Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2025-12-30 @ 10:50 PM
Study NCT ID:
NCT04964557
Status:
COMPLETED
Last Update Posted:
2023-12-15
First Post:
2021-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Assess the Safety, Efficacy and Tolerability of AZD8233 Treatment in Participants With Hyperlipidaemia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-08-02', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D006949', 'term': 'Hyperlipidemias'}], 'ancestors': [{'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'information.center@astrazeneca.com', 'phone': '+1-877-240-9479', 'title': 'AstraZeneca Clinical Study Information Center', 'organization': 'AstraZeneca'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'On-study includes adverse events with an onset date on or after the date of first dose of IP through study competition, planned visit date Day 281.', 'description': 'The safety analysis set consists of all subjects who have received at least one dose of investigational product. Erroneously treated subjects (e.g., those randomised to treatment A but actually given treatment B) are accounted for in the treatment group of the treatment they actually received.', 'eventGroups': [{'id': 'EG000', 'title': 'AZD8233', 'description': 'AZD8233 for subcutaneous use.', 'otherNumAtRisk': 207, 'deathsNumAtRisk': 207, 'otherNumAffected': 69, 'seriousNumAtRisk': 207, 'deathsNumAffected': 3, 'seriousNumAffected': 18}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Matching placebo solution for subcutaneous injection.', 'otherNumAtRisk': 203, 'deathsNumAtRisk': 203, 'otherNumAffected': 62, 'seriousNumAtRisk': 203, 'deathsNumAffected': 0, 'seriousNumAffected': 12}], 'otherEvents': [{'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 56, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 203, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Covid-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 33, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 203, 'numEvents': 37, 'numAffected': 36}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Diabetes mellitus inadequate control', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 19, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 203, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 203, 'numEvents': 16, 'numAffected': 13}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}], 'seriousEvents': [{'term': 'Amaurosis fugax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Duodenal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Sudden death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Covid-19 pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Clostridium difficile colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Gangrene', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Coagulation time prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Bladder transitional cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Lung adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Metastatic malignant melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Squamous cell carcinoma of lung', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Transitional cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Transitional cell carcinoma urethra', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Carotid artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Bipolar i disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Mental disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Haemothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Hypovolaemic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Iliac artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Atrioventricular block second degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Acute vestibular syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage Change From Baseline on Serum LDL-C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '206', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD8233', 'description': 'AZD8233 for subcutaneous use.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo solution for subcutaneous injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '-56.7', 'groupId': 'OG000', 'lowerLimit': '-60.8', 'upperLimit': '-52.7'}, {'value': '5.6', 'groupId': 'OG001', 'lowerLimit': '1.5', 'upperLimit': '9.6'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-62.3', 'ciLowerLimit': '-68', 'ciUpperLimit': '-56.6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From baseline to Day 197', 'description': 'Percentage change in Low-density Lipoprotein Cholesterol (LDL-C) from baseline to Day 197.', 'unitOfMeasure': 'percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set includes all subjects who were randomly assigned to study intervention. Subjects were analysed according to their randomised study medication assignment, irrespective of the treatment actually received.'