Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2026-03-06 @ 10:11 PM
Study NCT ID:
NCT01968967
Status:
COMPLETED
Last Update Posted:
2018-07-31
First Post:
2013-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Randomized Clinical Trial of Bococizumab (PF-04950615; RN316) in Subjects With Hyperlipidemia or Mixed Dyslipidemia at Risk of Cardiovascular Events
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006949', 'term': 'Hyperlipidemias'}], 'ancestors': [{'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000598888', 'term': 'bococizumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58', 'description': 'Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo (Treatment Period)', 'description': 'Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.', 'otherNumAtRisk': 1065, 'deathsNumAtRisk': 1065, 'otherNumAffected': 138, 'seriousNumAtRisk': 1065, 'deathsNumAffected': 9, 'seriousNumAffected': 150}, {'id': 'EG001', 'title': 'Bococizumab 150 mg (Treatment Period)', 'description': 'Participants received Bococizumab (PF--04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52 and were followed up to Week 58.', 'otherNumAtRisk': 1063, 'deathsNumAtRisk': 1063, 'otherNumAffected': 177, 'seriousNumAtRisk': 1063, 'deathsNumAffected': 2, 'seriousNumAffected': 116}, {'id': 'EG002', 'title': 'Placebo (Extension Period)', 'description': 'Participants randomized to Placebo arm in treatment period and consented for extension period after Week 58 follow-up visit, were followed for SAEs and concomitant medications up to Week 110.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 47, 'otherNumAffected': 0, 'seriousNumAtRisk': 47, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Bococizumab ADA Positive (Extension Period)', 'description': 'Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their ADA assessment at Week 58 follow-up visit. In extension period, participants who were ADA positive and consented for extension period were assessed for ADA and LDL-C direct measurement until ADA titers were no longer detectable or had returned to baseline titer (less than or equal to 1.58 (log2) units above a positive baseline titer) or until Week 110 along with SAEs and concomitant medication, from Week 58 follow up visit to Week 110.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 19, 'otherNumAffected': 0, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG004', 'title': 'Bococizumab ADA Negative (Extension Period)', 'description': 'Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their Week 58 follow-up ADA assessment. Participants who were ADA negative and consented for extension period were followed for SAEs and concomitant medication, from Week 58 follow up visit to Week 110.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 39, 'otherNumAffected': 0, 'seriousNumAtRisk': 39, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 97}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 60}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 50}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 61}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 47}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}], 'seriousEvents': [{'term': 'Left leg - severe pain, redness, and induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Aortic valve calcification', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Aortic valve stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Arteriosclerosis coronary artery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Arteriospasm coronary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Atrioventricular block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cardiorenal syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Coronary artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hypertensive heart disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Mitral valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Subvalvular aortic stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Ventricular extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': "Bartter's syndrome", 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Vertigo positional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Abdominal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Colitis ulcerative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Food poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Lower gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Oesophageal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Peptic ulcer haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Salivary gland calculus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Volvulus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Impaired healing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Peripheral swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Biliary colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Jaundice cholestatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Appendicitis perforated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Arthritis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cellulitis of male external genital organ', 'notes': 'This event was gender specific.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 635, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 630, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Device related infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Diabetic gangrene', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Escherichia sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Localised infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Otitis externa', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pneumonia bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pyelonephritis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Scrotal abscess', 'notes': 'This event was gender specific.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 635, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 630, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 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tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cervical spinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Costochondritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Flank pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Intervertebral disc degeneration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Intervertebral disc disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Lumbar spinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Metatarsalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Neck mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Polymyalgia rheumatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Rheumatoid arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Spinal column stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Synovial cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Acute myeloid leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Bladder cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Endometrial adenocarcinoma', 'notes': 'This event was gender specific.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 430, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Endometrial cancer', 'notes': 'This event was gender specific.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 430, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Gastric cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Glioblastoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Invasive ductal breast carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Lung adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Malignant melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Metastases to spine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Metastatic neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Ovarian cancer', 'notes': 'This event was gender specific.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 430, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Papillary thyroid cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Prostate cancer', 'notes': 'This event was gender specific.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 635, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 630, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Schwannoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Transitional cell carcinoma recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Uterine cancer', 'notes': 'This event was gender specific.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 430, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Uterine leiomyoma', 'notes': 'This event was gender specific.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 430, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Aphasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Carotid arteriosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cervical myelopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Embolic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Facial paralysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Lacunar infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Loss of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Mental impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Myelopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Radiculopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Drug dependence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Schizoaffective disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Chronic kidney disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Renal colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Renal mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Ureteric obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Urethral stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Prostatic haemorrhage', 'notes': 'This event was gender specific.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 635, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 630, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Scrotal ulcer', 'notes': 'This event was gender specific.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 635, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 630, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Vaginal prolapse', 'notes': 'This event was gender specific.