Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2026-02-24 @ 7:36 AM
Study NCT ID:
NCT02618967
Status:
COMPLETED
Last Update Posted:
2024-05-14
First Post:
2015-10-13
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Single Ascending Dose Study of AMG 570 in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008180', 'term': 'Lupus Erythematosus, Systemic'}], 'ancestors': [{'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': 'C000729492', 'term': 'rozibafusp alfa'}, {'id': 'D004341', 'term': 'Drug Evaluation'}], 'ancestors': [{'id': 'D000076722', 'term': 'Drug Development'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D005069', 'term': 'Evaluation Studies as Topic'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'medinfo@amgen.com', 'phone': '866-572-6436', 'title': 'Study Director', 'organization': 'Amgen Inc.'}, 'certainAgreement': {'otherDetails': "The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 105 days', 'description': 'All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'AMG 570 - 7 mg', 'description': 'Participants received a single dose 7 mg dose of AMG 570 administered subcutaneously.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'AMG 570 - 21 mg', 'description': 'Participants received a single 21 mg dose of AMG 570 administered subcutaneously.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 5, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'AMG 570 - 70 mg', 'description': 'Participants received a single 70 mg dose of AMG 570 administered subcutaneously.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 4, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'AMG 570 - 140 mg', 'description': 'Participants received a single 140 mg dose of AMG 570 administered subcutaneously.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 4, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'AMG 570 - 210 mg', 'description': 'Participants received a single 210 mg dose of AMG 570 administered subcutaneously.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 2, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'AMG 570 - 420 mg', 'description': 'Participants received a single 420 mg dose of AMG 570 administered subcutaneously.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 3, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'AMG 570 - 700 mg', 'description': 'Participants received 700 mg dose of AMG 570 administered as single dose subcutaneous in healthy volunteers.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 4, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'Placebo', 'description': 'Participants received a single dose of the matching AMG 570 placebo administered subcutaneously.', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 9, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Conjunctivitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Food poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Application site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Injection site haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Injection site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Injection site warmth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Vessel puncture site bruise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Vessel puncture site haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Hordeolum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Vaginal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Arthropod bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Exposure to toxic agent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Skin abrasion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Blood pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Blood pressure systolic increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Musculoskeletal stiffness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Hyperaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Pain of skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Papule', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Rash papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Skin hypopigmentation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}], 'seriousEvents': [{'term': 'Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Who Experienced One or More Treatment-emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '14', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'AMG 570 - 7 mg', 'description': 'Participants received a single dose 7 mg dose of AMG 570 administered subcutaneously.'}, {'id': 'OG001', 'title': 'AMG 570 - 21 mg', 'description': 'Participants received a single 21 mg dose of AMG 570 administered subcutaneously.'}, {'id': 'OG002', 'title': 'AMG 570 - 70 mg', 'description': 'Participants received a single 70 mg dose of AMG 570 administered subcutaneously.'}, {'id': 'OG003', 'title': 'AMG 570 - 140 mg', 'description': 'Participants received a single 140 mg dose of AMG 570 administered subcutaneously.'}, {'id': 'OG004', 'title': 'AMG 570 - 210 mg', 'description': 'Participants received a single 210 mg dose of AMG 570 administered subcutaneously.'}, {'id': 'OG005', 'title': 'AMG 570 - 420 mg', 'description': 'Participants received a single 420 mg dose of AMG 570 administered subcutaneously.'}, {'id': 'OG006', 'title': 'AMG 570 - 700 mg', 'description': 'Participants received a single 700 mg dose of AMG 570 administered subcutaneously.'}, {'id': 'OG007', 'title': 'Placebo', 'description': 'Participants received a single dose of the matching AMG 570 placebo administered subcutaneously.'}], 'classes': [{'title': 'TEAEs', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '9', 'groupId': 'OG007'}]}]}, {'title': 'Grade ≥ 2 TEAEs', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}]}]}, {'title': 'Grade ≥ 3 TEAEs', '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': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Grade ≥ 4 TEAEs', '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'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '1', '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'}]}]}, {'title': 'Life-threatening TEAEs', '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'}]}]}, {'title': 'Fatal TEAEs', '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'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 to Day 105', 'description': 'TEAEs were adverse events with an onset after the administration of study treatment.\n\nTEAEs were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.