Ignite Creation Date:
2025-12-24 @ 3:45 PM
Ignite Modification Date:
2026-01-07 @ 12:41 PM
Study NCT ID:
NCT04610892
Status:
COMPLETED
Last Update Posted:
2025-02-21
First Post:
2020-07-28
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of MEDI6570 in Patients With a History of Myocardial Infarction
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Russia'], 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-12-03', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D050197', 'term': 'Atherosclerosis'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'information.center@astrazeneca.com', 'phone': '1-877-240-9479', 'title': 'Global Clinical Lead', 'organization': 'AstraZeneca'}, 'certainAgreement': {'otherDetails': 'The investigator agrees to submit all manuscripts or abstracts to the sponsor for review before submission.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'During study follow-up (from day 1 to day 325/405). Day 325/405: for participants who completed the study under CSP Amendment 1 & 2, the end of study visits were Day 405 and Day 325, respectively.', 'description': 'Subjects initially randomized to the 250 mg group switched dose to 400 mg following CSP amendment 1 and were analysed according to the 400 mg group.', 'eventGroups': [{'id': 'EG000', 'title': 'MEDI6570 50 mg', 'description': 'Participants received MEDI6570 50 mg every 4 weeks for 32 weeks', 'otherNumAtRisk': 39, 'deathsNumAtRisk': 39, 'otherNumAffected': 15, 'seriousNumAtRisk': 39, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'MEDI6570 150 mg', 'description': 'Participants received MEDI6570 150 mg every 4 weeks for 32 weeks', 'otherNumAtRisk': 129, 'deathsNumAtRisk': 129, 'otherNumAffected': 33, 'seriousNumAtRisk': 129, 'deathsNumAffected': 1, 'seriousNumAffected': 17}, {'id': 'EG002', 'title': 'MEDI6570 400 mg', 'description': 'Participants received MEDI6570 400 mg every 4 weeks for 32 weeks', 'otherNumAtRisk': 126, 'deathsNumAtRisk': 126, 'otherNumAffected': 37, 'seriousNumAtRisk': 126, 'deathsNumAffected': 1, 'seriousNumAffected': 10}, {'id': 'EG003', 'title': 'Placebo', 'description': 'Participants received Placebo matched to MEDI6570 every 4 weeks for 32 weeks', 'otherNumAtRisk': 126, 'deathsNumAtRisk': 126, 'otherNumAffected': 23, 'seriousNumAtRisk': 126, 'deathsNumAffected': 0, 'seriousNumAffected': 13}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 129, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 126, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 129, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 126, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 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'numAtRisk': 129, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 126, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 129, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 126, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 126, 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'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 129, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 126, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 126, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}], 'seriousEvents': [{'term': 'Coronary artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 126, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Retinal detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Gastrointestinal polyp haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Ileal perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Incarcerated umbilical hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, 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'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Anaphylactic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Covid-19', 'notes': '8 Subjects 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[{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Lung adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Neuroendocrine tumour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 129, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 126, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Stag horn calculus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Epistaxis', 'notes': '8 Subjects initially randomized to the 250 mg group switched dose to 400 mg following CSP amendment 1 and were analysed according to the 400 mg group.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 129, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Psoriasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Aortic aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Peripheral artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Peripheral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Cardiogenic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline to Day 253 in Non-calcified Plaque Volume in the Most Diseased Coronary Segment (NCPVMD), as Measured by Computed Tomography Angiography (CTA) Imaging', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}, {'value': '245', 'groupId': 'OG003'}, {'value': '117', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI6570 50 mg', 'description': 'Participants received MEDI6570 50 mg every 4 weeks for 32 weeks'}, {'id': 'OG001', 'title': 'MEDI6570 150 mg', 'description': 'Participants received MEDI6570 150 mg every 4 weeks for 32 weeks'}, {'id': 'OG002', 'title': 'MEDI6570 400 mg', 'description': 'Participants received MEDI6570 400 mg every 4 weeks for 32 weeks'}, {'id': 'OG003', 'title': 'MEDI6570 150 mg or 400 mg', 'description': 'Participants received MEDI6570 150 mg or 400 mg every 4 weeks for 32 weeks'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Participants received Placebo matched to MEDI6570 every 4 weeks for 32 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-15.3220', 'spread': '4.9219', 'groupId': 'OG000'}, {'value': '-4.5509', 'spread': '3.1654', 'groupId': 'OG001'}, {'value': '-6.3658', 'spread': '3.2559', 'groupId': 'OG002'}, {'value': '-5.4220', 'spread': '2.6622', 'groupId': 'OG003'}, {'value': '-6.9424', 'spread': '3.2729', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.065', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Least Square Mean difference', 'ciPctValue': '90', 'paramValue': '-8.3797', 'ciLowerLimit': '-17.4980', 'ciUpperLimit': '0.7387', 'pValueComment': 'One-sided p-value', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The treatment as a fixed effects and the baseline value and the geographic region and statin therapy intensity at screening as covariates.'}, {'pValue': '0.747', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Least Square Mean difference', 'ciPctValue': '90', 'paramValue': '2.3915', 'ciLowerLimit': '-3.5338', 'ciUpperLimit': '8.3167', 'pValueComment': 'One-sided p-value', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The treatment as a fixed effects and the baseline value and the geographic region and statin therapy intensity at screening as covariates.'}, {'pValue': '0.563', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Least Square Mean difference', 'ciPctValue': '90', 'paramValue': '0.5766', 'ciLowerLimit': '-5.4389', 'ciUpperLimit': '6.5921', 'pValueComment': 'One-sided p-value', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The treatment as a fixed effects and the baseline value and the geographic region and statin therapy intensity at screening as covariates.'}, {'pValue': '0.685', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Least Square Mean difference', 'ciPctValue': '90', 'paramValue': '1.5204', 'ciLowerLimit': '-3.6657', 'ciUpperLimit': '6.7064', 'pValueComment': 'One-sided p-value', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The treatment as a fixed effects and the baseline value and the geographic region and statin therapy intensity at screening as covariates.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From baseline to Day 253', 'description': 'To evaluate the effect of MEDI6570 on non-calcified coronary atherosclerotic plaques compared with placebo. The primary endpoint of change in NCPVMD from baseline to Day 253 was assessed based on the CTA Analysis Populations.', 'unitOfMeasure': 'mm^3', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants within the Intention To Treat (ITT) Population who had interpretable CTA scans at baseline and at Day 253. Participants were analyzed according to their randomized treatment group.\n\nSubjects initially randomized to the 250 mg group switched dose to 400 mg following clinical study protocol (CSP) amendment 1 and were analysed according to the 400 mg group.