Ignite Creation Date:
2025-12-24 @ 3:38 PM
Ignite Modification Date:
2025-12-29 @ 1:21 AM
Study NCT ID:
NCT02890992
Status:
COMPLETED
Last Update Posted:
2019-09-06
First Post:
2016-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
An 8-Week Dose-Finding Study to Evaluate the Efficacy and Safety of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Australia']}, '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': 'D019161', 'term': 'Hydroxymethylglutaryl-CoA Reductase Inhibitors'}, {'id': 'D000069438', 'term': 'Ezetimibe'}, {'id': 'D002792', 'term': 'Cholestyramine Resin'}, {'id': 'D011345', 'term': 'Fenofibrate'}, {'id': 'D015525', 'term': 'Fatty Acids, Omega-3'}, {'id': 'D009525', 'term': 'Niacin'}], 'ancestors': [{'id': 'D000924', 'term': 'Anticholesteremic Agents'}, {'id': 'D000960', 'term': 'Hypolipidemic Agents'}, {'id': 'D000963', 'term': 'Antimetabolites'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D004791', 'term': 'Enzyme Inhibitors'}, {'id': 'D057847', 'term': 'Lipid Regulating Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D001384', 'term': 'Azetidines'}, {'id': 'D001385', 'term': 'Azetines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011137', 'term': 'Polystyrenes'}, {'id': 'D010969', 'term': 'Plastics'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D001697', 'term': 'Biomedical and Dental Materials'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}, {'id': 'D058607', 'term': 'Fibric Acids'}, {'id': 'D058610', 'term': 'Isobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010647', 'term': 'Phenyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D001577', 'term': 'Benzophenones'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D007659', 'term': 'Ketones'}, {'id': 'D004042', 'term': 'Dietary Fats, Unsaturated'}, {'id': 'D004041', 'term': 'Dietary Fats'}, {'id': 'D005223', 'term': 'Fats'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D005395', 'term': 'Fish Oils'}, {'id': 'D009821', 'term': 'Oils'}, {'id': 'D009539', 'term': 'Nicotinic Acids'}, {'id': 'D000147', 'term': 'Acids, Heterocyclic'}, {'id': 'D011725', 'term': 'Pyridines'}]}}, '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 Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.', 'description': "Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.", 'eventGroups': [{'id': 'EG000', 'title': 'Cohort 1 - Alirocumab 30 mg Q2W: <50 kg', 'description': 'Participants with body weight \\< 50 kg received SC injection of alirocumab 30 mg administered Q2W up to the switch of dosage added to LMT.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Cohort 1 - Alirocumab 50 mg Q2W: >=50 kg', 'description': 'Participants with body weight \\>= 50 kg received SC injection of alirocumab 50 mg administered Q2W up to the switch of dosage added to LMT.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 5, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Cohort 2 - Alirocumab 40 mg Q2W: <50 kg', 'description': 'Participants with body weight \\< 50 kg received SC injection of alirocumab 40 mg administered Q2W up to the switch of dosage added to LMT.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 1, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Cohort 2 - Alirocumab 75 mg Q2W: >=50 kg', 'description': 'Participants with body weight \\>= 50 kg received SC injection of alirocumab 75 mg administered Q2W up to the switch of dosage added to LMT.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 4, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Cohort 3 - Alirocumab 75 mg Q4W: <50 kg', 'description': 'Participants with body weight \\< 50 kg received SC injection of alirocumab 75 mg administered Q4W up to the switch of dosage added to LMT.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 5, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Cohort 3 - Alirocumab 150 mg Q4W: >=50 kg', 'description': 'Participants with body weight \\>= 50 kg received SC injection of alirocumab 150 mg administered Q4W up to the switch of dosage added to LMT.', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 3, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Cohort 4 - Alirocumab 150 mg Q4W: <50 kg', 'description': 'Participants with body weight \\< 50 kg received SC injection of alirocumab 150 mg administered Q4W up to the end of the OLE period (up to 130 weeks) added to LMT.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 3, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'Cohort 4 - Alirocumab 300 mg Q4W: >=50 kg', 'description': 'Participants with body weight \\>= 50 kg received SC injection of alirocumab 300 mg administered Q4W up to the end of the OLE period (up to 130 weeks) added to LMT.', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 4, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG008', 'title': 'Alirocumab 40 Q2W Post-switch', 'description': 'Participants with body weight \\< 50 kg from cohort 1, 2 and 3 switched to dosage and received SC injection of alirocumab 40 mg administered Q2W from the switch up to the end of the OLE period (up to 130 weeks) added to LMT.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 7, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG009', 'title': 'Alirocumab 75 Q2W Post-switch', 'description': 'Participants from Cohort 1 (7 participants), Cohort 2 and Cohort 3 (11 participants) switched to dosage and received SC injection of alirocumab 75 mg administered Q2W up to the end of the OLE period (up to 130 weeks) added to LMT.', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 9, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Lymphadenopathy', 'stats': 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'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Excessive Eye Blinking', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Abdominal Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Influenza Like Illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 10, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Injection Site Reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Food Allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 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'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Thoracic Outlet Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Alcohol Abuse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Anxiety Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Depressed Mood', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Premenstrual Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Oropharyngeal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Sinus Congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pallor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Change From Baseline in Calculated Low Density Lipoprotein Cholesterol (LDL-C) at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 - Alirocumab 30 mg Q2W: <50 kg', 'description': 'Participants with body weight \\< 50 kg received SC injection of alirocumab 30 mg administered Q2W up to 8 weeks added to LMT.'}, {'id': 'OG001', 'title': 'Cohort 1 - Alirocumab 50 mg Q2W: >=50 kg', 'description': 'Participants with body weight \\>= 50 kg received SC injection of alirocumab 50 mg administered Q2W up to 8 weeks added to LMT.'}, {'id': 'OG002', 'title': 'Cohort 2 - Alirocumab 40 mg Q2W: <50 kg', 'description': 'Participants with body weight \\< 50 kg received SC injection of alirocumab 40 mg administered Q2W up to 8 weeks added to LMT.'}, {'id': 'OG003', 'title': 'Cohort 2 - Alirocumab 75 mg Q2W: >=50 kg', 'description': 'Participants with body weight \\>= 50 kg received SC injection of alirocumab 75 mg administered Q2W up to 8 weeks added to LMT.'}, {'id': 'OG004', 'title': 'Cohort 3 - Alirocumab 75 mg Q4W: <50 kg', 'description': 'Participants with body weight \\< 50 kg received SC injection of alirocumab 75 mg administered Q4W up to 8 weeks added to LMT.'}, {'id': 'OG005', 'title': 'Cohort 3 - Alirocumab 150 mg Q4W: >=50 kg', 'description': 'Participants with body weight \\>= 50 kg received SC injection of alirocumab 150 mg administered Q4W up to Week 8 added to LMT.'}, {'id': 'OG006', 'title': 'Cohort 4 - Alirocumab 150 mg Q4W: <50 kg', 'description': 'Participants with body weight \\< 50 kg received SC injection of alirocumab 150 mg administered Q4W up to 12 weeks added to LMT.'}, {'id': 'OG007', 'title': 'Cohort 4 - Alirocumab 300 mg Q4W: >=50 kg', 'description': 'Participants with body weight \\>= 50 kg received SC injection of alirocumab 300 mg administered Q4W up to 12 weeks added to LMT.'}], 'classes': [{'categories': [{'measurements': [{'value': '-41.1', 'spread': '12.6', 'groupId': 'OG000'}, {'value': '-7.9', 'spread': '10.3', 'groupId': 'OG001'}, {'value': '-40.6', 'spread': '13.2', 'groupId': 'OG002'}, {'value': '-49.8', 'spread': '10.6', 'groupId': 'OG003'}, {'value': '-17.5', 'spread': '10.3', 'groupId': 'OG004'}, {'value': '4.0', 'spread': '11.2', 'groupId': 'OG005'}, {'value': '-31.9', 'spread': '10.3', 'groupId': 'OG006'}, {'value': '-59.8', 'spread': '11.2', 'groupId': 'OG007'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 8', 'description': 'Percent change in calculated LDL-C was defined as 100\\*(calculated LDL-C value at Week 8 - calculated LDL-C value at baseline)/calculated LDL-C value at baseline. All available baseline and post-baseline calculated LDL-C value during the OLDFI efficacy treatment period \\& within one of the analysis windows up to Week 8 were used in the model. OLDFI efficacy treatment period was defined as the period from first investigational medicinal product (IMP) injection to last OLDFI IMP injection + 21 days(for Cohorts 1 \\& 2) or +35 days (for Cohorts 3 \\& 4). Adjusted Least-squares (LS) mean \\& standard error (SE) at Week 8 were obtained from mixed-effect model with repeated measures (MMRM) analysis, with fixed categorical effects of alirocumab dose/dose regimen (30 mg Q2W \\[\\<50 kg\\], 40 mg Q2W \\[\\<50 kg\\], 50 mg Q2W \\[\\>=50 kg\\], 75 mg Q2W \\[\\>=50 kg\\], 75 mg Q4W \\[\\<50 kg\\],150 mg Q4W \\[\\>=50 kg\\], 150 mg Q4W \\[\\<50 kg\\] and 300 mg Q4W (\\[\\>=50 kg\\] dose), time point \\& dose/dose regimen-by-time point interaction.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on modified intent-to-treat (mITT) population which included all participants who received at least one dose or partial dose of IMP injection and had an evaluable outcome measure during the open-label dose finding efficacy treatment period.'}, {'type': 'SECONDARY', 'title': 'Absolute Change From Baseline in Calculated Low Density Lipoprotein Cholesterol (LDL-C) at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 - Alirocumab 30 mg Q2W: <50 kg', 'description': 'Participants with body weight \\< 50 kg received SC injection of alirocumab 30 milligram(mg) administered Q2W up to 8 weeks added to LMT.'}, {'id': 'OG001', 'title': 'Cohort 1 - Alirocumab 50 mg Q2W: >=50 kg', 'description': 'Participants with body weight \\>= 50 kg received SC injection of alirocumab 50 mg administered Q2W up to 8 weeks added to LMT.'}, {'id': 'OG002', 'title': 'Cohort 2 - Alirocumab 40 mg Q2W: <50 kg', 'description': 'Participants with body weight \\< 50 kg received SC injection of alirocumab 40 mg administered Q2W up to 8 weeks added to LMT.'}, {'id': 'OG003', 'title': 'Cohort 2 - Alirocumab 75 mg Q2W: >=50 kg', 'description': 'Participants with body weight \\>= 50 kg received SC injection of alirocumab 75 mg administered Q2W up to 8 weeks added to LMT.'}, {'id': 'OG004', 'title': 'Cohort 3 - Alirocumab 75 mg Q4W: <50 kg', 'description': 'Participants with body weight \\< 50 kg received SC injection of alirocumab 75 mg administered Q4W up to 8 weeks added to LMT.'}, {'id': 'OG005', 'title': 'Cohort 3 - Alirocumab 150 mg Q4W: >=50 kg', 'description': 'Participants with body weight \\>= 50 kg received SC injection of alirocumab 150 mg administered Q4W up to Week 8 added to LMT.'}, {'id': 'OG006', 'title': 'Cohort 4 - Alirocumab 150 mg Q4W: <50 kg', 'description': 'Participants with body weight \\< 50 kg received SC injection of alirocumab 150 mg administered Q4W up to 12 weeks added to LMT.'