\n\nGrade 2 Moderate; minimal, local or noninvasive intervention indicated; limited age appropriate instrumental activities of daily life (ADL).\n\nGrade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolonged hospitalization indicated; disabling; limited self care ADL.\n\nGrade 4 Life-threatening consequences; urgent interventions indicated.\n\nSerious adverse events (SAEs) were defined as meeting at least 1 of the following criteria:\n\n* Results in death (fatal)\n* Immediately life-threatening\n* Requires in-patient hospitalization or prolongation of existing hospitalization\n* Results in persistent or significant disability/incapacity\n* Is a congenital anomaly/birth defect\n* Other medically important serious event', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set: all participants who received AMG 570 or placebo.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Experienced a Clinically Significant Change in Physical Examinations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '14', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'AMG 570 - 7 mg', 'description': 'Participants received a single dose 7 mg dose of AMG 570 administered subcutaneously.'}, {'id': 'OG001', 'title': 'AMG 570 - 21 mg', 'description': 'Participants received a single 21 mg dose of AMG 570 administered subcutaneously.'}, {'id': 'OG002', 'title': 'AMG 570 - 70 mg', 'description': 'Participants received a single 70 mg dose of AMG 570 administered subcutaneously.'}, {'id': 'OG003', 'title': 'AMG 570 - 140 mg', 'description': 'Participants received a single 140 mg dose of AMG 570 administered subcutaneously.'}, {'id': 'OG004', 'title': 'AMG 570 - 210 mg', 'description': 'Participants received a single 210 mg dose of AMG 570 administered subcutaneously.'}, {'id': 'OG005', 'title': 'AMG 570 - 420 mg', 'description': 'Participants received a single 420 mg dose of AMG 570 administered subcutaneously.'}, {'id': 'OG006', 'title': 'AMG 570 - 700 mg', 'description': 'Participants received a single 700 mg dose of AMG 570 administered subcutaneously.'}, {'id': 'OG007', 'title': 'Placebo', 'description': 'Participants received a single dose of the matching AMG 570 placebo administered subcutaneously.'}], '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'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to Day 105', 'description': 'Physical examinations were performed by the investigator, designated physician, or nurse practitioner. A complete physical examination included, at a minimum, assessment of cardiovascular, respiratory, gastrointestinal and neurological systems. A brief physical examination included assessment of the skin, lungs, cardiovascular system, and abdomen (liver and spleen).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set: all participants who received AMG 570 or placebo.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Experienced a Clinically Significant Change in Vital Signs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '14', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'AMG 570 - 7 mg', 'description': 'Participants received a single dose 7 mg dose of AMG 570 administered subcutaneously.'}, {'id': 'OG001', 'title': 'AMG 570 - 21 mg', 'description': 'Participants received a single 21 mg dose of AMG 570 administered subcutaneously.'}, {'id': 'OG002', 'title': 'AMG 570 - 70 mg', 'description': 'Participants received a single 70 mg dose of AMG 570 administered subcutaneously.'}, {'id': 'OG003', 'title': 'AMG 570 - 140 mg', 'description': 'Participants received a single 140 mg dose of AMG 570 administered subcutaneously.'}, {'id': 'OG004', 'title': 'AMG 570 - 210 mg', 'description': 'Participants received a single 210 mg dose of AMG 570 administered subcutaneously.'}, {'id': 'OG005', 'title': 'AMG 570 - 420 mg', 'description': 'Participants received a single 420 mg dose of AMG 570 administered subcutaneously.'}, {'id': 'OG006', 'title': 'AMG 570 - 700 mg', 'description': 'Participants received a single 700 mg dose of AMG 570 administered subcutaneously.'}, {'id': 'OG007', 'title': 'Placebo', 'description': 'Participants received a single dose of the matching AMG 570 placebo administered subcutaneously.'}], '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'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to Day 105', 'description': 'Any changes in blood pressure, body temperature, heart rate, and pulse rate that were deemed as clinically significant by the Investigator were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set: all participants who received AMG 570 or placebo.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Experienced a Clinically Significant Change in Clinical Laboratory Safety Tests', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '14', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'AMG 570 - 7 mg', 'description': 'Participants received a single dose 7 mg dose of AMG 570 administered subcutaneously.'}, {'id': 'OG001', 'title': 'AMG 570 - 21 mg', 'description': 'Participants received a single 21 mg dose of AMG 570 administered subcutaneously.'}, {'id': 'OG002', 'title': 'AMG 570 - 70 mg', 'description': 'Participants received a single 70 mg dose of AMG 570 administered subcutaneously.'}, {'id': 'OG003', 'title': 'AMG 570 - 140 mg', 'description': 'Participants received a single 140 mg dose of AMG 570 administered subcutaneously.'}, {'id': 'OG004', 'title': 'AMG 570 - 210 mg', 'description': 'Participants received a single 210 mg dose of AMG 570 administered subcutaneously.'}, {'id': 'OG005', 'title': 'AMG 570 - 420 mg', 'description': 'Participants received a single 420 mg dose of AMG 570 administered subcutaneously.'}, {'id': 'OG006', 'title': 'AMG 570 - 700 mg', 'description': 'Participants received a single 700 mg dose of AMG 570 administered subcutaneously.'}, {'id': 'OG007', 'title': 'Placebo', 'description': 'Participants received a single dose of the matching AMG 570 placebo administered subcutaneously.'}], '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': '3', 'groupId': 'OG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to Day 105', 'description': 'Laboratory safety tests included chemistry, hematology, and urinalysis parameters. Clinically significant laboratory safety tests were any events assessed as CTCAE Grade ≥3 at any post-baseline visit.\n\nGrade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolonged hospitalization indicated; disabling; limited self care ADL.\n\nGrade 4 Life-threatening consequences; urgent interventions indicated.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set: all participants who received AMG 570 or placebo.