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Day 253 in N Terminal Prohormone Brain Natriuretic Peptide (NT-proBNP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}, {'value': '248', 'groupId': 'OG003'}, {'value': '118', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI6570 50 mg', 'description': 'Participants received MEDI6570 50 mg every 4 weeks for 32 weeks'}, {'id': 'OG001', 'title': 'MEDI6570 150 mg', 'description': 'Participants received MEDI6570 150 mg every 4 weeks for 32 weeks'}, {'id': 'OG002', 'title': 'MEDI6570 400 mg', 'description': 'Participants received MEDI6570 400 mg every 4 weeks for 32 weeks'}, {'id': 'OG003', 'title': 'MEDI6570 150 mg or 400 mg', 'description': 'Participants received MEDI6570 150 mg or 400 mg every 4 weeks for 32 weeks'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Participants received Placebo matched to MEDI6570 every 4 weeks for 32 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.8226', 'spread': '9.4', 'groupId': 'OG000'}, {'value': '0.7787', 'spread': '5.5', 'groupId': 'OG001'}, {'value': '0.7368', 'spread': '5.6', 'groupId': 'OG002'}, {'value': '0.7575', 'spread': '4.4', 'groupId': 'OG003'}, {'value': '0.7370', 'spread': '5.6', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.854', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Geometric LS mean ratio estimate', 'ciPctValue': '90', 'paramValue': '1.12', 'ciLowerLimit': '0.94', 'ciUpperLimit': '1.33', 'pValueComment': 'One sided p-value', 'statisticalMethod': 'Mixed model with repeated measurements', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The model was adjusted for the baseline value and the stratification factors (geographic region and statin therapy intensity at screening).'}, {'pValue': '0.790', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Geometric LS mean ratio estimate', 'ciPctValue': '90', 'paramValue': '1.06', 'ciLowerLimit': '0.94', 'ciUpperLimit': '1.18', 'pValueComment': 'One sided p-value', 'statisticalMethod': 'Mixed model with repeated measurements', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The model was adjusted for the baseline value and the stratification factors (geographic region and statin therapy intensity at screening).'}, {'pValue': '0.498', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Geometric LS mean ratio estimate', 'ciPctValue': '90', 'paramValue': '1.00', 'ciLowerLimit': '0.89', 'ciUpperLimit': '1.12', 'pValueComment': 'One sided p-value', 'statisticalMethod': 'Mixed model with repeated measurements', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The model was adjusted for the baseline value and the stratification factors (geographic region and statin therapy intensity at screening).'}, {'pValue': '0.678', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Geometric LS mean ratio estimate', 'ciPctValue': '90', 'paramValue': '1.03', 'ciLowerLimit': '0.93', 'ciUpperLimit': '1.13', 'pValueComment': 'One sided p-value', 'statisticalMethod': 'Mixed model with repeated measurements', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The model was adjusted for the baseline value and the stratification factors (geographic region and statin therapy intensity at screening).'}], 'paramType': 'GEOMETRIC_LEAST_SQUARES_MEAN', 'timeFrame': 'From baseline to Day 253', 'description': 'To evaluate the effect of MEDI6570 on a surrogate biomarker of Heart Failure (HF) compared with placebo', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized subjects who received any study treatment will be included in the As-treated Population. Subjects will be analysed according to the actual treatment they received, regardless of their randomized treatment group. Subjects treated within 250 mg group that received at least one 400 mg dose during the study will be analysed according to the 400mg group.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Day 253 in Left Ventricular Ejection Fraction (LVEF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '112', 'groupId': 'OG002'}, {'value': '227', 'groupId': 'OG003'}, {'value': '103', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI6570 50 mg', 'description': 'Participants received MEDI6570 50 mg every 4 weeks for 32 weeks'}, {'id': 'OG001', 'title': 'MEDI6570 150 mg', 'description': 'Participants received MEDI6570 150 mg every 4 weeks for 32 weeks'}, {'id': 'OG002', 'title': 'MEDI6570 400 mg', 'description': 'Participants received MEDI6570 400 mg every 4 weeks for 32 weeks'}, {'id': 'OG003', 'title': 'MEDI6570 150 mg or 400 mg', 'description': 'Participants received MEDI6570 150 mg or 400 mg every 4 weeks for 32 weeks'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Participants received Placebo matched to MEDI6570 every 4 weeks for 32 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.91', 'spread': '0.55', 'groupId': 'OG000'}, {'value': '0.32', 'spread': '0.34', 'groupId': 'OG001'}, {'value': '0.11', 'spread': '0.35', 'groupId': 'OG002'}, {'value': '0.22', 'spread': '0.28', 'groupId': 'OG003'}, {'value': '0.53', 'spread': '0.35', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.990', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Least Squares mean difference', 'ciPctValue': '90', 'paramValue': '-1.44', 'ciLowerLimit': '-2.44', 'ciUpperLimit': '-0.43', 'pValueComment': 'One sided p-value', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).'}, {'pValue': '0.697', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Least Squares mean difference', 'ciPctValue': '90', 'paramValue': '-0.21', 'ciLowerLimit': '-0.87', 'ciUpperLimit': '0.45', 'pValueComment': 'One sided p-value', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).'}, {'pValue': '0.849', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Least Squares mean difference', 'ciPctValue': '90', 'paramValue': '-0.42', 'ciLowerLimit': '-1.08', 'ciUpperLimit': '0.25', 'pValueComment': 'One sided p-value', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).'}, {'pValue': '0.811', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Least Squares mean difference', 'ciPctValue': '90', 'paramValue': '-0.31', 'ciLowerLimit': '-0.89', 'ciUpperLimit': '0.27', 'pValueComment': 'One sided p-value', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From baseline to Day 253', 'description': 'To evaluate the effect of MEDI6570 on left ventricular systolic function compared with placebo', 'unitOfMeasure': 'Percentage of LVEF', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects within the ITT population who have interpretable echocardiograms in the baseline and follow-up periods will be included in the Echocardiogram Analysis Population. Subjects will be analysed according to their randomized treatment group. subjects initially randomized to the 250 mg group switched dose to 400 mg following CSP amendment 1 and were analysed according to the 400 mg group'}, {'type': 'SECONDARY', 'title': 'Left Ventricular Ejection Fraction (LVEF) Change From Baseline to Day 253 Among Subjects With Reduced Ejection Fraction (< 50%)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI6570 50 mg', 'description': 'Participants received MEDI6570 50 mg every 4 weeks for 32 weeks'}, {'id': 'OG001', 'title': 'MEDI6570 150 mg', 'description': 'Participants received MEDI6570 150 mg every 4 weeks for 32 weeks'}, {'id': 'OG002', 'title': 'MEDI6570 400 mg', 'description': 'Participants received MEDI6570 400 mg every 4 weeks for 32 weeks'}, {'id': 'OG003', 'title': 'MEDI6570 150 mg or 400 mg', 'description': 'Participants received MEDI6570 150 mg or 400 mg every 4 weeks for 32 weeks'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Participants received Placebo matched to MEDI6570 every 4 weeks for 32 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.08', 'spread': '1.52', 'groupId': 'OG000'}, {'value': '1.32', 'spread': '1.13', 'groupId': 'OG001'}, {'value': '2.09', 'spread': '1.00', 'groupId': 'OG002'}, {'value': '1.79', 'spread': '0.82', 'groupId': 'OG003'}, {'value': '2.41', 'spread': '1.04', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.972', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Least Squares mean difference', 'ciPctValue': '90', 'paramValue': '-3.50', 'ciLowerLimit': '-6.49', 'ciUpperLimit': '-0.50', 'pValueComment': 'One sided p-value', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).'}, {'pValue': '0.777', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Least Squares mean difference', 'ciPctValue': '90', 'paramValue': '-1.10', 'ciLowerLimit': '-3.49', 'ciUpperLimit': '1.30', 'pValueComment': 'One sided p-value', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).'}, {'pValue': '0.596', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Least Squares mean difference', 'ciPctValue': '90', 'paramValue': '-0.32', 'ciLowerLimit': '-2.54', 'ciUpperLimit': '1.89', 'pValueComment': 'One sided p-value', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).'}, {'pValue': '0.698', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Least Squares mean difference', 'ciPctValue': '90', 'paramValue': '-0.63', 'ciLowerLimit': '-2.64', 'ciUpperLimit': '1.38', 'pValueComment': 'One sided p-value', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From baseline to Day 253', 'description': 'To evaluate the effect of MEDI6570 on left ventricular systolic function among participants with reduced ejection fraction (defined as \\<50%) compared with placebo', 'unitOfMeasure': 'Percentage of LVEF', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects within the ITT population who have interpretable echocardiograms in the baseline and follow-up periods will be included in the Echocardiogram Analysis Population. Subjects will be analysed according to their randomized treatment group. Subjects initially randomized to the 250 mg group switched dose to 400 mg following CSP amendment 1 and were analysed according to the 400 mg group.