}, {'type': 'SECONDARY', 'title': 'Percentage Change From Baseline on Serum PCSK9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '206', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD8233', 'description': 'AZD8233 for subcutaneous use.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo solution for subcutaneous injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '-77.5', 'groupId': 'OG000', 'lowerLimit': '-81.1', 'upperLimit': '-74'}, {'value': '-0.8', 'groupId': 'OG001', 'lowerLimit': '-4.3', 'upperLimit': '2.6'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-76.7', 'ciLowerLimit': '-81.7', 'ciUpperLimit': '-71.7', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From baseline to Day 197', 'description': 'Percentage change in Proprotein convertase subtilisin/kexin type-9 (PCSK9) from baseline to Day 197.', 'unitOfMeasure': 'percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set includes all subjects who were randomly assigned to study intervention. Subjects will be analysed according to their randomised study medication assignment, irrespective of the treatment actually received.'}, {'type': 'SECONDARY', 'title': 'Plasma Concentration of AZD8233', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD8233', 'description': 'AZD8233 for subcutaneous use.'}], 'classes': [{'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.2648', 'spread': '82.8352', 'groupId': 'OG000'}]}]}, {'title': 'Day 85', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.3927', 'spread': '84.9378', 'groupId': 'OG000'}]}]}, {'title': 'Day 141', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.5749', 'spread': '161.9301', 'groupId': 'OG000'}]}]}, {'title': 'Day 183', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.0441', 'spread': '178.5196', 'groupId': 'OG000'}]}]}, {'title': 'Day 197', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.6975', 'spread': '208.2431', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose of Day 29, Day 85, Day 141, Day 183, Day 197', 'description': 'AZD8233 full length ASO concentrations in plasma were summarised by descriptive statistics by sampling time point and listed on individual level based on the PK analysis set.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set consists of all subjects who receive at least 1 dose of AZD8233, for whom at least 1 post-dose PK concentration assessment is available. Subjects were allocated to the actual treatment received. The number analyzed represents the number of participants with available PK data at that time point, including lower limit of quantification (LLoQ) observations, but not included in the calculation of summary statistics of Geometric Mean and Geometric Coefficient of Variation.'}, {'type': 'SECONDARY', 'title': 'Anti-drug Antibodies (ADAs) During the Treatment Period and Follow-up Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD8233', 'description': 'AZD8233 for subcutaneous use.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo solution for subcutaneous injection.'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Day 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'OG000'}, {'value': '195', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Day 85', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Day 113', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Day 141', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '195', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Day 169', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '193', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Day 197', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Day 281', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Pre-dose of Day 1, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 197, Day 281', 'description': 'Number of ADA positive subjects at each time point during the treatment period and follow-up period.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set consists of all subjects who have received at least one dose of investigational product. Erroneously treated subjects (e.g., those randomised to treatment A but actually given treatment B) are accounted for in the treatment group of the treatment they actually received. The number analyzed represents the number of participants with available ADA data at that time point.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD8233', 'description': 'AZD8233 for subcutaneous use.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo solution for subcutaneous injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '141', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'On-study includes adverse events with an onset date on or after the date of first dose of IP through study competition, planned visit date Day 281.', 'description': 'Please refer to the adverse event module for specifics.