Ignite Creation Date:
2025-12-26 @ 4:00 PM
Ignite Modification Date:
2026-02-24 @ 5:04 PM
Study NCT ID:
NCT02476006
Status:
COMPLETED
Last Update Posted:
2022-03-28
First Post:
2015-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety, Tolerability, and Effect of Alirocumab in High Cardiovascular Risk Patients With Severe Hypercholesterolemia Not Adequately Controlled With Conventional Lipid-modifying Therapies (ODYSSEY APPRISE)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006937', 'term': 'Hypercholesterolemia'}], 'ancestors': [{'id': 'D006949', 'term': 'Hyperlipidemias'}, {'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': 'C571059', 'term': 'alirocumab'}, {'id': 'D000069438', 'term': 'Ezetimibe'}, {'id': 'D000069059', 'term': 'Atorvastatin'}, {'id': 'D000068718', 'term': 'Rosuvastatin Calcium'}, {'id': 'D019821', 'term': 'Simvastatin'}], 'ancestors': [{'id': 'D001384', 'term': 'Azetidines'}, {'id': 'D001385', 'term': 'Azetines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006538', 'term': 'Heptanoic Acids'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005464', 'term': 'Fluorobenzenes'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D008148', 'term': 'Lovastatin'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Contact-US@sanofi.com', 'phone': '800-633-1610', 'title': 'Trial Transparency Team', 'phoneExt': '1#', 'organization': 'Sanofi aventis recherche & développement'}, 'certainAgreement': {'otherDetails': 'The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).', 'description': 'Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). Analysis was performed on safety population.', 'eventGroups': [{'id': 'EG000', 'title': 'Alirocumab', 'description': 'Participants received Alirocumab 150 mg SC Q2W or 75 mg SC Q2W added to stable LMT up to a maximum of 120 weeks. Alirocumab dose was either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W, based on Investigator judgment and treatment response.', 'otherNumAtRisk': 994, 'deathsNumAtRisk': 994, 'otherNumAffected': 221, 'seriousNumAtRisk': 994, 'deathsNumAffected': 2, 'seriousNumAffected': 161}], 'otherEvents': [{'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 61, 'numAffected': 53}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 86, 'numAffected': 78}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 93, 'numAffected': 71}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 94, 'numAffected': 61}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Acute Coronary Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Acute Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Angina Pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Angina Unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 14, 'numAffected': 12}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Aortic Valve Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Arteriosclerosis Coronary Artery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Atrial Flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Atrial Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Atrioventricular Block Second Degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Cardiac Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Cardiac Failure Congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Coronary Artery Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Coronary Artery Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Coronary Ostial Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Mitral Valve Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Myocardial Ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Subendocardial Ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Ventricular Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Accessory Navicular Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Colitis Ischaemic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Diverticular Perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Diverticulum Intestinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Gastrooesophageal Reflux Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Haemorrhoidal Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Hypoaesthesia Oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Lower Gastrointestinal Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Melaena', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Perianal Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Rectal Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Umbilical Hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Chest Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Non-Cardiac Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Vascular Stent Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Bile Duct Stone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Chronic Hepatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Hepatocellular Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Hypertransaminasaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Campylobacter Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Diabetic Foot Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Escherichia Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Gastroenteritis Viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Liver Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Viral Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Wound Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Hip Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Joint Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Lower Limb Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Meniscus Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Peripheral Artery Restenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Post Procedural Complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Post Procedural Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Rib Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Scapula Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Spinal Column Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Tendon Rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Tibia Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Upper Limb Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Vascular Graft Occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Transaminases Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Diabetes Mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Diabetes Mellitus Inadequate Control', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Fibromyalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Intervertebral Disc Protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Myopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Polymyalgia Rheumatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Spondylolisthesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Tendonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Benign Neoplasm Of Prostate', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Bladder Cancer Stage 0, With Cancer In Situ', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Breast Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Clear Cell Renal Cell Carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Colon Adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Gastrointestinal Tract Adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Lung Adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Myelodysplastic Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Prostate Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Rectal Adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Transitional Cell Carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Uterine Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Amnesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Ataxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Carotid Artery Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Carpal Tunnel Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Cerebrovascular Accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Facial Paralysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Ischaemic Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Transient Ischaemic Attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Device Dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Completed Suicide', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Schizophrenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Bladder Trabeculation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Renal Impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Metrorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Prostatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Lung Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pulmonary Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Actinic Keratosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Parapsoriasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pregnancy Of Partner', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Aortic Aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Aortic Dissection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Deep Vein Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Intermittent Claudication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Peripheral Arterial Occlusive Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Peripheral Artery Aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Peripheral Artery Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Peripheral Artery Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 994, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '994', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Alirocumab', 'description': 'Participants received Alirocumab 150 mg SC Q2W or 75 mg SC Q2W added to stable LMT up to a maximum of 120 weeks. Alirocumab dose was either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W, based on Investigator judgment and treatment response.'}], 'classes': [{'title': 'Any TEAE', 'categories': [{'measurements': [{'value': '71.6', 'groupId': 'OG000'}]}]}, {'title': 'Any treatment emergent SAE', 'categories': [{'measurements': [{'value': '16.2', 'groupId': 'OG000'}]}]}, {'title': 'Any TEAE leading to death', 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000'}]}]}, {'title': 'Any TEAE leading to treatment discontinuation', 'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first injection of investigational medicinal product (IMP) up to 2 weeks after last dose of study drug (Week 120)', 'description': 'Adverse Event (AE) was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Treatment-emergent AEs (TEAEs) were defined as AEs that that developed or worsened or became serious during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). A Serious Adverse Event (SAE) was any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on safety population.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Calculated Low Density Lipoprotein Cholesterol (LDL-C) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '921', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Alirocumab', 'description': 'Participants received Alirocumab 150 mg SC Q2W or 75 mg SC Q2W added to stable LMT up to a maximum of 120 weeks. Alirocumab dose was either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W, based on Investigator judgment and treatment response.'}], 'classes': [{'categories': [{'measurements': [{'value': '-54.84', 'spread': '20.06', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'Calculated LDL-C values were obtained using the Friedewald formula. Calculated LDL-C in mg/dL from Friedewald formula (LDL cholesterol = Total cholesterol - HDL cholesterol - \\[Triglyceride/5\\]). Baseline value was defined as the last observation before the first dose of the treatment.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on modified intent-to-treat population (mITT): all enrolled participants who received at least one dose or part of a dose of alirocumab and had an evaluable efficacy endpoint during the efficacy treatment period (defined as time period from the first injection of alirocumab up to the day of last injection +21 days).'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '921', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Alirocumab', 'description': 'Participants received Alirocumab 150 mg SC Q2W or 75 mg SC Q2W added to stable LMT up to a maximum of 120 weeks. Alirocumab dose was either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W, based on Investigator judgment and treatment response.'}], 'classes': [{'categories': [{'measurements': [{'value': '74.6', 'groupId': 'OG000', 'lowerLimit': '71.7', 'upperLimit': '77.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 12', 'description': 'LDL-Cholesterol was calculated using the Friedewald formula. Percentage of participants who reached calculated LDL-C \\<100 mg/dL (2.59 mmol/L) at week 12 were reported.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on mITT population.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '921', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Alirocumab', 'description': 'Participants received Alirocumab 150 mg SC Q2W or 75 mg SC Q2W added to stable LMT up to a maximum of 120 weeks. Alirocumab dose was either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W, based on Investigator judgment and treatment response.'}], 'classes': [{'categories': [{'measurements': [{'value': '50.2', 'groupId': 'OG000', 'lowerLimit': '46.9', 'upperLimit': '53.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 12', 'description': 'LDL-Cholesterol was calculated using the Friedewald formula. Percentage of participants who reached calculated LDL-C \\<70 mg/dL (1.81 mmol/L) at week 12 were reported.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on mITT population.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) and/or >=50% Reduction From Baseline in LDL-C at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '921', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Alirocumab', 'description': 'Participants received Alirocumab 150 mg SC Q2W or 75 mg SC Q2W added to stable LMT up to a maximum of 120 weeks. Alirocumab dose was either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W, based on Investigator judgment and treatment response.'}], 'classes': [{'categories': [{'measurements': [{'value': '69.1', 'groupId': 'OG000', 'lowerLimit': '66.0', 'upperLimit': '72.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 12', 'description': 'LDL-Cholesterol was calculated using the Friedewald formula. Percentage of participants who reached LDL-C \\<70 mg/dL at Week 12 and/or \\>=50% reduction from baseline in LDL-C at Week 12 are reported.