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Day 253 in Global Longitudinal Strain (GLS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}, {'value': '109', 'groupId': 'OG002'}, {'value': '214', 'groupId': 'OG003'}, {'value': '100', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI6570 50 mg', 'description': 'Participants received MEDI6570 50 mg every 4 weeks for 32 weeks'}, {'id': 'OG001', 'title': 'MEDI6570 150 mg', 'description': 'Participants received MEDI6570 150 mg every 4 weeks for 32 weeks'}, {'id': 'OG002', 'title': 'MEDI6570 400 mg', 'description': 'Participants received MEDI6570 400 mg every 4 weeks for 32 weeks'}, {'id': 'OG003', 'title': 'MEDI6570 150 mg or 400 mg', 'description': 'Participants received MEDI6570 150 mg or 400 mg every 4 weeks for 32 weeks'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Participants received Placebo matched to MEDI6570 every 4 weeks for 32 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.20', 'spread': '0.56', 'groupId': 'OG000'}, {'value': '-0.70', 'spread': '0.35', 'groupId': 'OG001'}, {'value': '-0.77', 'spread': '0.35', 'groupId': 'OG002'}, {'value': '-0.74', 'spread': '0.29', 'groupId': 'OG003'}, {'value': '0.09', 'spread': '0.35', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.981', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Least Squares mean difference', 'ciPctValue': '90', 'paramValue': '-1.29', 'ciLowerLimit': '-2.32', 'ciUpperLimit': '-0.27', 'pValueComment': 'One sided p-value', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).'}, {'pValue': '0.974', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Least Squares mean difference', 'ciPctValue': '90', 'paramValue': '-0.80', 'ciLowerLimit': '-1.47', 'ciUpperLimit': '-0.12', 'pValueComment': 'One sided p-value', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).'}, {'pValue': '0.983', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Least Squares mean difference', 'ciPctValue': '90', 'paramValue': '-0.86', 'ciLowerLimit': '-1.53', 'ciUpperLimit': '-0.20', 'pValueComment': 'One sided p-value', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).'}, {'pValue': '0.990', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Least Squares mean difference', 'ciPctValue': '90', 'paramValue': '-0.83', 'ciLowerLimit': '-1.42', 'ciUpperLimit': '-0.25', 'pValueComment': 'One sided p-value', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From baseline to Day 253', 'description': 'To evaluate the effect of MEDI6570 on left ventricular systolic function compared with placebo', 'unitOfMeasure': 'Percentage of GLS', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects within the ITT population who have interpretable echocardiograms in the baseline and follow-up periods will be included in the Echocardiogram Analysis Population. Subjects will be analysed according to their randomized treatment group. Subjects initially randomized to the 250 mg group switched dose to 400 mg following CSP amendment 1 and were analysed according to the 400 mg group.'}, {'type': 'SECONDARY', 'title': 'Global Longitudinal Strain (GLS) Change From Baseline to Day 253 Among Subjects With Reduced Ejection Fraction (< 50%)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI6570 50 mg', 'description': 'Participants received MEDI6570 50 mg every 4 weeks for 32 weeks'}, {'id': 'OG001', 'title': 'MEDI6570 150 mg', 'description': 'Participants received MEDI6570 150 mg every 4 weeks for 32 weeks'}, {'id': 'OG002', 'title': 'MEDI6570 400 mg', 'description': 'Participants received MEDI6570 400 mg every 4 weeks for 32 weeks'}, {'id': 'OG003', 'title': 'MEDI6570 150 mg or 400 mg', 'description': 'Participants received MEDI6570 150 mg or 400 mg every 4 weeks for 32 weeks'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Participants received Placebo matched to MEDI6570 every 4 weeks for 32 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.39', 'spread': '1.03', 'groupId': 'OG000'}, {'value': '-1.16', 'spread': '0.78', 'groupId': 'OG001'}, {'value': '0.41', 'spread': '0.64', 'groupId': 'OG002'}, {'value': '-0.19', 'spread': '0.55', 'groupId': 'OG003'}, {'value': '1.76', 'spread': '0.66', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.959', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Least Squares mean difference', 'ciPctValue': '90', 'paramValue': '-2.14', 'ciLowerLimit': '-4.16', 'ciUpperLimit': '-0.12', 'pValueComment': 'One sided p-value', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).'}, {'pValue': '0.998', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Least Squares mean difference', 'ciPctValue': '90', 'paramValue': '-2.92', 'ciLowerLimit': '-4.53', 'ciUpperLimit': '-1.31', 'pValueComment': 'One sided p-value', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).'}, {'pValue': '0.939', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Least Squares mean difference', 'ciPctValue': '90', 'paramValue': '-1.35', 'ciLowerLimit': '-2.79', 'ciUpperLimit': '0.09', 'pValueComment': 'One sided p-value', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).'}, {'pValue': '0.991', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Least Squares mean difference', 'ciPctValue': '90', 'paramValue': '-1.94', 'ciLowerLimit': '-3.27', 'ciUpperLimit': '-0.62', 'pValueComment': 'One sided p-value', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From baseline to Day 253', 'description': 'To evaluate the effect of MEDI6570 on left ventricular systolic function among participants with reduced ejection fraction (defined as \\<50%) compared with placebo', 'unitOfMeasure': 'Percentage of GLS', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects within the ITT population who have interpretable echocardiograms in the baseline and follow-up periods will be included in the Echocardiogram Analysis Population. Subjects will be analysed according to their randomized treatment group. Subjects initially randomized to the 250 mg group switched dose to 400 mg following CSP amendment 1 and were analysed according to the 400 mg group.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Day 253 in Global Non-calcified Plaque Volume (NCPV)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}, {'value': '241', 'groupId': 'OG003'}, {'value': '117', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI6570 50 mg', 'description': 'Participants received MEDI6570 50 mg every 4 weeks for 32 weeks'}, {'id': 'OG001', 'title': 'MEDI6570 150 mg', 'description': 'Participants received MEDI6570 150 mg every 4 weeks for 32 weeks'}, {'id': 'OG002', 'title': 'MEDI6570 400 mg', 'description': 'Participants received MEDI6570 400 mg every 4 weeks for 32 weeks'}, {'id': 'OG003', 'title': 'MEDI6570 150 mg or 400 mg', 'description': 'Participants received MEDI6570 150 mg or 400 mg every 4 weeks for 32 weeks'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Participants received Placebo matched to MEDI6570 every 4 weeks for 32 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-26.4453', 'spread': '10.0524', 'groupId': 'OG000'}, {'value': '-10.9010', 'spread': '6.4671', 'groupId': 'OG001'}, {'value': '-10.4850', 'spread': '6.6607', 'groupId': 'OG002'}, {'value': '-10.7013', 'spread': '5.4415', 'groupId': 'OG003'}, {'value': '-10.3083', 'spread': '6.7052', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.077', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Least Squares mean difference', 'ciPctValue': '90', 'paramValue': '-16.1370', 'ciLowerLimit': '-34.7829', 'ciUpperLimit': '2.5089', 'pValueComment': 'One sided p-value', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).'}, {'pValue': '0.468', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Least Squares mean difference', 'ciPctValue': '90', 'paramValue': '-0.5927', 'ciLowerLimit': '-12.7267', 'ciUpperLimit': '11.5413', 'pValueComment': 'One sided p-value', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).'}, {'pValue': '0.491', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Least Squares mean difference', 'ciPctValue': '90', 'paramValue': '-0.1767', 'ciLowerLimit': '-12.4678', 'ciUpperLimit': '12.1144', 'pValueComment': 'One sided p-value', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).'}, {'pValue': '0.476', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Least Squares mean difference', 'ciPctValue': '90', 'paramValue': '-0.3930', 'ciLowerLimit': '-11.0022', 'ciUpperLimit': '10.2162', 'pValueComment': 'One sided p-value', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From baseline to Day 253', 'description': 'To evaluate the effect of MEDI6570 on other measures of non-calcified coronary atherosclerotic plaque compared with placebo', 'unitOfMeasure': 'mm^3', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants within the ITT Population who had interpretable b CTA scans at baseline and at Day 253 or at Day 122 were included. (Note that separate analyses were conducted for Day 253 and Day 122). Participants were analyzed according to their randomized treatment group.\n\nSubjects initially randomized to the 250 mg group switched dose to 400 mg following CSP amendment 1 and were analysed according to the 400 mg group.