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set consists of all subjects who have received at least one dose of investigational product. Erroneously treated subjects (e.g., those randomised to treatment A but actually given treatment B) are accounted for in the treatment group of the treatment they actually received.'}, {'type': 'PRIMARY', 'title': 'Vital Signs - Temperature', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD8233', 'description': 'AZD8233 for subcutaneous use.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo solution for subcutaneous injection.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '36.434', 'spread': '0.437', 'groupId': 'OG000'}, {'value': '36.369', 'spread': '0.389', 'groupId': 'OG001'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '36.344', 'spread': '0.404', 'groupId': 'OG000'}, {'value': '36.387', 'spread': '0.378', 'groupId': 'OG001'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '36.360', 'spread': '0.422', 'groupId': 'OG000'}, {'value': '36.361', 'spread': '0.386', 'groupId': 'OG001'}]}]}, {'title': 'Day 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '36.340', 'spread': '0.420', 'groupId': 'OG000'}, {'value': '36.396', 'spread': '0.368', 'groupId': 'OG001'}]}]}, {'title': 'Day 85', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '36.360', 'spread': '0.416', 'groupId': 'OG000'}, {'value': '36.362', 'spread': '0.363', 'groupId': 'OG001'}]}]}, {'title': 'Day 113', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '36.359', 'spread': '0.391', 'groupId': 'OG000'}, {'value': '36.399', 'spread': '0.348', 'groupId': 'OG001'}]}]}, {'title': 'Day 141', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '195', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '36.335', 'spread': '0.398', 'groupId': 'OG000'}, {'value': '36.373', 'spread': '0.341', 'groupId': 'OG001'}]}]}, {'title': 'Day 169', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '36.304', 'spread': '0.454', 'groupId': 'OG000'}, {'value': '36.353', 'spread': '0.411', 'groupId': 'OG001'}]}]}, {'title': 'Day 197', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}, {'value': '195', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '36.299', 'spread': '0.477', 'groupId': 'OG000'}, {'value': '36.352', 'spread': '0.316', 'groupId': 'OG001'}]}]}, {'title': 'Day 225', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '36.327', 'spread': '0.472', 'groupId': 'OG000'}, {'value': '36.365', 'spread': '0.37', 'groupId': 'OG001'}]}]}, {'title': 'Day 281', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '36.353', 'spread': '0.396', 'groupId': 'OG000'}, {'value': '36.391', 'spread': '0.363', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Days 15, 29, 57, 85, 113, 141, 169, 197, 225, and 281.', 'description': 'Mean and standard deviation of Temperature at each scheduled visit by treatment.', 'unitOfMeasure': 'Celsius', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set, the number analyzed represents the number of participants with available temperature data at that time point.'}, {'type': 'PRIMARY', 'title': 'Vital Sign - Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD8233', 'description': 'AZD8233 for subcutaneous use.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo solution for subcutaneous injection.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '86.642', 'spread': '17.054', 'groupId': 'OG000'}, {'value': '88.750', 'spread': '17.566', 'groupId': 'OG001'}]}]}, {'title': 'Day 281', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '85.493', 'spread': '16.561', 'groupId': 'OG000'}, {'value': '88.759', 'spread': '18.110', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Day 281.', 'description': 'Mean and standard deviation of Weight at each scheduled visit by treatment.', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set, the number analyzed represents the number of participants with available weight data at that time point.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With an ECG Determined to be Abnormal and Clinically Significant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD8233', 'description': 'AZD8233 for subcutaneous use.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo solution for subcutaneous injection.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 85', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Day 169', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '193', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 225', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 281', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, Days 85, 169, 225, and 281.', 'description': 'Number of participants With an ECG Determined to be Abnormal and Clinically Significant at each scheduled visit by treatment', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set, the number analyzed represents the number of participants with available ECG data at that time point.'