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on mITT population.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '921', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Alirocumab', 'description': 'Participants received Alirocumab 150 mg SC Q2W or 75 mg SC Q2W added to stable LMT up to a maximum of 120 weeks. Alirocumab dose was either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W, based on Investigator judgment and treatment response.'}], 'classes': [{'categories': [{'measurements': [{'value': '-45.89', 'spread': '35.82', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'Baseline value was defined as the last observation before the first dose of the treatment.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on mITT population.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Total Cholesterol (Total-C) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '921', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Alirocumab', 'description': 'Participants received Alirocumab 150 mg SC Q2W or 75 mg SC Q2W added to stable LMT up to a maximum of 120 weeks. Alirocumab dose was either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W, based on Investigator judgment and treatment response.'}], 'classes': [{'categories': [{'measurements': [{'value': '-38.28', 'spread': '15.20', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'Baseline value was defined as the last observation before the first dose of the treatment.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on mITT population.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in High Density Lipoprotein Cholesterol at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '921', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Alirocumab', 'description': 'Participants received Alirocumab 150 mg SC Q2W or 75 mg SC Q2W added to stable LMT up to a maximum of 120 weeks. Alirocumab dose was either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W, based on Investigator judgment and treatment response.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.37', 'spread': '17.29', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'Baseline value was defined as the last observation before the first dose of the treatment.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on mITT population.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Triglycerides at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '921', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Alirocumab', 'description': 'Participants received Alirocumab 150 mg SC Q2W or 75 mg SC Q2W added to stable LMT up to a maximum of 120 weeks. Alirocumab dose was either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W, based on Investigator judgment and treatment response.'}], 'classes': [{'categories': [{'measurements': [{'value': '-8.28', 'spread': '33.99', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'Baseline value was defined as the last observation before the first dose of the treatment.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on mITT population.'}, {'type': 'SECONDARY', 'title': "Assessment of Participant's Acceptability of Self-Injection Using Self Injection Assessment Questionnaire (SIAQ): Feeling About Injections, Self Confidence, Satisfaction With Self-Injections", 'denoms': [{'units': 'Participants', 'counts': [{'value': '952', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Alirocumab', 'description': 'Participants received Alirocumab 150 mg SC Q2W or 75 mg SC Q2W added to stable LMT up to a maximum of 120 weeks. Alirocumab dose was either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W, based on Investigator judgment and treatment response.'}], 'classes': [{'title': 'Feelings about injections: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '952', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.6', 'spread': '1.8', 'groupId': 'OG000'}]}]}, {'title': 'Feeling about injections: Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '909', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.1', 'spread': '1.4', 'groupId': 'OG000'}]}]}, {'title': 'Feeling about injections: Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '894', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.1', 'spread': '1.4', 'groupId': 'OG000'}]}]}, {'title': 'Feeling about injections: Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '847', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.2', 'spread': '1.4', 'groupId': 'OG000'}]}]}, {'title': 'Feeling about injections: Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '668', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.2', 'spread': '1.4', 'groupId': 'OG000'}]}]}, {'title': 'Feeling about injections: Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '547', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.2', 'spread': '1.4', 'groupId': 'OG000'}]}]}, {'title': 'Feeling about injections: Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '423', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.2', 'spread': '1.4', 'groupId': 'OG000'}]}]}, {'title': 'Feeling about injections: Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '343', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.3', 'spread': '1.3', 'groupId': 'OG000'}]}]}, {'title': 'Self confidence: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '943', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.9', 'spread': '2.4', 'groupId': 'OG000'}]}]}, {'title': 'Self Confidence: Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '905', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.0', 'spread': '2.1', 'groupId': 'OG000'}]}]}, {'title': 'Self Confidence: Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '889', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.1', 'spread': '2.0', 'groupId': 'OG000'}]}]}, {'title': 'Self Confidence: Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '844', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.1', 'spread': '1.9', 'groupId': 'OG000'}]}]}, {'title': 'Self Confidence: Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '666', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.0', 'spread': '2.1', 'groupId': 'OG000'}]}]}, {'title': 'Self Confidence: Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '548', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.1', 'spread': '2.1', 'groupId': 'OG000'}]}]}, {'title': 'Self Confidence: Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '420', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.3', 'spread': '2.0', 'groupId': 'OG000'}]}]}, {'title': 'Self Confidence: Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '340', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.4', 'spread': '2.0', 'groupId': 'OG000'}]}]}, {'title': 'Satisfaction with self injection: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '918', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.2', 'spread': '2.5', 'groupId': 'OG000'}]}]}, {'title': 'Satisfaction with self-injections: Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '906', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.5', 'spread': '1.6', 'groupId': 'OG000'}]}]}, {'title': 'Satisfaction with self-injections: Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '889', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.7', 'spread': '1.6', 'groupId': 'OG000'}]}]}, {'title': 'Satisfaction with self-injections: Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '842', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.7', 'spread': '1.6', 'groupId': 'OG000'}]}]}, {'title': 'Satisfaction with self-injections: Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '667', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.6', 'spread': '1.8', 'groupId': 'OG000'}]}]}, {'title': 'Satisfaction with self-injections: Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '542', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.7', 'spread': '1.5', 'groupId': 'OG000'}]}]}, {'title': 'Satisfaction with self-injections: Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '418', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.8', 'spread': '1.7', 'groupId': 'OG000'}]}]}, {'title': 'Satisfaction with self-injections: Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '338', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.8', 'spread': '1.