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Experienced a Clinically Significant Change in Electrocardiograms (ECGs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '14', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'AMG 570 - 7 mg', 'description': 'Participants received a single dose 7 mg dose of AMG 570 administered subcutaneously.'}, {'id': 'OG001', 'title': 'AMG 570 - 21 mg', 'description': 'Participants received a single 21 mg dose of AMG 570 administered subcutaneously.'}, {'id': 'OG002', 'title': 'AMG 570 - 70 mg', 'description': 'Participants received a single 70 mg dose of AMG 570 administered subcutaneously.'}, {'id': 'OG003', 'title': 'AMG 570 - 140 mg', 'description': 'Participants received a single 140 mg dose of AMG 570 administered subcutaneously.'}, {'id': 'OG004', 'title': 'AMG 570 - 210 mg', 'description': 'Participants received a single 210 mg dose of AMG 570 administered subcutaneously.'}, {'id': 'OG005', 'title': 'AMG 570 - 420 mg', 'description': 'Participants received a single 420 mg dose of AMG 570 administered subcutaneously.'}, {'id': 'OG006', 'title': 'AMG 570 - 700 mg', 'description': 'Participants received a single 700 mg dose of AMG 570 administered subcutaneously.'}, {'id': 'OG007', 'title': 'Placebo', 'description': 'Participants received a single dose of the matching AMG 570 placebo administered subcutaneously.'}], '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'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to Day 105', 'description': 'Any changes in ECG parameters that were deemed clinically significant by the Investigator were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set: all participants who received AMG 570 or placebo.'}, {'type': 'SECONDARY', 'title': 'Maximum Observed Concentration (Cmax) of AMG 570', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'AMG 570 - 7 mg', 'description': 'Participants received a single dose 7 mg dose of AMG 570 administered subcutaneously.'}, {'id': 'OG001', 'title': 'AMG 570 - 21 mg', 'description': 'Participants received a single 21 mg dose of AMG 570 administered subcutaneously.'}, {'id': 'OG002', 'title': 'AMG 570 - 70 mg', 'description': 'Participants received a single 70 mg dose of AMG 570 administered subcutaneously.'}, {'id': 'OG003', 'title': 'AMG 570 - 140 mg', 'description': 'Participants received a single 140 mg dose of AMG 570 administered subcutaneously.'}, {'id': 'OG004', 'title': 'AMG 570 - 210 mg', 'description': 'Participants received a single 210 mg dose of AMG 570 administered subcutaneously.'}, {'id': 'OG005', 'title': 'AMG 570 - 420 mg', 'description': 'Participants received a single 420 mg dose of AMG 570 administered subcutaneously.'}, {'id': 'OG006', 'title': 'AMG 570 - 700 mg', 'description': 'Participants received a single 700 mg dose of AMG 570 administered subcutaneously.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.08664', 'spread': '0.0539', 'groupId': 'OG000'}, {'value': '0.624', 'spread': '0.327', 'groupId': 'OG001'}, {'value': '4.33', 'spread': '3.53', 'groupId': 'OG002'}, {'value': '6.05', 'spread': '3.26', 'groupId': 'OG003'}, {'value': '17.2', 'spread': '3.78', 'groupId': 'OG004'}, {'value': '33.5', 'spread': '15.9', 'groupId': 'OG005'}, {'value': '58.5', 'spread': '19.9', 'groupId': 'OG006'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose and 12 hours post-dose on Day 1 and days 2, 3, 4, 6, 8, 11, 15, 22, 29, 43, 57, 71 and 105', 'description': 'AMG 570 pharmacokinetic (PK) parameters were estimated using non-compartmental analysis.', 'unitOfMeasure': 'µg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK concentration analysis set: all participants who received AMG 570 and had at least one quantifiable PK sample collected.'}, {'type': 'SECONDARY', 'title': 'Time to Reach Maximum Observed Concentration (Tmax) of AMG 570', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'AMG 570 - 7 mg', 'description': 'Participants received a single dose 7 mg dose of AMG 570 administered subcutaneously.'}, {'id': 'OG001', 'title': 'AMG 570 - 21 mg', 'description': 'Participants received a single 21 mg dose of AMG 570 administered subcutaneously.'}, {'id': 'OG002', 'title': 'AMG 570 - 70 mg', 'description': 'Participants received a single 70 mg dose of AMG 570 administered subcutaneously.'}, {'id': 'OG003', 'title': 'AMG 570 - 140 mg', 'description': 'Participants received a single 140 mg dose of AMG 570 administered subcutaneously.'}, {'id': 'OG004', 'title': 'AMG 570 - 210 mg', 'description': 'Participants received a single 210 mg dose of AMG 570 administered subcutaneously.'}, {'id': 'OG005', 'title': 'AMG 570 - 420 mg', 'description': 'Participants received a single 420 mg dose of AMG 570 administered subcutaneously.'}, {'id': 'OG006', 'title': 'AMG 570 - 700 mg', 'description': 'Participants received a single 700 mg dose of AMG 570 administered subcutaneously.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.0', 'groupId': 'OG000', 'lowerLimit': '2.0', 'upperLimit': '5.0'}, {'value': '3.0', 'groupId': 'OG001', 'lowerLimit': '2.0', 'upperLimit': '13'}, {'value': '3.0', 'groupId': 'OG002', 'lowerLimit': '0.5', 'upperLimit': '5.0'}, {'value': '5.0', 'groupId': 'OG003', 'lowerLimit': '5.0', 'upperLimit': '5.0'}, {'value': '5.0', 'groupId': 'OG004', 'lowerLimit': '3.0', 'upperLimit': '10'}, {'value': '5.0', 'groupId': 'OG005', 'lowerLimit': '3.0', 'upperLimit': '14'}, {'value': '5.0', 'groupId': 'OG006', 'lowerLimit': '3.0', 'upperLimit': '10'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose and 12 hours post-dose on Day 1 and days 2, 3, 4, 6, 8, 11, 15, 22, 29, 43, 57, 71 and 105', 'description': 'AMG 570 PK parameters were estimated using non-compartmental analysis.', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK concentration analysis set: all participants who received AMG 570 and had at least one quantifiable PK sample collected.'}, {'type': 'SECONDARY', 'title': 'Area Under the Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration (AUClast) of AMG 570', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'AMG 570 - 7 mg', 'description': 'Participants received a single dose 7 mg dose of AMG 570 administered subcutaneously.'}, {'id': 'OG001', 'title': 'AMG 570 - 21 mg', 'description': 'Participants received a single 21 mg dose of AMG 570 administered subcutaneously.'}, {'id': 'OG002', 'title': 'AMG 570 - 70 mg', 'description': 'Participants received a single 70 mg dose of AMG 570 administered subcutaneously.'