any dose level resulted in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalization, a persistent/significant disability/incapacity, a congenital anomaly or birth defect, or an important medical event that may jeopardize the subject and require medical or surgical intervention.', 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomised subjects exposed to at least one dose of NNC0142-0002 or placebo.'}, {'type': 'SECONDARY', 'title': 'Area Under the Concentration-time Curve (AUC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '8', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '5', 'groupId': 'OG010'}, {'value': '5', 'groupId': 'OG011'}, {'value': '5', 'groupId': 'OG012'}, {'value': '5', 'groupId': 'OG013'}, {'value': '9', 'groupId': 'OG014'}]}], 'groups': [{'id': 'OG000', 'title': 'SD 0.0002 mg/kg', 'description': 'Subjects were dosed once with NNC0142-0002 at a dose of 0.0002 mg/kg'}, {'id': 'OG001', 'title': 'SD 0.0012 mg/kg', 'description': 'Subjects were dosed once with NNC0142-0002 at a dose of 0.0012 mg/kg'}, {'id': 'OG002', 'title': 'SD 0.007 mg/kg', 'description': 'Subjects were dosed once with NNC0142-0002 at a dose of 0.007 mg/kg'}, {'id': 'OG003', 'title': 'SD 0.035 mg/kg', 'description': 'Subjects were dosed once with NNC0142-0002 at a dose of 0.035 mg/kg'}, {'id': 'OG004', 'title': 'SD 0.175 mg/kg', 'description': 'Subjects were dosed once with NNC0142-0002 at a dose of 0.175 mg/kg'}, {'id': 'OG005', 'title': 'SD 0.7 mg/kg', 'description': 'Subjects were dosed once with NNC0142-0002 at a dose of 0.7 mg/kg'}, {'id': 'OG006', 'title': 'SD 2.5 mg/kg', 'description': 'Subjects were dosed once with NNC0142-0002 at a dose of 2.5 mg/kg'}, {'id': 'OG007', 'title': 'SD 7.5 mg/kg', 'description': 'Subjects were dosed once with NNC0142-0002 at a dose of 7.5 mg/kg'}, {'id': 'OG008', 'title': 'SD Placebo', 'description': 'Subjects were dosed once with placebo'}, {'id': 'OG009', 'title': 'MD 0.02 mg/kg', 'description': 'Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.02 mg/kg'}, {'id': 'OG010', 'title': 'MD 0.3 mg/kg', 'description': 'Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.3 mg/kg'}, {'id': 'OG011', 'title': 'MD 1.0 mg/kg', 'description': 'Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.0 mg/kg'}, {'id': 'OG012', 'title': 'MD 1.6 mg/kg', 'description': 'Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.6 mg/kg'}, {'id': 'OG013', 'title': 'MD 4.0 mg/kg', 'description': 'Subjects were injected biweekly four times with NNC0142-0002 at a dose of 4.0 mg/kg'}, {'id': 'OG014', 'title': 'MD Placebo', 'description': 'Subjects were injected biweekly four times with placebo'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Exposure was below lower level of quantification.', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Exposure was below lower level of quantification.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Exposure was below lower level of quantification.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Exposure was below lower level of quantification.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '91', 'spread': '306.6', 'groupId': 'OG004', 'lowerLimit': '306.6'}, {'value': '4229', 'spread': '12.7', 'groupId': 'OG005', 'lowerLimit': '12.7'}, {'value': '16616', 'spread': '35.2', 'groupId': 'OG006', 'lowerLimit': '35.2'}, {'value': '87461', 'spread': '29.9', 'groupId': 'OG007', 'lowerLimit': '29.9'}, {'value': 'NA', 'spread': 'NA', 'comment': 'AUC was not calculated as subjects were not exposed to NNC0142-0002.', 'groupId': 'OG008', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Exposure was below lower level of quantification.', 