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Pre-SIAQ), Week 4, Week 8, Week 12, Week 24, Week 48, Week 72, Week 96', 'description': 'Pre-SIAQ: self-completed before first self-injection \\& Post-SIAQ: self-completed after self-injection. Pre-SIAQ consisted of 7 items grouped into 3 domains:feelings about injections,self-confidence \\& satisfaction with self-injection. Post-SIAQ consisted of 21 items grouped into 6 domains:feelings about injections,self-image,self-confidence,injection-site reactions,ease of use \\& satisfaction with self-injection. Participants rated each item on 5-point (or 6-point) semantic Likert-type scale, where lower numbers indicate a worse experience. Item scores were transformed to obtain a score ranging from 0 (worst experience) to 10 (best experience). Transformed scores for items contributing to a domain were then averaged into a domain score. Each domain score ranges from 0 (worst experience) to 10 (best experience), higher score=better acceptability. Domain scores common to the Pre \\& Post SIAQ were analyzed on participants belonging to Pre \\& Post-SIAQ population and are reported.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pre and Post-SIAQ population: participants from the safety population who self-injected the training injection \\& completed a Pre-SIAQ before first self-injection, who self-injected study drug at least once during the study and completed a Post-SIAQ. Here, number analyzed = participants with available data at specified time points.'}, {'type': 'SECONDARY', 'title': "Assessment of Participant's Acceptability of Self-Injection Using Self Injection Assessment Questionnaire (SIAQ): Self Image, Injection-Site Reactions, Ease of Use", 'denoms': [{'units': 'Participants', 'counts': [{'value': '979', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Alirocumab', 'description': 'Participants received Alirocumab 150 mg SC Q2W or 75 mg SC Q2W added to stable LMT up to a maximum of 120 weeks. Alirocumab dose was either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W, based on Investigator judgment and treatment response.'}], 'classes': [{'title': 'Self Image: Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '929', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.4', 'spread': '1.4', 'groupId': 'OG000'}]}]}, {'title': 'Self Image: Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '915', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.4', 'spread': '1.4', 'groupId': 'OG000'}]}]}, {'title': 'Self Image: Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '866', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.4', 'spread': '1.4', 'groupId': 'OG000'}]}]}, {'title': 'Self Image: Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '682', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.3', 'spread': '1.5', 'groupId': 'OG000'}]}]}, {'title': 'Self Image: Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '560', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.4', 'spread': '1.4', 'groupId': 'OG000'}]}]}, {'title': 'Self Image: Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '433', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.3', 'spread': '1.5', 'groupId': 'OG000'}]}]}, {'title': 'Self Image: Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '349', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.4', 'spread': '1.4', 'groupId': 'OG000'}]}]}, {'title': 'Injection-site reactions: Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '925', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.6', 'spread': '0.7', 'groupId': 'OG000'}]}]}, {'title': 'Injection-site reactions: Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '907', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.6', 'spread': '0.8', 'groupId': 'OG000'}]}]}, {'title': 'Injection-site reactions: Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '862', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.6', 'spread': '0.7', 'groupId': 'OG000'}]}]}, {'title': 'Injection-site reactions: Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '679', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.5', 'spread': '0.9', 'groupId': 'OG000'}]}]}, {'title': 'Injection-site reactions: Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '549', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.5', 'spread': '0.8', 'groupId': 'OG000'}]}]}, {'title': 'Injection-site reactions: Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '431', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.5', 'spread': '0.8', 'groupId': 'OG000'}]}]}, {'title': 'Injection-site reactions: Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '353', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.5', 'spread': '0.8', 'groupId': 'OG000'}]}]}, {'title': 'Ease of use: Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '927', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.7', 'spread': '1.5', 'groupId': 'OG000'}]}]}, {'title': 'Ease of use: Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '914', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.7', 'spread': '1.6', 'groupId': 'OG000'}]}]}, {'title': 'Ease of use: Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '866', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.8', 'spread': '1.6', 'groupId': 'OG000'}]}]}, {'title': 'Ease of use: Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '676', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.8', 'spread': '1.6', 'groupId': 'OG000'}]}]}, {'title': 'Ease of use: Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '559', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.9', 'spread': '1.4', 'groupId': 'OG000'}]}]}, {'title': 'Ease of use: Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '432', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.0', 'spread': '1.5', 'groupId': 'OG000'}]}]}, {'title': 'Ease of use: Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '353', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.0', 'spread': '1.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 4, Week 8, Week 12, Week 24, Week 48, Week 72, Week 96', 'description': 'SIAQ: contained 2 modules: Pre-SIAQ and Post-SIAQ. Post-SIAQ: self-completed after self-injection. Post-SIAQ consisted of 21 items grouped into 6 domains: feelings about injections, self-image, self-confidence, injection-site reactions, ease of use \\& satisfaction with self-injection. Participants rated each item on 5-point (or 6-point) semantic Likert-type scale, where lower numbers indicated a worse experience. Item scores were transformed to obtain a score ranging from 0 (worst experience) to 10 (best experience) for each item. Transformed scores for items contributing to a domain were then averaged into a domain score. Each domain score ranges from 0 (worst experience) to 10 (best experience), higher score=better acceptability. Domain scores which are not in common with Pre-SIAQ were analyzed on the Post-SIAQ population and are reported here.