}, {'type': 'PRIMARY', 'title': 'Vital Sign - Systolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD8233', 'description': 'AZD8233 for subcutaneous use.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo solution for subcutaneous injection.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '130.918', 'spread': '13.284', 'groupId': 'OG000'}, {'value': '131.325', 'spread': '11.281', 'groupId': 'OG001'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '130.438', 'spread': '13.541', 'groupId': 'OG000'}, {'value': '131.198', 'spread': '12.711', 'groupId': 'OG001'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '130.741', 'spread': '13.363', 'groupId': 'OG000'}, {'value': '133.152', 'spread': '11.881', 'groupId': 'OG001'}]}]}, {'title': 'Day 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '130.754', 'spread': '12.536', 'groupId': 'OG000'}, {'value': '131.465', 'spread': '14.073', 'groupId': 'OG001'}]}]}, {'title': 'Day 85', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '131.913', 'spread': '12.083', 'groupId': 'OG000'}, {'value': '132.111', 'spread': '12.238', 'groupId': 'OG001'}]}]}, {'title': 'Day 113', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '131.974', 'spread': '12.622', 'groupId': 'OG000'}, {'value': '132.493', 'spread': '12.022', 'groupId': 'OG001'}]}]}, {'title': 'Day 141', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '195', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '131.386', 'spread': '14.246', 'groupId': 'OG000'}, {'value': '132.041', 'spread': '14.081', 'groupId': 'OG001'}]}]}, {'title': 'Day 169', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '130.959', 'spread': '11.874', 'groupId': 'OG000'}, {'value': '132.706', 'spread': '12.481', 'groupId': 'OG001'}]}]}, {'title': 'Day 197', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}, {'value': '195', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '129.351', 'spread': '14.236', 'groupId': 'OG000'}, {'value': '133.149', 'spread': '11.838', 'groupId': 'OG001'}]}]}, {'title': 'Day 225', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '131.188', 'spread': '14.578', 'groupId': 'OG000'}, {'value': '133.165', 'spread': '12.746', 'groupId': 'OG001'}]}]}, {'title': 'Day 281', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '130.048', 'spread': '13.288', 'groupId': 'OG000'}, {'value': '131.043', 'spread': '13.069', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Days 15, 29, 57, 85, 113, 141, 169, 197, 225, and 281.', 'description': 'Mean and standard deviation of Systolic Blood Pressure at each scheduled visit by treatment.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set, the number analyzed represents the number of participants with available systolic blood pressure data at that time point.'}, {'type': 'PRIMARY', 'title': 'Vital Sign - Diastolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD8233', 'description': 'AZD8233 for subcutaneous use.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo solution for subcutaneous injection.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '78.937', 'spread': '7.608', 'groupId': 'OG000'}, {'value': '78.562', 'spread': '6.134', 'groupId': 'OG001'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '78.318', 'spread': '8.060', 'groupId': 'OG000'}, {'value': '78.559', 'spread': '6.946', 'groupId': 'OG001'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '78.408', 'spread': '8.157', 'groupId': 'OG000'}, {'value': '79.611', 'spread': '6.779', 'groupId': 'OG001'}]}]}, {'title': 'Day 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '78.714', 'spread': '7.799', 'groupId': 'OG000'}, {'value': '79.369', 'spread': '7.120', 'groupId': 'OG001'}]}]}, {'title': 'Day 85', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '78.867', 'spread': '8.053', 'groupId': 'OG000'}, {'value': '79.081', 'spread': '7.575', 'groupId': 'OG001'}]}]}, {'title': 'Day 113', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '79.164', 'spread': '8.393', 'groupId': 'OG000'}, {'value': '79.584', 'spread': '7.152', 'groupId': 'OG001'}]}]}, {'title': 'Day 141', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '195', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '78.698', 'spread': '8.505', 'groupId': 'OG000'}, {'value': '78.836', 'spread': '7.758', 'groupId': 'OG001'}]}]}, {'title': 'Day 169', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '78.139', 'spread': '8.489', 'groupId': 'OG000'}, {'value': '78.402', 'spread': '7.359', 'groupId': 'OG001'}]}]}, {'title': 'Day 197', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}, {'value': '195', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '78.382', 'spread': '7.736', 'groupId': 'OG000'}, {'value': '78.615', 'spread': '7.432', 'groupId': 'OG001'}]}]}, {'title': 'Day 225', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '78.582', 'spread': '8.313', 'groupId': 'OG000'}, {'value': '78.988', 'spread': '7.254', 'groupId': 'OG001'}]}]}, {'title': 'Day 281', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '78.812', 'spread': '8.484', 'groupId': 'OG000'}, {'value': '78.601', 'spread': '7.249', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Days 15, 29, 57, 85, 113, 141, 169, 197, 225, and 281.', 'description': 'Mean and standard deviation of Diastolic Blood Pressure at each scheduled visit by treatment.