}, {'id': 'OG003', 'title': 'AMG 570 - 140 mg', 'description': 'Participants received a single 140 mg dose of AMG 570 administered subcutaneously.'}, {'id': 'OG004', 'title': 'AMG 570 - 210 mg', 'description': 'Participants received a single 210 mg dose of AMG 570 administered subcutaneously.'}, {'id': 'OG005', 'title': 'AMG 570 - 420 mg', 'description': 'Participants received a single 420 mg dose of AMG 570 administered subcutaneously.'}, {'id': 'OG006', 'title': 'AMG 570 - 700 mg', 'description': 'Participants received a single 700 mg dose of AMG 570 administered subcutaneously.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.591', 'spread': '0.321', 'groupId': 'OG000'}, {'value': '5.12', 'spread': '2.62', 'groupId': 'OG001'}, {'value': '43.8', 'spread': '26.1', 'groupId': 'OG002'}, {'value': '88.3', 'spread': '50.1', 'groupId': 'OG003'}, {'value': '271', 'spread': '61.3', 'groupId': 'OG004'}, {'value': '561', 'spread': '221', 'groupId': 'OG005'}, {'value': '1660', 'spread': '759', 'groupId': 'OG006'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose and 12 hours post-dose on Day 1 and days 2, 3, 4, 6, 8, 11, 15, 22, 29, 43, 57, 71 and 105', 'description': 'AMG 570 PK parameters were estimated using non-compartmental analysis.', 'unitOfMeasure': 'day*µg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK concentration analysis set: all participants who received AMG 570 and had at least one quantifiable PK sample collected.'}, {'type': 'SECONDARY', 'title': 'Area Under the Concentration-time Curve Observed From Time Zero to Infinity (AUCinf) of AMG 570', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'AMG 570 - 7 mg', 'description': 'Participants received a single dose 7 mg dose of AMG 570 administered subcutaneously.'}, {'id': 'OG001', 'title': 'AMG 570 - 21 mg', 'description': 'Participants received a single 21 mg dose of AMG 570 administered subcutaneously.'}, {'id': 'OG002', 'title': 'AMG 570 - 70 mg', 'description': 'Participants received a single 70 mg dose of AMG 570 administered subcutaneously.'}, {'id': 'OG003', 'title': 'AMG 570 - 140 mg', 'description': 'Participants received a single 140 mg dose of AMG 570 administered subcutaneously.'}, {'id': 'OG004', 'title': 'AMG 570 - 210 mg', 'description': 'Participants received a single 210 mg dose of AMG 570 administered subcutaneously.'}, {'id': 'OG005', 'title': 'AMG 570 - 420 mg', 'description': 'Participants received a single 420 mg dose of AMG 570 administered subcutaneously.'}, {'id': 'OG006', 'title': 'AMG 570 - 700 mg', 'description': 'Participants received a single 700 mg dose of AMG 570 administered subcutaneously.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.928', 'spread': '0.248', 'groupId': 'OG000'}, {'value': '6.24', 'spread': '2.76', 'groupId': 'OG001'}, {'value': '51.1', 'spread': '21.9', 'groupId': 'OG002'}, {'value': '88.6', 'spread': '50.1', 'groupId': 'OG003'}, {'value': '284', 'spread': '59.2', 'groupId': 'OG004'}, {'value': '624', 'spread': '176', 'groupId': 'OG005'}, {'value': '1660', 'spread': '757', 'groupId': 'OG006'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose and 12 hours post-dose on Day 1 and days 2, 3, 4, 6, 8, 11, 15, 22, 29, 43, 57, 71 and 105', 'unitOfMeasure': 'day*µg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK concentration analysis set: all participants who received AMG 570 and had at least one quantifiable PK sample collected.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With an Anti-AMG 570 Binding Antibody Positive Postbaseline Result', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'AMG 570 - 7 mg', 'description': 'Participants received a single dose 7 mg dose of AMG 570 administered subcutaneously.'}, {'id': 'OG001', 'title': 'AMG 570 - 21 mg', 'description': 'Participants received a single 21 mg dose of AMG 570 administered subcutaneously.'}, {'id': 'OG002', 'title': 'AMG 570 - 70 mg', 'description': 'Participants received a single 70 mg dose of AMG 570 administered subcutaneously.'}, {'id': 'OG003', 'title': 'AMG 570 - 140 mg', 'description': 'Participants received a single 140 mg dose of AMG 570 administered subcutaneously.'}, {'id': 'OG004', 'title': 'AMG 570 - 210 mg', 'description': 'Participants received a single 210 mg dose of AMG 570 administered subcutaneously.'}, {'id': 'OG005', 'title': 'AMG 570 - 420 mg', 'description': 'Participants received a single 420 mg dose of AMG 570 administered subcutaneously.'}, {'id': 'OG006', 'title': 'AMG 570 - 700 mg', 'description': 'Participants received a single 700 mg dose of AMG 570 administered subcutaneously.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to Day 105', 'description': 'The presence of anti-AMG 570 binding antibodies was assessed using a validated assay. The number and percentage of participants who developed binding anti-AMG 570 antibodies at any postbaseline visit are presented.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received AMG 570 and had a negative or no result for binding antibodies at baseline.'}, {'type': 'SECONDARY', 'title': 'Mean Peripheral Blood B7-Related Protein-1 (B7RP-1) Receptor Occupancy on Total B Cells', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '14', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'AMG 570 - 7 mg', 'description': 'Participants received a single dose 7 mg dose of AMG 570 administered subcutaneously.'}, {'id': 'OG001', 'title': 'AMG 570 - 21 mg', 'description': 'Participants received a single 21 mg dose of AMG 570 administered subcutaneously.'}, {'id': 'OG002', 'title': 'AMG 570 - 70 mg', 'description': 'Participants received a single 70 mg dose of AMG 570 administered subcutaneously.'}, {'id': 'OG003', 'title': 'AMG 570 - 140 mg', 'description': 'Participants received a single 140 mg dose of AMG 570 administered subcutaneously.'}, {'id': 'OG004', 'title': 'AMG 570 - 210 mg', 'description': 'Participants received a single 210 mg dose of AMG 570 administered subcutaneously.'}, {'id': 'OG005', 'title': 'AMG 570 - 420 mg', 'description': 'Participants received a single 420 mg dose of AMG 570 administered subcutaneously.'}, {'id': 'OG006', 'title': 'AMG 570 - 700 mg', 'description': 'Participants received a single 700 mg dose of AMG 570 administered subcutaneously.'}, {'id': 'OG007', 'title': 'Placebo', 'description': 'Participants received a single dose of the matching AMG 570 placebo administered subcutaneously.'