}, {'id': 'OG007', 'title': 'Cohort 4 - Alirocumab 300 mg Q4W: >=50 kg', 'description': 'Participants with body weight \\>= 50 kg received SC injection of alirocumab 300 mg administered Q4W up to 12 weeks added to LMT.'}], 'classes': [{'categories': [{'measurements': [{'value': '-83.7', 'spread': '19.5', 'groupId': 'OG000'}, {'value': '-27.6', 'spread': '15.9', 'groupId': 'OG001'}, {'value': '-55.5', 'spread': '20.8', 'groupId': 'OG002'}, {'value': '-88.3', 'spread': '16.5', 'groupId': 'OG003'}, {'value': '-32.4', 'spread': '15.9', 'groupId': 'OG004'}, {'value': '0.1', 'spread': '17.4', 'groupId': 'OG005'}, {'value': '-55.9', 'spread': '15.9', 'groupId': 'OG006'}, {'value': '-104.3', 'spread': '17.4', 'groupId': 'OG007'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 8', 'description': 'Absolute change in LDL-C was calculated by subtracting baseline value from Week 8 value. Adjusted LS means and SE were obtained using MMRM analysis, with fixed categorical effects of alirocumab dose/dose regimen, time point and dose/dose regimen-by-time point interaction.', 'unitOfMeasure': 'milligram per deciliter (mg/dL)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on mITT population.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Calculated Low Density Lipoprotein Cholesterol (LDL-C) <130 mg/dL (3.37 mmol/L) at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 - Alirocumab 30 mg Q2W: <50 kg', 'description': 'Participants with body weight \\< 50 kg received SC injection of alirocumab 30 milligram(mg) administered Q2W up to 8 weeks added to LMT.'}, {'id': 'OG001', 'title': 'Cohort 1 - Alirocumab 50 mg Q2W: >=50 kg', 'description': 'Participants with body weight \\>= 50 kg received SC injection of alirocumab 50 mg administered Q2W up to 8 weeks added to LMT.'}, {'id': 'OG002', 'title': 'Cohort 2 - Alirocumab 40 mg Q2W: <50 kg', 'description': 'Participants with body weight \\< 50 kg received SC injection of alirocumab 40 mg administered Q2W up to 8 weeks added to LMT.'}, {'id': 'OG003', 'title': 'Cohort 2 - Alirocumab 75 mg Q2W: >=50 kg', 'description': 'Participants with body weight \\>= 50 kg received SC injection of alirocumab 75 mg administered Q2W up to 8 weeks added to LMT.'}, {'id': 'OG004', 'title': 'Cohort 3 - Alirocumab 75 mg Q4W: <50 kg', 'description': 'Participants with body weight \\< 50 kg received SC injection of alirocumab 75 mg administered Q4W up to 8 weeks added to LMT.'}, {'id': 'OG005', 'title': 'Cohort 3 - Alirocumab 150 mg Q4W: >=50 kg', 'description': 'Participants with body weight \\>= 50 kg received SC injection of alirocumab 150 mg administered Q4W up to Week 8 added to LMT.'}, {'id': 'OG006', 'title': 'Cohort 4 - Alirocumab 150 mg Q4W: <50 kg', 'description': 'Participants with body weight \\< 50 kg received SC injection of alirocumab 150 mg administered Q4W up to 12 weeks added to LMT.'}, {'id': 'OG007', 'title': 'Cohort 4 - Alirocumab 300 mg Q4W: >=50 kg', 'description': 'Participants with body weight \\>= 50 kg received SC injection of alirocumab 300 mg administered Q4W up to 12 weeks added to LMT.'}], 'classes': [{'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '33.3', 'groupId': 'OG001'}, {'value': '97.6', 'groupId': 'OG002'}, {'value': '83.0', 'groupId': 'OG003'}, {'value': '33.3', 'groupId': 'OG004'}, {'value': '20.0', 'groupId': 'OG005'}, {'value': '66.7', 'groupId': 'OG006'}, {'value': '80.0', 'groupId': 'OG007'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 8', 'description': 'Combined estimate for percentage of participants was obtained by averaging out all the imputed percentage of participants reaching the level of interest. A two-step multiple imputation procedure was used to address missing values in the mITT population in the two steps respectively; with number of imputations = 1000. In the first step, the monotone missing pattern was induced in the multiply-imputed data. In the second step, the missing data at subsequent visits were imputed using the regression method for continuous variables.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on mITT population.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Calculated LDL-C <110 mg/dL (2.84 mmol/L) at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 - Alirocumab 30 mg Q2W: <50 kg', 'description': 'Participants with body weight \\< 50 kg received SC injection of alirocumab 30 milligram (mg) administered Q2W up to 8 weeks added to LMT.'}, {'id': 'OG001', 'title': 'Cohort 1 - Alirocumab 50 mg Q2W: >=50 kg', 'description': 'Participants with body weight \\>= 50 kg received SC injection of alirocumab 50 mg administered Q2W up to 8 weeks added to LMT.'}, {'id': 'OG002', 'title': 'Cohort 2 - Alirocumab 40 mg Q2W: <50 kg', 'description': 'Participants with body weight \\< 50 kg received SC injection of alirocumab 40 mg administered Q2W up to 8 weeks added to LMT.'}, {'id': 'OG003', 'title': 'Cohort 2 - Alirocumab 75 mg Q2W: >=50 kg', 'description': 'Participants with body weight \\>= 50 kg received SC injection of alirocumab 75 mg administered Q2W up to 8 weeks added to LMT.'}, {'id': 'OG004', 'title': 'Cohort 3 - Alirocumab 75 mg Q4W: <50 kg', 'description': 'Participants with body weight \\< 50 kg received SC injection of alirocumab 75 mg administered Q4W up to 8 weeks added to LMT.'}, {'id': 'OG005', 'title': 'Cohort 3 - Alirocumab 150 mg Q4W: >=50 kg', 'description': 'Participants with body weight \\>= 50 kg received SC injection of alirocumab 150 mg administered Q4W up to Week 8 added to LMT.'}, {'id': 'OG006', 'title': 'Cohort 4 - Alirocumab 150 mg Q4W: <50 kg', 'description': 'Participants with body weight \\< 50 kg received SC injection of alirocumab 150 mg administered Q4W up to 12 weeks added to LMT.'}, {'id': 'OG007', 'title': 'Cohort 4 - Alirocumab 300 mg Q4W: >=50 kg', 'description': 'Participants with body weight \\>= 50 kg received SC injection of alirocumab 300 mg administered Q4W up to 12 weeks added to LMT.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '93.4', 'groupId': 'OG002'}, {'value': '65.7', 'groupId': 'OG003'}, {'value': '16.7', 'groupId': 'OG004'}, {'value': '20.0', 'groupId': 'OG005'}, {'value': '66.7', 'groupId': 'OG006'}, {'value': '80.0', 'groupId': 'OG007'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 8', 'description': 'Combined estimate for percentage of participants was obtained by averaging out all the imputed percentage of participants reaching the level of interest. A two-step multiple imputation procedure was used to address missing values in the mITT population in the two steps respectively; with number of imputations = 1000. In the first step, the monotone missing pattern was induced in the multiply-imputed data. In the second step, the missing data at subsequent visits were imputed using the regression method for continuous variables.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on mITT population.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Calculated LDL-C at Week 12: Cohort 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 4 - Alirocumab 150 mg Q4W: <50 kg', 'description': 'Participants with body weight \\< 50 kg received SC injection of alirocumab 150 mg administered Q4W up to 12 weeks added to LMT.'}, {'id': 'OG001', 'title': 'Cohort 4 - Alirocumab 300 mg Q4W: >=50 kg', 'description': 'Participants with body weight \\>= 50 kg received SC injection of alirocumab 300 mg administered Q4W up to 12 weeks added to LMT.'}], 'classes': [{'categories': [{'measurements': [{'value': '-29.7', 'spread': '6.9', 'groupId': 'OG000'}, {'value': '-49.2', 'spread': '7.5', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'Adjusted LS means and standard error at Week 12 were obtained from MMRM analysis, with fixed categorical effects of alirocumab dose/dose regimen, time point and dose/dose regimen-by-time point interaction.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on mITT population. Data for this outcome measure was planned to be collected for Cohort 4 only.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Apolipoprotein (Apo) B at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 - Alirocumab 30 mg Q2W: <50 kg', 'description': 'Participants with body weight \\< 50 kg received SC injection of alirocumab 30 milligram(mg) administered Q2W up to 8 weeks added to LMT.'}, {'id': 'OG001', 'title': 'Cohort 1 - Alirocumab 50 mg Q2W: >=50 kg', 'description': 'Participants with body weight \\>= 50 kg received SC injection of alirocumab 50 mg administered Q2W up to 8 weeks added to LMT.'}, {'id': 'OG002', 'title': 'Cohort 2 - Alirocumab 40 mg Q2W: <50 kg', 'description': 'Participants with body weight \\< 50 kg received SC injection of alirocumab 40 mg administered Q2W up to 8 weeks added to LMT.'}, {'id': 'OG003', 'title': 'Cohort 2 - Alirocumab 75 mg Q2W: >=50 kg', 'description': 'Participants with body weight \\>= 50 kg received SC injection of alirocumab 75 mg administered Q2W up to 8 weeks added to LMT.'}, {'id': 'OG004', 'title': 'Cohort 3 - Alirocumab 75 mg Q4W: <50 kg', 'description': 'Participants with body weight \\< 50 kg received SC injection of alirocumab 75 mg administered Q4W up to 8 weeks added to LMT.'}, {'id': 'OG005', 'title': 'Cohort 3 - Alirocumab 150 mg Q4W: >=50 kg', 'description': 'Participants with body weight \\>= 50 kg received SC injection of alirocumab 150 mg administered Q4W up to Week 8 added to LMT.'}, {'id': 'OG006', 'title': 'Cohort 4 - Alirocumab 150 mg Q4W: <50 kg', 'description': 'Participants with body weight \\< 50 kg received SC injection of alirocumab 150 mg administered Q4W up to 12 weeks added to LMT.'}, {'id': 'OG007', 'title': 'Cohort 4 - Alirocumab 300 mg Q4W: >=50 kg', 'description': 'Participants with body weight \\>= 50 kg received SC injection of alirocumab 300 mg administered Q4W up to 12 weeks added to LMT.'}], 'classes': [{'categories': [{'measurements': [{'value': '-38.4', 'spread': '12.8', 'groupId': 'OG000'}, {'value': '-9.7', 'spread': '9.1', 'groupId': 'OG001'}, {'value': '-36.4', 'spread': '12.8', 'groupId': 'OG002'}, {'value': '-40.1', 'spread': '9.9', 'groupId': 'OG003'}, {'value': '-12.6', 'spread': '9.1', 'groupId': 'OG004'}, {'value': '-0.9', 'spread': '9.9', 'groupId': 'OG005'}, {'value': '-27.2', 'spread': '9.1', 'groupId': 'OG006'}, {'value': '-51.4', 'spread': '9.9', 'groupId': 'OG007'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 8', 'description': 'Adjusted LS means and SE at Week 8 were obtained from MMRM analysis, with fixed categorical effects of alirocumab dose/dose regimen, time point and dose/dose regimen-by-time point interaction. All available baseline value and post-baseline values in at least one of the analysis windows used in the model.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on mITT population. Here, overall number of participants analyzed=participants with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Non-High Density Lipoprotein (HDL-C) at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 - Alirocumab 30 mg Q2W: <50 kg', 'description': 'Participants with body weight \\< 50 kg received SC injection of alirocumab 30 mg administered Q2W up to 8 weeks added to LMT.'}, {'id': 'OG001', 'title': 'Cohort 1 - Alirocumab 50 mg Q2W: >=50 kg', 'description': 'Participants with body weight \\>= 50 kg received SC injection of alirocumab 50 mg administered Q2W up to 8 weeks added to LMT.'}, {'id': 'OG002', 'title': 'Cohort 2 - Alirocumab 40 mg Q2W: <50 kg', 'description': 'Participants with body weight \\< 50 kg received SC injection of alirocumab 40 mg administered Q2W up to 8 weeks added to LMT.'}, {'id': 'OG003', 'title': 'Cohort 2 - Alirocumab 75 mg Q2W: >=50 kg', 'description': 'Participants with body weight \\>= 50 kg received SC injection of alirocumab 75 mg administered Q2W up to 8 weeks added to LMT.'}, {'id': 'OG004', 'title': 'Cohort 3 - Alirocumab 75 mg Q4W: <50 kg', 'description': 'Participants with body weight \\< 50 kg received SC injection of alirocumab 75 mg administered Q4W up to 8 weeks added to LMT.'}, {'id': 'OG005', 'title': 'Cohort 3 - Alirocumab 150 mg Q4W: >=50 kg', 'description': 'Participants with body weight \\>= 50 kg received SC injection of alirocumab 150 mg administered Q4W up to Week 8 added to LMT.'}, {'id': 'OG006', 'title': 'Cohort 4 - Alirocumab 150 mg Q4W: <50 kg', 'description': 'Participants with body weight \\< 50 kg received SC injection of alirocumab 150 mg administered Q4W up to 12 weeks added to LMT.'