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set, the number analyzed represents the number of participants with available diastolic blood pressure data at that time point.'}, {'type': 'PRIMARY', 'title': 'Vital Sign - Pulse Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD8233', 'description': 'AZD8233 for subcutaneous use.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo solution for subcutaneous injection.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '68.93', 'spread': '11.52', 'groupId': 'OG000'}, {'value': '67.88', 'spread': '10.47', 'groupId': 'OG001'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '70.63', 'spread': '10.07', 'groupId': 'OG000'}, {'value': '69.48', 'spread': '10.42', 'groupId': 'OG001'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '68.52', 'spread': '9.91', 'groupId': 'OG000'}, {'value': '68.90', 'spread': '10.05', 'groupId': 'OG001'}]}]}, {'title': 'Day 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '69.58', 'spread': '10.59', 'groupId': 'OG000'}, {'value': '69.90', 'spread': '11.56', 'groupId': 'OG001'}]}]}, {'title': 'Day 85', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '68.90', 'spread': '9.87', 'groupId': 'OG000'}, {'value': '69.53', 'spread': '11.10', 'groupId': 'OG001'}]}]}, {'title': 'Day 113', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '70.77', 'spread': '10.58', 'groupId': 'OG000'}, {'value': '70.03', 'spread': '10.48', 'groupId': 'OG001'}]}]}, {'title': 'Day 141', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '70.85', 'spread': '11.10', 'groupId': 'OG000'}, {'value': '70.00', 'spread': '10.84', 'groupId': 'OG001'}]}]}, {'title': 'Day 169', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '69.35', 'spread': '10.44', 'groupId': 'OG000'}, {'value': '68.38', 'spread': '10.31', 'groupId': 'OG001'}]}]}, {'title': 'Day 197', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}, {'value': '195', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '70.69', 'spread': '12.26', 'groupId': 'OG000'}, {'value': '69.43', 'spread': '8.94', 'groupId': 'OG001'}]}]}, {'title': 'Day 225', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '69.56', 'spread': '10.17', 'groupId': 'OG000'}, {'value': '68.79', 'spread': '10.48', 'groupId': 'OG001'}]}]}, {'title': 'Day 281', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '68.39', 'spread': '9.99', 'groupId': 'OG000'}, {'value': '69.31', 'spread': '10.90', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Days 15, 29, 57, 85, 113, 141, 169, 197, 225, and 281.', 'description': 'Mean and standard deviation of Pulse rate at each scheduled visit by treatment.', 'unitOfMeasure': 'beats/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set, the number analyzed represents the number of participants with available pulse rate data at that time point.'}, {'type': 'PRIMARY', 'title': 'Treatment Emergent Platelet Count Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD8233', 'description': 'AZD8233 for subcutaneous use.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo solution for subcutaneous injection.'}], 'classes': [{'title': 'Platelet count < LLN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '206', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Platelet count > ULN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '206', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Platelet count < 50 x 10^9/L', 'denoms': [{'units': 'Participants', 'counts': [{'value': '206', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Platelet count < 75 x 10^9/L', 'denoms': [{'units': 'Participants', 'counts': [{'value': '206', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Platelet count < 100 x 10^9/L', 'denoms': [{'units': 'Participants', 'counts': [{'value': '206', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Platelet count < 150 x 10^9/L', 'denoms': [{'units': 'Participants', 'counts': [{'value': '206', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': '>30% decrease from baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '206', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': '<150 x 10^9/L or >30% decrease from baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '206', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}, {'title': '<150 x 10^9/L and >30% decrease from baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '206', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Treatment emergent includes results after the first dose of IP through study competition, planned visit date Day 281.', 'description': 'Treatment emergent platelet count abnormalities by pre-specified criteria by treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'AZD8233', 'description': 'AZD8233 for subcutaneous use.