'groupId': 'OG009', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '4034', 'spread': '62.8', 'groupId': 'OG010', 'lowerLimit': '62.8'}, {'value': '21883', 'spread': '29.6', 'groupId': 'OG011', 'lowerLimit': '29.6'}, {'value': '30212', 'spread': '25.4', 'groupId': 'OG012', 'lowerLimit': '25.4'}, {'value': '83307', 'spread': '38.3', 'groupId': 'OG013', 'lowerLimit': '38.3'}, {'value': 'NA', 'spread': 'NA', 'comment': 'AUC was not calculated as subjects were not exposed to NNC0142-0002.', 'groupId': 'OG014', 'lowerLimit': 'NA'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Data were collected from 0 hours to at least Day 43 (SD cohorts) and Day 85 (MD cohorts), and until the receptor occupancy was confirmed below the cut-off level for receptor positivity.', 'description': 'Systemic exposure to NNC0142-0002.', 'unitOfMeasure': 'microgram×h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomised subjects exposed to at least one dose of NNC0142-0002 or placebo. Serum drug concentrations after dosing with less than 0.175 mg/kg (SD cohorts) and 0.3 mg/kg (MD cohorts) were below the lower limit of quantification.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SD 0.0002 mg/kg', 'description': 'Subjects were dosed once with NNC0142-0002 at a dose of 0.0002 mg/kg'}, {'id': 'FG001', 'title': 'SD 0.0012 mg/kg', 'description': 'Subjects were dosed once with NNC0142-0002 at a dose of 0.0012 mg/kg'}, {'id': 'FG002', 'title': 'SD 0.007 mg/kg', 'description': 'Subjects were dosed once with NNC0142-0002 at a dose of 0.007 mg/kg'}, {'id': 'FG003', 'title': 'SD 0.035 mg/kg', 'description': 'Subjects were dosed once with NNC0142-0002 at a dose of 0.035 mg/kg'}, {'id': 'FG004', 'title': 'SD 0.175 mg/kg', 'description': 'Subjects were dosed once with NNC0142-0002 at a dose of 0.175 mg/kg'}, {'id': 'FG005', 'title': 'SD 0.7 mg/kg', 'description': 'Subjects were dosed once with NNC0142-0002 at a dose of 0.7 mg/kg'}, {'id': 'FG006', 'title': 'SD 2.5 mg/kg', 'description': 'Subjects were dosed once with NNC0142-0002 at a dose of 2.5 mg/kg'}, {'id': 'FG007', 'title': 'SD 7.5 mg/kg', 'description': 'Subjects were dosed once with NNC0142-0002 at a dose of 7.5 mg/kg'}, {'id': 'FG008', 'title': 'SD Placebo', 'description': 'Subjects were dosed once with placebo'}, {'id': 'FG009', 'title': 'MD 0.02 mg/kg', 'description': 'Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.02 mg/kg'}, {'id': 'FG010', 'title': 'MD 0.3 mg/kg', 'description': 'Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.3 mg/kg'}, {'id': 'FG011', 'title': 'MD 1.0 mg/kg', 'description': 'Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.0 mg/kg'}, {'id': 'FG012', 'title': 'MD 1.6 mg/kg', 'description': 'Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.6 mg/kg'}, {'id': 'FG013', 'title': 'MD 4.0 mg/kg', 'description': 'Subjects were injected biweekly four times with NNC0142-0002 at a dose of 4.0 mg/kg'}, {'id': 'FG014', 'title': 'MD Placebo', 'description': 'Subjects were injected biweekly four times with placebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '3'}, {'groupId': 'FG007', 'numSubjects': '3'}, {'groupId': 'FG008', 'numSubjects': '8'}, {'groupId': 'FG009', 'numSubjects': '3'}, {'groupId': 'FG010', 'numSubjects': '5'}, {'groupId': 'FG011', 'numSubjects': '6'}, {'groupId': 'FG012', 'numSubjects': '5'}, {'groupId': 'FG013', 'numSubjects': '5'}, {'groupId': 'FG014', 'numSubjects': '9'}]}, {'type': 'Exposed', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '3'}, {'groupId': 'FG007', 'numSubjects': '3'}, {'groupId': 'FG008', 'numSubjects': '8'}, {'groupId': 'FG009', 'numSubjects': '3'}, {'groupId': 'FG010', 