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'POST-SIAQ population: participants from safety population who self-injected at least once during the study and completed a POST-SIAQ regardless of completion of PRE-SIAQ. Here, number analyzed = participants with available data at specified time points.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Alirocumab', 'description': 'Participants received Alirocumab 150 milligram (mg) subcutaneously (SC) once every two weeks (Q2W) or 75 mg SC Q2W added to stable lipid modifying therapies (LMT) up to a maximum of 120 weeks. Alirocumab dose was either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W, based on Investigator judgment and treatment response.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '998'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '994'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '878'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '120'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Lack of treatment efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Participant did not wish to continue', 'reasons': [{'groupId': 'FG000', 'numSubjects': '39'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '41'}]}, {'type': 'Poor compliance to study protocol', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Sponsor decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'Study ended treatment not available', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Switched to commercial drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Excluded from study', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Enrolled but not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}]}], 'recruitmentDetails': 'The study was conducted at 156 sites in 17 countries. A total of 1305 participants were screened between 23-June-2015 to 27-December 2016, of whom 307 were screen failures. Screen failures were mainly due to exclusion criteria met.', 'preAssignmentDetails': 'A total of 998 participants were enrolled in the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '994', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Alirocumab', 'description': 'Participants received Alirocumab 150 mg SC Q2W or 75 mg SC Q2W added to stable LMT up to a maximum of 120 weeks. Alirocumab dose was either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W, based on Investigator judgment and treatment response.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.6', 'spread': '11.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '369', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '625', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'White/Caucasian', 'measurements': [{'value': '969', 'groupId': 'BG000'}]}, {'title': 'Black', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'Asian/Oriental', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Multiracial', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Other', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Analysis was performed on safety population that included all participants who had signed the informed consent form (ICF) and who had received at least one dose or partial dose of alirocumab.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-03-01', 'size': 936345, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-03-13T10:45', 'hasProtocol': True}, {'date': '2018-10-11', 'size': 563100, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-03-13T10:44', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 998}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2019-04-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-21', 'studyFirstSubmitDate': '2015-06-16', 'resultsFirstSubmitDate': '2020-03-13', 'studyFirstSubmitQcDate': '2015-06-16', 'lastUpdatePostDateStruct': {'date': '2022-03-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-03-13', 'studyFirstPostDateStruct': {'date': '2015-06-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-03-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)', 'timeFrame': 'From first injection of investigational medicinal product (IMP) up to 2 weeks after last dose of study drug (Week 120)', 'description': 'Adverse Event (AE) was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Treatment-emergent AEs (TEAEs) were defined as AEs that that developed or worsened or became serious during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). A Serious Adverse Event (SAE) was any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event.'}], 'secondaryOutcomes': [{'measure': 'Percent Change From Baseline in Calculated Low Density Lipoprotein Cholesterol (LDL-C) at Week 12', 'timeFrame': 'Baseline, Week 12', 'description': 'Calculated LDL-C values were obtained using the Friedewald formula. Calculated LDL-C in mg/dL from Friedewald formula (LDL cholesterol = Total cholesterol - HDL cholesterol - \\[Triglyceride/5\\]). Baseline value was defined as the last observation before the first dose of the treatment.'}, {'measure': 'Percentage of Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) at Week 12', 'timeFrame': 'At Week 12', 'description': 'LDL-Cholesterol was calculated using the Friedewald formula. Percentage of participants who reached calculated LDL-C \\<100 mg/dL (2.59 mmol/L) at week 12 were reported.'}, {'measure': 'Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 12', 'timeFrame': 'At Week 12', 'description': 'LDL-Cholesterol was calculated using the Friedewald formula. Percentage of participants who reached calculated LDL-C \\<70 mg/dL (1.81 mmol/L) at week 12 were reported.'}, {'measure': 'Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) and/or >=50% Reduction From Baseline in LDL-C at Week 12', 'timeFrame': 'At Week 12', 'description': 'LDL-Cholesterol was calculated using the Friedewald formula. Percentage of participants who reached LDL-C \\<70 mg/dL at Week 12 and/or \\>=50% reduction from baseline in LDL-C at Week 12 are reported.'}, {'measure': 'Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12', 'timeFrame': 'Baseline, Week 12', 'description': 'Baseline value was defined as the last observation before the first dose of the treatment.'}, {'measure': 'Percent Change From Baseline in Total Cholesterol (Total-C) at Week 12', 'timeFrame': 'Baseline, Week 12', 'description': 'Baseline value was defined as the last observation before the first dose of the treatment.'}, {'measure': 'Percent Change From Baseline in High Density Lipoprotein Cholesterol at Week 12', 'timeFrame': 'Baseline, Week 12', 'description': 'Baseline value was defined as the last observation before the first dose of the treatment.'}, {'measure': 'Percent Change From Baseline in Triglycerides at Week 12', 'timeFrame': 'Baseline, Week 12', 'description': 'Baseline value was defined as the last observation before the first dose of the treatment.'