}], 'classes': [{'title': 'Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '14', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '13.73', 'spread': '8.81', 'groupId': 'OG000'}, {'value': '43.76', 'spread': '16.90', 'groupId': 'OG001'}, {'value': '64.37', 'spread': '14.80', 'groupId': 'OG002'}, {'value': '80.82', 'spread': '6.60', 'groupId': 'OG003'}, {'value': '88.87', 'spread': '1.83', 'groupId': 'OG004'}, {'value': '92.52', 'spread': '1.52', 'groupId': 'OG005'}, {'value': '95.97', 'spread': '1.85', 'groupId': 'OG006'}, {'value': '-0.98', 'spread': '13.52', 'groupId': 'OG007'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '14', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '0.36', 'spread': '19.12', 'groupId': 'OG000'}, {'value': '20.98', 'spread': '16.60', 'groupId': 'OG001'}, {'value': '19.96', 'spread': '10.94', 'groupId': 'OG002'}, {'value': '38.30', 'spread': '9.95', 'groupId': 'OG003'}, {'value': '72.96', 'spread': '9.21', 'groupId': 'OG004'}, {'value': '86.64', 'spread': '4.12', 'groupId': 'OG005'}, {'value': '89.60', 'spread': '9.00', 'groupId': 'OG006'}, {'value': '0.27', 'spread': '14.86', 'groupId': 'OG007'}]}]}, {'title': 'Day 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '14', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '3.30', 'spread': '14.27', 'groupId': 'OG000'}, {'value': '11.28', 'spread': '9.20', 'groupId': 'OG001'}, {'value': '10.14', 'spread': '8.50', 'groupId': 'OG002'}, {'value': '6.74', 'spread': '5.47', 'groupId': 'OG003'}, {'value': '4.55', 'spread': '15.36', 'groupId': 'OG004'}, {'value': '33.20', 'spread': '20.56', 'groupId': 'OG005'}, {'value': '65.88', 'spread': '31.67', 'groupId': 'OG006'}, {'value': '0.85', 'spread': '14.42', 'groupId': 'OG007'}]}]}, {'title': 'Day 105', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '13', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '-8.94', 'spread': '26.16', 'groupId': 'OG000'}, {'value': '4.53', 'spread': '10.31', 'groupId': 'OG001'}, {'value': '-4.54', 'spread': '8.76', 'groupId': 'OG002'}, {'value': '1.37', 'spread': '4.45', 'groupId': 'OG003'}, {'value': '-2.25', 'spread': '8.94', 'groupId': 'OG004'}, {'value': '-0.08', 'spread': '7.93', 'groupId': 'OG005'}, {'value': '13.33', 'spread': '17.05', 'groupId': 'OG006'}, {'value': '-2.90', 'spread': '15.86', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 8; Day 29; Day 57; and Day 105', 'description': 'Peripheral B7RP1 (also known as inducible costimulator ligand \\[ICOSL\\]) receptor occupancy was calculated from the free ICOSL and total ICOSL measurement from B cells in whole blood.', 'unitOfMeasure': 'Percentage B7RP-1 receptor occupancy', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacodynamic (PD) analysis set: all participants who had received AMG 570 or placebo and for whom at least one PD parameter had quantifiable baseline sample and a quantifiable PD sample collected at each specified visit.'}, {'type': 'SECONDARY', 'title': 'Percentage Change From Baseline for Cluster of Differentiation (CD)19+ Total B Cells Counts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '14', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'AMG 570 - 7 mg', 'description': 'Participants received a single dose 7 mg dose of AMG 570 administered subcutaneously.'}, {'id': 'OG001', 'title': 'AMG 570 - 21 mg', 'description': 'Participants received a single 21 mg dose of AMG 570 administered subcutaneously.'}, {'id': 'OG002', 'title': 'AMG 570 - 70 mg', 'description': 'Participants received a single 70 mg dose of AMG 570 administered subcutaneously.'}, {'id': 'OG003', 'title': 'AMG 570 - 140 mg', 'description': 'Participants received a single 140 mg dose of AMG 570 administered subcutaneously.'}, {'id': 'OG004', 'title': 'AMG 570 - 210 mg', 'description': 'Participants received a single 210 mg dose of AMG 570 administered subcutaneously.'}, {'id': 'OG005', 'title': 'AMG 570 - 420 mg', 'description': 'Participants received a single 420 mg dose of AMG 570 administered subcutaneously.'}, {'id': 'OG006', 'title': 'AMG 570 - 700 mg', 'description': 'Participants received a single 700 mg dose of AMG 570 administered subcutaneously.'}, {'id': 'OG007', 'title': 'Placebo', 'description': 'Participants received a single dose of the matching AMG 570 placebo administered subcutaneously.'}], 'classes': [{'title': 'Percentage change from Baseline at Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '13', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '41.333', 'spread': '73.517', 'groupId': 'OG000'}, {'value': '53.770', 'spread': '43.216', 'groupId': 'OG001'}, {'value': '66.531', 'spread': '28.057', 'groupId': 'OG002'}, {'value': '32.861', 'spread': '21.296', 'groupId': 'OG003'}, {'value': '57.123', 'spread': '75.399', 'groupId': 'OG004'}, {'value': '57.478', 'spread': '28.365', 'groupId': 'OG005'}, {'value': '74.509', 'spread': '70.354', 'groupId': 'OG006'}, {'value': '2.671', 'spread': '20.898', 'groupId': 'OG007'}]}]}, {'title': 'Percentage change from Baseline at Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '12', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '-20.284', 'spread': '22.310', 'groupId': 'OG000'}, {'value': '-8.084', 'spread': '10.212', 'groupId': 'OG001'}, {'value': '-17.994', 'spread': '15.582', 'groupId': 'OG002'}, {'value': '-10.047', 'spread': '19.791', 'groupId': 'OG003'}, {'value': '22.735', 'spread': '51.384', 'groupId': 'OG004'}, {'value': '26.305', 'spread': '28.795', 'groupId': 'OG005'}, {'value': '9.637', 'spread': '28.555', 'groupId': 'OG006'}, {'value': '3.031', 'spread': '23.358', 'groupId': 'OG007'}]}]}, {'title': 'Percentage change from Baseline at Day 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '14', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '-2.548', 'spread': '41.873', 'groupId': 'OG000'}, {'value': '-14.215', 'spread': '14.903', 'groupId': 'OG001'}, {'value': '-27.494', 'spread': '20.918', 'groupId': 'OG002'}, {'value': '-37.481', 'spread': '17.440', 'groupId': 'OG003'}, {'value': '0.386', 'spread': '50.044', 'groupId': 'OG004'}, {'value': '-8.882', 'spread': '21.936', 'groupId': 'OG005'}, {'value': '1.212', 'spread': '42.870', 'groupId': 'OG006'}, {'value': '5.726', 'spread': '28.059', 'groupId': 'OG007'}]}]}, {'title': 'Percentage change from Baseline at Day 105', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '12', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '-15.143', 'spread': '22.117', 'groupId': 'OG000'}, {'value': '17.010', 'spread': '33.957', 'groupId': 'OG001'}, {'value': '-16.872', 'spread': '19.064', 'groupId': 'OG002'}, {'value': '0.841', 'spread': '48.458', 'groupId': 'OG003'}, {'value': '-8.111', 'spread': '32.077', 'groupId': 'OG004'}, {'value': '-24.059', 'spread': '25.753', 'groupId': 'OG005'}, {'value': '-30.413', 'spread': '26.863', 'groupId': 'OG006'}, {'value': '1.023', 'spread': '13.612', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Day 8; Day 29; Day 57 and Day 105', 'unitOfMeasure': 'Percentage of change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacodynamic (PD) analysis set: all participants who had received AMG 570 or placebo and for whom at least one PD parameter had quantifiable baseline sample and a quantifiable PD sample collected at each specified visit.'