}, {'id': 'OG007', 'title': 'Cohort 4 - Alirocumab 300 mg Q4W: >=50 kg', 'description': 'Participants with body weight \\>= 50 kg received SC injection of alirocumab 300 mg administered Q4W up to 12 weeks added to LMT.'}], 'classes': [{'categories': [{'measurements': [{'value': '-39.6', 'spread': '11.9', 'groupId': 'OG000'}, {'value': '-7.1', 'spread': '9.7', 'groupId': 'OG001'}, {'value': '-39.7', 'spread': '12.5', 'groupId': 'OG002'}, {'value': '-43.9', 'spread': '10.0', 'groupId': 'OG003'}, {'value': '-14.4', 'spread': '9.7', 'groupId': 'OG004'}, {'value': '3.2', 'spread': '10.7', 'groupId': 'OG005'}, {'value': '-31.5', 'spread': '9.7', 'groupId': 'OG006'}, {'value': '-54.6', 'spread': '10.7', 'groupId': 'OG007'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 8', 'description': 'Adjusted LS means and SE at Week 8 were obtained from MMRM analysis, with fixed categorical effects of alirocumab dose/dose regimen, time point and dose/dose regimen-by-time point interaction. All available baselines value and post-baseline values in at least one of the analysis windows up to Week 8 were used in the model.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on mITT population.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Total Cholesterol (Total-C) at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 - Alirocumab 30 mg Q2W: <50 kg', 'description': 'Participants with body weight \\< 50 kg received SC injection of alirocumab 30 mg administered Q2W up to 8 weeks added to LMT.'}, {'id': 'OG001', 'title': 'Cohort 1 - Alirocumab 50 mg Q2W: >=50 kg', 'description': 'Participants with body weight \\>= 50 kg received SC injection of alirocumab 50 mg administered Q2W up to 8 weeks added to LMT.'}, {'id': 'OG002', 'title': 'Cohort 2 - Alirocumab 40 mg Q2W: <50 kg', 'description': 'Participants with body weight \\< 50 kg received SC injection of alirocumab 40 mg administered Q2W up to 8 weeks added to LMT.'}, {'id': 'OG003', 'title': 'Cohort 2 - Alirocumab 75 mg Q2W: >=50 kg', 'description': 'Participants with body weight \\>= 50 kg received SC injection of alirocumab 75 mg administered Q2W up to 8 weeks added to LMT.'}, {'id': 'OG004', 'title': 'Cohort 3 - Alirocumab 75 mg Q4W: <50 kg', 'description': 'Participants with body weight \\< 50 kg received SC injection of alirocumab 75 mg administered Q4W up to 8 weeks added to LMT.'}, {'id': 'OG005', 'title': 'Cohort 3 - Alirocumab 150 mg Q4W: >=50 kg', 'description': 'Participants with body weight \\>= 50 kg received SC injection of alirocumab 150 mg administered Q4W up to Week 8 added to LMT.'}, {'id': 'OG006', 'title': 'Cohort 4 - Alirocumab 150 mg Q4W: <50 kg', 'description': 'Participants with body weight \\< 50 kg received SC injection of alirocumab 150 mg administered Q4W up to 12 weeks added to LMT.'}, {'id': 'OG007', 'title': 'Cohort 4 - Alirocumab 300 mg Q4W: >=50 kg', 'description': 'Participants with body weight \\>= 50 kg received SC injection of alirocumab 300 mg administered Q4W up to 12 weeks added to LMT.'}], 'classes': [{'categories': [{'measurements': [{'value': '-29.0', 'spread': '9.7', 'groupId': 'OG000'}, {'value': '-4.1', 'spread': '7.9', 'groupId': 'OG001'}, {'value': '-28.6', 'spread': '10.1', 'groupId': 'OG002'}, {'value': '-34.2', 'spread': '8.1', 'groupId': 'OG003'}, {'value': '-10.7', 'spread': '7.9', 'groupId': 'OG004'}, {'value': '5.2', 'spread': '8.6', 'groupId': 'OG005'}, {'value': '-24.0', 'spread': '7.9', 'groupId': 'OG006'}, {'value': '-41.8', 'spread': '8.6', 'groupId': 'OG007'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 8', 'description': 'Adjusted LS means and SE at Week 8 were obtained from MMRM analysis, with fixed categorical effects of alirocumab dose/dose regimen, time point and dose/dose regimen-by-time point interaction. All available baseline values and post-baseline values in at least one of the analysis windows up to Week 8 were used in the model.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on mITT population.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Lipoprotein(a) at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 - Alirocumab 30 mg Q2W: <50 kg', 'description': 'Participants with body weight \\< 50 kg received SC injection of alirocumab 30 mg administered Q2W up to 8 weeks added to LMT.'}, {'id': 'OG001', 'title': 'Cohort 1 - Alirocumab 50 mg Q2W: >=50 kg', 'description': 'Participants with body weight \\>= 50 kg received SC injection of alirocumab 50 mg administered Q2W up to 8 weeks added to LMT.'}, {'id': 'OG002', 'title': 'Cohort 2 - Alirocumab 40 mg Q2W: <50 kg', 'description': 'Participants with body weight \\< 50 kg received SC injection of alirocumab 40 mg administered Q2W up to 8 weeks added to LMT.'}, {'id': 'OG003', 'title': 'Cohort 2 - Alirocumab 75 mg Q2W: >=50 kg', 'description': 'Participants with body weight \\>= 50 kg received SC injection of alirocumab 75 mg administered Q2W up to 8 weeks added to LMT.'}, {'id': 'OG004', 'title': 'Cohort 3 - Alirocumab 75 mg Q4W: <50 kg', 'description': 'Participants with body weight \\< 50 kg received SC injection of alirocumab 75 mg administered Q4W up to 8 weeks added to LMT.'}, {'id': 'OG005', 'title': 'Cohort 3 - Alirocumab 150 mg Q4W: >=50 kg', 'description': 'Participants with body weight \\>= 50 kg received SC injection of alirocumab 150 mg administered Q4W up to Week 8 added to LMT.'}, {'id': 'OG006', 'title': 'Cohort 4 - Alirocumab 150 mg Q4W: <50 kg', 'description': 'Participants with body weight \\< 50 kg received SC injection of alirocumab 150 mg administered Q4W up to 12 weeks added to LMT.'}, {'id': 'OG007', 'title': 'Cohort 4 - Alirocumab 300 mg Q4W: >=50 kg', 'description': 'Participants with body weight \\>= 50 kg received SC injection of alirocumab 300 mg administered Q4W up to 12 weeks added to LMT.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.5', 'spread': '21.1', 'groupId': 'OG000'}, {'value': '-26.9', 'spread': '11.6', 'groupId': 'OG001'}, {'value': '1.5', 'spread': '15.1', 'groupId': 'OG002'}, {'value': '-25.2', 'spread': '14.4', 'groupId': 'OG003'}, {'value': '2.2', 'spread': '10.5', 'groupId': 'OG004'}, {'value': '-7.7', 'spread': '11.4', 'groupId': 'OG005'}, {'value': '0.1', 'spread': '10.2', 'groupId': 'OG006'}, {'value': '-7.7', 'spread': '11.1', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 8', 'description': 'Combined estimates and SE were obtained by combining adjusted means and SE from robust regression model analyses of the different imputed data sets. The robust regression models included the fixed categorical effect of alirocumab dose/dose regimen. A two-step multiple imputation procedure was used to address missing values in the mITT population in the two steps respectively (with number of imputations = 1000). In the first step, the monotone missing pattern was induced in the multiply-imputed data. In the second step, the missing data at subsequent visits were imputed using the regression method for continuous variables.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on mITT population.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Fasting Triglyceride at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 - Alirocumab 30 mg Q2W: <50 kg', 'description': 'Participants with body weight \\< 50 kg received SC injection of alirocumab 30 mg administered Q2W up to 8 weeks added to LMT.'}, {'id': 'OG001', 'title': 'Cohort 1 - Alirocumab 50 mg Q2W: >=50 kg', 'description': 'Participants with body weight \\>= 50 kg received SC injection of alirocumab 50 mg administered Q2W up to 8 weeks added to LMT.'}, {'id': 'OG002', 'title': 'Cohort 2 - Alirocumab 40 mg Q2W: <50 kg', 'description': 'Participants with body weight \\< 50 kg received SC injection of alirocumab 40 mg administered Q2W up to 8 weeks added to LMT.'}, {'id': 'OG003', 'title': 'Cohort 2 - Alirocumab 75 mg Q2W: >=50 kg', 'description': 'Participants with body weight \\>= 50 kg received SC injection of alirocumab 75 mg administered Q2W up to 8 weeks added to LMT.'}, {'id': 'OG004', 'title': 'Cohort 3 - Alirocumab 75 mg Q4W: <50 kg', 'description': 'Participants with body weight \\< 50 kg received SC injection of alirocumab 75 mg administered Q4W up to 8 weeks added to LMT.'}, {'id': 'OG005', 'title': 'Cohort 3 - Alirocumab 150 mg Q4W: >=50 kg', 'description': 'Participants with body weight \\>= 50 kg received SC injection of alirocumab 150 mg administered Q4W up to Week 8 added to LMT.'}, {'id': 'OG006', 'title': 'Cohort 4 - Alirocumab 150 mg Q4W: <50 kg', 'description': 'Participants with body weight \\< 50 kg received SC injection of alirocumab 150 mg administered Q4W up to 12 weeks added to LMT.'}, {'id': 'OG007', 'title': 'Cohort 4 - Alirocumab 300 mg Q4W: >=50 kg', 'description': 'Participants with body weight \\>= 50 kg received SC injection of alirocumab 300 mg administered Q4W up to 12 weeks added to LMT.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.4', 'spread': '19.6', 'groupId': 'OG000'}, {'value': '-4.0', 'spread': '16.0', 'groupId': 'OG001'}, {'value': '-7.4', 'spread': '28.4', 'groupId': 'OG002'}, {'value': '14.5', 'spread': '19.0', 'groupId': 'OG003'}, {'value': '19.3', 'spread': '16.0', 'groupId': 'OG004'}, {'value': '-3.1', 'spread': '17.5', 'groupId': 'OG005'}, {'value': '-32.1', 'spread': '16.0', 'groupId': 'OG006'}, {'value': '-7.1', 'spread': '17.5', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 8', 'description': 'Combined estimates and SE were obtained by combining adjusted means and SE from robust regression model analyses of the different imputed data sets. The robust regression models included the fixed categorical effect of alirocumab dose/dose regimen. A two-step multiple imputation procedure was used to address missing values in the mITT population (in the two steps respectively; with number of imputations = 1000). In the first step, the monotone missing pattern was induced in the multiply-imputed data. In the second step, the missing data at subsequent visits were imputed using the regression method for continuous variables.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on mITT population.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 - Alirocumab 30 mg Q2W: <50 kg', 'description': 'Participants with body weight \\< 50 kg received SC injection of alirocumab 30 mg administered Q2W up to 8 weeks added to LMT.'}, {'id': 'OG001', 'title': 'Cohort 1 - Alirocumab 50 mg Q2W: >=50 kg', 'description': 'Participants with body weight \\>= 50 kg received SC injection of alirocumab 50 mg administered Q2W up to 8 weeks added to LMT.'}, {'id': 'OG002', 'title': 'Cohort 2 - Alirocumab 40 mg Q2W: <50 kg', 'description': 'Participants with body weight \\< 50 kg received SC injection of alirocumab 40 mg administered Q2W up to 8 weeks added to LMT.'}, {'id': 'OG003', 'title': 'Cohort 2 - Alirocumab 75 mg Q2W: >=50 kg', 'description': 'Participants with body weight \\>= 50 kg received SC injection of alirocumab 75 mg administered Q2W up to 8 weeks added to LMT.'}, {'id': 'OG004', 'title': 'Cohort 3 - Alirocumab 75 mg Q4W: <50 kg', 'description': 'Participants with body weight \\< 50 kg received SC injection of alirocumab 75 mg administered Q4W up to 8 weeks added to LMT.'}, {'id': 'OG005', 'title': 'Cohort 3 - Alirocumab 150 mg Q4W: >=50 kg', 'description': 'Participants with body weight \\>= 50 kg received SC injection of alirocumab 150 mg administered Q4W up to Week 8 added to LMT.'}, {'id': 'OG006', 'title': 'Cohort 4 - Alirocumab 150 mg Q4W: <50 kg', 'description': 'Participants with body weight \\< 50 kg received SC injection of alirocumab 150 mg administered Q4W up to 12 weeks added to LMT.'}, {'id': 'OG007', 'title': 'Cohort 4 - Alirocumab 300 mg Q4W: >=50 kg', 'description': 'Participants with body weight \\>= 50 kg received SC injection of alirocumab 300 mg administered Q4W up to 12 weeks added to LMT.