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 430, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 433, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Dyspnoea exertional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Sleep apnoea syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Aortic stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hypovolaemic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Intermittent claudication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Peripheral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Peripheral vascular disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Vena cava thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Venous thrombosis limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Condition aggravated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pulmonary mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1065, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '994', 'groupId': 'OG000'}, {'value': '980', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (Treatment Period)', 'description': 'Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.'}, {'id': 'OG001', 'title': 'Bococizumab 150 mg (Treatment Period)', 'description': 'Participants received Bococizumab (PF--04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.0', 'spread': '22.55', 'groupId': 'OG000'}, {'value': '-54.9', 'spread': '26.84', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-56.2', 'ciLowerLimit': '-58.3', 'ciUpperLimit': '-54.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.10', 'groupDescription': 'Least square (LS) mean difference and associated 95 percent (%) confidence interval (CI), and p-value were derived from mixed effect model repeat measurement (MMRM) model with fixed effects for treatment group, visit, treatment group\\*visit interaction, baseline value, baseline value\\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were randomized. Here, "Number of participants analyzed (N)" signifies number of participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Fasting Total Cholesterol (TC) at Week 12, 24 and 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1071', 'groupId': 'OG000'}, {'value': '1068', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (Treatment Period)', 'description': 'Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.'}, {'id': 'OG001', 'title': 'Bococizumab 150 mg (Treatment Period)', 'description': 'Participants received Bococizumab (PF--04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.'}], 'classes': [{'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '997', 'groupId': 'OG000'}, {'value': '981', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '16.18', 'groupId': 'OG000'}, {'value': '-34.9', 'spread': '18.34', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '988', 'groupId': 'OG000'}, {'value': '988', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': '18.68', 'groupId': 'OG000'}, {'value': '-30.5', 'spread': '21.56', 'groupId': 'OG001'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '920', 'groupId': 'OG000'}, {'value': '932', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'spread': '18.75', 'groupId': 'OG000'}, {'value': '-25.3', 'spread': '23.43', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-35.0', 'ciLowerLimit': '-36.5', 'ciUpperLimit': '-33.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.76', 'groupDescription': 'Week 12: LS mean difference and associated 95% CI and p-value were derived from MMRM model with fixed effects for treatment group, visit, treatment group\\*visit interaction, baseline value, baseline value\\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-31.6', 'ciLowerLimit': '-33.3', 'ciUpperLimit': '-29.8', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.89', 'groupDescription': 'Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\\*visit interaction, baseline value, baseline value\\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-24.7', 'ciLowerLimit': '-26.6', 'ciUpperLimit': '-22.8', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.96', 'groupDescription': 'Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\\*visit interaction, baseline value, baseline value\\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12, 24, 52', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were randomized. Here, "n" signifies number of participants who were evaluable at the specified time points.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) at Week 12, 24 and 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1071', 'groupId': 'OG000'}, {'value': '1068', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (Treatment Period)', 'description': 'Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.'}, {'id': 'OG001', 'title': 'Bococizumab 150 mg (Treatment Period)', 'description': 'Participants received Bococizumab (PF--04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.'}], 'classes': [{'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '994', 'groupId': 'OG000'}, {'value': '978', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '18.83', 'groupId': 'OG000'}, {'value': '-50.4', 'spread': '27.42', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '987', 'groupId': 'OG000'}, {'value': '988', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.5', 'spread': '21.43', 'groupId': 'OG000'}, {'value': '-44.9', 'spread': '31.17', 'groupId': 'OG001'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '915', 'groupId': 'OG000'}, {'value': '929', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'spread': '21.78', 'groupId': 'OG000'}, {'value': '-37.4', 'spread': '32.92', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-50.8', 'ciLowerLimit': '-52.9', 'ciUpperLimit': '-48.8', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.04', 'groupDescription': 'Week 12: LS mean difference and associated 95% CI and p-value were derived from MMRM model with fixed effects for treatment group, visit, treatment group\\*visit interaction, baseline value, baseline value\\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-46.1', 'ciLowerLimit': '-48.5', 'ciUpperLimit': '-43.8', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.19', 'groupDescription': 'Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\\*visit interaction, baseline value, baseline value\\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-36.1', 'ciLowerLimit': '-38.6', 'ciUpperLimit': '-33.6', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.28', 'groupDescription': 'Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\\*visit interaction, baseline value, baseline value\\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12, 24, 52', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were randomized. Here, "n" signifies number of participants who were evaluable at the specified time points.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24 and 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1071', 'groupId': 'OG000'}, {'value': '1068', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (Treatment Period)', 'description': 'Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.'}, {'id': 'OG001', 'title': 'Bococizumab 150 mg (Treatment Period)', 'description': 'Participants received Bococizumab (PF--04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.'}], 'classes': [{'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '996', 'groupId': 'OG000'}, {'value': '980', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '21.22', 'groupId': 'OG000'}, {'value': '-49.7', 'spread': '25.51', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '987', 'groupId': 'OG000'}, {'value': '987', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.6', 'spread': '24.65', 'groupId': 'OG000'}, {'value': '-43.8', 'spread': '30.02', 'groupId': 'OG001'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '919', 'groupId': 'OG000'}, {'value': '932', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'spread': '24.62', 'groupId': 'OG000'}, {'value': '-36.8', 'spread': '32.73', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-50.1', 'ciLowerLimit': '-52.1', 'ciUpperLimit': '-48.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.04', 'groupDescription': 'Week 12: LS mean difference and associated 95% CI and p-value were derived from MMRM model with fixed effects for treatment group, visit, treatment group\\*visit interaction, baseline value, baseline value\\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-45.5', 'ciLowerLimit': '-47.9', 'ciUpperLimit': '-43.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.22', 'groupDescription': 'Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\\*visit interaction, baseline value, baseline value\\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-35.9', 'ciLowerLimit': '-38.5', 'ciUpperLimit': '-33.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.33', 'groupDescription': 'Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\\*visit interaction, baseline value, baseline value\\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12, 24, 52', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were randomized. Here, "n" signifies number of participants who were evaluable at the specified time points.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides (TG) Cut-off of Less Than (<) 200 Milligram Per Deciliter (mg/dL) at Week 12, 24 and 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '791', 'groupId': 'OG000'}, {'value': '788', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (Treatment Period)', 'description': 'Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.'}, {'id': 'OG001', 'title': 'Bococizumab 150 mg (Treatment Period)', 'description': 'Participants received Bococizumab (PF--04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.'}], 'classes': [{'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '734', 'groupId': 'OG000'}, {'value': '725', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.9', 'spread': '23.07', 'groupId': 'OG000'}, {'value': '-55.6', 'spread': '26.81', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '730', 'groupId': 'OG000'}, {'value': '729', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.9', 'spread': '27.17', 'groupId': 'OG000'}, {'value': '-49.2', 'spread': '32.58', 'groupId': 'OG001'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '683', 'groupId': 'OG000'}, {'value': '688', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.2', 'spread': '26.65', 'groupId': 'OG000'}, {'value': '-40.6', 'spread': '36.45', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-57.7', 'ciLowerLimit': '-60.2', 'ciUpperLimit': '-55.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.29', 'groupDescription': 'Week 12: LS mean difference and associated 95% CI and p-value were derived from MMRM model with fixed effects for treatment group, visit, treatment group\\*visit interaction, baseline value, baseline value\\*visit interaction and geographical region. An unstructured variance covariance matrix was used.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-53.1', 'ciLowerLimit': '-56.1', 'ciUpperLimit': '-50.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.55', 'groupDescription': 'Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\\*visit interaction, baseline value, baseline value\\*visit interaction and geographical region. An unstructured variance covariance matrix was used.