'numSubjects': '5'}, {'groupId': 'FG011', 'numSubjects': '5'}, {'groupId': 'FG012', 'numSubjects': '5'}, {'groupId': 'FG013', 'numSubjects': '5'}, {'groupId': 'FG014', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '3'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '8'}, {'groupId': 'FG009', 'numSubjects': '3'}, {'groupId': 'FG010', 'numSubjects': '5'}, {'comment': 'One subject withdrew consent after being randomised but before receiving any trial product.', 'groupId': 'FG011', 'numSubjects': '4'}, {'groupId': 'FG012', 'numSubjects': '5'}, {'groupId': 'FG013', 'numSubjects': '5'}, {'groupId': 'FG014', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '2'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '2'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '2'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '2'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The trial was conducted at one site in Germany.', 'preAssignmentDetails': 'A total of 65 subjects were randomised, but only 64 subjects were exposed to trial product. One subject withdrew consent after being randomised but before receiving any trial product.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '8', 'groupId': 'BG008'}, {'value': '3', 'groupId': 'BG009'}, {'value': '5', 'groupId': 'BG010'}, {'value': '5', 'groupId': 'BG011'}, {'value': '5', 'groupId': 'BG012'}, {'value': '5', 'groupId': 'BG013'}, {'value': '9', 'groupId': 'BG014'}, {'value': '64', 'groupId': 'BG015'}]}], 'groups': [{'id': 'BG000', 'title': 'SD 0.0002 mg/kg', 'description': 'Subjects were dosed once with NNC0142-0002 at a dose of 0.0002 mg/kg'}, {'id': 'BG001', 'title': 'SD 0.0012 mg/kg', 'description': 'Subjects were dosed once with NNC0142-0002 at a dose of 0.0012 mg/kg'}, {'id': 'BG002', 'title': 'SD 0.007 mg/kg', 'description': 'Subjects were dosed once with NNC0142-0002 at a dose of 0.007 mg/kg'}, {'id': 'BG003', 'title': 'SD 0.035 mg/kg', 'description': 'Subjects were dosed once with NNC0142-0002 at a dose of 0.035 mg/kg'}, {'id': 'BG004', 'title': 'SD 0.175 mg/kg', 'description': 'Subjects were dosed once with NNC0142-0002 at a dose of 0.175 mg/kg'}, {'id': 'BG005', 'title': 'SD 0.7 mg/kg', 'description': 'Subjects were dosed once with NNC0142-0002 at a dose of 0.7 mg/kg'}, {'id': 'BG006', 'title': 'SD 2.5 mg/kg', 'description': 'Subjects were dosed once with NNC0142-0002 at a dose of 2.5 mg/kg'}, {'id': 'BG007', 'title': 'SD 7.5 mg/kg', 'description': 'Subjects were dosed once with NNC0142-0002 at a dose of 7.5 mg/kg'}, {'id': 'BG008', 'title': 'SD Placebo', 'description': 'Subjects were dosed once with placebo'}, {'id': 'BG009', 'title': 'MD 0.02 mg/kg', 'description': 'Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.02 mg/kg'}, {'id': 'BG010', 'title': 'MD 0.3 mg/kg', 'description': 'Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.3 mg/kg'}, {'id': 'BG011', 'title': 'MD 1.0 mg/kg', 'description': 'Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.0 mg/kg'}, {'id': 'BG012', 'title': 'MD 1.6 mg/kg', 'description': 'Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.6 mg/kg'}, {'id': 'BG013', 'title': 'MD 4.0 mg/kg', 'description': 'Subjects were injected biweekly four times with NNC0142-0002 at a dose of 4.0 mg/kg'}, {'id': 'BG014', 'title': 'MD Placebo', 'description': 'Subjects were injected biweekly four times with placebo'}, {'id': 'BG015', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.0', 'spread': '7.9', 'groupId': 'BG000'}, {'value': '60.7', 'spread': '8.1', 'groupId': 'BG001'}, {'value': '66.7', 'spread': '8.1', 'groupId': 'BG002'}, {'value': '58.3', 'spread': '5.1', 'groupId': 'BG003'}, {'value': '58.7', 