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Day 253 in Low Attenuation Plaque Volume (LAPV)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}, {'value': '241', 'groupId': 'OG003'}, {'value': '117', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI6570 50 mg', 'description': 'Participants received MEDI6570 50 mg every 4 weeks for 32 weeks'}, {'id': 'OG001', 'title': 'MEDI6570 150 mg', 'description': 'Participants received MEDI6570 150 mg every 4 weeks for 32 weeks'}, {'id': 'OG002', 'title': 'MEDI6570 400 mg', 'description': 'Participants received MEDI6570 400 mg every 4 weeks for 32 weeks'}, {'id': 'OG003', 'title': 'MEDI6570 150 mg or 400 mg', 'description': 'Participants received MEDI6570 150 mg or 400 mg every 4 weeks for 32 weeks'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Participants received Placebo matched to MEDI6570 every 4 weeks for 32 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.9167', 'spread': '3.5226', 'groupId': 'OG000'}, {'value': '-4.8101', 'spread': '2.2690', 'groupId': 'OG001'}, {'value': '-4.2748', 'spread': '2.3363', 'groupId': 'OG002'}, {'value': '-4.5532', 'spread': '1.9099', 'groupId': 'OG003'}, {'value': '-3.5733', 'spread': '2.3481', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.136', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Least Squares mean difference', 'ciPctValue': '90', 'paramValue': '-4.3435', 'ciLowerLimit': '-10.8637', 'ciUpperLimit': '2.1768', 'pValueComment': 'One sided p-value', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).'}, {'pValue': '0.316', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Least Squares mean difference', 'ciPctValue': '90', 'paramValue': '-1.2369', 'ciLowerLimit': '-5.4796', 'ciUpperLimit': '3.0059', 'pValueComment': 'One sided p-value', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).'}, {'pValue': '0.394', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Least Squares mean difference', 'ciPctValue': '90', 'paramValue': '-0.7015', 'ciLowerLimit': '-5.0096', 'ciUpperLimit': '3.6065', 'pValueComment': 'One sided p-value', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).'}, {'pValue': '0.332', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Least Squares mean difference', 'ciPctValue': '90', 'paramValue': '-0.9799', 'ciLowerLimit': '-4.6927', 'ciUpperLimit': '2.7329', 'pValueComment': 'One sided p-value', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From baseline to Day 253', 'description': 'To evaluate the effect of MEDI6570 on other measures of non-calcified coronary atherosclerotic plaque compared with placebo', 'unitOfMeasure': 'mm3', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants within the ITT Population who had interpretable CTA scans at baseline and at Day 253. Participants were analyzed according to their randomized treatment group.\n\nSubjects initially randomized to the 250 mg group switched dose to 400 mg following CSP amendment 1 and were analysed according to the 400 mg group.'}, {'type': 'SECONDARY', 'title': 'Summary of ADA (Anti-drug Antibody) Responses During the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '126', 'groupId': 'OG002'}, {'value': '294', 'groupId': 'OG003'}, {'value': '126', 'groupId': 'OG004'}, {'value': '420', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI6570 50 mg', 'description': 'Participants received MEDI6570 50 mg very 4 weeks for 32 weeks'}, {'id': 'OG001', 'title': 'MEDI6570 150 mg', 'description': 'Participants received MEDI6570 150 mg very 4 weeks for 32 weeks'}, {'id': 'OG002', 'title': 'MEDI6570 400 mg', 'description': 'Participants received MEDI6570 400 mg very 4 weeks for 32 weeks'}, {'id': 'OG003', 'title': 'MEDI6570 Total', 'description': 'Number of participants received MEDI6570 50 mg, MEDI6570 150 mg and 400 mg'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Participants received Placebo matched to MEDI6570 very 4 weeks for 32 weeks'}, {'id': 'OG005', 'title': 'Total', 'description': 'Overall Total'}], 'classes': [{'title': 'ADA (anti-drug antibody) prevalence (positive at baseline or post-baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '126', 'groupId': 'OG002'}, {'value': '294', 'groupId': 'OG003'}, {'value': '126', 'groupId': 'OG004'}, {'value': '420', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '16', 'groupId': 'OG005'}]}]}, {'title': 'ADA (anti-drug antibody) incidence (TEADA positive)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '124', 'groupId': 'OG002'}, {'value': '290', 'groupId': 'OG003'}, {'value': '123', 'groupId': 'OG004'}, {'value': '413', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}]}, {'title': 'Treatment-induced ADA (anti-drug antibody) positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '124', 'groupId': 'OG002'}, {'value': '290', 'groupId': 'OG003'}, {'value': '123', 'groupId': 'OG004'}, {'value': '413', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}]}, {'title': 'Treatment-boosted ADA (anti-drug antibody) positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '124', 'groupId': 'OG002'}, {'value': '289', 'groupId': 'OG003'}, {'value': '118', 'groupId': 'OG004'}, {'value': '407', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': 'ADA (anti-drug antibody) persistently positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '124', 'groupId': 'OG002'}, {'value': '289', 'groupId': 'OG003'}, {'value': '118', 'groupId': 'OG004'}, {'value': '407', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From baseline to Day 325/405. Day 325/405: for participants who completed the study under clinical study protocol (CSP) Amendment 1 & 2, the end of study visits were Day 405 and Day 325 respectively.', 'description': 'To evaluate the immunogenicity of MEDI6570', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects included in the As-treated Population who have ≥ 1 immunogenicity sample will be included in the Immunogenicity Population. Subjects will be analysed according to the actual treatment they received. Subjects initially randomized to the 250 mg group switched dose to 400 mg following CSP amendment 1 and were analysed according to the 400 mg group.'}, {'type': 'SECONDARY', 'title': 'Anti-drug Antibody Titre Summary by Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '126', 'groupId': 'OG002'}, {'value': '294', 'groupId': 'OG003'}, {'value': '126', 'groupId': 'OG004'}, {'value': '420', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI6570 50 mg', 'description': 'Participants received MEDI6570 50 mg every 4 weeks for 32 weeks'}, {'id': 'OG001', 'title': 'MEDI6570 150 mg', 'description': 'Participants received MEDI6570 150 mg every 4 weeks for 32 weeks'}, {'id': 'OG002', 'title': 'MEDI6570 400 mg', 'description': 'Participants received MEDI6570 400 mg every 4 weeks for 32 weeks'}, {'id': 'OG003', 'title': 'MEDI6570 Total', 'description': 'Number of participants received MEDI6570 50 mg, MEDI6570 150 mg and 400 mg'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Participants received Placebo matched to MEDI6570 every 4 weeks for 32 weeks'}, {'id': 'OG005', 'title': 'Total', 'description': 'Overall Total'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG001', 'lowerLimit': '80', 'upperLimit': '80'}, {'value': '320', 'groupId': 'OG002', 'lowerLimit': '320', 'upperLimit': '320'}, {'value': '200', 'groupId': 'OG003', 'lowerLimit': '80', 'upperLimit': '320'}, {'value': '200', 'groupId': 'OG005', 'lowerLimit': '80', 'upperLimit': '320'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '640', 'groupId': 'OG001', 'lowerLimit': '640', 'upperLimit': '640'}, {'value': '640', 'groupId': 'OG003', 'lowerLimit': '640', 'upperLimit': '640'}, {'value': '640', 'groupId': 'OG005', 'lowerLimit': '640', 'upperLimit': '640'}]}]}, {'title': 'Day 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG001', 'lowerLimit': '80', 'upperLimit': '80'}, {'value': '80', 'groupId': 'OG003', 'lowerLimit': '80', 'upperLimit': '80'}, {'value': '80', 'groupId': 'OG005', 'lowerLimit': '80', 'upperLimit': '80'}]}]}, {'title': 'Day 113', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '640', 'groupId': 'OG000', 'lowerLimit': '640', 'upperLimit': '640'}, {'value': '640', 'groupId': 'OG001', 'lowerLimit': '640', 'upperLimit': '640'}, {'value': '640', 'groupId': 'OG003', 'lowerLimit': '640', 'upperLimit': '640'}, {'value': '640', 'groupId': 'OG005', 'lowerLimit': '640', 'upperLimit': '640'}]}]}, {'title': 'Day 169', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '320', 'groupId': 'OG000', 'lowerLimit': '320', 'upperLimit': '320'}, {'value': '1600', 'groupId': 'OG001', 'lowerLimit': '640', 'upperLimit': '2560'}, {'value': '640', 'groupId': 'OG003', 'lowerLimit': '320', 'upperLimit': '2560'}, {'value': '640.0', 'groupId': 'OG005', 'lowerLimit': '320', 'upperLimit': '2560'}]}]}, {'title': 'Day 253', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '160', 'groupId': 'OG000', 'lowerLimit': '160', 'upperLimit': '160'}, {'value': '1360', 'groupId': 'OG001', 'lowerLimit': '160', 'upperLimit': '2560'}, {'value': '80', 'groupId': 'OG002', 'lowerLimit': '80', 'upperLimit': '80'}, {'value': '160', 'groupId': 'OG003', 'lowerLimit': '80', 'upperLimit': '2560'}, {'value': '160', 'groupId': 'OG005', 'lowerLimit': '80', 'upperLimit': '2560'}]}]}, {'title': 'Day 325/405', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '120.0', 'groupId': 'OG000', 'lowerLimit': '80', 'upperLimit': '160'}, {'value': '320', 'groupId': 'OG001', 'lowerLimit': '80', 'upperLimit': '1280'}, {'value': '80', 'groupId': 'OG002', 'lowerLimit': '80', 'upperLimit': '80'}, {'value': '160', 'groupId': 'OG003', 'lowerLimit': '80', 'upperLimit': '1280'}, {'value': 'NA', 'comment': 'Result is positive but not quantifiable', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '160', 'groupId': 'OG005', 'lowerLimit': '80', 'upperLimit': '1280'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From Baseline to Day 325/405. Day 325/405: for participants who completed the study under CSP Amendment 1 & 2, the end of study visits were Day 405 and Day 325 respectively.', 'description': 'To evaluate the immunogenicity of MEDI6570', 'unitOfMeasure': 'Titer units', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects included in the As-treated Population who have ≥ 1 immunogenicity sample will be included in the Immunogenicity Population. Subjects will be analysed according to the actual treatment they received. Subjects initially randomized to the 250 mg group switched dose to 400 mg following CSP amendment 1 and were analysed according to the 400 mg group.'