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.7', 'spread': '7.1', 'groupId': 'OG000'}, {'value': '16.5', 'spread': '5.8', 'groupId': 'OG001'}, {'value': '14.7', 'spread': '7.7', 'groupId': 'OG002'}, {'value': '10.6', 'spread': '6.1', 'groupId': 'OG003'}, {'value': '5.2', 'spread': '5.8', 'groupId': 'OG004'}, {'value': '13.8', 'spread': '6.4', 'groupId': 'OG005'}, {'value': '4.5', 'spread': '5.8', 'groupId': 'OG006'}, {'value': '2.8', 'spread': '6.4', 'groupId': 'OG007'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 8', 'description': 'Adjusted LS means and SE at Week 8 were obtained from MMRM analysis, with fixed categorical effects of alirocumab dose/dose regimen, time point and dose/dose regimen-by-time point interaction. All available baseline values and post-baseline values in at least one of the analysis windows up to Week 8 were used in the model.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on mITT population.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Apolipoprotein A-1 at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 - Alirocumab 30 mg Q2W: <50 kg', 'description': 'Participants with body weight \\< 50 kg received SC injection of alirocumab 30 mg administered Q2W up to 8 weeks added to LMT.'}, {'id': 'OG001', 'title': 'Cohort 1 - Alirocumab 50 mg Q2W: >=50 kg', 'description': 'Participants with body weight \\>= 50 kg received SC injection of alirocumab 50 mg administered Q2W up to 8 weeks added to LMT.'}, {'id': 'OG002', 'title': 'Cohort 2 - Alirocumab 40 mg Q2W: <50 kg', 'description': 'Participants with body weight \\< 50 kg received SC injection of alirocumab 40 mg administered Q2W up to 8 weeks added to LMT.'}, {'id': 'OG003', 'title': 'Cohort 2 - Alirocumab 75 mg Q2W: >=50 kg', 'description': 'Participants with body weight \\>= 50 kg received SC injection of alirocumab 75 mg administered Q2W up to 8 weeks added to LMT.'}, {'id': 'OG004', 'title': 'Cohort 3 - Alirocumab 75 mg Q4W: <50 kg', 'description': 'Participants with body weight \\< 50 kg received SC injection of alirocumab 75 mg administered Q4W up to 8 weeks added to LMT.'}, {'id': 'OG005', 'title': 'Cohort 3 - Alirocumab 150 mg Q4W: >=50 kg', 'description': 'Participants with body weight \\>= 50 kg received SC injection of alirocumab 150 mg administered Q4W up to Week 8 added to LMT.'}, {'id': 'OG006', 'title': 'Cohort 4 - Alirocumab 150 mg Q4W: <50 kg', 'description': 'Participants with body weight \\< 50 kg received SC injection of alirocumab 150 mg administered Q4W up to 12 weeks added to LMT.'}, {'id': 'OG007', 'title': 'Cohort 4 - Alirocumab 300 mg Q4W: >=50 kg', 'description': 'Participants with body weight \\>= 50 kg received SC injection of alirocumab 300 mg administered Q4W up to 12 weeks added to LMT.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.4', 'spread': '7.2', 'groupId': 'OG000'}, {'value': '14.8', 'spread': '5.1', 'groupId': 'OG001'}, {'value': '10.7', 'spread': '7.2', 'groupId': 'OG002'}, {'value': '1.8', 'spread': '5.6', 'groupId': 'OG003'}, {'value': '8.9', 'spread': '5.1', 'groupId': 'OG004'}, {'value': '7.4', 'spread': '5.6', 'groupId': 'OG005'}, {'value': '5.8', 'spread': '5.1', 'groupId': 'OG006'}, {'value': '7.2', 'spread': '5.6', 'groupId': 'OG007'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 8', 'description': 'Adjusted LS means and SE at Week 8 were obtained from MMRM analysis, with fixed categorical effects of alirocumab dose/dose regimen, time point and dose/dose regimen-by-time point interaction. All available baseline values and post-baseline values in at least one of the analysis windows up to Week 8 were used in the model.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on mITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Absolute Change From Baseline in Apolipoprotein B at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 - Alirocumab 30 mg Q2W: <50 kg', 'description': 'Participants with body weight \\< 50 kg received SC injection of alirocumab 30 mg administered Q2W up to 8 weeks added to LMT.'}, {'id': 'OG001', 'title': 'Cohort 1 - Alirocumab 50 mg Q2W: >=50 kg', 'description': 'Participants with body weight \\>= 50 kg received SC injection of alirocumab 50 mg administered Q2W up to 8 weeks added to LMT.'}, {'id': 'OG002', 'title': 'Cohort 2 - Alirocumab 40 mg Q2W: <50 kg', 'description': 'Participants with body weight \\< 50 kg received SC injection of alirocumab 40 mg administered Q2W up to 8 weeks added to LMT.'}, {'id': 'OG003', 'title': 'Cohort 2 - Alirocumab 75 mg Q2W: >=50 kg', 'description': 'Participants with body weight \\>= 50 kg received SC injection of alirocumab 75 mg administered Q2W up to 8 weeks added to LMT.'}, {'id': 'OG004', 'title': 'Cohort 3 - Alirocumab 75 mg Q4W: <50 kg', 'description': 'Participants with body weight \\< 50 kg received SC injection of alirocumab 75 mg administered Q4W up to 8 weeks added to LMT.'}, {'id': 'OG005', 'title': 'Cohort 3 - Alirocumab 150 mg Q4W: >=50 kg', 'description': 'Participants with body weight \\>= 50 kg received SC injection of alirocumab 150 mg administered Q4W up to Week 8 added to LMT.'}, {'id': 'OG006', 'title': 'Cohort 4 - Alirocumab 150 mg Q4W: <50 kg', 'description': 'Participants with body weight \\< 50 kg received SC injection of alirocumab 150 mg administered Q4W up to 12 weeks added to LMT.'}, {'id': 'OG007', 'title': 'Cohort 4 - Alirocumab 300 mg Q4W: >=50 kg', 'description': 'Participants with body weight \\>= 50 kg received SC injection of alirocumab 300 mg administered Q4W up to 12 weeks added to LMT.'}], 'classes': [{'categories': [{'measurements': [{'value': '-51.7', 'spread': '15.8', 'groupId': 'OG000'}, {'value': '-18.5', 'spread': '11.1', 'groupId': 'OG001'}, {'value': '-35.3', 'spread': '15.8', 'groupId': 'OG002'}, {'value': '-53.4', 'spread': '12.2', 'groupId': 'OG003'}, {'value': '-15.3', 'spread': '11.1', 'groupId': 'OG004'}, {'value': '-5.4', 'spread': '12.2', 'groupId': 'OG005'}, {'value': '-34.2', 'spread': '11.1', 'groupId': 'OG006'}, {'value': '-63.5', 'spread': '12.2', 'groupId': 'OG007'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 8', 'description': 'Adjusted LS means and SE at Week 8 were obtained from MMRM analysis, with fixed categorical effects of alirocumab dose/dose regimen, time point and dose/dose regimen-by-time point interaction. 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Here, overall number of participants analyzed = participants with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Absolute Change From Baseline in Non-High-Density Lipoprotein (Non-HDL-C) at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 - Alirocumab 30 mg Q2W: <50 kg', 'description': 'Participants with body weight \\< 50 kg received SC injection of alirocumab 30 mg administered Q2W up to 8 weeks added to LMT.'}, {'id': 'OG001', 'title': 'Cohort 1 - Alirocumab 50 mg Q2W: >=50 kg', 'description': 'Participants with body weight \\>= 50 kg received SC injection of alirocumab 50 mg administered Q2W up to 8 weeks added to LMT.'}, {'id': 'OG002', 'title': 'Cohort 2 - Alirocumab 40 mg Q2W: <50 kg', 'description': 'Participants with body weight \\< 50 kg received SC injection of alirocumab 40 mg administered Q2W up to 8 weeks added to LMT.'}, {'id': 'OG003', 'title': 'Cohort 2 - Alirocumab 75 mg Q2W: >=50 kg', 'description': 'Participants with body weight \\>= 50 kg received SC injection of alirocumab 75 mg administered Q2W up to 8 weeks added to LMT.'}, {'id': 'OG004', 'title': 'Cohort 3 - Alirocumab 75 mg Q4W: <50 kg', 'description': 'Participants with body weight \\< 50 kg received SC injection of alirocumab 75 mg administered Q4W up to 8 weeks added to LMT.'}, {'id': 'OG005', 'title': 'Cohort 3 - Alirocumab 150 mg Q4W: >=50 kg', 'description': 'Participants with body weight \\>= 50 kg received SC injection of alirocumab 150 mg administered Q4W up to Week 8 added to LMT.'}, {'id': 'OG006', 'title': 'Cohort 4 - Alirocumab 150 mg Q4W: <50 kg', 'description': 'Participants with body weight \\< 50 kg received SC injection of alirocumab 150 mg administered Q4W up to 12 weeks added to LMT.'}, {'id': 'OG007', 'title': 'Cohort 4 - Alirocumab 300 mg Q4W: >=50 kg', 'description': 'Participants with body weight \\>= 50 kg received SC injection of alirocumab 300 mg administered Q4W up to 12 weeks added to LMT.'}], 'classes': [{'categories': [{'measurements': [{'value': '-86.1', 'spread': '20.8', 'groupId': 'OG000'}, {'value': '-28.7', 'spread': '17.0', 'groupId': 'OG001'}, {'value': '-62.7', 'spread': '22.1', 'groupId': 'OG002'}, {'value': '-88.5', 'spread': '17.6', 'groupId': 'OG003'}, {'value': '-29.5', 'spread': '17.0', 'groupId': 'OG004'}, {'value': '-0.6', 'spread': '18.6', 'groupId': 'OG005'}, {'value': '-63.1', 'spread': '17.0', 'groupId': 'OG006'}, {'value': '-106.4', 'spread': '18.6', 'groupId': 'OG007'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 8', 'description': 'Adjusted LS means and SE at Week 8 were obtained from MMRM analysis, with fixed categorical effects of alirocumab dose/dose regimen, time point and dose/dose regimen-by-time point interaction. 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The robust regression models included the fixed categorical effect of alirocumab dose/dose regimen. A two-step multiple imputation procedure was used to address missing values in the mITT population (in the two steps respectively; with number of imputations = 1000). In the first step, the monotone missing pattern was induced in the multiply-imputed data. In the second step, the missing data at subsequent visits were imputed using the regression method for continuous variables.', 'unitOfMeasure': 'gram/Liter (g/L)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on mITT population.'}, {'type': 'SECONDARY', 'title': 'Absolute Change From Baseline in HDL-C at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 - Alirocumab 30 mg Q2W: <50 kg', 'description': 'Participants with body weight \\< 50 kg received SC injection of alirocumab 30 mg administered Q2W up to 8 weeks added to LMT.'}, {'id': 'OG001', 'title': 'Cohort 1 - Alirocumab 50 mg Q2W: >=50 kg', 'description': 'Participants with body weight \\>= 50 kg received SC injection of alirocumab 50 mg administered Q2W up to 8 weeks added to LMT.'}, {'id': 'OG002', 'title': 'Cohort 2 - Alirocumab 40 mg Q2W: <50 kg', 'description': 'Participants with body weight \\< 50 kg received SC injection of alirocumab 40 mg administered Q2W up to 8 weeks added to LMT.'}, {'id': 'OG003', 'title': 'Cohort 2 - Alirocumab 75 mg Q2W: >=50 kg', 'description': 'Participants with body weight \\>= 50 kg received SC injection of alirocumab 75 mg administered Q2W up to 8 weeks added to LMT.'}, {'id': 'OG004', 'title': 'Cohort 3 - Alirocumab 75 mg Q4W: <50 kg', 'description': 'Participants with body weight \\< 50 kg received SC injection of alirocumab 75 mg administered Q4W up to 8 weeks added to LMT.'}, {'id': 'OG005', 'title': 'Cohort 3 - Alirocumab 150 mg Q4W: >=50 kg', 'description': 'Participants with body weight \\>= 50 kg received SC injection of alirocumab 150 mg administered Q4W up to Week 8 added to LMT.'}, {'id': 'OG006', 'title': 'Cohort 4 - Alirocumab 150 mg Q4W: <50 kg', 'description': 'Participants with body weight \\< 50 kg received SC injection of alirocumab 150 mg administered Q4W up to 12 weeks added to LMT.'}, {'id': 'OG007', 'title': 'Cohort 4 - Alirocumab 300 mg Q4W: >=50 kg', 'description': 'Participants with body weight \\>= 50 kg received SC injection of alirocumab 300 mg administered Q4W up to 12 weeks added to LMT.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.9', 'spread': '3.4', 'groupId': 'OG000'}, {'value': '7.7', 'spread': '2.8', 'groupId': 'OG001'}, {'value': '5.5', 'spread': '3.7', 'groupId': 'OG002'}, {'value': '4.9', 'spread': '2.9', 'groupId': 'OG003'}, {'value': '2.4', 'spread': '2.8', 'groupId': 'OG004'}, {'value': '5.9', 'spread': '3.1', 'groupId': 'OG005'}, {'value': '2.2', 'spread': '2.8', 'groupId': 'OG006'}, {'value': '1.2', 'spread': '3.1', 'groupId': 'OG007'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 8', 'description': 'Adjusted LS means and SE at Week 8 were obtained from MMRM analysis, with fixed categorical effects of alirocumab dose/dose regimen, time point and dose/dose regimen-by-time point interaction. All available baseline values and post-baseline values in at least one of the analysis windows up to Week 8 were used in the model.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on mITT population.'