}, {'measure': "Assessment of Participant's Acceptability of Self-Injection Using Self Injection Assessment Questionnaire (SIAQ): Feeling About Injections, Self Confidence, Satisfaction With Self-Injections", 'timeFrame': 'Baseline (Pre-SIAQ), Week 4, Week 8, Week 12, Week 24, Week 48, Week 72, Week 96', 'description': 'Pre-SIAQ: self-completed before first self-injection \\& Post-SIAQ: self-completed after self-injection. Pre-SIAQ consisted of 7 items grouped into 3 domains:feelings about injections,self-confidence \\& satisfaction with self-injection. Post-SIAQ consisted of 21 items grouped into 6 domains:feelings about injections,self-image,self-confidence,injection-site reactions,ease of use \\& satisfaction with self-injection. Participants rated each item on 5-point (or 6-point) semantic Likert-type scale, where lower numbers indicate a worse experience. Item scores were transformed to obtain a score ranging from 0 (worst experience) to 10 (best experience). Transformed scores for items contributing to a domain were then averaged into a domain score. Each domain score ranges from 0 (worst experience) to 10 (best experience), higher score=better acceptability. Domain scores common to the Pre \\& Post SIAQ were analyzed on participants belonging to Pre \\& Post-SIAQ population and are reported.'}, {'measure': "Assessment of Participant's Acceptability of Self-Injection Using Self Injection Assessment Questionnaire (SIAQ): Self Image, Injection-Site Reactions, Ease of Use", 'timeFrame': 'Week 4, Week 8, Week 12, Week 24, Week 48, Week 72, Week 96', 'description': 'SIAQ: contained 2 modules: Pre-SIAQ and Post-SIAQ. Post-SIAQ: self-completed after self-injection. Post-SIAQ consisted of 21 items grouped into 6 domains: feelings about injections, self-image, self-confidence, injection-site reactions, ease of use \\& satisfaction with self-injection. Participants rated each item on 5-point (or 6-point) semantic Likert-type scale, where lower numbers indicated a worse experience. Item scores were transformed to obtain a score ranging from 0 (worst experience) to 10 (best experience) for each item. Transformed scores for items contributing to a domain were then averaged into a domain score. Each domain score ranges from 0 (worst experience) to 10 (best experience), higher score=better acceptability. Domain scores which are not in common with Pre-SIAQ were analyzed on the Post-SIAQ population and are reported here.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True}, 'conditionsModule': {'conditions': ['Hypercholesterolemia']}, 'referencesModule': {'references': [{'pmid': '36064689', 'type': 'DERIVED', 'citation': 'Cefalu AB, Garbelotto R, Mombelli G, Pirro M, Rubba P, Arca M, Borghi C, Bonomo K, Gonnelli S, Massaroni K, Tirone G, Averna M; ODYSSEY APPRISE Study Italian Investigators. A subgroup analysis of the ODYSSEY APPRISE study: Safety and efficacy of alirocumab in the Italian cohort. Nutr Metab Cardiovasc Dis. 2022 Nov;32(11):2638-2646. doi: 10.1016/j.numecd.2022.07.020. Epub 2022 Aug 9.'}]}, 'descriptionModule': {'briefSummary': "Primary Objective:\n\nTo provide participants with severe hypercholesterolemia at risk for subsequent cardiovascular (CV) events and not adequately controlled with currently available lipid-modifying therapy (LMT) access to alirocumab ahead of commercial availability and to document the overall safety and tolerability of alirocumab in this participant population.\n\nSecondary Objectives:\n\nTo document the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels as well as non-high-density lipoprotein cholesterol (non-HDL-C), total cholesterol (total-C), high-density lipoprotein cholesterol (HDL-C), and triglyceride (TG) levels after 12 weeks of treatment.\n\nTo document participant's acceptability of self-injection (Self Injection Assessment Questionnaire, SIAQ).", 'detailedDescription': 'The study duration included a screening period of up to 3 weeks, a treatment period of a minimum of 12 weeks and up to a maximum of 120 weeks (30 months), and at least 2 weeks after the last study treatment injection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\nEither A, B, C, D, or E below and not adequately controlled with a maximally tolerated dose of statin with or without other LMTs, all at stable doses for at least 4 weeks prior to the screening visit (Week-3):\n\nA. Participants suffering from heterozygous familial hypercholesterolemia (heFH) with LDL-C concentrations greater than or equal to (\\>=)160 mg/dL (4.14 millimoles per liter \\[mmol/L\\]) despite treatment.\n\nB. Participants suffering from heFH with LDL-C concentrations \\>=130 mg/dL (3.36 mmol/L) despite treatment and two or more CV risk factors among this list:\n\n* LDL-C greater than (\\>) 250 milligrams per deciliter (mg/dL) (6.46 mmol/L) at the time of the familial hypercholesterolemia (FH) diagnosis (before treatment).\n* Family history of premature-onset coronary heart disease (CHD; first-degree male relative with onset before age 55 years; first-degree female relative with onset before age 65 years).\n* Metabolic syndrome.\n* HDL-C less than (\\<) 40 mg/dL (1.03 mmol/L).\n* Hypertension (blood pressure \\>140/90 mmHg or drug treatment).\n* Lipoprotein a (Lp\\[a\\]) \\>=50 mg/dL (1.78 µmol/L).\n* Tendon xanthoma.\n\nC. Participants suffering from heFH with LDL-C concentrations \\>=130 mg/dL (3.36 mmol/L) despite treatment and one of the following characteristics:\n\n* Established CHD or other cardiovascular disease (CVD; history of acute myocardial infarction, ischemic stroke, peripheral arterial disease, coronary or peripheral arterial revascularization, stable or unstable angina, transient ischemic attack, carotid artery stenosis \\>=50 percent (%), or aortic abdominal aneurysm).\n* Drug-treated type 2 diabetes mellitus or type 1 with target organ damage.\n* Family history of first- or second-degree relative with very premature onset CHD (first- or second-degree male relative with onset before age 45; first- or second-degree female relative with onset before age 55).\n\nD. Non-FH participants suffering from established CHD or other CVD (history of acute myocardial infarction (MI), ischemic stroke, peripheral arterial disease, coronary or peripheral arterial revascularization, stable or unstable angina, transient ischemic attack, carotid artery stenosis \\>=50%, or aortic abdominal aneurysm) and with LDL-C concentrations \\>=130 mg/dL (3.36 mmol/L).\n\nE. Participants suffering from progressive CVD (coronary artery disease, or peripheral arterial occlusive disease or cerebrovascular disease as documented clinically or by imaging techniques, with a subsequent CV event \\[acute MI, ischemic stroke, ischemia-driven revascularization, unstable angina, transient ischemic attack\\] occurring despite stable doses of maximally tolerated LMT) with LDL-C concentrations \\>=100 mg/dL (2.59 mmol/L).\n\nExclusion criteria:\n\nNot on a stable dose of LMT (including statin) for at least 4 weeks prior to the screening visit (Week -3) and from screening to enrollment.\n\nUse of a fibrate other than fenofibrate within 4 weeks of the screening visit (Week-3) or between screening and enrollment.\n\nDaily doses above atorvastatin 80 mg, rosuvastatin 40 mg, or simvastatin 40 mg (except for participants on simvastatin 80 mg for more than one year, who were eligible).\n\nUse of statin other than simvastatin, atorvastatin, or rosuvastatin prior to the screening visit (Week-3) or between screening and enrollment, except when there was a documented reason for intolerance to the above mentioned potent statins (in which case the use of a different statin was allowed).