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Matching placebo solution for subcutaneous injection.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '206'}, {'groupId': 'FG001', 'numSubjects': '205'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '196'}, {'groupId': 'FG001', 'numSubjects': '201'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Reported by investigator as completed but did not fulfil the Completed study definition.', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This study was conducted at a total of 66 study centres in 8 countries: Czech Republic (10 centres), Denmark (8 centres), Hungary (4 centres), Netherlands (6 centres), Poland (8 centres), Slovakia (7 centres), Spain (7 centres), and United States (16 centres). First subject enrolled: 07 July 2021 and Last subject last visit: 15 July 2022.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '206', 'groupId': 'BG000'}, {'value': '205', 'groupId': 'BG001'}, {'value': '411', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'AZD8233', 'description': 'AZD8233 for subcutaneous use.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Matching placebo solution for subcutaneous injection.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.4', 'spread': '8.1', 'groupId': 'BG000'}, {'value': '62.2', 'spread': '7.7', 'groupId': 'BG001'}, {'value': '62.3', 'spread': '7.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '101', 'groupId': 'BG000'}, {'value': '94', 'groupId': 'BG001'}, {'value': '195', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '105', 'groupId': 'BG000'}, {'value': '111', 'groupId': 'BG001'}, {'value': '216', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'Native Hawaiian or other Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '194', 'groupId': 'BG000'}, {'value': '199', 'groupId': 'BG001'}, {'value': '393', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'USA', 'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}]}, {'title': 'Czech Republic', 'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}]}]}, {'title': 'Denmark', 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}]}, {'title': 'Hungary', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}, {'title': 'Netherlands', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}, {'title': 'Slovakia', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants', 'populationDescription': 'The table contains all subjects randomized (Full analysis set)'}, {'title': 'LDL-C', 'classes': [{'categories': [{'measurements': [{'value': '103', 'spread': '31.8', 'groupId': 'BG000'}, {'value': '107.4', 'spread': '31.9', 'groupId': 'BG001'}, {'value': '105.2', 'spread': '31.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Baseline LDL-C', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Baseline analysis population is based on the Full analysis set (FAS) which includes all subjects who were randomly assigned to study intervention. Subjects were analysed according to their randomised study medication assignment, irrespective of the treatment actually received. Number Started in the Participant Flow is the number of subjects who were randomised.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-02-08', 'size': 16241435, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-07-11T01:26', 'hasProtocol': True}, {'date': '2022-07-08', 'size': 1525613, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-07-11T01:27', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 411}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2022-07-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-20', 'studyFirstSubmitDate': '2021-06-15', 'resultsFirstSubmitDate': '2023-07-12', 'studyFirstSubmitQcDate': '2021-07-06', 'lastUpdatePostDateStruct': {'date': '2023-12-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-11-20', 'studyFirstPostDateStruct': {'date': '2021-07-16', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-12-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage Change From Baseline on Serum LDL-C', 'timeFrame': 'From baseline to Day 197', 'description': 'Percentage change in Low-density Lipoprotein Cholesterol (LDL-C) from baseline to Day 197.'}, {'measure': 'Number of Subjects With Adverse Events (AEs)', 'timeFrame': 'On-study includes adverse events with an onset date on or after the date of first dose of IP through study competition, planned visit date Day 281.', 'description': 'Please refer to the adverse event module for specifics.'