}, {'type': 'SECONDARY', 'title': 'Absolute Change From Baseline in Fasting Triglyceride at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 - Alirocumab 30 mg Q2W: <50 kg', 'description': 'Participants with body weight \\< 50 kg received SC injection of alirocumab 30 mg administered Q2W up to 8 weeks added to LMT.'}, {'id': 'OG001', 'title': 'Cohort 1 - Alirocumab 50 mg Q2W: >=50 kg', 'description': 'Participants with body weight \\>= 50 kg received SC injection of alirocumab 50 mg administered Q2W up to 8 weeks added to LMT.'}, {'id': 'OG002', 'title': 'Cohort 2 - Alirocumab 40 mg Q2W: <50 kg', 'description': 'Participants with body weight \\< 50 kg received SC injection of alirocumab 40 mg administered Q2W up to 8 weeks added to LMT.'}, {'id': 'OG003', 'title': 'Cohort 2 - Alirocumab 75 mg Q2W: >=50 kg', 'description': 'Participants with body weight \\>= 50 kg received SC injection of alirocumab 75 mg administered Q2W up to 8 weeks added to LMT.'}, {'id': 'OG004', 'title': 'Cohort 3 - Alirocumab 75 mg Q4W: <50 kg', 'description': 'Participants with body weight \\< 50 kg received SC injection of alirocumab 75 mg administered Q4W up to 8 weeks added to LMT.'}, {'id': 'OG005', 'title': 'Cohort 3 - Alirocumab 150 mg Q4W: >=50 kg', 'description': 'Participants with body weight \\>= 50 kg received SC injection of alirocumab 150 mg administered Q4W up to Week 8 added to LMT.'}, {'id': 'OG006', 'title': 'Cohort 4 - Alirocumab 150 mg Q4W: <50 kg', 'description': 'Participants with body weight \\< 50 kg received SC injection of alirocumab 150 mg administered Q4W up to 12 weeks added to LMT.'}, {'id': 'OG007', 'title': 'Cohort 4 - Alirocumab 300 mg Q4W: >=50 kg', 'description': 'Participants with body weight \\>= 50 kg received SC injection of alirocumab 300 mg administered Q4W up to 12 weeks added to LMT.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.121', 'spread': '0.193', 'groupId': 'OG000'}, {'value': '-0.076', 'spread': '0.157', 'groupId': 'OG001'}, {'value': '0.168', 'spread': '0.226', 'groupId': 'OG002'}, {'value': '0.111', 'spread': '0.188', 'groupId': 'OG003'}, {'value': '0.117', 'spread': '0.157', 'groupId': 'OG004'}, {'value': '-0.045', 'spread': '0.172', 'groupId': 'OG005'}, {'value': '-0.402', 'spread': '0.157', 'groupId': 'OG006'}, {'value': '-0.107', 'spread': '0.172', 'groupId': 'OG007'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 8', 'description': 'Combined estimates and SE were obtained by combining adjusted means and SE from robust regression model analyses of the different imputed data sets. The robust regression models included the fixed categorical effect of alirocumab dose/dose regimen. A two-step multiple imputation procedure was used to address missing values in the mITT population (in the two steps respectively; with number of imputations = 1000). In the first step, the monotone missing pattern was induced in the multiply-imputed data. In the second step, the missing data at subsequent visits were imputed using the regression method for continuous variables.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on mITT population.'}, {'type': 'SECONDARY', 'title': 'Absolute Change From Baseline in Apolipoprotein A-1 at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 - Alirocumab 30 mg Q2W: <50 kg', 'description': 'Participants with body weight \\< 50 kg received SC injection of alirocumab 30 mg administered Q2W up to 8 weeks added to LMT.'}, {'id': 'OG001', 'title': 'Cohort 1 - Alirocumab 50 mg Q2W: >=50 kg', 'description': 'Participants with body weight \\>= 50 kg received SC injection of alirocumab 50 mg administered Q2W up to 8 weeks added to LMT.'}, {'id': 'OG002', 'title': 'Cohort 2 - Alirocumab 40 mg Q2W: <50 kg', 'description': 'Participants with body weight \\< 50 kg received SC injection of alirocumab 40 mg administered Q2W up to 8 weeks added to LMT.'}, {'id': 'OG003', 'title': 'Cohort 2 - Alirocumab 75 mg Q2W: >=50 kg', 'description': 'Participants with body weight \\>= 50 kg received SC injection of alirocumab 75 mg administered Q2W up to 8 weeks added to LMT.'}, {'id': 'OG004', 'title': 'Cohort 3 - Alirocumab 75 mg Q4W: <50 kg', 'description': 'Participants with body weight \\< 50 kg received SC injection of alirocumab 75 mg administered Q4W up to 8 weeks added to LMT.'}, {'id': 'OG005', 'title': 'Cohort 3 - Alirocumab 150 mg Q4W: >=50 kg', 'description': 'Participants with body weight \\>= 50 kg received SC injection of alirocumab 150 mg administered Q4W up to Week 8 added to LMT.'}, {'id': 'OG006', 'title': 'Cohort 4 - Alirocumab 150 mg Q4W: <50 kg', 'description': 'Participants with body weight \\< 50 kg received SC injection of alirocumab 150 mg administered Q4W up to 12 weeks added to LMT.'}, {'id': 'OG007', 'title': 'Cohort 4 - Alirocumab 300 mg Q4W: >=50 kg', 'description': 'Participants with body weight \\>= 50 kg received SC injection of alirocumab 300 mg administered Q4W up to 12 weeks added to LMT.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.0', 'spread': '9.3', 'groupId': 'OG000'}, {'value': '17.7', 'spread': '6.5', 'groupId': 'OG001'}, {'value': '11.3', 'spread': '9.3', 'groupId': 'OG002'}, {'value': '-0.4', 'spread': '7.2', 'groupId': 'OG003'}, {'value': '10.5', 'spread': '6.5', 'groupId': 'OG004'}, {'value': '8.0', 'spread': '7.2', 'groupId': 'OG005'}, {'value': '7.5', 'spread': '6.5', 'groupId': 'OG006'}, {'value': '11.0', 'spread': '7.2', 'groupId': 'OG007'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 8', 'description': 'Adjusted LS means and SE at Week 8 were obtained from MMRM analysis, with fixed categorical effects of alirocumab dose/dose regimen, time point and dose/dose regimen-by-time point interaction. All available baseline values and post-baseline values in at least one of the analysis windows up to Week 8 were used in the model.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on mITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Absolute Change From Baseline in Ratio Apolipoprotein B/Apolipoprotein A-1 at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 - Alirocumab 30 mg Q2W: <50 kg', 'description': 'Participants with body weight \\< 50 kg received SC injection of alirocumab 30 mg administered Q2W up to 8 weeks added to LMT.'}, {'id': 'OG001', 'title': 'Cohort 1 - Alirocumab 50 mg Q2W: >=50 kg', 'description': 'Participants with body weight \\>= 50 kg received SC injection of alirocumab 50 mg administered Q2W up to 8 weeks added to LMT.'}, {'id': 'OG002', 'title': 'Cohort 2 - Alirocumab 40 mg Q2W: <50 kg', 'description': 'Participants with body weight \\< 50 kg received SC injection of alirocumab 40 mg administered Q2W up to 8 weeks added to LMT.'}, {'id': 'OG003', 'title': 'Cohort 2 - Alirocumab 75 mg Q2W: >=50 kg', 'description': 'Participants with body weight \\>= 50 kg received SC injection of alirocumab 75 mg administered Q2W up to 8 weeks added to LMT.'}, {'id': 'OG004', 'title': 'Cohort 3 - Alirocumab 75 mg Q4W: <50 kg', 'description': 'Participants with body weight \\< 50 kg received SC injection of alirocumab 75 mg administered Q4W up to Week 8 added to LMT.'}, {'id': 'OG005', 'title': 'Cohort 3 - Alirocumab 150 mg Q4W: >=50 kg', 'description': 'Participants with body weight \\>= 50 kg received SC injection of alirocumab 150 mg administered Q4W up to Week 8 added to LMT.'}, {'id': 'OG006', 'title': 'Cohort 4 - Alirocumab 150 mg Q4W: <50 kg', 'description': 'Participants with body weight \\< 50 kg received SC injection of alirocumab 150 mg administered Q4W up to 12 weeks added to LMT.'}, {'id': 'OG007', 'title': 'Cohort 4 - Alirocumab 300 mg Q4W: >=50 kg', 'description': 'Participants with body weight \\>= 50 kg received SC injection of alirocumab 300 mg administered Q4W up to 12 weeks added to LMT.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.363', 'spread': '0.123', 'groupId': 'OG000'}, {'value': '-0.262', 'spread': '0.087', 'groupId': 'OG001'}, {'value': '-0.370', 'spread': '0.123', 'groupId': 'OG002'}, {'value': '-0.402', 'spread': '0.096', 'groupId': 'OG003'}, {'value': '-0.190', 'spread': '0.087', 'groupId': 'OG004'}, {'value': '-0.086', 'spread': '0.096', 'groupId': 'OG005'}, {'value': '-0.282', 'spread': '0.087', 'groupId': 'OG006'}, {'value': '-0.473', 'spread': '0.096', 'groupId': 'OG007'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 8', 'description': 'Adjusted LS means and SE at Week 8 were obtained from MMRM analysis, with fixed categorical effects of alirocumab dose/dose regimen, time point and dose/dose regimen-by-time point interaction. All available baseline values and post-baseline values in at least one of the analysis windows up to Week 8 were used in the model.', 'unitOfMeasure': 'ratio (Apo B/Apo A-1)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on mITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cohort 1 - Alirocumab 30 mg Q2W: <50 kg', 'description': 'Period 1: Participants with body weight less than (\\<) 50 kilograms (kg) received subcutaneous (SC) injection of alirocumab 30 milligram (mg) administered every 2 weeks (Q2W) up to 8 weeks added to lipid modifying therapy (LMT).\n\nPeriod 2: Participants with body weight \\< 50 kg received SC injection of alirocumab 30 mg administered Q2W from Week 16 until switch to Cohort 2 dosage including dose adjustment to body weight as required, then Cohort 2 dosage: if body weight was still \\< 50 kg, participants received SC injection of alirocumab 40 mg administered Q2W until Week 130; if body weight was \\> = 50 kg participants received SC injection of alirocumab 75 mg administered Q2W until Week 130.'}, {'id': 'FG001', 'title': 'Cohort 1 - Alirocumab 50 mg Q2W: >=50 kg', 'description': 'Period 1: Participants with body weight greater than or equal to (\\>=) 50 kg received SC injection of alirocumab 50 mg administered Q2W up to 8 weeks added to LMT.\n\nPeriod 2: Participants with body weight \\>= 50 kg received SC injection of alirocumab 50 mg administered Q2W from Week 16 until switch to Cohort 2 dosage then SC injection of alirocumab 75 mg administered Q2W until Week 130.'}, {'id': 'FG002', 'title': 'Cohort 2 - Alirocumab 40 mg Q2W: <50 kg', 'description': 'Period 1: Participants with body weight \\< 50 kg received SC injection of alirocumab 40 mg administered Q2W up to 8 weeks added to LMT.\n\nPeriod 2: Participants with body weight \\< 50 kg received SC injection of alirocumab 40 mg administered Q2W from Week 16 until switch of dosage in Cohorts 1 and 3. If body weight was still \\< 50 kg, participants continued to receive SC injection of alirocumab 40 mg administered Q2W until Week 130; if body weight was \\> = 50 kg participants received SC injection of alirocumab 75 mg administered Q2W until Week 130.'}, {'id': 'FG003', 'title': 'Cohort 2 - Alirocumab 75 mg Q2W: >=50 kg', 'description': 'Period 1: Participants with body weight \\>= 50 kg received SC injection of alirocumab 75 mg administered Q2W up to 8 weeks added to LMT.\n\nPeriod 2: Participants with body weight \\>= 50 kg received SC injection of alirocumab 75 mg administered Q2W from Week 16 until Week 130.'}, {'id': 'FG004', 'title': 'Cohort 3 - Alirocumab 75 mg Q4W: <50 kg', 'description': 'Period 1: Participants with body weight \\< 50 kg received SC injection of alirocumab 75 mg administered Q4W up to 8 weeks added to LMT.\n\nPeriod 2: Participants with body weight \\< 50 kg received SC injection of alirocumab 75 mg administered Q4W from Week 14 until switch to Cohort 2 dosage including dose adjustment to body weight as required, then Cohort 2 dosage: if body weight was still \\< 50 kg, participants received SC injection of alirocumab 40 mg administered Q2W until Week 130; if body weight was \\> = 50 kg participants received SC injection of alirocumab 75 mg administered Q2W until Week 130.'}, {'id': 'FG005', 'title': 'Cohort 3 - Alirocumab 150 mg Q4W: >=50 kg', 'description': 'Period 1: Participants with body weight \\>= 50 kg received SC injection of alirocumab 150 mg administered Q4W up to Week 8 added to LMT.\n\nPeriod 2: Participants with body weight \\>= 50 kg received SC injection of alirocumab 150 mg administered Q4W from Week 14 until switch to Cohort 2 dosage then SC injection of alirocumab 75 mg administered Q2W until Week 130.'}, {'id': 'FG006', 'title': 'Cohort 4 - Alirocumab 150 mg Q4W: <50 kg', 'description': 'Period 1: Participants with body weight \\< 50 kg received SC injection of alirocumab 150 mg administered Q4W up to 12 weeks added to LMT.