\n\nFasting serum TG \\>400 mg/dL (\\>4.52 mmol/L) at the screening visit (Week -3). Uncontrolled hypertension (\\>180 mmHg systolic and/or \\>110 mmHg diastolic at randomization visit).\n\nNew York Heart Association Class III or IV congestive heart failure persisting despite treatment.\n\nHistory of hemorrhagic stroke. Liver transaminases \\>3 times the upper limit of normal. Laboratory evidence of current hepatitis B or C infection. Creatine kinase \\>3 times the upper limit of normal. Estimated glomerular filtration rate \\<30 mL/min/1.73 m\\^2. Pregnant or breastfeeding woman or with childbearing potential without appropriate contraception.\n\nMale participant with a female partner of childbearing potential not protected by a highly-effective method(s) of birth control.\n\nParticipants eligible for enrollment into an ongoing clinical study of alirocumab conducted at the same investigational site.\n\nHypersensitivity to alirocumab or any of the excipients.\n\nThe above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT02476006', 'briefTitle': 'Safety, Tolerability, and Effect of Alirocumab in High Cardiovascular Risk Patients With Severe Hypercholesterolemia Not Adequately Controlled With Conventional Lipid-modifying Therapies (ODYSSEY APPRISE)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'A Multi-country, Multicenter, Single-arm, Open-label Study to Document the Safety, Tolerability and Effect of Alirocumab on Atherogenic Lipoproteins in High Cardio-vascular Risk Patients With Severe Hypercholesterolemia Not Adequately Controlled With Conventional Lipid-modifying Therapies', 'orgStudyIdInfo': {'id': 'LPS14245'}, 'secondaryIdInfos': [{'id': '2015-000620-28', 'type': 'EUDRACT_NUMBER'}, {'id': 'U1111-1163-0984', 'type': 'OTHER', 'domain': 'UTN'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Alirocumab', 'description': 'Participants received Alirocumab 150 milligram (mg) subcutaneously (SC) once every two weeks (Q2W) or 75 mg SC Q2W added to stable LMT up to a maximum of 120 weeks. Alirocumab dose was either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W, based on Investigator judgment and treatment response.', 'interventionNames': ['Drug: ALIROCUMAB SAR236553 (REGN727)', 'Drug: placebo (for injection training only)', 'Drug: ezetimibe', 'Drug: atorvastatin', 'Drug: rosuvastatin', 'Drug: simvastatin']}], 'interventions': [{'name': 'ALIROCUMAB SAR236553 (REGN727)', 'type': 'DRUG', 'otherNames': ['Praluent®'], 'description': 'Pharmaceutical form:solution Route of administration: subcutaneous', 'armGroupLabels': ['Alirocumab']}, {'name': 'placebo (for injection training only)', 'type': 'DRUG', 'description': 'Pharmaceutical form:solution Route of administration: subcutaneous', 'armGroupLabels': ['Alirocumab']}, {'name': 'ezetimibe', 'type': 'DRUG', 'description': 'Pharmaceutical form:capsule Route of administration: oral', 'armGroupLabels': ['Alirocumab']}, {'name': 'atorvastatin', 'type': 'DRUG', 'description': 'Pharmaceutical form:tablet Route of administration: oral', 'armGroupLabels': ['Alirocumab']}, {'name': 'rosuvastatin', 'type': 'DRUG', 'description': 'Pharmaceutical form:tablet Route of administration: oral', 'armGroupLabels': ['Alirocumab']}, {'name': 'simvastatin', 'type': 'DRUG', 'description': 'Pharmaceutical form:tablet Route of administration: oral', 'armGroupLabels': ['Alirocumab']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Graz', 'country': 'Austria', 'facility': 'Investigational Site Number 040001', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'zip': '6020', 'city': 'Innsbruck', 'country': 'Austria', 'facility': 'Investigational Site Number 040008', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}, {'zip': '4010', 'city': 'Linz', 'country': 'Austria', 'facility': 'Investigational Site Number 040005', 'geoPoint': {'lat': 48.30639, 'lon': 14.28611}}, {'zip': '4021', 'city': 'Linz', 'country': 'Austria', 'facility': 'Investigational Site Number 040006', 'geoPoint': {'lat': 48.30639, 'lon': 14.28611}}, {'zip': '1030', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Investigational Site Number 040003', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '1090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Investigational Site Number 040002', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '1130', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Investigational Site Number 040004', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '1160', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Investigational Site Number 040007', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '1160', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Investigational Site Number 040010', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '9300', 'city': 'Aalst', 'country': 'Belgium', 'facility': 'Investigational Site Number 056005', 'geoPoint': {'lat': 50.93604, 'lon': 4.0355}}, {'zip': '2020', 'city': 'Antwerp', 'country': 'Belgium', 'facility': 'Investigational Site Number 056018', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}, {'zip': '6700', 'city': 'Arlon', 'country': 'Belgium', 'facility': 'Investigational Site Number 056008', 'geoPoint': {'lat': 49.68333, 'lon': 5.81667}}, {'zip': '8000', 'city': 'Bruges', 'country': 'Belgium', 'facility': 'Investigational Site Number 056013', 'geoPoint': {'lat': 51.20892, 'lon': 3.22424}}, {'zip': '1090', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Investigational Site Number 056010', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '1200', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Investigational Site Number 056003', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '6000', 'city': 'Charleroi', 'country': 'Belgium', 'facility': 'Investigational Site Number 056006', 'geoPoint': {'lat': 50.41136, 'lon': 4.44448}}, {'zip': '2650', 'city': 'Edegem', 'country': 'Belgium', 'facility': 'Investigational Site Number 056007', 'geoPoint': {'lat': 51.15662, 'lon': 4.44504}}, {'zip': '3600', 'city': 'Genk', 'country': 'Belgium', 'facility': 'Investigational Site Number 056019', 'geoPoint': {'lat': 50.965, 'lon': 5.50082}}, {'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'Investigational Site Number 056001', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'Investigational Site Number 056017', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '7100', 'city': 'Haine-Saint-Paul', 'country': 'Belgium', 'facility': 'Investigational Site Number 056002', 'geoPoint': {'lat': 50.45544, 'lon': 4.1885}}, {'zip': '8500', 'city': 'Kortrijk', 'country': 'Belgium', 'facility': 'Investigational Site Number 056015', 'geoPoint': {'lat': 50.82803, 'lon': 3.26487}}, {'zip': '7100', 'city': 'La Louvière', 'country': 'Belgium', 'facility': 'Investigational Site Number 056009', 'geoPoint': {'lat': 50.48657, 'lon': 4.18785}}, {'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'Investigational Site Number 056004', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '4000', 'city': 'Liège', 'country': 'Belgium', 'facility': 'Investigational Site Number 056014', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'zip': '3900', 'city': 'Overpelt', 'country': 'Belgium', 'facility': 'Investigational Site Number 056011', 'geoPoint': {'lat': 51.21038, 'lon': 5.41557}}, {'zip': '8800', 'city': 'Roeselare', 'country': 'Belgium', 