}, {'type': 'SECONDARY', 'title': 'Percentage Change From Baseline for CD19+ Total B Cells Percentages (%)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '14', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'AMG 570 - 7 mg', 'description': 'Participants received a single dose 7 mg dose of AMG 570 administered subcutaneously.'}, {'id': 'OG001', 'title': 'AMG 570 - 21 mg', 'description': 'Participants received a single 21 mg dose of AMG 570 administered subcutaneously.'}, {'id': 'OG002', 'title': 'AMG 570 - 70 mg', 'description': 'Participants received a single 70 mg dose of AMG 570 administered subcutaneously.'}, {'id': 'OG003', 'title': 'AMG 570 - 140 mg', 'description': 'Participants received a single 140 mg dose of AMG 570 administered subcutaneously.'}, {'id': 'OG004', 'title': 'AMG 570 - 210 mg', 'description': 'Participants received a single 210 mg dose of AMG 570 administered subcutaneously.'}, {'id': 'OG005', 'title': 'AMG 570 - 420 mg', 'description': 'Participants received a single 420 mg dose of AMG 570 administered subcutaneously.'}, {'id': 'OG006', 'title': 'AMG 570 - 700 mg', 'description': 'Participants received a single 700 mg dose of AMG 570 administered subcutaneously.'}, {'id': 'OG007', 'title': 'Placebo', 'description': 'Participants received a single dose of the matching AMG 570 placebo administered subcutaneously.'}], 'classes': [{'title': 'Percentage change from Baseline at Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '13', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '56.111', 'spread': '88.264', 'groupId': 'OG000'}, {'value': '24.057', 'spread': '10.041', 'groupId': 'OG001'}, {'value': '28.291', 'spread': '16.950', 'groupId': 'OG002'}, {'value': '20.942', 'spread': '7.799', 'groupId': 'OG003'}, {'value': '26.538', 'spread': '28.906', 'groupId': 'OG004'}, {'value': '45.886', 'spread': '25.595', 'groupId': 'OG005'}, {'value': '23.693', 'spread': '21.414', 'groupId': 'OG006'}, {'value': '-1.241', 'spread': '12.309', 'groupId': 'OG007'}]}]}, {'title': 'Percentage change from Baseline at Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '12', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '-13.714', 'spread': '17.368', 'groupId': 'OG000'}, {'value': '-13.258', 'spread': '17.292', 'groupId': 'OG001'}, {'value': '-22.000', 'spread': '9.603', 'groupId': 'OG002'}, {'value': '-5.778', 'spread': '12.947', 'groupId': 'OG003'}, {'value': '2.765', 'spread': '28.960', 'groupId': 'OG004'}, {'value': '7.836', 'spread': '20.250', 'groupId': 'OG005'}, {'value': '4.063', 'spread': '15.629', 'groupId': 'OG006'}, {'value': '-0.582', 'spread': '17.259', 'groupId': 'OG007'}]}]}, {'title': 'Percentage change from Baseline at Day 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '14', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '29.484', 'spread': '84.641', 'groupId': 'OG000'}, {'value': '-21.751', 'spread': '11.893', 'groupId': 'OG001'}, {'value': '-26.000', 'spread': '20.346', 'groupId': 'OG002'}, {'value': '-36.293', 'spread': '18.635', 'groupId': 'OG003'}, {'value': '-16.667', 'spread': '35.355', 'groupId': 'OG004'}, {'value': '-10.467', 'spread': '4.058', 'groupId': 'OG005'}, {'value': '-7.500', 'spread': '19.632', 'groupId': 'OG006'}, {'value': '0.167', 'spread': '16.092', 'groupId': 'OG007'}]}]}, {'title': 'Percentage change from Baseline at Day 105', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '12', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '-7.738', 'spread': '8.988', 'groupId': 'OG000'}, {'value': '-1.524', 'spread': '17.352', 'groupId': 'OG001'}, {'value': '-23.333', 'spread': '14.530', 'groupId': 'OG002'}, {'value': '-9.947', 'spread': '17.880', 'groupId': 'OG003'}, {'value': '-15.152', 'spread': '13.165', 'groupId': 'OG004'}, {'value': '-23.966', 'spread': '13.136', 'groupId': 'OG005'}, {'value': '-35.474', 'spread': '10.308', 'groupId': 'OG006'}, {'value': '3.895', 'spread': '16.653', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Day 8; Day 29; Day 57 and Day 105', 'unitOfMeasure': 'Percentage of change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PD analysis set: all participants who had received AMG 570 or placebo and for whom at least one PD parameters had quantifiable baseline sample and at quantifiable PD sample collected at each specified visit.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'AMG 570 - 7 mg', 'description': 'Participants received a single dose 7 mg dose of AMG 570 administered subcutaneously.'}, {'id': 'FG001', 'title': 'AMG 570 - 21 mg', 'description': 'Participants received a single 21 mg dose of AMG 570 administered subcutaneously.'}, {'id': 'FG002', 'title': 'AMG 570 - 70 mg', 'description': 'Participants received a single 70 mg dose of AMG 570 administered subcutaneously.'}, {'id': 'FG003', 'title': 'AMG 570 - 140 mg', 'description': 'Participants received a single 140 mg dose of AMG 570 administered subcutaneously.'}, {'id': 'FG004', 'title': 'AMG 570 - 210 mg', 'description': 'Participants received a single 210 mg dose of AMG 570 administered subcutaneously.'}, {'id': 'FG005', 'title': 'AMG 570 - 420 mg', 'description': 'Participants received a single 420 mg dose of AMG 570 administered subcutaneously.'}, {'id': 'FG006', 'title': 'AMG 570 - 700 mg', 'description': 'Participants received a single 700 mg dose of AMG 570 administered subcutaneously.'}, {'id': 'FG007', 'title': 'Placebo', 'description': 'Participants received a single dose of the matching AMG 570 placebo administered subcutaneously.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '6'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '14'}]}, {'type': 'Received Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '6'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '6'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'A total of 56 healthy participants were enrolled at 3 research centers in the United States from 28 March 2016 to 06 September 2018.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '14', 'groupId': 'BG007'}, {'value': '56', 'groupId': 'BG008'}]}], 'groups': [{'id': 'BG000', 'title': 'AMG 570 - 7 mg', 'description': 'Participants received a single dose 7 mg dose of AMG 570 administered subcutaneously.'