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-42.8', 'ciLowerLimit': '-46.2', 'ciUpperLimit': '-39.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.70', 'groupDescription': 'Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\\*visit interaction, baseline value, baseline value\\*visit interaction and geographical region. An unstructured variance covariance matrix was used.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12, 24, 52', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A subset of FAS included all participants who were randomized and had TG \\<200 mg/dL at pre-randomization. Here, "n" signifies number of participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides Cut-off of Greater Than or Equal to (>=) 200 Milligram Per Deciliter (mg/dL) at Week 12, 24 and 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '280', 'groupId': 'OG000'}, {'value': '280', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (Treatment Period)', 'description': 'Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.'}, {'id': 'OG001', 'title': 'Bococizumab 150 mg (Treatment Period)', 'description': 'Participants received Bococizumab (PF--04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.'}], 'classes': [{'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '255', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.5', 'spread': '20.82', 'groupId': 'OG000'}, {'value': '-53.0', 'spread': '26.90', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '257', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.1', 'spread': '28.21', 'groupId': 'OG000'}, {'value': '-42.8', 'spread': '31.87', 'groupId': 'OG001'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '237', 'groupId': 'OG000'}, {'value': '241', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.2', 'spread': '27.78', 'groupId': 'OG000'}, {'value': '-36.3', 'spread': '34.88', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-51.8', 'ciLowerLimit': '-55.9', 'ciUpperLimit': '-47.7', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.09', 'groupDescription': 'Week 12: LS mean difference and associated 95% CI and p-value were derived from MMRM model with fixed effects for treatment group, visit, treatment group\\*visit interaction, baseline value, baseline value\\*visit interaction and geographical region. An unstructured variance covariance matrix was used.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-44.0', 'ciLowerLimit': '-49.1', 'ciUpperLimit': '-38.8', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.61', 'groupDescription': 'Week 24: LS mean difference and associated 95% CI were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\\*visit interaction, baseline value, baseline value\\*visit interaction and geographical region. An unstructured variance covariance matrix was used.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-34.6', 'ciLowerLimit': '-40.2', 'ciUpperLimit': '-29.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.83', 'groupDescription': 'Week 52: LS mean difference and associated 95% CI were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\\*visit interaction, baseline value, baseline value\\*visit interaction and geographical region. An unstructured variance covariance matrix was used.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12, 24, 52', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A subset of FAS included all participants who were randomized and had TG \\>=200 mg/dL at pre-randomization. Here, "n" signifies number of participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Fasting Lipoprotein (a) (Lp[a]) at Week 12, 24 and 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1071', 'groupId': 'OG000'}, {'value': '1068', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (Treatment Period)', 'description': 'Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.'}, {'id': 'OG001', 'title': 'Bococizumab 150 mg (Treatment Period)', 'description': 'Participants received Bococizumab (PF--04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.'}], 'classes': [{'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '994', 'groupId': 'OG000'}, {'value': '975', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.4', 'spread': '85.08', 'groupId': 'OG000'}, {'value': '-26.3', 'spread': '42.63', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '984', 'groupId': 'OG000'}, {'value': '983', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.7', 'spread': '146.00', 'groupId': 'OG000'}, {'value': '-22.7', 'spread': '51.48', 'groupId': 'OG001'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '918', 'groupId': 'OG000'}, {'value': '927', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.3', 'spread': '139.49', 'groupId': 'OG000'}, {'value': '-20.9', 'spread': '110.14', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-28.5', 'ciLowerLimit': '-34.4', 'ciUpperLimit': '-22.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.04', 'groupDescription': 'Week 12: LS mean difference and associated 95% CI and p-value were derived from MMRM model with fixed effects for treatment group, visit, treatment group\\*visit interaction, baseline value, baseline value\\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-31.1', 'ciLowerLimit': '-40.6', 'ciUpperLimit': '-21.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.86', 'groupDescription': 'Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\\*visit interaction, baseline value, baseline value\\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-25.3', 'ciLowerLimit': '-36.8', 'ciUpperLimit': '-13.7', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.89', 'groupDescription': 'Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\\*visit interaction, baseline value, baseline value\\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12, 24, 52', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were randomized. Here, "n" signifies number of participants who were evaluable at the specified time points.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24 and 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1071', 'groupId': 'OG000'}, {'value': '1068', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (Treatment Period)', 'description': 'Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.'}, {'id': 'OG001', 'title': 'Bococizumab 150 mg (Treatment Period)', 'description': 'Participants received Bococizumab (PF--04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.'}], 'classes': [{'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '996', 'groupId': 'OG000'}, {'value': '981', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '13.92', 'groupId': 'OG000'}, {'value': '6.2', 'spread': '14.99', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '987', 'groupId': 'OG000'}, {'value': '987', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.5', 'spread': '15.25', 'groupId': 'OG000'}, {'value': '6.1', 'spread': '15.32', 'groupId': 'OG001'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '919', 'groupId': 'OG000'}, {'value': '932', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.2', 'spread': '16.09', 'groupId': 'OG000'}, {'value': '6.5', 'spread': '17.87', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.8', 'ciLowerLimit': '4.5', 'ciUpperLimit': '7.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.63', 'groupDescription': 'Week 12: LS mean difference and associated 95% CI and p-value were derived from MMRM model with fixed effects for treatment group, visit, treatment group\\*visit interaction, baseline value, baseline value\\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.5', 'ciLowerLimit': '4.2', 'ciUpperLimit': '6.8', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.67', 'groupDescription': 'Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\\*visit interaction, baseline value, baseline value\\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.2', 'ciLowerLimit': '3.7', 'ciUpperLimit': '6.7', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.76', 'groupDescription': 'Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\\*visit interaction, baseline value, baseline value\\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12, 24, 52', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were randomized. Here, "n" signifies number of participants who were evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 24, 52: Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1071', 'groupId': 'OG000'}, {'value': '1068', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (Treatment Period)', 'description': 'Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.'}, {'id': 'OG001', 'title': 'Bococizumab 150 mg (Treatment Period)', 'description': 'Participants received Bococizumab (PF--04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.'}], 'classes': [{'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '987', 'groupId': 'OG000'}, {'value': '989', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.2', 'spread': '27.45', 'groupId': 'OG000'}, {'value': '-47.5', 'spread': '32.50', 'groupId': 'OG001'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '920', 'groupId': 'OG000'}, {'value': '929', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.1', 'spread': '27.00', 'groupId': 'OG000'}, {'value': '-39.5', 'spread': '36.08', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-50.7', 'ciLowerLimit': '-53.3', 'ciUpperLimit': '-48.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.34', 'groupDescription': 'Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\\*visit interaction, baseline value, baseline value\\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-40.7', 'ciLowerLimit': '-43.5', 'ciUpperLimit': '-37.8', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.46', 'groupDescription': 'Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\\*visit interaction, baseline value, baseline value\\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24, 52', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were randomized. Here, "N" signifies number of participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Fasting Triglycerides (TG) at Week 12, 24 and 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1071', 'groupId': 'OG000'}, {'value': '1068', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (Treatment Period)', 'description': 'Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.'}, {'id': 'OG001', 'title': 'Bococizumab 150 mg (Treatment Period)', 'description': 'Participants received Bococizumab (PF--04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.'