'spread': '3.1', 'groupId': 'BG004'}, {'value': '52.7', 'spread': '11.0', 'groupId': 'BG005'}, {'value': '49.0', 'spread': '10.8', 'groupId': 'BG006'}, {'value': '69.0', 'spread': '4.6', 'groupId': 'BG007'}, {'value': '52.8', 'spread': '7.8', 'groupId': 'BG008'}, {'value': '55.3', 'spread': '5.0', 'groupId': 'BG009'}, {'value': '56.4', 'spread': '9.4', 'groupId': 'BG010'}, {'value': '58.4', 'spread': '5.5', 'groupId': 'BG011'}, {'value': '53.0', 'spread': '17.9', 'groupId': 'BG012'}, {'value': '48.2', 'spread': '7.7', 'groupId': 'BG013'}, {'value': '53.7', 'spread': '11.0', 'groupId': 'BG014'}, {'value': '56.0', 'spread': '9.8', 'groupId': 'BG015'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'participants', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '6', 'groupId': 'BG008'}, {'value': '2', 'groupId': 'BG009'}, {'value': '5', 'groupId': 'BG010'}, {'value': '3', 'groupId': 'BG011'}, {'value': '4', 'groupId': 'BG012'}, {'value': '2', 'groupId': 'BG013'}, {'value': '8', 'groupId': 'BG014'}, {'value': '49', 'groupId': 'BG015'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '2', 'groupId': 'BG011'}, {'value': '1', 'groupId': 'BG012'}, {'value': '3', 'groupId': 'BG013'}, {'value': '1', 'groupId': 'BG014'}, {'value': '15', 'groupId': 'BG015'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-24', 'studyFirstSubmitDate': '2009-06-24', 'resultsFirstSubmitDate': '2013-04-25', 'studyFirstSubmitQcDate': '2009-06-24', 'lastUpdatePostDateStruct': {'date': '2016-10-03', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-10-08', 'studyFirstPostDateStruct': {'date': '2009-06-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-10-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of Adverse Events', 'timeFrame': 'Adverse events were collected for a mean (min; max) of 15.7 (6.4; 42.6) weeks for single-dose subjects, and 30.6 (12.7; 43.1) for multiple-dose subjects. Visits were scheduled until receptor occupancy was below the cut-off level for receptor positivity.', 'description': 'Adverse event: any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have a causal relationship with this treatment. Serious AE: AE that at any dose level resulted in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalization, a persistent/significant disability/incapacity, a congenital anomaly or birth defect, or an important medical event that may jeopardize the subject and require medical or surgical intervention.'}], 'secondaryOutcomes': [{'measure': 'Area Under the Concentration-time Curve (AUC)', 'timeFrame': 'Data were collected from 0 hours to at least Day 43 (SD cohorts) and Day 85 (MD cohorts), and until the receptor occupancy was confirmed below the cut-off level for receptor positivity.', 'description': 'Systemic exposure to NNC0142-0002.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Inflammation', 'Rheumatoid Arthritis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://novonordisk-trials.com', 'label': 'Clinical Trials at Novo Nordisk'}]}, 'descriptionModule': {'briefSummary': 'This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety, tolerability, pharmacokinetic (the effect of the body on the investigated drug) and signs of clinical efficacy of increasing single doses or four repeated doses of NNC 0142-0002 in patients with rheumatoid arthritis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Active rheumatoid arthritis, characterized by a Disease Activity Score (DAS28) above 3.2, and a diagnosis of at least three months duration\n* Aged between 18 and 75 years (both inclusive)\n* Subjects on stable doses of methotrexate for at least 4 weeks prior to dosing\n* Use of highly effective