}, {'type': 'SECONDARY', 'title': 'Summary of Serum Concentrations (ug/mL) of MEDI6570', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '117', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI6570 50 mg', 'description': 'Participants received MEDI6570 50 mg every 4 weeks for 32 weeks'}, {'id': 'OG001', 'title': 'MEDI6570 150 mg', 'description': 'Participants received MEDI6570 150 mg every 4 weeks for 32 weeks'}, {'id': 'OG002', 'title': 'MEDI6570 400 mg', 'description': 'Participants received MEDI6570 400 mg every 4 weeks for 32 weeks'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '117', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'All subjects had values below limit of quantification (LLOQ)', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'All subjects had values below limit of quantification (LLOQ)', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'All subjects had values below limit of quantification (LLOQ)', 'groupId': 'OG002'}]}]}, {'title': 'Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '111', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.3126', 'spread': '101.5', 'groupId': 'OG000'}, {'value': '7.0296', 'spread': '125.9', 'groupId': 'OG001'}, {'value': '20.4472', 'spread': '37.2', 'groupId': 'OG002'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}, {'value': '113', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.6154', 'spread': '170.7', 'groupId': 'OG000'}, {'value': '3.4641', 'spread': '103.2', 'groupId': 'OG001'}, {'value': '9.5328', 'spread': '115.4', 'groupId': 'OG002'}]}]}, {'title': 'Day 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}, {'value': '107', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.7622', 'spread': '235.5', 'groupId': 'OG000'}, {'value': '4.3897', 'spread': '145.9', 'groupId': 'OG001'}, {'value': '15.0108', 'spread': '50.3', 'groupId': 'OG002'}]}]}, {'title': 'Day 85', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.1353', 'spread': '217.3', 'groupId': 'OG000'}, {'value': '6.4317', 'spread': '62.0', 'groupId': 'OG001'}, {'value': '10.8714', 'spread': '608.2', 'groupId': 'OG002'}]}]}, {'title': 'Day 113', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '101', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.0084', 'spread': '176.7', 'groupId': 'OG000'}, {'value': '5.4403', 'spread': '120.1', 'groupId': 'OG001'}, {'value': '15.5611', 'spread': '77.1', 'groupId': 'OG002'}]}]}, {'title': 'Day 122', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.6703', 'spread': '37.0', 'groupId': 'OG000'}, {'value': '8.1229', 'spread': '792.0', 'groupId': 'OG001'}, {'value': '28.1805', 'spread': '168.8', 'groupId': 'OG002'}]}]}, {'title': 'Day 141', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.4191', 'spread': '129.5', 'groupId': 'OG000'}, {'value': '8.0736', 'spread': '47.2', 'groupId': 'OG001'}, {'value': '10.4080', 'spread': '647.5', 'groupId': 'OG002'}]}]}, {'title': 'Day 169', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}, {'value': '97', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.8016', 'spread': '171.6', 'groupId': 'OG000'}, {'value': '5.2865', 'spread': '163.4', 'groupId': 'OG001'}, {'value': '15.9449', 'spread': '145.9', 'groupId': 'OG002'}]}]}, {'title': 'Day 197', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Not calculable. only 1 patient attend on Day 197 in this group', 'groupId': 'OG002'}]}]}, {'title': 'Day 225', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.2469', 'spread': '86.3', 'groupId': 'OG000'}, {'value': '3.6384', 'spread': '633.4', 'groupId': 'OG001'}]}]}, {'title': 'Day 253', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}, {'value': '108', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.7253', 'spread': '288.4', 'groupId': 'OG000'}, {'value': '5.6832', 'spread': '136.0', 'groupId': 'OG001'}, {'value': '14.9944', 'spread': '173.4', 'groupId': 'OG002'}]}]}, {'title': 'Day 325/Day 405', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}, {'value': '97', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'All subjects had values below limit of quantification (LLOQ)', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'All subjects had values below limit of quantification (LLOQ)', 'groupId': 'OG001'}, {'value': '0.5955', 'spread': '720.6', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'From baseline to Day 325/Day 405', 'description': 'MEDI6570 concentrations as measured in serum during the intervention and follow-up periods', 'unitOfMeasure': 'ug/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who received ≥ 1 dose of MEDI6570 and have ≥ 1 one post dose evaluable MEDI6570 serum concentration will be included in the PK population. Subjects will be analysed according to the actual treatment they received. The pk data was analysed only for 50 mg, 150mg and 400mg groups.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events in Any Category', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '126', 'groupId': 'OG002'}, {'value': '294', 'groupId': 'OG003'}, {'value': '126', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI6570 50 mg', 'description': 'Participants received MEDI6570 50 mg every 4 weeks for 32 weeks'}, {'id': 'OG001', 'title': 'MEDI6570 150 mg', 'description': 'Participants received MEDI6570 150 mg every 4 weeks for 32 weeks'}, {'id': 'OG002', 'title': 'MEDI6570 400 mg', 'description': 'Participants received MEDI6570 400 mg every 4 weeks for 32 weeks'}, {'id': 'OG003', 'title': 'MEDI6570 Total', 'description': 'Participants received MEDI6570 50 mg or 150 mg or 400 mg every 4 weeks for 32 weeks'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Participants received Placebo matched to MEDI6570 every 4 weeks for 32 weeks'}], 'classes': [{'title': 'Any AEs', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}, {'value': '192', 'groupId': 'OG003'}, {'value': '65', 'groupId': 'OG004'}]}]}, {'title': 'Any AEs with outcome of death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Any SAE (including events with outcome of death)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}]}]}, {'title': 'Any AE leading to treatment discontinuation', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}, {'title': 'Any AE leading to withdrawal from study', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During study follow-up (from day 1 to day 325)', 'description': 'To assess the safety and tolerability of MEDI6570 compared with placebo', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized subjects who received any study treatment will be included in the As-treated Population. Subjects will be analysed according to the actual treatment they received, regardless of their randomized treatment group. Subjects treated within 250 mg group that received at least one 400 mg dose during the study will be analysed according to the 400mg group.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Most Common Adverse Events (Frequency > 5%)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '126', 'groupId': 'OG002'}, {'value': '294', 'groupId': 'OG003'}, {'value': '126', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI6570 50 mg', 'description': 'Participants received MEDI6570 50 mg every 4 weeks for 32 weeks'}, {'id': 'OG001', 'title': 'MEDI6570 150 mg', 'description': 'Participants received MEDI6570 150 mg every 4 weeks for 32 weeks'}, {'id': 'OG002', 'title': 'MEDI6570 400 mg', 'description': 'Participants received MEDI6570 400 mg every 4 weeks for 32 weeks'}, {'id': 'OG003', 'title': 'MEDI6570 Total', 'description': 'Participants received MEDI6570 50 mg or 150 mg or 400 mg every 4 weeks for 32 weeks'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Participants received Placebo matched to MEDI6570 every 4 weeks for 32 weeks'}], 'classes': [{'title': 'Participants with any AE', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '89', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}]}]}, {'title': 'COVID-19', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}]}, {'title': 'Hypertension', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}]}, {'title': 'Non-cardiac chest pain', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}]}, {'title': 'Dyspnoea', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}, {'title': 'Hypotension', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Angina pectoris', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}]}, {'title': 'Pyrexia', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Diarrhoea', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}]}, {'title': 'Epistaxis', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Influenza', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Nausea', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Pain in extremity', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During study follow-up (from day 1 to day 325)', 'description': 'To assess the safety and tolerability of MEDI6570 compared with placebo', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized subjects who received any study treatment will be included in the As-treated Population. Subjects will be analysed according to the actual treatment they received, regardless of their randomized treatment group. Subjects treated within 250 mg group that received at least one 400 mg dose during the study will be analysed according to the 400mg group.'