}], 'classes': [{'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '997', 'groupId': 'OG000'}, {'value': '981', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.5', 'spread': '38.25', 'groupId': 'OG000'}, {'value': '-12.9', 'spread': '39.99', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '988', 'groupId': 'OG000'}, {'value': '988', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.1', 'spread': '51.06', 'groupId': 'OG000'}, {'value': '-11.5', 'spread': '41.33', 'groupId': 'OG001'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '920', 'groupId': 'OG000'}, {'value': '932', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '43.63', 'groupId': 'OG000'}, {'value': '-12.5', 'spread': '40.82', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-16.6', 'ciLowerLimit': '-20.0', 'ciUpperLimit': '-13.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.73', 'groupDescription': 'Week 12: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\\*visit interaction, baseline value, baseline value\\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-16.7', 'ciLowerLimit': '-20.7', 'ciUpperLimit': '-12.6', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.05', 'groupDescription': 'Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\\*visit interaction, baseline value, baseline value\\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-12.8', 'ciLowerLimit': '-16.5', 'ciUpperLimit': '-9.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.91', 'groupDescription': 'Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\\*visit interaction, baseline value, baseline value\\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12, 24, 52', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were randomized. Here, "n" signifies number of participants who were evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Fasting Apolipoprotein A-I (ApoA-I) at Week 12, 24 and 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1071', 'groupId': 'OG000'}, {'value': '1068', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (Treatment Period)', 'description': 'Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.'}, {'id': 'OG001', 'title': 'Bococizumab 150 mg (Treatment Period)', 'description': 'Participants received Bococizumab (PF--04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.'}], 'classes': [{'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '995', 'groupId': 'OG000'}, {'value': '980', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.6', 'spread': '11.22', 'groupId': 'OG000'}, {'value': '2.8', 'spread': '11.73', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '987', 'groupId': 'OG000'}, {'value': '988', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.9', 'spread': '12.10', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '11.93', 'groupId': 'OG001'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '916', 'groupId': 'OG000'}, {'value': '929', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.2', 'spread': '12.34', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '13.75', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.4', 'ciLowerLimit': '2.4', 'ciUpperLimit': '4.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.49', 'groupDescription': 'Week 12: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\\*visit interaction, baseline value, baseline value\\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.5', 'ciLowerLimit': '2.5', 'ciUpperLimit': '4.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.51', 'groupDescription': 'Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\\*visit interaction, baseline value, baseline value\\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.8', 'ciLowerLimit': '2.7', 'ciUpperLimit': '4.9', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.57', 'groupDescription': 'Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\\*visit interaction, baseline value, baseline value\\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12, 24, 52', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were randomized. Here, "n" signifies number of participants who were evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Fasting Apolipoprotein A-II (ApoA-II) at Week 12, 24 and 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1071', 'groupId': 'OG000'}, {'value': '1068', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (Treatment Period)', 'description': 'Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.'}, {'id': 'OG001', 'title': 'Bococizumab 150 mg (Treatment Period)', 'description': 'Participants received Bococizumab (PF--04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.'}], 'classes': [{'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '993', 'groupId': 'OG000'}, {'value': '972', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.2', 'spread': '13.05', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '13.75', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '986', 'groupId': 'OG000'}, {'value': '986', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.9', 'spread': '13.56', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '14.28', 'groupId': 'OG001'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '916', 'groupId': 'OG000'}, {'value': '928', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.5', 'spread': '13.50', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '13.72', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-0.9', 'ciUpperLimit': '1.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.59', 'groupDescription': 'Week 12: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\\*visit interaction, baseline value, baseline value\\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.1', 'ciLowerLimit': '-0.1', 'ciUpperLimit': '2.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.61', 'groupDescription': 'Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\\*visit interaction, baseline value, baseline value\\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.5', 'ciLowerLimit': '0.3', 'ciUpperLimit': '2.7', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.61', 'groupDescription': 'Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\\*visit interaction, baseline value, baseline value\\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12, 24, 52', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were randomized. Here, "n" signifies number of participants who were evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Fasting Very Low Density Lipoprotein Cholesterol (VLDL-C) at Week 12, 24 and 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1071', 'groupId': 'OG000'}, {'value': '1068', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (Treatment Period)', 'description': 'Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.'}, {'id': 'OG001', 'title': 'Bococizumab 150 mg (Treatment Period)', 'description': 'Participants received Bococizumab (PF--04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.'}], 'classes': [{'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '997', 'groupId': 'OG000'}, {'value': '981', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.5', 'spread': '38.25', 'groupId': 'OG000'}, {'value': '-12.9', 'spread': '39.99', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '988', 'groupId': 'OG000'}, {'value': '988', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.1', 'spread': '51.06', 'groupId': 'OG000'}, {'value': '-11.5', 'spread': '41.33', 'groupId': 'OG001'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '920', 'groupId': 'OG000'}, {'value': '932', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '43.63', 'groupId': 'OG000'}, {'value': '-12.5', 'spread': '40.82', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-16.6', 'ciLowerLimit': '-20.0', 'ciUpperLimit': '-13.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.73', 'groupDescription': 'Week 12: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\\*visit interaction, baseline value, baseline value\\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-16.7', 'ciLowerLimit': '-20.7', 'ciUpperLimit': '-12.6', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.05', 'groupDescription': 'Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\\*visit interaction, baseline value, baseline value\\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-12.8', 'ciLowerLimit': '-16.5', 'ciUpperLimit': '-9.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.91', 'groupDescription': 'Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\\*visit interaction, baseline value, baseline value\\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12, 24, 52', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were randomized. Here, "n" signifies number of participants who were evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides Cut-off of Less Than (<) 200 Milligram Per Deciliter (mg/dL) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '791', 'groupId': 'OG000'}, {'value': '788', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (Treatment Period)', 'description': 'Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.'}, {'id': 'OG001', 'title': 'Bococizumab 150 mg (Treatment Period)', 'description': 'Participants received Bococizumab (PF--04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '791', 'groupId': 'OG000'}, {'value': '787', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '109.1', 'spread': '33.24', 'groupId': 'OG000'}, {'value': '107.1', 'spread': '30.43', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '734', 'groupId': 'OG000'}, {'value': '725', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '25.70', 'groupId': 'OG000'}, {'value': '-59.3', 'spread': '32.30', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-60.4', 'ciLowerLimit': '-63.1', 'ciUpperLimit': '-57.6', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.40', 'groupDescription': 'LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\\*visit interaction, baseline value, baseline value\\*visit interaction and geographical region. An unstructured variance covariance matrix was used.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A subset of FAS included all participants who were randomized and had TG \\<200 mg/dL at pre-randomization. Here, "n" signifies number of participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides Cut-off of Greater Than or Equal to (>=) 200 Milligram Per Deciliter (mg/dL) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '280', 'groupId': 'OG000'}, {'value': '280', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (Treatment Period)', 'description': 'Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.'}, {'id': 'OG001', 'title': 'Bococizumab 150 mg (Treatment Period)', 'description': 'Participants received Bococizumab (PF--04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '280', 'groupId': 'OG000'}, {'value': '280', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '125.9', 'spread': '40.08', 'groupId': 'OG000'}, {'value': '121.5', 'spread': '37.84', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '255', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.4', 'spread': '29.08', 'groupId': 'OG000'}, {'value': '-64.8', 'spread': '38.94', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-62.8', 'ciLowerLimit': '-68.3', 'ciUpperLimit': '-57.