\n\nPeriod 2: Participants with body weight \\< 50 kg received SC injection of Alirocumab 150 mg administered Q4W from Week 12 until Week 48.'}, {'id': 'FG007', 'title': 'Cohort 4 - Alirocumab 300 mg Q4W: >=50 kg', 'description': 'Period 1: Participants with body weight \\>= 50 kg received SC injection of alirocumab 300 mg administered Q4W up to 12 weeks added to LMT.\n\nPeriod 2: Participants with body weight \\>= 50 kg received SC injection of alirocumab 300 mg administered Q4W from Week 12 until Week 48.'}], 'periods': [{'title': '12 Weeks Open-Label Dose Finding Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '5'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '5'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '5'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Out of 4 participants, 3 participants entered into the open-label extension (OLE) period.', 'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '5'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}]}, {'title': '130 Weeks Open-Label Extension Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '3 participants from Open-Label Dose Finding Period (OLDFI) entered in OLE period.', 'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '5'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '5'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '5'}, {'groupId': 'FG006', 'numSubjects': '5'}, {'groupId': 'FG007', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '5'}, {'groupId': 'FG006', 'numSubjects': '5'}, {'groupId': 'FG007', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Included but not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '1'}]}, {'type': 'Other than specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The study was conducted at 16 sites in 10 countries. Overall 63 participants were screened between 15 September 2016 and 13 June 2018, of whom 21 participants were screen failures. Screen failures were mainly due to exclusion criteria met.', 'preAssignmentDetails': 'A total of 42 participants were included in this study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '5', 'groupId': 'BG007'}, {'value': '42', 'groupId': 'BG008'}]}], 'groups': [{'id': 'BG000', 'title': 'Cohort 1 - Alirocumab 30 mg Q2W: <50 kg', 'description': 'Period 1: Participants with body weight \\< 50 kg received SC injection of alirocumab 30 mg administered Q2W up to 8 weeks added to LMT.\n\nPeriod 2: Participants with body weight \\< 50 kg received SC injection of alirocumab 30 mg administered Q2W from Week 16 until switch to Cohort 2 dosage including dose adjustment to body weight as required, then Cohort 2 dosage: if body weight was still \\< 50 kg, participants received SC injection of alirocumab 40 mg administered Q2W until Week 130; if body weight was \\> = 50 kg participants received SC injection of alirocumab 75 mg administered Q2W until Week 130.'}, {'id': 'BG001', 'title': 'Cohort 1 - Alirocumab 50 mg Q2W: >=50 kg', 'description': 'Period 1: Participants with body weight \\>= 50 kg received SC injection of alirocumab 50 mg administered Q2W up to 8 weeks added to LMT.\n\nPeriod 2: Participants with body weight \\>= 50 kg received SC injection of alirocumab 50 mg administered Q2W from Week 16 until switch to Cohort 2 dosage then SC injection of alirocumab 75 mg administered Q2W until Week 130.'}, {'id': 'BG002', 'title': 'Cohort 2 - Alirocumab 40 mg Q2W: <50 kg', 'description': 'Period 1: Participants with body weight \\< 50 kg received SC injection of alirocumab 40 mg administered Q2W up to 8 weeks added to LMT.\n\nPeriod 2: Participants with body weight \\< 50 kg received SC injection of alirocumab 40 mg administered Q2W from Week 16 until switch of dosage in Cohorts 1 and 3. If body weight was still \\< 50 kg, participants continued to receive SC injection of alirocumab 40 mg administered Q2W until Week 130; if body weight was \\> = 50 kg participants received SC injection of alirocumab 75 mg administered Q2W until Week 130.'}, {'id': 'BG003', 'title': 'Cohort 2 - Alirocumab 75 mg Q2W: >=50 kg', 'description': 'Period 1: Participants with body weight \\>= 50 kg received SC injection of alirocumab 75 mg administered Q2W up to 8 weeks added to LMT.\n\nPeriod 2: Participants with body weight \\>= 50 kg received SC injection of alirocumab 75 mg administered Q2W from Week 16 until Week 130.'}, {'id': 'BG004', 'title': 'Cohort 3 - Alirocumab 75 mg Q4W: <50 kg', 'description': 'Period 1: Participants with body weight \\< 50 kg received SC injection of alirocumab 75 mg administered every 4 weeks (Q4W) up to 8 weeks added to LMT.\n\nPeriod 2: Participants with body weight \\< 50 kg received SC injection of alirocumab 75 mg administered Q4W from Week 14 until switch to Cohort 2 dosage including dose adjustment to body weight as required, then Cohort 2 dosage: if body weight was still \\< 50 kg, participants received SC injection of alirocumab 40 mg administered Q2W until Week 130; if body weight was \\> = 50 kg participants received SC injection of alirocumab 75 mg administered Q2W until Week 130.'}, {'id': 'BG005', 'title': 'Cohort 3 - Alirocumab 150 mg Q4W: >=50 kg', 'description': 'Period 1: Participants with body weight \\>= 50 kg received SC injection of alirocumab 150 mg administered Q4W up to Week 8 added to LMT.\n\nPeriod 2: Participants with body weight \\>= 50 kg received SC injection of alirocumab 150 mg administered Q4W from Week 14 until switch to Cohort 2 dosage then SC injection of alirocumab 75 mg administered Q2W until Week 130.'}, {'id': 'BG006', 'title': 'Cohort 4 - Alirocumab 150 mg Q4W: <50 kg', 'description': 'Period 1: Participants with body weight \\< 50 kg received SC injection of alirocumab 150 mg administered Q4W up to 12 weeks added to LMT.\n\nPeriod 2: Participants with body weight \\< 50 kg received SC injection of alirocumab 150 mg administered Q4W from Week 12 until Week 48.'}, {'id': 'BG007', 'title': 'Cohort 4 - Alirocumab 300 mg Q4W: >=50 kg', 'description': 'Period 1: Participants with body weight \\>= 50 kg received SC injection of alirocumab 300 mg administered Q4W up to 12 weeks added to LMT.\n\nPeriod 2: Participants with body weight \\>= 50 kg received SC injection of alirocumab 300 mg administered Q4W from Week 12 until Week 48.'}, {'id': 'BG008', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '11.0', 'spread': '2.0', 'groupId': 'BG000'}, {'value': '13.8', 'spread': '2.7', 'groupId': 'BG001'}, {'value': '11.3', 'spread': '2.2', 'groupId': 'BG002'}, {'value': '14.3', 'spread': '2.3', 'groupId': 'BG003'}, {'value': '9.8', 'spread': '1.9', 'groupId': 'BG004'}, {'value': '13.8', 'spread': '1.6', 'groupId': 'BG005'}, {'value': '11.3', 'spread': '2.2', 'groupId': 'BG006'}, {'value': '13.6', 'spread': '2.1', 'groupId': 'BG007'}, {'value': '12.4', 'spread': '2.6', 'groupId': 'BG008'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '19', 'groupId': 'BG008'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '23', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Black or African American', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}]}]}, {'title': 'Black or African American/White', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '39', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Low Density Lipoprotein Cholesterol (LDL-C)', 'classes': [{'categories': [{'measurements': [{'value': '5.169', 'spread': '0.736', 'groupId': 'BG000'}, {'value': '4.339', 'spread': '1.200', 'groupId': 'BG001'}, {'value': '3.596', 'spread': '0.630', 'groupId': 'BG002'}, {'value': '4.510', 'spread': '1.052', 'groupId': 'BG003'}, {'value': '4.337', 'spread': '1.147', 'groupId': 'BG004'}, {'value': '4.642', 'spread': '1.272', 'groupId': 'BG005'}, {'value': '5.100', 'spread': '1.136', 'groupId': 'BG006'}, {'value': '4.641', 'spread': '0.926', 'groupId': 'BG007'}, {'value': '4.6', 'spread': '1.1', 'groupId': 'BG008'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'millimoles per litre (mmol/L)', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Analysis was performed on safety population that included population who did actually received at least one dose or part of a dose of the open-label investigational medicinal product (IMP). Participants were analyzed according to the dose of alirocumab actually received.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-12-11', 'size': 1320095, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-08-15T10:20', 'hasProtocol': True}, {'date': '2018-05-15', 'size': 1598894, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-08-15T10:22', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-02-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-15', 'studyFirstSubmitDate': '2016-08-31', 'resultsFirstSubmitDate': '2019-08-15', 'studyFirstSubmitQcDate': '2016-08-31', 'lastUpdatePostDateStruct': {'date': '2019-09-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-08-15', 'studyFirstPostDateStruct': {'date': '2016-09-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-09-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change From Baseline in Calculated Low Density Lipoprotein Cholesterol (LDL-C) at Week 8', 'timeFrame': 'Baseline, Week 8', 'description': 'Percent change in calculated LDL-C was defined as 100\\*(calculated LDL-C value at Week 8 - calculated LDL-C value at baseline)/calculated LDL-C value at baseline. All available baseline and post-baseline calculated LDL-C value during the OLDFI efficacy treatment period \\& within one of the analysis windows up to Week 8 were used in the model. OLDFI efficacy treatment period was defined as the period from first investigational medicinal product (IMP) injection to last OLDFI IMP injection + 21 days(for Cohorts 1 \\& 2) or +35 days (for Cohorts 3 \\& 4). Adjusted Least-squares (LS) mean \\& standard error (SE) at Week 8 were obtained from mixed-effect model with repeated measures (MMRM) analysis, with fixed categorical effects of alirocumab dose/dose regimen (30 mg Q2W \\[\\<50 kg\\], 40 mg Q2W \\[\\<50 kg\\], 50 mg Q2W \\[\\>=50 kg\\], 75 mg Q2W \\[\\>=50 kg\\], 75 mg Q4W \\[\\<50 kg\\],150 mg Q4W \\[\\>=50 kg\\], 150 mg Q4W \\[\\<50 kg\\] and 300 mg Q4W (\\[\\>=50 kg\\] dose), time point \\& dose/dose regimen-by-time point interaction.'}], 'secondaryOutcomes': [{'measure': 'Absolute Change From Baseline in Calculated Low Density Lipoprotein Cholesterol (LDL-C) at Week 8', 'timeFrame': 'Baseline, Week 8', 'description': 'Absolute change in LDL-C was calculated by subtracting baseline value from Week 8 value. Adjusted LS means and SE were obtained using MMRM analysis, with fixed categorical effects of alirocumab dose/dose regimen, time point and dose/dose regimen-by-time point interaction.'}, {'measure': 'Percentage of Participants Achieving Calculated Low Density Lipoprotein Cholesterol (LDL-C) <130 mg/dL (3.37 mmol/L) at Week 8', 'timeFrame': 'At Week 8', 'description': 'Combined estimate for percentage of participants was obtained by averaging out all the imputed percentage of participants reaching the level of interest. A two-step multiple imputation procedure was used to address missing values in the mITT population in the two steps respectively; with number of imputations = 1000. In the first step, the monotone missing pattern was induced in the multiply-imputed data. In the second step, the missing data at subsequent visits were imputed using the regression method for continuous variables.'}, {'measure': 'Percentage of Participants Achieving Calculated LDL-C <110 mg/dL (2.84 mmol/L) at Week 8', 'timeFrame': 'At Week 8', 'description': 'Combined estimate for percentage of participants was obtained by averaging out all the imputed percentage of participants reaching the level of interest. A two-step multiple imputation procedure was used to address missing values in the mITT population in the two steps respectively; with number of imputations = 1000. In the first step, the monotone missing pattern was induced in the multiply-imputed data. In the second step, the missing data at subsequent visits were imputed using the regression method for continuous variables.'