}, {'measure': 'Vital Signs - Temperature', 'timeFrame': 'Baseline, Days 15, 29, 57, 85, 113, 141, 169, 197, 225, and 281.', 'description': 'Mean and standard deviation of Temperature at each scheduled visit by treatment.'}, {'measure': 'Vital Sign - Weight', 'timeFrame': 'Baseline and Day 281.', 'description': 'Mean and standard deviation of Weight at each scheduled visit by treatment.'}, {'measure': 'Number of Participants With an ECG Determined to be Abnormal and Clinically Significant', 'timeFrame': 'Baseline, Days 85, 169, 225, and 281.', 'description': 'Number of participants With an ECG Determined to be Abnormal and Clinically Significant at each scheduled visit by treatment'}, {'measure': 'Vital Sign - Systolic Blood Pressure', 'timeFrame': 'Baseline, Days 15, 29, 57, 85, 113, 141, 169, 197, 225, and 281.', 'description': 'Mean and standard deviation of Systolic Blood Pressure at each scheduled visit by treatment.'}, {'measure': 'Vital Sign - Diastolic Blood Pressure', 'timeFrame': 'Baseline, Days 15, 29, 57, 85, 113, 141, 169, 197, 225, and 281.', 'description': 'Mean and standard deviation of Diastolic Blood Pressure at each scheduled visit by treatment.'}, {'measure': 'Vital Sign - Pulse Rate', 'timeFrame': 'Baseline, Days 15, 29, 57, 85, 113, 141, 169, 197, 225, and 281.', 'description': 'Mean and standard deviation of Pulse rate at each scheduled visit by treatment.'}, {'measure': 'Treatment Emergent Platelet Count Abnormalities', 'timeFrame': 'Treatment emergent includes results after the first dose of IP through study competition, planned visit date Day 281.', 'description': 'Treatment emergent platelet count abnormalities by pre-specified criteria by treatment.'}], 'secondaryOutcomes': [{'measure': 'Percentage Change From Baseline on Serum PCSK9', 'timeFrame': 'From baseline to Day 197', 'description': 'Percentage change in Proprotein convertase subtilisin/kexin type-9 (PCSK9) from baseline to Day 197.'}, {'measure': 'Plasma Concentration of AZD8233', 'timeFrame': 'Pre-dose of Day 29, Day 85, Day 141, Day 183, Day 197', 'description': 'AZD8233 full length ASO concentrations in plasma were summarised by descriptive statistics by sampling time point and listed on individual level based on the PK analysis set.'}, {'measure': 'Anti-drug Antibodies (ADAs) During the Treatment Period and Follow-up Period', 'timeFrame': 'Pre-dose of Day 1, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 197, Day 281', 'description': 'Number of ADA positive subjects at each time point during the treatment period and follow-up period.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['AZD8233', 'Efficacy', 'PK', 'PD', 'Safety', 'Tolerability'], 'conditions': ['Hyperlipidaemia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D7990C00004&attachmentIdentifier=a87bb6e5-4f84-4af3-a19b-5b24e99a5ec2&fileName=d7990c00004-study-synopsis_(1)_Redacted.pdf&versionIdentifier=', 'label': 'CSRsynopsis\\_redacted'}, {'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D7990C00004&attachmentIdentifier=6ba09ee4-0e01-41bd-936b-b22d2fec79ce&fileName=D7990C00004__Protocol_Redacted.pdf&versionIdentifier=', 'label': 'CSP\\_redacted'}, {'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D7990C00004&attachmentIdentifier=51966def-7e02-40e9-ad3b-c72fa72efdbd&fileName=d7990c00004-sap-ed-4_Redacted.pdf&versionIdentifier=', 'label': 'SAP\\_redacted'}]}, 'descriptionModule': {'briefSummary': 'AZD8233 is a PCSK9-targeted ASO for the reduction of circulating levels of LDL-C. This study aims to evaluate safety, efficacy and tolerability of AZD8233.', 'detailedDescription': 'This is a randomized parallel, double-blind, placebo-controlled Phase 2b study in approximately 376 participants with hyperlipidaemia. The primary objective of the study is to assess the safety and tolerability of AZD8233 as compared with placebo, and the effect of AZD8233 versus placebo on relative change in LDL-C. The study will be conducted at up to 100 sites in up to 8 countries.\n\nThe screening period starts up to 28 days before the randomization visit and ends on Day -1. Eligible participants will attend 1 enrollment visit and 15 visits during the treatment period and 2 additional visits during the safety follow up period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participant must be 18 to 75 years of age, inclusive, at the time of signing the informed consent\n* Participants who have a fasting LDL-C ≥ 70 mg/dL (1.8 mmol/L) but \\< 190 mg/dL (4.9 mmol/L) at screening\n* Participants who have fasting triglycerides \\< 400 mg/dL (\\< 4.52 mmol/L) at screening\n* Participants are receiving a stable dose (≥ 3 months) of maximally tolerated statin and/or ezetimibe therapy\n* Male or female of non-childbearing potential\n* Signed and dated written informed consent prior to any mandatory study specific procedures, sampling, and analyses\n\nExclusion Criteria:\n\n* eGFR \\< 40 mL/min/1.73m2 using the CKD-EPI\n* History or presence of