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.80', 'groupDescription': 'LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\\*visit interaction, baseline value, baseline value\\*visit interaction and geographical region. An unstructured variance covariance matrix was used.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A subset of FAS included all participants who were randomized and had TG \\>=200 mg/dL at pre-randomization. Here, "n" signifies number of participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1071', 'groupId': 'OG000'}, {'value': '1068', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (Treatment Period)', 'description': 'Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.'}, {'id': 'OG001', 'title': 'Bococizumab 150 mg (Treatment Period)', 'description': 'Participants received Bococizumab (PF--04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1071', 'groupId': 'OG000'}, {'value': '1067', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '113.5', 'spread': '35.90', 'groupId': 'OG000'}, {'value': '110.9', 'spread': '33.13', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '994', 'groupId': 'OG000'}, {'value': '980', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.7', 'spread': '26.66', 'groupId': 'OG000'}, {'value': '-60.7', 'spread': '34.22', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-61.0', 'ciLowerLimit': '-63.5', 'ciUpperLimit': '-58.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.27', 'groupDescription': 'LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\\*visit interaction, baseline value, baseline value\\*visit interaction geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were randomized. Here, "n" signifies number of participants who were evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Absolute Change From Baseline in Fasting Total Cholesterol (TC) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1071', 'groupId': 'OG000'}, {'value': '1068', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (Treatment Period)', 'description': 'Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.'}, {'id': 'OG001', 'title': 'Bococizumab 150 mg (Treatment Period)', 'description': 'Participants received Bococizumab (PF--04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1071', 'groupId': 'OG000'}, {'value': '1067', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '186.3', 'spread': '40.77', 'groupId': 'OG000'}, {'value': '183.1', 'spread': '38.31', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '997', 'groupId': 'OG000'}, {'value': '981', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.8', 'spread': '31.62', 'groupId': 'OG000'}, {'value': '-64.5', 'spread': '38.01', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-63.7', 'ciLowerLimit': '-66.6', 'ciUpperLimit': '-60.9', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.46', 'groupDescription': 'LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\\*visit interaction, baseline value, baseline value\\*visit interaction geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were randomized. Here, "n" signifies number of participants who were evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Absolute Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (HDL-C) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1071', 'groupId': 'OG000'}, {'value': '1068', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (Treatment Period)', 'description': 'Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.'}, {'id': 'OG001', 'title': 'Bococizumab 150 mg (Treatment Period)', 'description': 'Participants received Bococizumab (PF--04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1071', 'groupId': 'OG000'}, {'value': '1066', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '138.0', 'spread': '39.67', 'groupId': 'OG000'}, {'value': '135.3', 'spread': '36.85', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '996', 'groupId': 'OG000'}, {'value': '980', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.6', 'spread': '30.93', 'groupId': 'OG000'}, {'value': '-67.0', 'spread': '38.89', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-66.4', 'ciLowerLimit': '-69.3', 'ciUpperLimit': '-63.6', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.46', 'groupDescription': 'LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\\*visit interaction, baseline value, baseline value\\*visit interaction geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were randomized. Here, "n" signifies number of participants who were evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Absolute Change From Baseline in Fasting Apolipoprotein B (ApoB) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1071', 'groupId': 'OG000'}, {'value': '1068', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (Treatment Period)', 'description': 'Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.'}, {'id': 'OG001', 'title': 'Bococizumab 150 mg (Treatment Period)', 'description': 'Participants received Bococizumab (PF--04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1070', 'groupId': 'OG000'}, {'value': '1067', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '94.0', 'spread': '24.26', 'groupId': 'OG000'}, {'value': '92.3', 'spread': '22.74', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '994', 'groupId': 'OG000'}, {'value': '978', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.7', 'spread': '18.35', 'groupId': 'OG000'}, {'value': '-46.0', 'spread': '26.58', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-45.8', 'ciLowerLimit': '-47.7', 'ciUpperLimit': '-43.9', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.97', 'groupDescription': 'LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\\*visit interaction, baseline value, baseline value\\*visit interaction geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were randomized. Here, "n" signifies number of participants who were evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Absolute Change From Baseline in Fasting Lipoprotein (a) (Lp[a]) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1071', 'groupId': 'OG000'}, {'value': '1068', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (Treatment Period)', 'description': 'Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.'}, {'id': 'OG001', 'title': 'Bococizumab 150 mg (Treatment Period)', 'description': 'Participants received Bococizumab (PF--04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1069', 'groupId': 'OG000'}, {'value': '1063', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '45.3', 'spread': '49.77', 'groupId': 'OG000'}, {'value': '46.4', 'spread': '55.57', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '994', 'groupId': 'OG000'}, {'value': '975', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.0', 'spread': '12.07', 'groupId': 'OG000'}, {'value': '-10.6', 'spread': '18.36', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-10.6', 'ciLowerLimit': '-11.8', 'ciUpperLimit': '-9.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.63', 'groupDescription': 'LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\\*visit interaction, baseline value, baseline value\\*visit interaction geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were randomized. Here, "n" signifies number of participants who were evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Absolute Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1071', 'groupId': 'OG000'}, {'value': '1068', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (Treatment Period)', 'description': 'Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.'}, {'id': 'OG001', 'title': 'Bococizumab 150 mg (Treatment Period)', 'description': 'Participants received Bococizumab (PF--04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1071', 'groupId': 'OG000'}, {'value': '1066', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '48.3', 'spread': '12.42', 'groupId': 'OG000'}, {'value': '47.8', 'spread': '12.72', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '996', 'groupId': 'OG000'}, {'value': '981', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '6.84', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '7.07', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.7', 'ciLowerLimit': '2.1', 'ciUpperLimit': '3.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.31', 'groupDescription': 'LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\\*visit interaction, baseline value, baseline value\\*visit interaction geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were randomized. Here, "n" signifies number of participants who were evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Absolute Change From Baseline in Ratio of Fasting Total Cholesterol (TC) to High Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24 and 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1071', 'groupId': 'OG000'}, {'value': '1068', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (Treatment Period)', 'description': 'Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.'}, {'id': 'OG001', 'title': 'Bococizumab 150 mg (Treatment Period)', 'description': 'Participants received Bococizumab (PF--04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1071', 'groupId': 'OG000'}, {'value': '1066', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.1', 'spread': '1.22', 'groupId': 'OG000'}, {'value': '4.0', 'spread': '1.19', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '996', 'groupId': 'OG000'}, {'value': '980', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.0', 'spread': '0.86', 'groupId': 'OG000'}, {'value': '-1.5', 'spread': '1.09', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '987', 'groupId': 'OG000'}, {'value': '987', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.96', 'groupId': 'OG000'}, {'value': '-1.4', 'spread': '1.15', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '919', 'groupId': 'OG000'}, {'value': '932', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.0', 'spread': '0.97', 'groupId': 'OG000'}, {'value': '-1.1', 'spread': '1.21', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.6', 'ciLowerLimit': '-1.6', 'ciUpperLimit': '-1.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.04', 'groupDescription': 'Week 12: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\\*visit interaction, baseline value, baseline value\\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.4', 'ciLowerLimit': '-1.5', 'ciUpperLimit': '-1.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.05', 'groupDescription': 'Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\\*visit interaction, baseline value, baseline value\\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.1', 'ciLowerLimit': '-1.2', 'ciUpperLimit': '-1.