}, {'measure': 'Percent Change From Baseline in Calculated LDL-C at Week 12: Cohort 4', 'timeFrame': 'Baseline, Week 12', 'description': 'Adjusted LS means and standard error at Week 12 were obtained from MMRM analysis, with fixed categorical effects of alirocumab dose/dose regimen, time point and dose/dose regimen-by-time point interaction.'}, {'measure': 'Percent Change From Baseline in Apolipoprotein (Apo) B at Week 8', 'timeFrame': 'Baseline, Week 8', 'description': 'Adjusted LS means and SE at Week 8 were obtained from MMRM analysis, with fixed categorical effects of alirocumab dose/dose regimen, time point and dose/dose regimen-by-time point interaction. All available baseline value and post-baseline values in at least one of the analysis windows used in the model.'}, {'measure': 'Percent Change From Baseline in Non-High Density Lipoprotein (HDL-C) at Week 8', 'timeFrame': 'Baseline, Week 8', 'description': 'Adjusted LS means and SE at Week 8 were obtained from MMRM analysis, with fixed categorical effects of alirocumab dose/dose regimen, time point and dose/dose regimen-by-time point interaction. All available baselines value and post-baseline values in at least one of the analysis windows up to Week 8 were used in the model.'}, {'measure': 'Percent Change From Baseline in Total Cholesterol (Total-C) at Week 8', 'timeFrame': 'Baseline, Week 8', 'description': 'Adjusted LS means and SE at Week 8 were obtained from MMRM analysis, with fixed categorical effects of alirocumab dose/dose regimen, time point and dose/dose regimen-by-time point interaction. All available baseline values and post-baseline values in at least one of the analysis windows up to Week 8 were used in the model.'}, {'measure': 'Percent Change From Baseline in Lipoprotein(a) at Week 8', 'timeFrame': 'Baseline, Week 8', 'description': 'Combined estimates and SE were obtained by combining adjusted means and SE from robust regression model analyses of the different imputed data sets. The robust regression models included the fixed categorical effect of alirocumab dose/dose regimen. A two-step multiple imputation procedure was used to address missing values in the mITT population in the two steps respectively (with number of imputations = 1000). In the first step, the monotone missing pattern was induced in the multiply-imputed data. In the second step, the missing data at subsequent visits were imputed using the regression method for continuous variables.'}, {'measure': 'Percent Change From Baseline in Fasting Triglyceride at Week 8', 'timeFrame': 'Baseline, Week 8', 'description': 'Combined estimates and SE were obtained by combining adjusted means and SE from robust regression model analyses of the different imputed data sets. The robust regression models included the fixed categorical effect of alirocumab dose/dose regimen. A two-step multiple imputation procedure was used to address missing values in the mITT population (in the two steps respectively; with number of imputations = 1000). In the first step, the monotone missing pattern was induced in the multiply-imputed data. In the second step, the missing data at subsequent visits were imputed using the regression method for continuous variables.'}, {'measure': 'Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 8', 'timeFrame': 'Baseline, Week 8', 'description': 'Adjusted LS means and SE at Week 8 were obtained from MMRM analysis, with fixed categorical effects of alirocumab dose/dose regimen, time point and dose/dose regimen-by-time point interaction. All available baseline values and post-baseline values in at least one of the analysis windows up to Week 8 were used in the model.'}, {'measure': 'Percent Change From Baseline in Apolipoprotein A-1 at Week 8', 'timeFrame': 'Baseline, Week 8', 'description': 'Adjusted LS means and SE at Week 8 were obtained from MMRM analysis, with fixed categorical effects of alirocumab dose/dose regimen, time point and dose/dose regimen-by-time point interaction. All available baseline values and post-baseline values in at least one of the analysis windows up to Week 8 were used in the model.'}, {'measure': 'Absolute Change From Baseline in Apolipoprotein B at Week 8', 'timeFrame': 'Baseline, Week 8', 'description': 'Adjusted LS means and SE at Week 8 were obtained from MMRM analysis, with fixed categorical effects of alirocumab dose/dose regimen, time point and dose/dose regimen-by-time point interaction. All available baseline values and post-baseline values in at least one of the analysis windows up to Week 8 were used in the model.'}, {'measure': 'Absolute Change From Baseline in Non-High-Density Lipoprotein (Non-HDL-C) at Week 8', 'timeFrame': 'Baseline, Week 8', 'description': 'Adjusted LS means and SE at Week 8 were obtained from MMRM analysis, with fixed categorical effects of alirocumab dose/dose regimen, time point and dose/dose regimen-by-time point interaction. All available baseline values and post-baseline values in at least one of the analysis windows up to Week 8 were used in the model.'}, {'measure': 'Absolute Change From Baseline in Total Cholesterol (Total-C) at Week 8', 'timeFrame': 'Baseline, Week 8', 'description': 'Adjusted LS means and SE at Week 8 were obtained from MMRM analysis, with fixed categorical effects of alirocumab dose/dose regimen, time point and dose/dose regimen-by-time point interaction. All available baseline values and post-baseline values in at least one of the analysis windows up to Week 8 were used in the model.'}, {'measure': 'Absolute Change From Baseline in Lipoprotein(a) at Week 8', 'timeFrame': 'Baseline, Week 8', 'description': 'Combined estimates and SE were obtained by combining adjusted means and SE from robust regression model analyses of the different imputed data sets. The robust regression models included the fixed categorical effect of alirocumab dose/dose regimen. A two-step multiple imputation procedure was used to address missing values in the mITT population (in the two steps respectively; with number of imputations = 1000). In the first step, the monotone missing pattern was induced in the multiply-imputed data. In the second step, the missing data at subsequent visits were imputed using the regression method for continuous variables.'}, {'measure': 'Absolute Change From Baseline in HDL-C at Week 8', 'timeFrame': 'Baseline, Week 8', 'description': 'Adjusted LS means and SE at Week 8 were obtained from MMRM analysis, with fixed categorical effects of alirocumab dose/dose regimen, time point and dose/dose regimen-by-time point interaction. All available baseline values and post-baseline values in at least one of the analysis windows up to Week 8 were used in the model.'}, {'measure': 'Absolute Change From Baseline in Fasting Triglyceride at Week 8', 'timeFrame': 'Baseline, Week 8', 'description': 'Combined estimates and SE were obtained by combining adjusted means and SE from robust regression model analyses of the different imputed data sets. The robust regression models included the fixed categorical effect of alirocumab dose/dose regimen. A two-step multiple imputation procedure was used to address missing values in the mITT population (in the two steps respectively; with number of imputations = 1000). In the first step, the monotone missing pattern was induced in the multiply-imputed data. In the second step, the missing data at subsequent visits were imputed using the regression method for continuous variables.'}, {'measure': 'Absolute Change From Baseline in Apolipoprotein A-1 at Week 8', 'timeFrame': 'Baseline, Week 8', 'description': 'Adjusted LS means and SE at Week 8 were obtained from MMRM analysis, with fixed categorical effects of alirocumab dose/dose regimen, time point and dose/dose regimen-by-time point interaction. All available baseline values and post-baseline values in at least one of the analysis windows up to Week 8 were used in the model.'}, {'measure': 'Absolute Change From Baseline in Ratio Apolipoprotein B/Apolipoprotein A-1 at Week 8', 'timeFrame': 'Baseline, Week 8', 'description': 'Adjusted LS means and SE at Week 8 were obtained from MMRM analysis, with fixed categorical effects of alirocumab dose/dose regimen, time point and dose/dose regimen-by-time point interaction. All available baseline values and post-baseline values in at least one of the analysis windows up to Week 8 were used in the model.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Hypercholesterolaemia']}, 'referencesModule': {'references': [{'pmid': '32331936', 'type': 'DERIVED', 'citation': 'Daniels S, Caprio S, Chaudhari U, Manvelian G, Baccara-Dinet MT, Brunet A, Scemama M, Loizeau V, Bruckert E. PCSK9 inhibition with alirocumab in pediatric patients with heterozygous familial hypercholesterolemia: The ODYSSEY KIDS study. J Clin Lipidol. 2020 May-Jun;14(3):322-330.e5. doi: 10.1016/j.jacl.2020.03.001. Epub 2020 Mar 28.'}]}, 'descriptionModule': {'briefSummary': 'Primary Objective:\n\nTo evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels after 8 weeks of treatment in heterozygous familial hypercholesterolemia (heFH) participants aged of 8 to 17 years, with LDL-C \\>=130 milligrams per deciliter (mg/dL) (3.37 millimoles per litre \\[mmol/L\\]) on optimal stable daily dose of statin therapy +/- other lipid modifying therapies (LMTs) or a stable dose of non-statin LMTs in case of intolerance to statins for at least 4 weeks prior to the screening period.\n\nSecondary Objective:\n\n* To evaluate the safety and tolerability of alirocumab.\n* To evaluate the pharmacokinetics profile of alirocumab.\n* To evaluate the effects of alirocumab on other lipid parameters.', 'detailedDescription': 'For Cohorts 1 to 3, a study duration of approximately 16-23 weeks (screening period: up to 6 (+1) weeks, open-label dose finding treatment period: 8 weeks, follow up period: 6-8 weeks).\n\nFor Cohort 4, a study duration of approximately 14-19 weeks (screening period up to 6 \\[+1\\] weeks, open-label dose finding treatment period: 12 weeks).\n\nOptional extension period: up to a maximum of 2 years for the first participants enrolled in Cohorts 1 to 3, but a maximum of approximately 5 months for the first participants enrolled in Cohort 4.\n\nFor all participants who declined participation in the phase 3 study, their last alirocumab injection was on December 2018.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria :\n\n* Children and adolescent male and female participants aged of 8 to 17 years at the time of signed informed consent. For Russia only: Male and female participants aged \\>=12 and \\<=17 years at the time of signed informed consent.\n* Participants with diagnosis of heterozygous familial hypercholesterolemia (heFH) through genotyping or clinical criteria.\n* Participants treated with optimal dose of statin +/- other LMT(s) or non-statin LMT(s) if statin intolerant at stable dose for at least 4 weeks prior to screening lipid sampling.\n* Participants with calculated LDL-C greater than or equal to 130 mg/dL (\\>=3.37 mmol/L) at the screening visit.\n* Participants with body weight greater than or equal to 25 kg.\n* Participants aged of 8 to 9 years to be at Tanner stage 1 and participants aged of 10 to 17 years to be at least at Tanner stage 2 in their development.\n* A signed informed consent indicating parental permission with or without participant assent.\n\nExclusion criteria:\n\n* Participant with secondary hyperlipidemia.\n* Diagnosis of homozygous familial hypercholesterolemia.\n* Participant who had received lipid apheresis treatment within 2 months prior to the screening period, or has plans to receive it during the study.\n* Known history of type 1 or type 2 diabetes mellitus.\n* Known history of thyroid disease.\n* Known history of hypertension.\n* Fasting triglycerides \\>350 mg/dL (3.95 mmol/L).\n* Severe renal impairment (i.e., estimated glomerular filtration rate \\[eGFR\\] \\<30 mL/min/1.73 m\\^2).\n* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\>2 x upper limit of normal (ULN).\n* Creatinine phosphokinase (CPK) \\>3 x ULN.