'facility': 'Investigational Site Number 056016', 'geoPoint': {'lat': 50.94653, 'lon': 3.12269}}, {'zip': 'T2E7C5', 'city': 'Calgary', 'country': 'Canada', 'facility': 'Investigational Site Number 124018', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'N1R6V6', 'city': 'Cambridge', 'country': 'Canada', 'facility': 'Investigational Site Number 124015', 'geoPoint': {'lat': 43.3601, 'lon': -80.31269}}, {'zip': 'G7H7K9', 'city': 'Chicoutimi', 'country': 'Canada', 'facility': 'Investigational Site Number 124002', 'geoPoint': {'lat': 48.41963, 'lon': -71.06369}}, {'zip': 'V3K3P4', 'city': 'Coquitlam', 'country': 'Canada', 'facility': 'Investigational Site Number 124027', 'geoPoint': {'lat': 49.2846, 'lon': -122.78217}}, {'zip': 'T6G2B7', 'city': 'Edmonton', 'country': 'Canada', 'facility': 'Investigational Site Number 124025', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'B3H1V7', 'city': 'Halifax', 'country': 'Canada', 'facility': 'Investigational Site Number 124017', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'zip': 'L8L 2X2', 'city': 'Hamilton', 'country': 'Canada', 'facility': 'Investigational Site Number 124013', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'N6A 4L6', 'city': 'London', 'country': 'Canada', 'facility': 'Investigational Site Number 124008', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'V2X5Z6', 'city': 'Maple Ridge', 'country': 'Canada', 'facility': 'Investigational Site Number 124026', 'geoPoint': {'lat': 49.21939, 'lon': -122.60193}}, {'zip': 'H2W1R7', 'city': 'Montreal', 'country': 'Canada', 'facility': 'Investigational Site Number 124020', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H4A3J1', 'city': 'Montreal', 'country': 'Canada', 'facility': 'Investigational Site Number 124022', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'A1N1W7', 'city': 'Mount Pearl', 'country': 'Canada', 'facility': 'Investigational Site Number 124032', 'geoPoint': {'lat': 47.51659, 'lon': -52.78135}}, {'zip': 'K1Y4W7', 'city': 'Ottawa', 'country': 'Canada', 'facility': 'Investigational Site Number 124005', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'K9J0B2', 'city': 'Peterborough', 'country': 'Canada', 'facility': 'Investigational Site Number 124024', 'geoPoint': {'lat': 44.30012, 'lon': -78.31623}}, {'zip': 'G1V4W2', 'city': 'Québec', 'country': 'Canada', 'facility': 'Investigational Site Number 124003', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'zip': 'J6E6J2', 'city': 'Saint-Charles-Borromée', 'country': 'Canada', 'facility': 'Investigational Site Number 124019', 'geoPoint': {'lat': 46.05007, 'lon': -73.46586}}, {'zip': 'N7T 4X3', 'city': 'Sarnia', 'country': 'Canada', 'facility': 'Investigational Site Number 124007', 'geoPoint': {'lat': 42.97866, 'lon': -82.40407}}, {'zip': 'J1H 5N4', 'city': 'Sherbrooke', 'country': 'Canada', 'facility': 'Investigational Site Number 124001', 'geoPoint': {'lat': 45.40008, 'lon': -71.89908}}, {'zip': 'K7A4W8', 'city': 'Smiths Falls', 'country': 'Canada', 'facility': 'Investigational Site Number 124030', 'geoPoint': {'lat': 44.90452, 'lon': -76.02333}}, {'zip': 'M4N3M5', 'city': 'Toronto', 'country': 'Canada', 'facility': 'Investigational Site Number 124023', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M5B1W8', 'city': 'Toronto', 'country': 'Canada', 'facility': 'Investigational Site Number 124014', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'city': 'Trois-Rivières', 'country': 'Canada', 'facility': 'Investigational Site Number 124028', 'geoPoint': {'lat': 46.34515, 'lon': -72.5477}}, {'zip': 'V5Y3W2', 'city': 'Vancouver', 'country': 'Canada', 'facility': 'Investigational Site Number 124011', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'V8T5G4', 'city': 'Victoria', 'country': 'Canada', 'facility': 'Investigational Site Number 124012', 'geoPoint': {'lat': 48.4359, 'lon': -123.35155}}, {'zip': 'R2H2A6', 'city': 'Winnipeg', 'country': 'Canada', 'facility': 'Investigational Site Number 124031', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}, {'zip': 'N4S5P5', 'city': 'Woodstock', 'country': 'Canada', 'facility': 'Investigational Site Number 124009', 'geoPoint': {'lat': 43.13339, 'lon': -80.7497}}, {'zip': '65691', 'city': 'Brno', 'country': 'Czechia', 'facility': 'Investigational Site Number 203004', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}, {'zip': '50005', 'city': 'Hradec Králové', 'country': 'Czechia', 'facility': 'Investigational Site Number 203002', 'geoPoint': {'lat': 50.20923, 'lon': 15.83277}}, {'zip': '12808', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Investigational Site Number 203001', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '68601', 'city': 'Uherské Hradiště', 'country': 'Czechia', 'facility': 'Investigational Site Number 203005', 'geoPoint': {'lat': 49.06975, 'lon': 17.45969}}, {'zip': '9000', 'city': 'Aalborg', 'country': 'Denmark', 'facility': 'Investigational Site Number 208003', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}, {'zip': '6700', 'city': 'Esbjerg', 'country': 'Denmark', 'facility': 'Investigational Site Number 208001', 'geoPoint': {'lat': 55.47028, 'lon': 8.45187}}, {'zip': '4000', 'city': 'Roskilde', 'country': 'Denmark', 'facility': 'Investigational Site Number 208002', 'geoPoint': {'lat': 55.64152, 'lon': 12.08035}}, {'zip': '20520', 'city': 'Turku', 'country': 'Finland', 'facility': 'Investigational Site Number 246003', 'geoPoint': {'lat': 60.45148, 'lon': 22.26869}}, {'zip': '78300', 'city': 'Varkaus', 'country': 'Finland', 'facility': 'Investigational Site Number 246001', 'geoPoint': {'lat': 62.31533, 'lon': 27.873}}, {'zip': '80054', 'city': 'Amiens', 'country': 'France', 'facility': 'Investigational Site Number 250027', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'zip': '89011', 'city': 'Auxerre', 'country': 'France', 'facility': 'Investigational Site Number 250034', 'geoPoint': {'lat': 47.7996, 'lon': 3.57033}}, {'zip': '84000', 'city': 'Avignon', 'country': 'France', 'facility': 'Investigational Site Number 250016', 'geoPoint': {'lat': 43.94834, 'lon': 4.80892}}, {'zip': '64100', 'city': 'Bayonne', 'country': 'France', 'facility': 'Investigational Site Number 250021', 'geoPoint': {'lat': 43.49316, 'lon': -1.473}}, {'zip': '93009', 'city': 'Bobigny', 'country': 'France', 'facility': 'Investigational Site Number 250030', 'geoPoint': {'lat': 48.90982, 'lon': 2.45012}}, {'zip': '33075', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Investigational Site Number 250045', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '29610', 'city': 'Brest', 'country': 'France', 'facility': 'Investigational Site Number 250049', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'zip': '69677', 'city': 'Bron', 'country': 'France', 'facility': 'Investigational Site Number 250054', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}, {'zip': '14000', 'city': 'Caen', 'country': 'France', 'facility': 'Investigational Site Number 250015', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'zip': '63003', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'Investigational Site Number 250047', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '91100', 'city': 'Corbeil-Essonnes', 'country': 'France', 'facility': 'Investigational Site Number 250013', 'geoPoint': {'lat': 48.60603, 'lon': 2.48757}}, {'zip': '28630', 'city': 'Coudray', 'country': 'France', 'facility': 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