}, {'id': 'BG001', 'title': 'AMG 570 - 21 mg', 'description': 'Participants received a single 21 mg dose of AMG 570 administered subcutaneously.'}, {'id': 'BG002', 'title': 'AMG 570 - 70 mg', 'description': 'Participants received a single 70 mg dose of AMG 570 administered subcutaneously.'}, {'id': 'BG003', 'title': 'AMG 570 - 140 mg', 'description': 'Participants received a single 140 mg dose of AMG 570 administered subcutaneously.'}, {'id': 'BG004', 'title': 'AMG 570 - 210 mg', 'description': 'Participants received a single 210 mg dose of AMG 570 administered subcutaneously.'}, {'id': 'BG005', 'title': 'AMG 570 - 420 mg', 'description': 'Participants received a single 420 mg dose of AMG 570 administered subcutaneously.'}, {'id': 'BG006', 'title': 'AMG 570 - 700 mg', 'description': 'Participants received a single 700 mg dose of AMG 570 administered subcutaneously.'}, {'id': 'BG007', 'title': 'Placebo', 'description': 'Participants received a single dose of the matching AMG 570 placebo administered subcutaneously.'}, {'id': 'BG008', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '47.7', 'spread': '11.4', 'groupId': 'BG000'}, {'value': '45.8', 'spread': '14.3', 'groupId': 'BG001'}, {'value': '43.2', 'spread': '16.7', 'groupId': 'BG002'}, {'value': '42.0', 'spread': '9.8', 'groupId': 'BG003'}, {'value': '39.8', 'spread': '17.6', 'groupId': 'BG004'}, {'value': '39.8', 'spread': '11.4', 'groupId': 'BG005'}, {'value': '40.0', 'spread': '17.1', 'groupId': 'BG006'}, {'value': '44.4', 'spread': '12.1', 'groupId': 'BG007'}, {'value': '43.1', 'spread': '13.1', 'groupId': 'BG008'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '9', 'groupId': 'BG008'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '12', 'groupId': 'BG007'}, {'value': '47', 'groupId': 'BG008'}]}]}], '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': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '4', 'groupId': 'BG008'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '12', 'groupId': 'BG007'}, {'value': '52', 'groupId': 'BG008'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', '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'}]}, {'title': 'Asian', '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'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '15', 'groupId': 'BG008'}]}, {'title': 'White', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}, {'value': '11', 'groupId': 'BG007'}, {'value': '40', 'groupId': 'BG008'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The safety analysis set: all participants who received AMG 570 or the placebo.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-01-24', 'size': 1441449, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-08-05T07:16', 'hasProtocol': True}, {'date': '2018-03-26', 'size': 581770, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-08-05T07:16', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2018-12-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-10', 'studyFirstSubmitDate': '2015-10-13', 'resultsFirstSubmitDate': '2021-08-05', 'studyFirstSubmitQcDate': '2015-11-30', 'lastUpdatePostDateStruct': {'date': '2024-05-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-09-20', 'studyFirstPostDateStruct': {'date': '2015-12-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-10-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Who Experienced One or More Treatment-emergent Adverse Events (TEAEs)', 'timeFrame': 'Day 1 to Day 105', 'description': 'TEAEs were adverse events with an onset after the administration of study treatment.\n\nTEAEs were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.\n\nGrade 2 Moderate; minimal, local or noninvasive intervention indicated; limited age appropriate instrumental activities of daily life (ADL).\n\nGrade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolonged hospitalization indicated; disabling; limited self care ADL.\n\nGrade 4 Life-threatening consequences; urgent interventions indicated.\n\nSerious adverse events (SAEs) were defined as meeting at least 1 of the following criteria:\n\n* Results in death (fatal)\n* Immediately life-threatening\n* Requires in-patient hospitalization or prolongation of existing hospitalization\n* Results in persistent or significant disability/incapacity\n* Is a congenital anomaly/birth defect\n* Other medically important serious event'}, {'measure': 'Number of Participants Who Experienced a Clinically Significant Change in Physical Examinations', 'timeFrame': 'Baseline to Day 105', 'description': 'Physical examinations were performed by the investigator, designated physician, or nurse practitioner. A complete physical examination included, at a minimum, assessment of cardiovascular, respiratory, gastrointestinal and neurological systems. A brief physical examination included assessment of the skin, lungs, cardiovascular system, and abdomen (liver and spleen).'}, {'measure': 'Number of Participants Who Experienced a Clinically Significant Change in Vital Signs', 'timeFrame': 'Baseline to Day 105', 'description': 'Any changes in blood pressure, body temperature, heart rate, and pulse rate that were deemed as clinically significant by the Investigator were reported.'}, {'measure': 'Number of Participants Who Experienced a Clinically Significant Change in Clinical Laboratory Safety Tests', 'timeFrame': 'Baseline to Day 105', 'description': 'Laboratory safety tests included chemistry, hematology, and urinalysis parameters. Clinically significant laboratory safety tests were any events assessed as CTCAE Grade ≥3 at any post-baseline visit.\n\nGrade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolonged hospitalization indicated; disabling; limited self care ADL.\n\nGrade 4 Life-threatening consequences; urgent interventions indicated.'}, {'measure': 'Number of Participants Who Experienced a Clinically Significant Change in Electrocardiograms (ECGs)', 'timeFrame': 'Baseline to Day 105', 'description': 'Any changes in ECG parameters that were deemed clinically significant by the Investigator were reported.'}], 'secondaryOutcomes': [{'measure': 'Maximum Observed Concentration (Cmax) of AMG 570', 'timeFrame': 'Pre-dose and 12 hours post-dose on Day 1 and days 2, 3, 4, 6, 8, 11, 15, 22, 29, 43, 57, 71 and 105', 'description': 'AMG 570 pharmacokinetic (PK) parameters were estimated using non-compartmental analysis.'