}, {'type': 'SECONDARY', 'title': 'Vital Signs (Change in Systolic and Diastolic Blood Pressure From Baseline) Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '126', 'groupId': 'OG002'}, {'value': '126', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI6570 50 mg', 'description': 'Participants received MEDI6570 50 mg every 4 weeks for 32 weeks'}, {'id': 'OG001', 'title': 'MEDI6570 150 mg', 'description': 'Participants received MEDI6570 150 mg every 4 weeks for 32 weeks'}, {'id': 'OG002', 'title': 'MEDI6570 400 mg', 'description': 'Participants received MEDI6570 400 mg every 4 weeks for 32 weeks'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received Placebo matched to MEDI6570 every 4 weeks for 32 weeks'}], 'classes': [{'title': 'Systolic blood pressure Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}, {'value': '120', 'groupId': 'OG002'}, {'value': '121', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '9.9', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '12.7', 'groupId': 'OG001'}, {'value': '-1.4', 'spread': '13.0', 'groupId': 'OG002'}, {'value': '0.4', 'spread': '12.8', 'groupId': 'OG003'}]}]}, {'title': 'Systolic blood pressure Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}, {'value': '122', 'groupId': 'OG002'}, {'value': '122', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.7', 'spread': '10.8', 'groupId': 'OG000'}, {'value': '-1.1', 'spread': '14.6', 'groupId': 'OG001'}, {'value': '-1.5', 'spread': '11.9', 'groupId': 'OG002'}, {'value': '-1.3', 'spread': '12.6', 'groupId': 'OG003'}]}]}, {'title': 'Systolic blood pressure Day 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}, {'value': '119', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.4', 'spread': '11.6', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '14.1', 'groupId': 'OG001'}, {'value': '-1.6', 'spread': '12.3', 'groupId': 'OG002'}, {'value': '-0.1', 'spread': '12.8', 'groupId': 'OG003'}]}]}, {'title': 'Systolic blood pressure Day 85', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '119', 'groupId': 'OG002'}, {'value': '116', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': '10.2', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '13.8', 'groupId': 'OG001'}, {'value': '-1.2', 'spread': '12.7', 'groupId': 'OG002'}, {'value': 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'14.9', 'groupId': 'OG002'}, {'value': '0.5', 'spread': '14.5', 'groupId': 'OG003'}]}]}, {'title': 'Systolic blood pressure Day 197', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}, {'value': '109', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': '15.8', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '14.0', 'groupId': 'OG001'}, {'value': '-3.6', 'spread': '13.5', 'groupId': 'OG002'}, {'value': '-0.4', 'spread': '13.6', 'groupId': 'OG003'}]}]}, {'title': 'Systolic blood pressure Day 225', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '112', 'groupId': 'OG002'}, {'value': '110', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.8', 'spread': '14.3', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '14.8', 'groupId': 'OG001'}, {'value': 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'groupId': 'OG001'}, {'value': '-2.5', 'spread': '14.7', 'groupId': 'OG002'}, {'value': '0.1', 'spread': '16.0', 'groupId': 'OG003'}]}]}, {'title': 'Diastolic blood pressure Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}, {'value': '120', 'groupId': 'OG002'}, {'value': '121', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'spread': '6.0', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '8.5', 'groupId': 'OG001'}, {'value': '-0.3', 'spread': '8.4', 'groupId': 'OG002'}, {'value': '-0.4', 'spread': '8.7', 'groupId': 'OG003'}]}]}, {'title': 'Diastolic blood pressure Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}, {'value': '122', 'groupId': 'OG002'}, {'value': '122', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '8.5', 'groupId': 'OG000'}, {'value': '-1.3', 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{'value': '-0.5', 'spread': '10.5', 'groupId': 'OG001'}, {'value': '-0.9', 'spread': '8.9', 'groupId': 'OG002'}, {'value': '-0.6', 'spread': '9.2', 'groupId': 'OG003'}]}]}, {'title': 'Diastolic blood pressure Day 113', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '113', 'groupId': 'OG002'}, {'value': '114', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'spread': '8.5', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '9.4', 'groupId': 'OG001'}, {'value': '-0.5', 'spread': '8.9', 'groupId': 'OG002'}, {'value': '1.0', 'spread': '9.1', 'groupId': 'OG003'}]}]}, {'title': 'Diastolic blood pressure Day 122', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-3.7', 'spread': '10.4', 'groupId': 'OG000'}, {'value': '-3.9', 'spread': '8.0', 'groupId': 'OG001'}, {'value': '-2.0', 'spread': '7.5', 'groupId': 'OG002'}, {'value': '4.1', 'spread': '12.3', 'groupId': 'OG003'}]}]}, {'title': 'Diastolic blood pressure Day 141', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '117', 'groupId': 'OG002'}, {'value': '112', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.5', 'spread': '8.4', 'groupId': 'OG000'}, {'value': '-1.1', 'spread': '9.6', 'groupId': 'OG001'}, {'value': '-0.3', 'spread': '8.5', 'groupId': 'OG002'}, {'value': '0.2', 'spread': '7.9', 'groupId': 'OG003'}]}]}, {'title': 'Diastolic blood pressure Day 169', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}, {'value': '115', 'groupId': 'OG002'}, {'value': '110', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'spread': '9.5', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '9.2', 'groupId': 'OG001'}, {'value': '-0.8', 'spread': '9.0', 'groupId': 'OG002'}, {'value': '-0.4', 'spread': '9.2', 'groupId': 'OG003'}]}]}, {'title': 'Diastolic blood pressure Day 197', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}, {'value': '109', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.6', 'spread': '7.7', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '9.5', 'groupId': 'OG001'}, {'value': '-2.0', 'spread': '9.8', 'groupId': 'OG002'}, {'value': '-0.3', 'spread': '9.0', 'groupId': 'OG003'}]}]}, {'title': 'Diastolic blood pressure Day 225', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '112', 'groupId': 'OG002'}, {'value': '110', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '9.5', 'groupId': 'OG000'}, {'value': '-1.6', 'spread': '9.8', 'groupId': 'OG001'}, {'value': '-0.9', 'spread': '8.8', 'groupId': 'OG002'}, {'value': '-0.8', 'spread': '8.4', 'groupId': 'OG003'}]}]}, {'title': 'Diastolic blood pressure Day 253', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}, {'value': '114', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-3.7', 'spread': '7.9', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '10.7', 'groupId': 'OG001'}, {'value': '-1.0', 'spread': '9.9', 'groupId': 'OG002'}, {'value': '-0.4', 'spread': '9.3', 'groupId': 'OG003'}]}]}, {'title': 'Diastolic blood pressure Day 325/405', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '104', 'groupId': 'OG002'}, {'value': '99', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.8', 'spread': '8.5', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '9.1', 'groupId': 'OG001'}, {'value': '-1.5', 'spread': '10.3', 'groupId': 'OG002'}, {'value': '-0.7', 'spread': '9.8', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to Day 325/405. 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[{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '113', 'groupId': 'OG002'}, {'value': '114', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.8', 'spread': '9.8', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '10.1', 'groupId': 'OG001'}, {'value': '0.2', 'spread': '8.7', 'groupId': 'OG002'}, {'value': '0.2', 'spread': '10.7', 'groupId': 'OG003'}]}]}, {'title': 'Heart rate Day 122', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-3.3', 'spread': '10.8', 'groupId': 'OG000'}, {'value': '-1.2', 'spread': '13.4', 'groupId': 'OG001'}, {'value': '-1.3', 'spread': '7.6', 'groupId': 'OG002'}, {'value': '0.7', 'spread': '16.0', 'groupId': 'OG003'}]}]}, {'title': 'Heart rate Day 141', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '117', 'groupId': 'OG002'}, {'value': '112', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.3', 'spread': '10.4', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '9.2', 'groupId': 'OG001'}, {'value': '2.0', 'spread': '9.4', 'groupId': 'OG002'}, {'value': '2.2', 'spread': '10.4', 'groupId': 'OG003'}]}]}, {'title': 'Heart rate Day 169', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}, {'value': '115', 'groupId': 'OG002'}, {'value': '110', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': '10.1', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '11.0', 'groupId': 'OG001'}, {'value': '3.0', 'spread': '8.8', 'groupId': 'OG002'}, {'value': '1.5', 'spread': '9.7', 'groupId': 'OG003'}]}]}, {'title': 'Heart rate Day 197', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}, {'value': '109', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.1', 'spread': '12.5', 'groupId': 'OG000'}, {'value': '2.3', 'spread': '9.8', 'groupId': 'OG001'}, {'value': '1.7', 'spread': '9.5', 'groupId': 'OG002'}, {'value': '1.8', 'spread': '10.4', 'groupId': 'OG003'}]}]}, {'title': 'Heart rate Day 225', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '112', 'groupId': 'OG002'}, {'value': '110', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.9', 'spread': '10.0', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '11.0', 'groupId': 'OG001'}, {'value': '2.5', 'spread': '10.1', 'groupId': 'OG002'}, {'value': '1.8', 'spread': '10.4', 'groupId': 'OG003'}]}]}, {'title': 'Heart rate Day 253', 'denoms': [{'units': 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Day 325/405: for participants who completed the study under CSP Amendment 1 & 2, the end of study visits were Day 405 and Day 325 respectively.', 'description': 'To assess the safety and tolerability of MEDI6570 compared with placebo', 'unitOfMeasure': 'beats/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized subjects who received any study treatment will be included in the As-treated Population. Subjects will be analysed according to the actual treatment they received, regardless of their randomized treatment group. 