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.05', 'groupDescription': 'Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\\*visit interaction, baseline value, baseline value\\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12, 24, 52', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were randomized. Here, "n" signifies number of participants who were evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Ratio of Fasting Apolipoprotein B (ApoB) to Apolipoprotein A-I (ApoA-I) at Week 12, 24 and 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1071', 'groupId': 'OG000'}, {'value': '1068', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (Treatment Period)', 'description': 'Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.'}, {'id': 'OG001', 'title': 'Bococizumab 150 mg (Treatment Period)', 'description': 'Participants received Bococizumab (PF--04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1070', 'groupId': 'OG000'}, {'value': '1067', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': '0.21', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '0.20', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '994', 'groupId': 'OG000'}, {'value': '978', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '0.21', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '987', 'groupId': 'OG000'}, {'value': '988', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '0.23', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '915', 'groupId': 'OG000'}, {'value': '929', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '0.23', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '-0.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.01', 'groupDescription': 'Week 12: LS mean difference and associated 95% confidence interval CI were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\\*visit interaction, baseline value, baseline value\\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '-0.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.01', 'groupDescription': 'Week 24: LS mean difference and associated 95% confidence interval CI were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\\*visit interaction, baseline value, baseline value\\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '-0.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.01', 'groupDescription': 'Week 52: LS mean difference and associated 95% confidence interval CI were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\\*visit interaction, baseline value, baseline value\\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12, 24, 52', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were randomized. Here, "n" signifies number of participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Fasting Low Density Lipoprotein Cholesterol (LDL-C) Less Than or Equal to (<=) 100 Milligram Per Deciliter (mg/dL) at Week 12, 24 and 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1071', 'groupId': 'OG000'}, {'value': '1068', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (Treatment Period)', 'description': 'Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.'}, {'id': 'OG001', 'title': 'Bococizumab 150 mg (Treatment Period)', 'description': 'Participants received Bococizumab (PF--04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.'}], 'classes': [{'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '994', 'groupId': 'OG000'}, {'value': '980', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '45.3', 'groupId': 'OG000'}, {'value': '90.9', 'groupId': 'OG001'}]}]}, {'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '987', 'groupId': 'OG000'}, {'value': '990', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '43.2', 'groupId': 'OG000'}, {'value': '85.8', 'groupId': 'OG001'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '920', 'groupId': 'OG000'}, {'value': '930', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '45.0', 'groupId': 'OG000'}, {'value': '79.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '27.0', 'ciLowerLimit': '19.21', 'ciUpperLimit': '38.02', 'groupDescription': 'Week 12: Odds ratio, associated 95% CI were derived from a logistic regression model with fixed effects for treatment group, baseline value, geographical region and triglyceride subgroup.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.9', 'ciLowerLimit': '9.84', 'ciUpperLimit': '16.86', 'groupDescription': 'Week 24: Odds ratio, associated 95% CI were derived from a logistic regression model with fixed effects for treatment group, baseline value, geographical region and triglyceride subgroup.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.3', 'ciLowerLimit': '4.99', 'ciUpperLimit': '8.06', 'groupDescription': 'Week 52: Odds ratio, associated 95% CI were derived from a logistic regression model with fixed effects for treatment group, baseline value, geographical region and triglyceride subgroup.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12, 24, 52', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm respectively."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Fasting Low Density Lipoprotein Cholesterol (LDL-C) Less Than or Equal to (<=) 70 Milligram Per Deciliter (mg/dL) at Week 12, 24 and 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1071', 'groupId': 'OG000'}, {'value': '1068', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (Treatment Period)', 'description': 'Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.'}, {'id': 'OG001', 'title': 'Bococizumab 150 mg (Treatment Period)', 'description': 'Participants received Bococizumab (PF--04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.'}], 'classes': [{'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '994', 'groupId': 'OG000'}, {'value': '980', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000'}, {'value': '78.6', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '987', 'groupId': 'OG000'}, {'value': '990', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.8', 'groupId': 'OG000'}, {'value': '69.8', 'groupId': 'OG001'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '920', 'groupId': 'OG000'}, {'value': '930', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.8', 'groupId': 'OG000'}, {'value': '61.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '86.5', 'ciLowerLimit': '61.74', 'ciUpperLimit': '121.25', 'groupDescription': 'Week 12: Odds ratio, associated 95% CI were derived from a logistic regression model with fixed effects for treatment group, baseline value, geographical region and triglyceride subgroup.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '35.9', 'ciLowerLimit': '26.83', 'ciUpperLimit': '47.96', 'groupDescription': 'Week 24: Odds ratio, associated 95% CI were derived from a logistic regression model with fixed effects for treatment group, baseline value, geographical region and triglyceride subgroup.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '25.5', 'ciLowerLimit': '18.90', 'ciUpperLimit': '34.47', 'groupDescription': 'Week 52: Odds ratio, associated 95% CI were derived from a logistic regression model with fixed effects for treatment group, baseline value, geographical region and triglyceride subgroup.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12, 24, 52', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm respectively."}, {'type': 'SECONDARY', 'title': 'Plasma Concentration of PF-04950615 at Week 12, 24 and 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1063', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bococizumab 150 mg (Treatment Period)', 'description': 'Participants received Bococizumab (PF--04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.'}], 'classes': [{'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '996', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.91', 'spread': '4.987', 'groupId': 'OG000'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '975', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.74', 'spread': '5.772', 'groupId': 'OG000'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '915', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.60', 'spread': '4.685', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 12, 24, 52', 'description': 'Plasma concentration of PF-04950615 at Week 12, 24 and 52 was reported.', 'unitOfMeasure': 'Microgram per milliliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis set included participants who received at least 1 dose of PF-04950615. Here, "n" signifies those participants who were evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events (AEs) Related to Type 1 or 3 Hypersensitivity Reactions and Injection Site Reactions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1065', 'groupId': 'OG000'}, {'value': '1063', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (Treatment Period)', 'description': 'Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.'}, {'id': 'OG001', 'title': 'Bococizumab 150 mg (Treatment Period)', 'description': 'Participants received Bococizumab (PF--04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.'}], 'classes': [{'title': 'Type 1 or 3 hypersensitivity reactions', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Injection site reactions', 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to Week 58', 'description': "Type 1 hypersensitivity or allergic reactions were possible in response to any injected protein and included shortness of breath, urticaria, anaphylaxis and angioedema. Type 3 hypersensitivity reactions were similar to Type 1 hypersensitivity reactions but were likely to be delayed from the time of injection and included symptoms such as rash, urticaria, polyarthritis, myalgia's, polysynovitis, fever and if severe then included glomerulonephritis. Injection site reactions included injection site bruising, discolouration, erythema, haematoma, haemorrhage, nodule, induration, inflammation, mass, pain, paraesthesia, pruritus, swelling, vesicles, warmth, scab and rash. Participants with type 1 or type 3 hypersensitivity reactions and participants with injection site reactions were reported in this outcome measure.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who received at least 1 dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb): Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'OG000'}, {'value': '1046', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (Treatment Period)', 'description': 'Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.'}, {'id': 'OG001', 'title': 'Bococizumab 150 mg (Treatment Period)', 'description': 'Participants received Bococizumab (PF--04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.'}], 'classes': [{'title': 'Baseline up to Week 58: ADA', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '46.7', 'groupId': 'OG001'}]}]}, {'title': 'Baseline up to Week 58: nAb', 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000'}, {'value': '30.