\n\nThe above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT02890992', 'acronym': 'ODYSSEY KIDS', 'briefTitle': 'An 8-Week Dose-Finding Study to Evaluate the Efficacy and Safety of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'An 8-Week Open-Label, Sequential, Repeated Dose-Finding Study to Evaluate the Efficacy and Safety of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia Followed by an Extension Phase', 'orgStudyIdInfo': {'id': 'DFI14223'}, 'secondaryIdInfos': [{'id': '2015-003766-85', 'type': 'EUDRACT_NUMBER'}, {'id': 'U1111-1178-4764', 'type': 'OTHER', 'domain': 'UTN'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1 - Alirocumab 30 mg Q2W: <50 kg', 'description': 'Period 1: Participants with body weight less than (\\<) 50 kilograms (kg) received subcutaneous (SC) injection of alirocumab 30 milligram(mg) administered every 2 weeks (Q2W) up to 8 weeks added to lipid modifying therapy (LMT).\n\nPeriod 2: Participants with body weight \\< 50 kg received SC injection of alirocumab 30 mg administered Q2W from Week 16 until they started receiving dose matching to Cohort 2 dosage including dose adjustment to body weight as required. Cohort 2 dosage was: if body weight was still \\< 50 kg, participants received SC injection of alirocumab 40 mg administered Q2W until Week 130; if body weight was \\> = 50 kg participants received SC injection of alirocumab 75 mg administered Q2W until Week 130.', 'interventionNames': ['Drug: alirocumab SAR236553 (REGN727)', 'Drug: statins', 'Drug: ezetimibe', 'Drug: cholestyramine', 'Drug: fenofibrate', 'Drug: omega-3 fatty acids', 'Drug: nicotinic acid']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 1 - Alirocumab 50 mg Q2W: >=50 kg', 'description': 'Period 1: Participants with body weight greater than or equal to (\\>=) 50 kg received SC injection of alirocumab 50 mg administered Q2W up to 8 weeks added to LMT.\n\nPeriod 2: Participants with body weight \\>= 50 kg received SC injection of alirocumab 50 mg administered Q2W from Week 16 until switch to Cohort 2 dosage then SC injection of alirocumab 75 mg administered Q2W until Week 130.', 'interventionNames': ['Drug: alirocumab SAR236553 (REGN727)', 'Drug: statins', 'Drug: ezetimibe', 'Drug: cholestyramine', 'Drug: fenofibrate', 'Drug: omega-3 fatty acids', 'Drug: nicotinic acid']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2 - Alirocumab 40 mg Q2W: <50 kg', 'description': 'Period 1: Participants with body weight \\< 50 kg received SC injection of alirocumab 40 mg administered Q2W up to 8 weeks added to LMT.\n\nPeriod 2: Participants with body weight \\< 50 kg received SC injection of alirocumab 40 mg administered Q2W from Week 16 until switch of dosage in Cohorts 1 and 3. If body weight was still \\< 50 kg, participants continued to receive SC injection of alirocumab 40 mg administered Q2W until Week 130; if body weight was \\> = 50 kg participants received SC injection of alirocumab 75 mg administered Q2W until Week 130.', 'interventionNames': ['Drug: alirocumab SAR236553 (REGN727)', 'Drug: statins', 'Drug: ezetimibe', 'Drug: cholestyramine', 'Drug: fenofibrate', 'Drug: omega-3 fatty acids', 'Drug: nicotinic acid']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2 - Alirocumab 75 mg Q2W: >=50 kg', 'description': 'Period 1: Participants with body weight \\>= 50 kg received SC injection of alirocumab 75 mg administered Q2W up to 8 weeks added to LMT.\n\nPeriod 2: Participants with body weight \\>= 50 kg received SC injection of alirocumab 75 mg administered Q2W from Week 16 until Week 130.', 'interventionNames': ['Drug: alirocumab SAR236553 (REGN727)', 'Drug: statins', 'Drug: ezetimibe', 'Drug: cholestyramine', 'Drug: fenofibrate', 'Drug: omega-3 fatty acids', 'Drug: nicotinic acid']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 3 - Alirocumab 75 mg Q4W: <50 kg', 'description': 'Period 1: Participants with body weight \\< 50 kg received SC injection of alirocumab 75 mg administered every 4 weeks (Q4W) up to 8 weeks added to LMT.\n\nPeriod 2: Participants with body weight \\< 50 kg received SC injection of alirocumab 75 mg administered Q4W from Week 14 until switch to Cohort 2 dosage including dose adjustment to body weight as required, then Cohort 2 dosage: if body weight was still \\< 50 kg, participants received SC injection of alirocumab 40 mg administered Q2W until Week 130; if body weight was \\> = 50 kg participants received SC injection of alirocumab 75 mg administered Q2W until Week 130.', 'interventionNames': ['Drug: alirocumab SAR236553 (REGN727)', 'Drug: statins', 'Drug: ezetimibe', 'Drug: cholestyramine', 'Drug: fenofibrate', 'Drug: omega-3 fatty acids', 'Drug: nicotinic acid']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 3 - Alirocumab 150 mg Q4W: >=50 kg', 'description': 'Period 1: Participants with body weight \\>= 50 kg received SC injection of alirocumab 150 mg administered Q4W up to Week 8 added to LMT.\n\nPeriod 2: Participants with body weight \\>= 50 kg received SC injection of alirocumab 150 mg administered Q4W from Week 14 until switch to Cohort 2 dosage then SC injection of alirocumab 75 mg administered Q2W until Week 130.', 'interventionNames': ['Drug: alirocumab SAR236553 (REGN727)', 'Drug: statins', 'Drug: ezetimibe', 'Drug: cholestyramine', 'Drug: fenofibrate', 'Drug: omega-3 fatty acids', 'Drug: nicotinic acid']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 4 - Alirocumab 150 mg Q4W: <50 kg', 'description': 'Period 1: Participants with body weight \\< 50 kg received SC injection of alirocumab 150 mg administered Q4W up to 12 weeks added to LMT.\n\nPeriod 2: Participants with body weight \\< 50 kg received SC injection of Alirocumab 150 mg administered Q4W from Week 12 until Week 48.', 'interventionNames': ['Drug: alirocumab SAR236553 (REGN727)', 'Drug: statins', 'Drug: ezetimibe', 'Drug: cholestyramine', 'Drug: fenofibrate', 'Drug: omega-3 fatty acids', 'Drug: nicotinic acid']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 4 - Alirocumab 300 mg Q4W: >=50 kg', 'description': 'Period 1: Participants with body weight \\>= 50 kg received SC injection of alirocumab 300 mg administered Q4W up to 12 weeks added to LMT.\n\nPeriod 2: Participants with body weight \\>= 50 kg received SC injection of alirocumab 300 mg administered Q4W from Week 12 until Week 48.', 'interventionNames': ['Drug: alirocumab SAR236553 (REGN727)', 'Drug: statins', 'Drug: ezetimibe', 'Drug: cholestyramine', 'Drug: fenofibrate', 'Drug: omega-3 fatty acids', 'Drug: nicotinic acid']}], 'interventions': [{'name': 'alirocumab SAR236553 (REGN727)', 'type': 'DRUG', 'otherNames': ['Praluent'], 'description': 'Pharmaceutical form: solution Route of administration: subcutaneous injection', 'armGroupLabels': ['Cohort 1 - Alirocumab 30 mg Q2W: <50 kg', 'Cohort 1 - Alirocumab 50 mg Q2W: >=50 kg', 'Cohort 2 - Alirocumab 40 mg Q2W: <50 kg', 'Cohort 2 - Alirocumab 75 mg Q2W: >=50 kg', 'Cohort 3 - Alirocumab 150 mg Q4W: >=50 kg', 'Cohort 3 - Alirocumab 75 mg Q4W: <50 kg', 'Cohort 4 - Alirocumab 150 mg Q4W: <50 kg', 'Cohort 4 - Alirocumab 300 mg Q4W: >=50 kg']}, {'name': 'statins', 'type': 'DRUG', 'description': 'Pharmaceutical form: tablet Route of administration: oral', 'armGroupLabels': ['Cohort 1 - Alirocumab 30 mg Q2W: <50 kg', 'Cohort 1 - Alirocumab 50 mg Q2W: >=50 kg', 'Cohort 2 - Alirocumab 40 mg Q2W: <50 kg', 'Cohort 2 - Alirocumab 75 mg Q2W: >=50 kg', 'Cohort 3 - Alirocumab 150 mg Q4W: >=50 kg', 'Cohort 3 - Alirocumab 75 mg Q4W: <50 kg', 'Cohort 4 - Alirocumab 150 mg Q4W: <50 kg', 'Cohort 4 - Alirocumab 300 mg Q4W: >=50 kg']}, {'name': 'ezetimibe', 'type': 'DRUG', 'description': 'Pharmaceutical form:tablet Route of administration: oral', 'armGroupLabels': ['Cohort 1 - Alirocumab 30 mg Q2W: <50 kg', 'Cohort 1 - Alirocumab 50 mg Q2W: >=50 kg', 'Cohort 2 - Alirocumab 40 mg Q2W: <50 kg', 'Cohort 2 - Alirocumab 75 mg Q2W: >=50 kg', 'Cohort 3 - Alirocumab 150 mg Q4W: >=50 kg', 'Cohort 3 - Alirocumab 75 mg Q4W: <50 kg', 'Cohort 4 - Alirocumab 150 mg Q4W: <50 kg', 'Cohort 4 - Alirocumab 300 mg Q4W: >=50 kg']}, {'name': 'cholestyramine', 'type': 'DRUG', 'description': 'Pharmaceutical form:tablet Route of administration: oral', 'armGroupLabels': ['Cohort 1 - Alirocumab 30 mg Q2W: <50 kg', 'Cohort 1 - Alirocumab 50 mg Q2W: >=50 kg', 'Cohort 2 - Alirocumab 40 mg Q2W: <50 kg', 'Cohort 2 - Alirocumab 75 mg Q2W: >=50 kg', 'Cohort 3 - Alirocumab 150 mg Q4W: >=50 kg', 'Cohort 3 - Alirocumab 75 mg Q4W: <50 kg', 'Cohort 4 - Alirocumab 150 mg Q4W: <50 kg', 'Cohort 4 - Alirocumab 300 mg Q4W: >=50 kg']}, {'name': 'fenofibrate', 'type': 'DRUG', 'description': 'Pharmaceutical form: tablet Route of administration: oral', 'armGroupLabels': ['Cohort 1 - Alirocumab 30 mg Q2W: <50 kg', 'Cohort 1 - Alirocumab 50 mg Q2W: >=50 kg', 'Cohort 2 - Alirocumab 40 mg Q2W: <50 kg', 'Cohort 2 - Alirocumab 75 mg Q2W: >=50 kg', 'Cohort 3 - Alirocumab 150 mg Q4W: >=50 kg', 'Cohort 3 - Alirocumab 75 mg Q4W: <50 kg', 'Cohort 4 - Alirocumab 150 mg Q4W: <50 kg', 'Cohort 4 - Alirocumab 300 mg Q4W: >=50 kg']}, {'name': 'omega-3 fatty acids', 'type': 'DRUG', 'description': 'Pharmaceutical form: tablet Route of administration: oral', 'armGroupLabels': ['Cohort 1 - Alirocumab 30 mg Q2W: <50 kg', 'Cohort 1 - Alirocumab 50 mg Q2W: >=50 kg', 'Cohort 2 - Alirocumab 40 mg Q2W: <50 kg', 'Cohort 2 - Alirocumab 75 mg Q2W: >=50 kg', 'Cohort 3 - Alirocumab 150 mg Q4W: >=50 kg', 'Cohort 3 - Alirocumab 75 mg Q4W: <50 kg', 'Cohort 4 - Alirocumab 150 mg Q4W: <50 kg', 'Cohort 4 - Alirocumab 300 mg Q4W: >=50 kg']}, {'name': 'nicotinic acid', 'type': 'DRUG', 'description': 'Pharmaceutical form: tablet Route of administration: oral', 'armGroupLabels': ['Cohort 1 - Alirocumab 30 mg Q2W: <50 kg', 'Cohort 1 - Alirocumab 50 mg Q2W: >=50 kg', 'Cohort 2 - Alirocumab 40 mg Q2W: <50 kg', 'Cohort 2 - Alirocumab 75 mg Q2W: >=50 kg', 'Cohort 3 - Alirocumab 150 mg Q4W: >=50 kg', 'Cohort 3 - Alirocumab 75 mg Q4W: <50 kg', 'Cohort 4 - Alirocumab 150 mg Q4W: <50 kg', 'Cohort 4 - Alirocumab 300 mg Q4W: >=50 kg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Investigational Site Number 8400002', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '28204', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Investigational Site Number 8400005', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Investigational Site Number 8400001', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': 'G1V 4W2', 'city': 'Québec', 'country': 'Canada', 'facility': 'Investigational Site Number 1240001', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'zip': '62500', 'city': 'Brno', 'country': 'Czechia', 'facility': 'Investigational Site Number 2030001', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}, {'zip': '15006', 'city': 'Praha 5 - Motol', 'country': 'Czechia', 'facility': 'Investigational Site Number 2030003'}, {'zip': '76275', 'city': 'Zlín', 'country': 'Czechia', 'facility': 'Investigational Site Number 2030002', 'geoPoint': {'lat': 49.22645, 'lon': 17.67065}}, {'zip': '69677', 'city': 'Bron', 'country': 'France', 'facility': 'Investigational Site Number 2500001', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}, {'zip': '1105AZ', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Investigational Site Number 5280001', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'Oslo', 'country': 'Norway', 'facility': 'Investigational Site Number 5780001', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}, {'zip': '650002', 'city': 'Kemerovo', 'country': 'Russia', 'facility': 'Investigational Site Number 6430001', 'geoPoint': {'lat': 55.35417, 'lon': 86.10435}}, {'zip': '194100', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Investigational Site Number 6430004', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '7500', 'city': 'Parow', 'country': 'South Africa', 'facility': 'Investigational Site Number 7100001', 'geoPoint': {'lat': -33.89723, 'lon': 18.59992}}, {'zip': '15001', 'city': 'A Coruña', 'country': 'Spain', 'facility': 'Investigational Site Number 7240004', 'geoPoint': {'lat': 43.37135, 'lon': -8.396}}, {'zip': '28009', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Investigational Site Number 7240001', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '171 76', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Investigational Site Number 7520001', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'Clinical Sciences & Operations', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Regeneron Pharmaceuticals', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}