contraception during the trial (both males and females)\n\nExclusion Criteria:\n\n* A chronic inflammatory autoimmune or joint disease other than RA (rheumatoid arthritis)\n* An active or latent tuberculosis\n* Any investigational or experimental therapy within 4 weeks or 5 half-lives (whichever is longer) prior to the screening visit\n* A known significant cardio-vascular disease\n* Vaccination against live virus or bacteria within 4 weeks prior to randomization\n* The use of concomitant medications that are prohibited in the trial (e.g., certain DMARDs (antirheumatic therapies that are disease modifying), biologics (here: biotechnologically produced antibodies), intra-articular corticoid-injections, etc.)\n* A positive test result for human immunodeficiency virus (HIV) infection, hepatitis B and/or hepatitis C, or tuberculosis skin test\n* Donation of greater than or equal to 400 ml of blood within 8 weeks prior to trial entry'}, 'identificationModule': {'nctId': 'NCT00927927', 'briefTitle': 'First-in-man Trial of NNC0142-0002 in Patients With Rheumatoid Arthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Janssen Research & Development, LLC'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled, Dose-escalation, Single and Multiple Dose Trial to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0142-0002 Administered Subcutaneously to Subjects With Rheumatoid Arthritis', 'orgStudyIdInfo': {'id': 'NN8555-3618'}, 'secondaryIdInfos': [{'id': '2008-008703-18', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SD 0.0002 mg/kg', 'description': 'Subjects were injected once with NNC0142-0002 at a dose of 0.0002 mg/kg', 'interventionNames': ['Drug: NNC0142-0002']}, {'type': 'EXPERIMENTAL', 'label': 'SD 0.0012 mg/kg', 'description': 'Subjects were injected once with NNC0142-0002 at a dose of 0.0012 mg/kg', 'interventionNames': ['Drug: NNC0142-0002']}, {'type': 'EXPERIMENTAL', 'label': 'SD 0.007 mg/kg', 'description': 'Subjects were injected once with NNC0142-0002 at a dose of 0.007 mg/kg', 'interventionNames': ['Drug: NNC0142-0002']}, {'type': 'EXPERIMENTAL', 'label': 'SD 0.035 mg/kg', 'description': 'Subjects were injected once with NNC0142-0002 at a dose of 0.035 mg/kg', 'interventionNames': ['Drug: NNC0142-0002']}, {'type': 'EXPERIMENTAL', 'label': 'SD 0.175 mg/kg', 'description': 'Subjects were injected once with NNC0142-0002 at a dose of 0.175 mg/kg', 'interventionNames': ['Drug: NNC0142-0002']}, {'type': 'EXPERIMENTAL', 'label': 'SD 0.7 mg/kg', 'description': 'Subjects were injected once with NNC0142-0002 at a dose of 0.7 mg/kg', 'interventionNames': ['Drug: NNC0142-0002']}, {'type': 'EXPERIMENTAL', 'label': 'SD 2.5 mg/kg', 'description': 'Subjects were injected once with NNC0142-0002 at a dose of 2.5 mg/kg', 'interventionNames': ['Drug: NNC0142-0002']}, {'type': 'EXPERIMENTAL', 'label': 'SD 7.5 mg/kg', 'description': 'Subjects were injected once with NNC0142-0002 at a dose of 7.5 mg/kg', 'interventionNames': ['Drug: NNC0142-0002']}, {'type': 'EXPERIMENTAL', 'label': 'SD Placebo', 'description': 'Subjects were injected once with placebo', 'interventionNames': ['Drug: placebo']}, {'type': 'EXPERIMENTAL', 'label': 'MD 0.02 mg/kg', 'description': 'Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.02 mg/kg', 'interventionNames': ['Drug: NNC0142-0002']}, {'type': 'EXPERIMENTAL', 'label': 'MD 0.3 mg/kg', 'description': 'Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.3 mg/kg', 'interventionNames': ['Drug: NNC0142-0002']}, {'type': 'EXPERIMENTAL', 'label': 'MD 1.0 mg/kg', 'description': 'Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.0 mg/kg', 'interventionNames': ['Drug: NNC0142-0002']}, {'type': 'EXPERIMENTAL', 'label': 'MD 1.6 mg/kg', 'description': 'Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.6 mg/kg', 'interventionNames': ['Drug: NNC0142-0002']}, {'type': 'EXPERIMENTAL', 'label': 'MD 4.0 mg/kg', 'description': 'Subjects were injected biweekly four times with NNC0142-0002 at a dose of 4.0 mg/kg', 'interventionNames': ['Drug: NNC0142-0002']}, {'type': 'EXPERIMENTAL', 'label': 'MD Placebo', 'description': 'Subjects were injected biweekly four times with placebo', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'NNC0142-0002', 'type': 'DRUG', 'description': 'Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1', 'armGroupLabels': ['SD 0.0002 mg/kg']}, {'name': 'NNC0142-0002', 'type': 'DRUG', 'description': 'Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1', 'armGroupLabels': ['SD 0.0012 mg/kg']}, {'name': 'NNC0142-0002', 'type': 'DRUG', 'description': 'Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1', 'armGroupLabels': ['SD 0.007 mg/kg']}, {'name': 'NNC0142-0002', 'type': 'DRUG', 'description': 'Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1', 'armGroupLabels': ['SD 0.035 mg/kg']}, {'name': 'NNC0142-0002', 'type': 'DRUG', 'description': 'Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1', 'armGroupLabels': ['SD 0.175 mg/kg']}, {'name': 'NNC0142-0002', 'type': 'DRUG', 'description': 'Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1', 'armGroupLabels': ['SD 0.7 mg/kg']}, {'name': 'NNC0142-0002', 'type': 'DRUG', 'description': 'Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1', 'armGroupLabels': ['SD 2.5 mg/kg']}, {'name': 'NNC0142-0002', 'type': 'DRUG', 'description': 'Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1', 'armGroupLabels': ['SD 7.5 mg/kg']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'Single dose of 0 mg/kg administered subcutaneously (under the skin); cohort 1-7b on day 1, cohort 8-11 biweekly four times', 'armGroupLabels': ['SD Placebo']}, {'name': 'NNC0142-0002', 'type': 'DRUG', 'description': 'Multiple dose, ranging from 0.02 mg/kg up to max 4.0 mg/kg, administered subcutaneously (under the skin) four times biweekly', 'armGroupLabels': ['MD 0.02 mg/kg']}, {'name': 'NNC0142-0002', 'type': 'DRUG', 'description': 'Multiple dose, ranging from 0.02 mg/kg up to max 4.0 mg/kg, administered subcutaneously (under the skin) four times biweekly', 'armGroupLabels': ['MD 0.3 mg/kg']}, {'name': 'NNC0142-0002', 'type': 'DRUG', 'description': 'Multiple dose, ranging from 0.02 mg/kg up to max 4.0 mg/kg, administered subcutaneously (under the skin) four times biweekly', 'armGroupLabels': ['MD 1.0 mg/kg']}, {'name': 'NNC0142-0002', 'type': 'DRUG', 'description': 'Multiple dose, ranging from 0.02 mg/kg up to max 4.0 mg/kg, administered subcutaneously (under the skin) four times biweekly', 'armGroupLabels': ['MD 1.6 mg/kg']}, {'name': 'NNC0142-0002', 'type': 'DRUG', 'description': 'Multiple dose, ranging from 0.02 mg/kg up to max 4.0 mg/kg, administered subcutaneously (under the skin) four times biweekly', 'armGroupLabels': ['MD 4.0 mg/kg']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'Single dose of 0 mg/kg administered subcutaneously (under the skin); cohort 1-7b on day 1, cohort 8-11 biweekly four times', 'armGroupLabels': ['MD Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10117', 'city': 'Berlin', 'country': 'Germany', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Britta Væver Bysted, DVM, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novo Nordisk A/S'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Janssen Research & Development, LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}