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Week 58', 'description': 'Percentage of participants with at least 1 positive ADA titer or 1 positive nAb titer were reported. ADA titer \\>=6.23 (log2) unit was considered to be ADA positive and nAb titer \\>=1.58 (log2) unit was considered to be nAb positive.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis population included all participants who received at least 1 dose of study treatment. Here, "N" signifies those participants who were evaluable for this outcome measure for each reporting arm respectively.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Changed Concomitant Medication During Extension Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (Extension Period)', 'description': 'Participants randomized to Placebo arm in treatment period and consented for extension period after Week 58 follow-up visit, were followed for SAEs and concomitant medications up to Week 110.'}, {'id': 'OG001', 'title': 'Bococizumab ADA Positive (Extension Period)', 'description': 'Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their ADA assessment at Week 58 follow-up visit. In extension period, participants who were ADA positive and consented for extension period were assessed for ADA and LDL-C direct measurement until ADA titers were no longer detectable or had returned to baseline titer (less than or equal to 1.58 (log2) units above a positive baseline titer) or until Week 110 along with SAEs and concomitant medication, from Week 58 follow up visit to Week 110.'}, {'id': 'OG002', 'title': 'Bococizumab ADA Negative (Extension Period)', 'description': 'Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their Week 58 follow-up ADA assessment. Participants who were ADA negative and consented for extension period were followed for SAEs and concomitant medication, from Week 58 follow up visit to Week 110.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 58 follow-up visit to Week 110', 'description': 'In this outcome measure, total number of participants who changed their lipid-lowering medications or added a monoclonal antibody medication during the extension period were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who consented for extension period.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 58 Follow-up Visit, 71, 84, 97 and 110: Extension Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bococizumab ADA Positive (Extension Period)', 'description': 'Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their ADA assessment at Week 58 follow-up visit. In extension period, participants who were ADA positive and consented for extension period were assessed for ADA and LDL-C direct measurement until ADA titers were no longer detectable or had returned to baseline titer (less than or equal to 1.58 (log2) units above a positive baseline titer) or until Week 110 along with SAEs and concomitant medication, from Week 58 follow up visit to Week 110.'}], 'classes': [{'title': 'Week 58 follow-up visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-6.4', 'spread': '24.67', 'groupId': 'OG000'}]}]}, {'title': 'Week 71', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-10.4', 'spread': '41.51', 'groupId': 'OG000'}]}]}, {'title': 'Week 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-15.8', 'spread': '25.65', 'groupId': 'OG000'}]}]}, {'title': 'Week 97', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-20.8', 'spread': '31.08', 'groupId': 'OG000'}]}]}, {'title': 'Week 110', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.0', 'spread': '28.65', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 58 follow-up visit, 71, 84, 97, 110', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who consented for extension period. This outcome measure was planned not to be analyzed for reporting arms: Placebo (Extension Period) and Bococizumab ADA negative (Extension Period). Here, "n" signifies number of participants who were evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb): Extension Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bococizumab ADA Positive (Extension Period)', 'description': 'Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their ADA assessment at Week 58 follow-up visit. In extension period, participants who were ADA positive and consented for extension period were assessed for ADA and LDL-C direct measurement until ADA titers were no longer detectable or had returned to baseline titer (less than or equal to 1.58 (log2) units above a positive baseline titer) or until Week 110 along with SAEs and concomitant medication, from Week 58 follow up visit to Week 110.'}], 'classes': [{'title': 'Week 58 follow-up visit: ADA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}]}]}, {'title': 'Week 58 follow-up visit: nAB', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '36.8', 'groupId': 'OG000'}]}]}, {'title': 'Week 71: ADA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '62.5', 'groupId': 'OG000'}]}]}, {'title': 'Week 71: nAB', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '31.3', 'groupId': 'OG000'}]}]}, {'title': 'Week 84: ADA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '81.8', 'groupId': 'OG000'}]}]}, {'title': 'Week 84: nAB', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '45.5', 'groupId': 'OG000'}]}]}, {'title': 'Week 97: ADA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}]}]}, {'title': 'Week 97: nAB', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Week 110: ADA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '85.7', 'groupId': 'OG000'}]}]}, {'title': 'Week 110: nAB', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '57.1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 58 follow-up visit, Week 71, Week 84, Week 97, Week 110', 'description': 'Percentage of participants with at least 1 positive ADA titer or 1 positive nAb titer were reported. ADA titer \\>=6.23 (log2) unit was considered to be ADA positive and nAb titer \\>=1.58 (log2) unit was considered to be nAb positive.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who consented for extension period. This outcome measure was planned not to be analyzed for reporting arms Placebo (Extension period) and Bococizumab ADA negative (Extension period). Here, "n" signifies number of participants who were evaluable at specified time points.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo (Treatment Period)', 'description': 'Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.'}, {'id': 'FG001', 'title': 'Bococizumab 150 mg (Treatment Period)', 'description': 'Participants received Bococizumab (PF-04950615) 150 milligram (mg) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.'}, {'id': 'FG002', 'title': 'Placebo (Extension Period)', 'description': 'Participants randomized to Placebo arm in treatment period and consented for extension period after Week 58 follow-up visit, were followed for SAEs and concomitant medications up to Week 110.'}, {'id': 'FG003', 'title': 'Bococizumab ADA Positive (Extension Period)', 'description': 'Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their ADA assessment at Week 58 follow-up visit. In extension period, participants who were ADA positive and consented for extension period were assessed for ADA and LDL-C direct measurement until ADA titers were no longer detectable or had returned to baseline titer (less than or equal to 1.58 (log2) units above a positive baseline titer) or until Week 110 along with SAEs and concomitant medication, from Week 58 follow up visit to Week 110.'}, {'id': 'FG004', 'title': 'Bococizumab ADA Negative (Extension Period)', 'description': 'Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their Week 58 follow-up ADA assessment. Participants who were ADA negative and consented for extension period were followed for SAEs and concomitant medication, from Week 58 follow up visit to Week 110.'}], 'periods': [{'title': 'Treatment Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1071'}, {'groupId': 'FG001', 'numSubjects': '1068'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1065'}, {'groupId': 'FG001', 'numSubjects': '1063'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '925'}, {'groupId': 'FG001', 'numSubjects': '934'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '146'}, {'groupId': 'FG001', 'numSubjects': '134'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '22'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '71'}, {'groupId': 'FG001', 'numSubjects': '61'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Did Not Meet Entrance Criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '31'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Randomized Not Treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}, {'title': 'Extension Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '47'}, {'groupId': 'FG003', 'numSubjects': '19'}, {'groupId': 'FG004', 'numSubjects': '39'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '45'}, {'groupId': 'FG003', 'numSubjects': '19'}, {'groupId': 'FG004', 'numSubjects': '34'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Withdrew Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '5'}]}]}], 'preAssignmentDetails': 'This study was conducted at multiple sites from 28 October 2014 to 15 July 2016 for the Treatment Period and up to 10 July 2017 for the Extension Period.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1071', 'groupId': 'BG000'}, {'value': '1068', 'groupId': 'BG001'}, {'value': '2139', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo (Treatment Period)', 'description': 'Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.'}, {'id': 'BG001', 'title': 'Bococizumab 150 mg (Treatment Period)', 'description': 'Participants received Bococizumab (PF--04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52 and were followed up to Week 58.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.2', 'spread': '9.8', 'groupId': 'BG000'}, {'value': '61.8', 'spread': '9.3', 'groupId': 'BG001'}, {'value': '62', 'spread': '9.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '434', 'groupId': 'BG000'}, {'value': '434', 'groupId': 'BG001'}, {'value': '868', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '637', 'groupId': 'BG000'}, {'value': '634', 'groupId': 'BG001'}, {'value': '1271', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Full analysis set (FAS) included all participants who were randomized.