}, {'measure': 'Time to Reach Maximum Observed Concentration (Tmax) of AMG 570', 'timeFrame': 'Pre-dose and 12 hours post-dose on Day 1 and days 2, 3, 4, 6, 8, 11, 15, 22, 29, 43, 57, 71 and 105', 'description': 'AMG 570 PK parameters were estimated using non-compartmental analysis.'}, {'measure': 'Area Under the Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration (AUClast) of AMG 570', 'timeFrame': 'Pre-dose and 12 hours post-dose on Day 1 and days 2, 3, 4, 6, 8, 11, 15, 22, 29, 43, 57, 71 and 105', 'description': 'AMG 570 PK parameters were estimated using non-compartmental analysis.'}, {'measure': 'Area Under the Concentration-time Curve Observed From Time Zero to Infinity (AUCinf) of AMG 570', 'timeFrame': 'Pre-dose and 12 hours post-dose on Day 1 and days 2, 3, 4, 6, 8, 11, 15, 22, 29, 43, 57, 71 and 105'}, {'measure': 'Number of Participants With an Anti-AMG 570 Binding Antibody Positive Postbaseline Result', 'timeFrame': 'Baseline to Day 105', 'description': 'The presence of anti-AMG 570 binding antibodies was assessed using a validated assay. The number and percentage of participants who developed binding anti-AMG 570 antibodies at any postbaseline visit are presented.'}, {'measure': 'Mean Peripheral Blood B7-Related Protein-1 (B7RP-1) Receptor Occupancy on Total B Cells', 'timeFrame': 'Day 8; Day 29; Day 57; and Day 105', 'description': 'Peripheral B7RP1 (also known as inducible costimulator ligand \\[ICOSL\\]) receptor occupancy was calculated from the free ICOSL and total ICOSL measurement from B cells in whole blood.'}, {'measure': 'Percentage Change From Baseline for Cluster of Differentiation (CD)19+ Total B Cells Counts', 'timeFrame': 'Baseline to Day 8; Day 29; Day 57 and Day 105'}, {'measure': 'Percentage Change From Baseline for CD19+ Total B Cells Percentages (%)', 'timeFrame': 'Baseline to Day 8; Day 29; Day 57 and Day 105'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Lupus', 'Healthy Volunteer', 'Safety Study', 'Placebo Control', 'Phase 1'], 'conditions': ['Systemic Lupus Erythematosus']}, 'referencesModule': {'references': [{'pmid': '37150935', 'type': 'BACKGROUND', 'citation': 'Abuqayyas L, Chen PW, Dos Santos MT, Parnes JR, Doshi S, Dutta S, Houk BE. Pharmacokinetics and Pharmacokinetic/Pharmacodynamic Properties of Rozibafusp Alfa, a Bispecific Inhibitor of BAFF and ICOSL: Analyses of Phase I Clinical Trials. Clin Pharmacol Ther. 2023 Aug;114(2):371-380. doi: 10.1002/cpt.2929. Epub 2023 May 24.'}], 'seeAlsoLinks': [{'url': 'http://www.amgentrials.com', 'label': 'AmgenTrials clinical trials website'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to obtain initial information on the safety and tolerability (effects good or bad), pharmacokinetics (what the body does to the drug), and pharmacodynamics (what the drug does to the body) of a single dose of AMG 570.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy as determined by the investigator\n* Normal or clinically acceptable electrocardiogram (ECG)\n* Female subjects must be of documented non-reproductive potential\n* Subjects must be current for all vaccinations\n* Other inclusion criteria may apply\n\nExclusion Criteria:\n\n* Current or chronic history of liver disease\n* History of active infections\n* History of significant respiratory disorder\n* Evidence of renal disease\n* Other exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT02618967', 'briefTitle': 'Single Ascending Dose Study of AMG 570 in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amgen'}, 'officialTitle': 'A Randomized, Double Blind Placebo Controlled, First in Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Subcutaneous Doses of AMG 570 in Healthy Subjects', 'orgStudyIdInfo': {'id': '20140322'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AMG 570 - 7 mg', 'description': 'Participants will receive a single dose 7 mg dose of AMG 570 administered subcutaneously.', 'interventionNames': ['Biological: AMG 570']}, {'type': 'EXPERIMENTAL', 'label': 'AMG 570 - 21 mg', 'description': 'Participants will receive a single 21 mg dose of AMG 570 administered subcutaneously.', 'interventionNames': ['Biological: AMG 570']}, {'type': 'EXPERIMENTAL', 'label': 'AMG 570 - 70 mg', 'description': 'Participants will receive a single 70 mg dose of AMG 570 administered subcutaneously.', 'interventionNames': ['Biological: AMG 570']}, {'type': 'EXPERIMENTAL', 'label': 'AMG 570 - 140 mg', 'description': 'Participants will receive a single 140 mg dose of AMG 570 administered subcutaneously.', 'interventionNames': ['Biological: AMG 570']}, {'type': 'EXPERIMENTAL', 'label': 'AMG 570 - 210 mg', 'description': 'Participants will receive a single 210 mg dose of AMG 570 administered subcutaneously.', 'interventionNames': ['Biological: AMG 570']}, {'type': 'EXPERIMENTAL', 'label': 'AMG 570 - 420 mg', 'description': 'Participants will receive a single 420 mg dose of AMG 570 administered subcutaneously.', 'interventionNames': ['Biological: AMG 570']}, {'type': 'EXPERIMENTAL', 'label': 'AMG 570 - 700 mg', 'description': 'Participants will receive a single 700 mg dose of AMG 570 administered subcutaneously.', 'interventionNames': ['Biological: AMG 570']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants will receive a single dose of the matching AMG 570 placebo administered subcutaneously.', 'interventionNames': ['Biological: AMG 570 Matching Placebo']}], 'interventions': [{'name': 'AMG 570', 'type': 'BIOLOGICAL', 'otherNames': ['Active Comparator, Investigational Product, and Study drug'], 'description': '7 dose levels of AMG 570 administered as single dose subcutaneous in healthy volunteers.', 'armGroupLabels': ['AMG 570 - 140 mg', 'AMG 570 - 21 mg', 'AMG 570 - 210 mg', 'AMG 570 - 420 mg', 'AMG 570 - 7 mg', 'AMG 570 - 70 mg', 'AMG 570 - 700 mg']}, {'name': 'AMG 570 Matching Placebo', 'type': 'BIOLOGICAL', 'otherNames': ['Placebo, Investigational Product, and Study drug'], 'description': 'Placebo administered as single dose subcutaneous in healthy volunteers.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '47710', 'city': 'Evansville', 'state': 'Indiana', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 37.97476, 'lon': -87.55585}}, {'zip': '66212', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}, {'zip': '53704', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Amgen'}]}, 'ipdSharingStatementModule': {'url': 'https://www.amgen.com/datasharing', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.', 'ipdSharing': 'YES', 'description': 'De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request', 'accessCriteria': 'Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amgen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}