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Day 325/405: for participants who completed the study under CSP Amendment 1 & 2, the end of study visits were Day 405 and Day 325 respectively', 'description': 'To assess the safety and tolerability of MEDI6570 compared with placebo', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized subjects who received any study treatment will be included in the As-treated Population. Subjects will be analysed according to the actual treatment they received, regardless of their randomized treatment group. Subjects treated within 250 mg group that received at least one 400 mg dose during the study will be analysed according to the 400mg group.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'MEDI6570 50 mg', 'description': 'Participants received MEDI6570 50 mg every 4 weeks for 32 weeks'}, {'id': 'FG001', 'title': 'MEDI6570 150 mg', 'description': 'Participants received MEDI6570 150 mg every 4 weeks for 32 weeks'}, {'id': 'FG002', 'title': 'MEDI6570 250 mg/400 mg', 'description': 'Participants received MEDI6570 250 mg/400 mg every 4 weeks for 32 weeks.'}, {'id': 'FG003', 'title': 'MEDI6570 400 mg', 'description': 'Participants received MEDI6570 400 mg every 4 weeks for 32 weeks'}, {'id': 'FG004', 'title': 'Placebo', 'description': 'Participants received Placebo matched to MEDI6570 every 4 weeks for 32 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '129'}, {'comment': 'MEDI6570 250 mg/400 mg : subjects initially randomized to 250 mg that switched dose to 400 mg during the trial.', 'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '118'}, {'groupId': 'FG004', 'numSubjects': '128'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '126'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '110'}, {'groupId': 'FG004', 'numSubjects': '117'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '11'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '3'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '6'}]}, {'type': 'Subjects who did not receive treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '129', 'groupId': 'BG001'}, {'value': '126', 'groupId': 'BG002'}, {'value': '128', 'groupId': 'BG003'}, {'value': '423', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'MEDI6570 50 mg', 'description': 'Participants received MEDI6570 50 mg every 4 weeks for 32 weeks'}, {'id': 'BG001', 'title': 'MEDI6570 150 mg', 'description': 'Participants received MEDI6570 150 mg every 4 weeks for 32 weeks'}, {'id': 'BG002', 'title': 'MEDI6570 400 mg', 'description': 'Participants received MEDI6570 400 mg every 4 weeks for 32 weeks'}, {'id': 'BG003', 'title': 'Placebo', 'description': 'Participants received Placebo matched to MEDI6570 every 4 weeks for 32 weeks'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.1', 'spread': '8.3', 'groupId': 'BG000'}, {'value': '59.9', 'spread': '9.2', 'groupId': 'BG001'}, {'value': '59.4', 'spread': '9.6', 'groupId': 'BG002'}, {'value': '60.4', 'spread': '9.5', 'groupId': 'BG003'}, {'value': '59.9', 'spread': '9.3', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '75', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '110', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}, {'value': '107', 'groupId': 'BG003'}, {'value': '348', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '124', 'groupId': 'BG001'}, {'value': '124', 'groupId': 'BG002'}, {'value': '121', 'groupId': 'BG003'}, {'value': '404', 'groupId': 'BG004'}]}, {'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'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'AMERICAN INDIAN OR ALASKA NATIVE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}, {'title': 'ASIAN', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '34', 'groupId': 'BG004'}]}]}, {'title': 'BLACK OR AFRICAN AMERICAN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}, {'title': 'NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}, {'title': 'OTHER', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}, {'title': 'WHITE', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '116', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}, {'value': '118', 'groupId': 'BG003'}, {'value': '385', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '116', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}, {'value': '118', 'groupId': 'BG003'}, {'value': '385', 'groupId': 'BG004'}]}]}, {'title': 'Non-caucasian', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '38', 'groupId': 'BG004'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Australia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '15', 'groupId': 'BG004'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}]}, {'title': 'Czech Republic', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}, {'value': '54', 'groupId': 'BG004'}]}]}, {'title': 'Hungary', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '55', 'groupId': 'BG004'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}, {'value': '54', 'groupId': 'BG004'}]}]}, {'title': 'Japan', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '32', 'groupId': 'BG004'}]}]}, {'title': 'Netherlands', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '41', 'groupId': 'BG004'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '40', 'groupId': 'BG004'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}, {'value': '69', 'groupId': 'BG004'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}]}]}, {'title': 'United States of America', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '48', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}], 'populationDescription': '8 subjects initially randomized to the 250 mg group switched dose to 400 mg following CSP amendment 1 and were analysed according to the 400 mg group.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-11-10', 'size': 3306403, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-11-08T08:10', 'hasProtocol': True}, {'date': '2023-12-06', 'size': 1826920, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-11-08T08:10', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 423}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2023-11-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-31', 'studyFirstSubmitDate': '2020-07-28', 'resultsFirstSubmitDate': '2024-11-08', 'studyFirstSubmitQcDate': '2020-10-26', 'lastUpdatePostDateStruct': {'date': '2025-02-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-01-31', 'studyFirstPostDateStruct': {'date': '2020-11-02', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline to Day 253 in Non-calcified Plaque Volume in the Most Diseased Coronary Segment (NCPVMD), as Measured by Computed Tomography Angiography (CTA) Imaging', 'timeFrame': 'From baseline to Day 253', 'description': 'To evaluate the effect of MEDI6570 on non-calcified coronary atherosclerotic plaques compared with placebo. The primary endpoint of change in NCPVMD from baseline to Day 253 was assessed based on the CTA Analysis Populations.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline to Day 253 in N Terminal Prohormone Brain Natriuretic Peptide (NT-proBNP)', 'timeFrame': 'From baseline to Day 253', 'description': 'To evaluate the effect of MEDI6570 on a surrogate biomarker of Heart Failure (HF) compared with placebo'}, {'measure': 'Change From Baseline to Day 253 in Left Ventricular Ejection Fraction (LVEF)', 'timeFrame': 'From baseline to Day 253', 'description': 'To evaluate the effect of MEDI6570 on left ventricular systolic function compared with placebo'}, {'measure': 'Left Ventricular Ejection Fraction (LVEF) Change From Baseline to Day 253 Among Subjects With Reduced Ejection Fraction (< 50%)', 'timeFrame': 'From baseline to Day 253', 'description': 'To evaluate the effect of MEDI6570 on left ventricular systolic function among participants with reduced ejection fraction (defined as \\<50%) compared with placebo'}, {'measure': 'Change From Baseline to Day 253 in Global Longitudinal Strain (GLS)', 'timeFrame': 'From baseline to Day 253', 'description': 'To evaluate the effect of MEDI6570 on left ventricular systolic function compared with placebo'}, {'measure': 'Global Longitudinal Strain (GLS) Change From Baseline to Day 253 Among Subjects With Reduced Ejection Fraction (< 50%)', 'timeFrame': 'From baseline to Day 253', 'description': 'To evaluate the effect of MEDI6570 on left ventricular systolic function among participants with reduced ejection fraction (defined as \\<50%) compared with