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2139}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2017-07-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-02', 'studyFirstSubmitDate': '2013-10-21', 'resultsFirstSubmitDate': '2017-06-22', 'studyFirstSubmitQcDate': '2013-10-21', 'lastUpdatePostDateStruct': {'date': '2018-07-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-06-22', 'studyFirstPostDateStruct': {'date': '2013-10-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-07-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12', 'timeFrame': 'Baseline, Week 12'}], 'secondaryOutcomes': [{'measure': 'Percent Change From Baseline in Fasting Total Cholesterol (TC) at Week 12, 24 and 52', 'timeFrame': 'Baseline, Week 12, 24, 52'}, {'measure': 'Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) at Week 12, 24 and 52', 'timeFrame': 'Baseline, Week 12, 24, 52'}, {'measure': 'Percent Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24 and 52', 'timeFrame': 'Baseline, Week 12, 24, 52'}, {'measure': 'Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides (TG) Cut-off of Less Than (<) 200 Milligram Per Deciliter (mg/dL) at Week 12, 24 and 52', 'timeFrame': 'Baseline, Week 12, 24, 52'}, {'measure': 'Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides Cut-off of Greater Than or Equal to (>=) 200 Milligram Per Deciliter (mg/dL) at Week 12, 24 and 52', 'timeFrame': 'Baseline, Week 12, 24, 52'}, {'measure': 'Percent Change From Baseline in Fasting Lipoprotein (a) (Lp[a]) at Week 12, 24 and 52', 'timeFrame': 'Baseline, Week 12, 24, 52'}, {'measure': 'Percent Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24 and 52', 'timeFrame': 'Baseline, Week 12, 24, 52'}, {'measure': 'Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 24, 52: Treatment Period', 'timeFrame': 'Baseline, Week 24, 52'}, {'measure': 'Percent Change From Baseline in Fasting Triglycerides (TG) at Week 12, 24 and 52', 'timeFrame': 'Baseline, Week 12, 24, 52'}, {'measure': 'Percent Change From Baseline in Fasting Apolipoprotein A-I (ApoA-I) at Week 12, 24 and 52', 'timeFrame': 'Baseline, Week 12, 24, 52'}, {'measure': 'Percent Change From Baseline in Fasting Apolipoprotein A-II (ApoA-II) at Week 12, 24 and 52', 'timeFrame': 'Baseline, Week 12, 24, 52'}, {'measure': 'Percent Change From Baseline in Fasting Very Low Density Lipoprotein Cholesterol (VLDL-C) at Week 12, 24 and 52', 'timeFrame': 'Baseline, Week 12, 24, 52'}, {'measure': 'Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides Cut-off of Less Than (<) 200 Milligram Per Deciliter (mg/dL) at Week 12', 'timeFrame': 'Baseline, Week 12'}, {'measure': 'Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides Cut-off of Greater Than or Equal to (>=) 200 Milligram Per Deciliter (mg/dL) at Week 12', 'timeFrame': 'Baseline, Week 12'}, {'measure': 'Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12', 'timeFrame': 'Baseline, Week 12'}, {'measure': 'Absolute Change From Baseline in Fasting Total Cholesterol (TC) at Week 12', 'timeFrame': 'Baseline, Week 12'}, {'measure': 'Absolute Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (HDL-C) at Week 12', 'timeFrame': 'Baseline, Week 12'}, {'measure': 'Absolute Change From Baseline in Fasting Apolipoprotein B (ApoB) at Week 12', 'timeFrame': 'Baseline, Week 12'}, {'measure': 'Absolute Change From Baseline in Fasting Lipoprotein (a) (Lp[a]) at Week 12', 'timeFrame': 'Baseline, Week 12'}, {'measure': 'Absolute Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Week 12', 'timeFrame': 'Baseline, Week 12'}, {'measure': 'Absolute Change From Baseline in Ratio of Fasting Total Cholesterol (TC) to High Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24 and 52', 'timeFrame': 'Baseline, Week 12, 24, 52'}, {'measure': 'Change From Baseline in Ratio of Fasting Apolipoprotein B (ApoB) to Apolipoprotein A-I (ApoA-I) at Week 12, 24 and 52', 'timeFrame': 'Baseline, Week 12, 24, 52'}, {'measure': 'Percentage of Participants Achieving Fasting Low Density Lipoprotein Cholesterol (LDL-C) Less Than or Equal to (<=) 100 Milligram Per Deciliter (mg/dL) at Week 12, 24 and 52', 'timeFrame': 'Week 12, 24, 52'}, {'measure': 'Percentage of Participants Achieving Fasting Low Density Lipoprotein Cholesterol (LDL-C) Less Than or Equal to (<=) 70 Milligram Per Deciliter (mg/dL) at Week 12, 24 and 52', 'timeFrame': 'Week 12, 24, 52'}, {'measure': 'Plasma Concentration of PF-04950615 at Week 12, 24 and 52', 'timeFrame': 'Week 12, 24, 52', 'description': 'Plasma concentration of PF-04950615 at Week 12, 24 and 52 was reported.'}, {'measure': 'Number of Participants With Adverse Events (AEs) Related to Type 1 or 3 Hypersensitivity Reactions and Injection Site Reactions', 'timeFrame': 'Baseline up to Week 58', 'description': "Type 1 hypersensitivity or allergic reactions were possible in response to any injected protein and included shortness of breath, urticaria, anaphylaxis and angioedema. Type 3 hypersensitivity reactions were similar to Type 1 hypersensitivity reactions but were likely to be delayed from the time of injection and included symptoms such as rash, urticaria, polyarthritis, myalgia's, polysynovitis, fever and if severe then included glomerulonephritis. Injection site reactions included injection site bruising, discolouration, erythema, haematoma, haemorrhage, nodule, induration, inflammation, mass, pain, paraesthesia, pruritus, swelling, vesicles, warmth, scab and rash. Participants with type 1 or type 3 hypersensitivity reactions and participants with injection site reactions were reported in this outcome measure."}, {'measure': 'Percentage of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb): Treatment Period', 'timeFrame': 'Baseline up to Week 58', 'description': 'Percentage of participants with at least 1 positive ADA titer or 1 positive nAb titer were reported. ADA titer \\>=6.23 (log2) unit was considered to be ADA positive and nAb titer \\>=1.58 (log2) unit was considered to be nAb positive.'}, {'measure': 'Number of Participants Who Changed Concomitant Medication During Extension Period', 'timeFrame': 'Week 58 follow-up visit to Week 110', 'description': 'In this outcome measure, total number of participants who changed their lipid-lowering medications or added a monoclonal antibody medication during the extension period were reported.'}, {'measure': 'Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 58 Follow-up Visit, 71, 84, 97 and 110: Extension Period', 'timeFrame': 'Baseline, Week 58 follow-up visit, 71, 84, 97, 110'}, {'measure': 'Percentage of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb): Extension Period', 'timeFrame': 'Week 58 follow-up visit, Week 71, Week 84, Week 97, Week 110', 'description': 'Percentage of participants with at least 1 positive ADA titer or 1 positive nAb titer were reported. ADA titer \\>=6.23 (log2) unit was considered to be ADA positive and nAb titer \\>=1.58 (log2) unit was considered to be nAb positive.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['mixed dyslipidemia', 'high risk of cardiovascular events', 'multiple cardiovascular disease risk factors'], 'conditions': ['Hyperlipidemia']}, 'referencesModule': {'references': [{'pmid': '37994400', 'type': 'DERIVED', 'citation': 'Wang EQ, Kaila N, Plowchalk D, Gibiansky L, Yunis C, Sweeney K. Population PK/PD modeling of low-density lipoprotein cholesterol response in hypercholesterolemic participants following administration of bococizumab, a potent anti-PCSK9 monoclonal antibody. CPT Pharmacometrics Syst Pharmacol. 2023 Dec;12(12):2013-2026. doi: 10.1002/psp4.13050. Epub 2023 Nov 22.'}, {'pmid': '37658997', 'type': 'DERIVED', 'citation': 'McCush F, Wang E, Yunis C, Schwartz P, Baltrukonis D. Anti-drug Antibody Magnitude and Clinical Relevance Using Signal to Noise (S/N): Bococizumab Case Study. AAPS J. 2023 Sep 2;25(5):85. doi: 10.1208/s12248-023-00846-x.'}, {'pmid': '35277540', 'type': 'DERIVED', 'citation': 'Chasman DI, Hyde CL, Giulianini F, Danning RD, Wang EQ, Hickling T, Ridker PM, Loomis AK. Genome-wide pharmacogenetics of anti-drug antibody response to bococizumab highlights key residues in HLA DRB1 and DQB1. Sci Rep. 2022 Mar 11;12(1):4266. doi: 10.1038/s41598-022-07997-5.'}, {'pmid': '29685591', 'type': 'DERIVED', 'citation': 'Ridker PM, Rose LM, Kastelein JJP, Santos RD, Wei C, Revkin J, Yunis C, Tardif JC, Shear CL; Studies of PCSK9 Inhibition and the Reduction of vascular Events (SPIRE) Investigators. Cardiovascular event reduction with PCSK9 inhibition among 1578 patients with familial hypercholesterolemia: Results from the SPIRE randomized trials of bococizumab. J Clin Lipidol. 2018 Jul-Aug;12(4):958-965. doi: 10.1016/j.jacl.2018.03.088. Epub 2018 Apr 3.'}, {'pmid': '28304227', 'type': 'DERIVED', 'citation': 'Ridker PM, Tardif JC, Amarenco P, Duggan W, Glynn RJ, Jukema JW, Kastelein JJP, Kim AM, Koenig W, Nissen S, Revkin J, Rose LM, Santos RD, Schwartz PF, Shear CL, Yunis C; SPIRE Investigators. Lipid-Reduction Variability and Antidrug-Antibody Formation with Bococizumab. N Engl J Med. 2017 Apr 20;376(16):1517-1526. doi: 10.1056/NEJMoa1614062. Epub 2017 Mar 17.'}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1481020&StudyName=Randomized%20Clinical%20Trial%20of%20RN316%20%28PF-04950615%29%20in%20Subjects%20with%20Hyperlipidemia%20or%20Mixed%20Dyslipidemia%20at%20Risk%20of%20Cardiovascular%20Events', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'This study is a multicenter, randomized study in subjects with high cholesterol receiving highly effective statins to assess the efficacy, safety and tolerability of Bococizumab (PF-04950615;RN316) to lower LDL-C.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Treated with a statin.\n* Fasting LDL-C \\> 70 mg/dL and triglyceride \\<=400 mg/dL.\n* High or very high risk of incurring a cardiovascular event.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding females.\n* Cardiovascular or cerebrovascular event of procedures during the past 30 days.\n* Congestive heart failure NYHA class IV.\n* Poorly controlled hypertension.'}, 'identificationModule': {'nctId': 'NCT01968967', 'acronym': 'SPIRE-LDL', 'briefTitle': 'Randomized Clinical Trial of Bococizumab (PF-04950615; RN316) in Subjects With Hyperlipidemia or Mixed Dyslipidemia at Risk of Cardiovascular Events', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Phase 3 Double-blind, Randomized, Placebo-controlled, Parallel-group Study To Assess The Efficacy, Long-term Safety And Tolerability Of Pf-04950615 In Subjects With Primary Hyperlipidemia Or Mixed Dyslipidemia At Risk Of Cardiovascular Events', 'orgStudyIdInfo': {'id': 'B1481020'}, 'secondaryIdInfos': [{'id': '2013-002643-28', 'type': 'EUDRACT_NUMBER'}, {'id': 'SPIRE-LDL', 'type': 'OTHER', 'domain': 'Alias Study Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bococizumab (PF-04950615; RN316)', 'interventionNames': ['Drug: Bococizumab (PF-04950615; RN316)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Bococizumab (PF-04950615; RN316)', 'type': 'DRUG', 'description': '150 mg every 2 weeks, subcutaneous injection, 12 months', 'armGroupLabels': ['Bococizumab (PF-04950615; RN316)']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'subcutaneous injection every 2 weeks for 12 months', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35611', 'city': 'Athens', 'state': 'Alabama', 'country': 'United States', 'facility': 'Ernest L. 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