placebo'}, {'measure': 'Change From Baseline to Day 253 in Global Non-calcified Plaque Volume (NCPV)', 'timeFrame': 'From baseline to Day 253', 'description': 'To evaluate the effect of MEDI6570 on other measures of non-calcified coronary atherosclerotic plaque compared with placebo'}, {'measure': 'Change From Baseline to Day 253 in Low Attenuation Plaque Volume (LAPV)', 'timeFrame': 'From baseline to Day 253', 'description': 'To evaluate the effect of MEDI6570 on other measures of non-calcified coronary atherosclerotic plaque compared with placebo'}, {'measure': 'Summary of ADA (Anti-drug Antibody) Responses During the Study', 'timeFrame': 'From baseline to Day 325/405. Day 325/405: for participants who completed the study under clinical study protocol (CSP) Amendment 1 & 2, the end of study visits were Day 405 and Day 325 respectively.', 'description': 'To evaluate the immunogenicity of MEDI6570'}, {'measure': 'Anti-drug Antibody Titre Summary by Visit', 'timeFrame': 'From Baseline to Day 325/405. Day 325/405: for participants who completed the study under CSP Amendment 1 & 2, the end of study visits were Day 405 and Day 325 respectively.', 'description': 'To evaluate the immunogenicity of MEDI6570'}, {'measure': 'Summary of Serum Concentrations (ug/mL) of MEDI6570', 'timeFrame': 'From baseline to Day 325/Day 405', 'description': 'MEDI6570 concentrations as measured in serum during the intervention and follow-up periods'}, {'measure': 'Number of Participants With Adverse Events in Any Category', 'timeFrame': 'During study follow-up (from day 1 to day 325)', 'description': 'To assess the safety and tolerability of MEDI6570 compared with placebo'}, {'measure': 'Number of Participants With Most Common Adverse Events (Frequency > 5%)', 'timeFrame': 'During study follow-up (from day 1 to day 325)', 'description': 'To assess the safety and tolerability of MEDI6570 compared with placebo'}, {'measure': 'Vital Signs (Change in Systolic and Diastolic Blood Pressure From Baseline) Over Time', 'timeFrame': 'From baseline to Day 325/405. Day 325/405: for participants who completed the study under CSP Amendment 1 & 2, the end of study visits were Day 405 and Day 325 respectively.', 'description': 'To assess the safety and tolerability of MEDI6570 compared with placebo'}, {'measure': 'Vital Signs (Change in Heart Rate From Baseline) Variables Over Time', 'timeFrame': 'From baseline to Day 325/405. Day 325/405: for participants who completed the study under CSP Amendment 1 & 2, the end of study visits were Day 405 and Day 325 respectively.', 'description': 'To assess the safety and tolerability of MEDI6570 compared with placebo'}, {'measure': 'Vital Signs (Change of Weight From Baseline to Day 325/405 )', 'timeFrame': 'From baseline to Day 325/405. Day 325/405: for participants who completed the study under CSP Amendment 1 & 2, the end of study visits were Day 405 and Day 325 respectively', 'description': 'To assess the safety and tolerability of MEDI6570 compared with placebo'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Coronary Heart Disease', 'Atherosclerosis'], 'conditions': ['Coronary Heart Disease (CHD)']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D4920C00002&attachmentIdentifier=596f3ac2-1432-4b10-b785-8bf7e7a911d6&fileName=D4920C00002_redacted_CSP.pdf&versionIdentifier=', 'label': 'redacted CSP'}, {'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D4920C00002&attachmentIdentifier=7c8d42e1-7892-43fd-85de-c2dbbcd00c67&fileName=D4920C00002_redacted_SAP.pdf&versionIdentifier=', 'label': 'redacted SAP'}, {'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D4920C00002&attachmentIdentifier=4135a31f-bf26-4a01-bd9c-fda516aec2ef&fileName=D4920C00002-_redacted_CSR_synopsis.pdf&versionIdentifier=', 'label': 'redacted CSR'}]}, 'descriptionModule': {'briefSummary': 'A Phase IIB Parallel group Study to Evaluate the Efficacy and Safety of MEDI6570 in Participants with a Prior Myocardial Infarction.', 'detailedDescription': 'This Phase IIB, proof-of-concept, dose-range finding clinical study is being conducted to evaluate the anti-inflammatory potential of MEDI6570 and its effect on surrogates for atherosclerotic and heart failure (HF) events in patients with a history of myocardial infarction (MI). The results of the Phase IIB study will inform future clinical development options and precision medicine strategy for future clinical studies.\n\nParticipants will be randomized in a 2:2:1:1 ratio after protocol Amend 2, 360 evaluable participants (111 evaluable participants in each of the 2 MEDI6570 groups, plus 27 evaluable participants in the legacy low dose MEDI6570 group, plus 111 participants in pooled placebo) will complete the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Participant must provide informed consent before any study specific activities are performed, must be able and willing to meet all requirements for randomization within 42 days after signing the full ICF, and must adhere to the schedules of activities.\n2. Women must be ≥ 40 years of age at the time of signing the ICF. Men must be ≥ 21 years of age at the time of signing the ICF.\n3. Participant must:\n\n 1. be 30 to 365 days after presumed type-1 (ie, due to plaque rupture or erosion) MI (either STEMI or NSTEMI) at the time of enrollment.\n 2. have persistent inflammation, defined as hs CRP ≥ 1 mg/L, as measured centrally at screening Visit 1.\n4. Participant must have body mass index within the range 18 to 40 kg/m2 inclusive.\n5. For female participants, the participant must not be pregnant or lactating and must be of non-childbearing potential, confirmed at screening Visit 1 by one of the following:\n\n 1. Postmenopausal, defined as amenorrhea for ≥ 12 months following cessation of all exogenous hormonal treatments, and with luteinizing hormone and follicle stimulating hormone levels in the postmenopausal range.\n 2. Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy. Tubal ligation is not considered as irreversible surgical sterilization.\n6. Participant must have an evaluable, pre-randomization CTA with quantifiable, non calcified plaque.\n\nExclusion Criteria:\n\n1. History of any clinically important disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study.\n2. Percutaneous coronary intervention or diagnostic angiogram planned after screening. Eligible participants who have a diagnostic angiogram performed in the absence of undergoing a new PCI may continue screening after the diagnostic angiogram has been performed or may be rescreened.\n3. History of or planned coronary artery bypass grafting.\n4. Documented episode of post-MI pericarditis in the 3 months before enrollment.\n5. Ongoing New York Heart Association Class IV HF.\n6. Increased risk of bleeding\n\n 1. Patients with history or presence of any bleeding disorder.\n 2. Signs of ongoing bleeding at screening (eg, identified macroscopic bleeding, low hemoglobin presumed to be caused by bleeding) or high risk for major bleeding in accordance with the Investigator's assessment.\n 3. Need for chronic therapeutic anticoagulation therapy anticipated to be required throughout the course of the study (short-term treatment with prophylactic doses of heparin/low molecular weight heparin are allowed).\n 4. Known severe liver disease.\n7. History or presence of any of the following:\n\n 1. Ongoing infection or febrile illness that in the opinion of the investigator may be the cause of elevated hs-CRP on screening.\n 2. Ongoing atrial fibrillation or flutter.\n 3. Cancer within 5 years before randomization, with the exception of non melanoma skin cancer.\n 4. Alcohol or substance abuse within 6 months before randomization, as judged by the investigator.\n 5. Known history of hypersensitivity reactions to other biologics, to human IgG preparations, or to any component of MEDI6570, or ongoing severe allergy as judged by the investigator.\n 6. Patients with active positive results on screening for serum hepatitis B surface antigen, hepatitis C antibody, or HIV.\n8. Any clinically important abnormalities in clinical chemistry, hematology, coagulation parameters, as judged by the investigator.\n9. BP values at screening:\n\n 1. Systolic BP \\< 90 mmHg or \\> 180 mmHg.\n 2. Diastolic BP \\> 100 mmHg.\n 3. Participants who are excluded based on elevated BP may be rescreened following adequate treatment.\n10. Participants with any of the following contraindications to CTA:\n\n 1. eGFR \\< 50 mL/min/1.73 m2 by the Chronic Kidney Disease Epidemiology Collaboration equation, or end stage renal disease treated with kidney transplant or renal replacement therapy.\n 2. Allergy to iodinated contrast.\n 3. History of contrast-induced nephropathy.\n 4. Contraindication to nitroglycerin.\n 5. Rapid heart rate that is uncontrolled by medical therapy.\n 6. Inability to hold breath for at least 6 seconds.\n11. Receipt of any investigational device or therapy within 6 months or 5 half lives before screening (whichever is longer).\n\n This criterion does NOT apply for inactive, non replicating COVID-19 vaccines approved by Health Authorities or under emergency use authorization.\n12. Planned participation in an additional investigational study of an intervention or biologic before the end of the follow-up period. Participation in observational studies or studies without investigational drugs or devices is allowed.\n13. Participants who are legally institutionalized.\n14. 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