gastrointestinal, hepatic or renal disease or any other conditions known to interfere with absorption, distribution, metabolism or excretion of drugs\n* Any uncontrolled or serious disease, or any medical (eg,. known major active infection or major haematological, renal, metabolic, gastrointestinal or endocrine dysfunction) or surgical condition that, in the opinion of the investigator, may either interfere with participation in the clinical study and/or put the participant at significant risk (according to the investigator's judgment) if he/she participates in the clinical study\n* Poorly controlled T2DM, defined as HbA1c \\> 10%\n* Acute ischaemic cardiovascular events including stroke within 30 days, or heart failure with New York Heart Association (NYHA) Class III to IV\n* Blood dyscrasias with increased risk of bleeding including idiopathic thrombocytopenic purpura and thrombotic thrombocytopenic purpura or symptoms of increased risk of bleeding (frequent bleeding gums or nose bleeds)\n* High-risk of bleeding diathesis or anti-platelet therapy other than low dose aspirin (≤100mg/day).\n* Malignancy within the last 10 years\n* Recipient of any major organ transplant\n* LDL or plasma apheresis within 12 months prior to randomisation\n* Uncontrolled hypertension defined as average supine SBP \\> 160 mmHg or DBP \\> 90 mmHg\n* Heart rate after 10 minutes supine rest \\< 50 or \\> 100 bpm\n* Any laboratory values with the following deviations at the Screening Visit; test may be repeated at the discretion of the investigator if abnormal:\n\n * Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody, and human immunodeficiency virus (HIV)\n * ALT \\> 1.5 × ULN\n * AST \\> 1.5 × ULN\n * TBL \\> ULN\n * ALP \\> 1.5 × ULN\n * WBC \\< lower limit of normal (LLN).\n * Haemoglobin \\< 12 g/dL in males or \\< 11 g/dL in females\n * Platelet count ≤ LLN\n * aPTT \\> ULN or Prothrombin Time \\> ULN\n * UACR \\> 11 mg/mmol (100 mg/g)\n * UPCR \\> 300 mg/g\n* Any clinically important abnormalities in rhythm, conduction or morphology of the resting ECG and any clinically important abnormalities in the 12-lead ECG\n* QTcF \\> 470 ms; high degree atrioventricular (AV)-block grade II-III and sinus node dysfunction with significant sinus pause untreated with pacemaker; and cardiac tachyarrhythmias\n* History of drug and/or alcohol abuse or a positive screen for drugs of abuse\n* Use of warfarin, direct or indirect thrombin inhibitors or factor Xa inhibitors\n* Mipomersen, or lomitapide within 12 months prior to randomisation\n* Any fibrate therapy other than fenofibrate; if the participant is on fenofibrate therapy, the dose should be stable for at least 6 weeks prior to randomisation\n* Previous administration of AZD8233/AZD6615) or inclisiran (LEQVIO ® Novartis)\n* Use of evolocumab (REPATHA® Amgen) and alirocumab (PRALUENT® Regeneron) within 3 months of screening"}, 'identificationModule': {'nctId': 'NCT04964557', 'acronym': 'SOLANO', 'briefTitle': 'A Study to Assess the Safety, Efficacy and Tolerability of AZD8233 Treatment in Participants With Hyperlipidaemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Randomised, Parallel, Double-Blind, Placebo-Controlled Phase 2b Study to Assess the Safety, Tolerability and Efficacy of AZD8233 Treatment in Participants With Hyperlipidaemia', 'orgStudyIdInfo': {'id': 'D7990C00004'}, 'secondaryIdInfos': [{'id': '2020-005845-18', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AZD8233', 'description': 'AZD8233 for subcutaneous use', 'interventionNames': ['Drug: AZD8233']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo solution for subcutaneous injection', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'AZD8233', 'type': 'DRUG', 'description': 'PCSK9-targeted ASO for the reduction of circulating levels of LDL-C.', 'armGroupLabels': ['AZD8233']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo solution', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35801', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '91303', 'city': 'Canoga Park', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.20112, 'lon': -118.59814}}, {'zip': '95648', 'city': 'Lincoln', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 38.89156, 'lon': -121.29301}}, {'zip': '34452', 'city': 'Inverness', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 28.83582, 'lon': -82.33037}}, {'zip': '32216', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33024', 'city': 'Pembroke Pines', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 26.00315, 'lon': -80.22394}}, {'zip': '83646', 'city': 'Meridian', 'state': 'Idaho', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 43.61211, 'lon': -116.39151}}, {'zip': '46260', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '12553', 'city': 'New Windsor', 'state': 'New York', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 41.47676, 'lon': -74.02375}}, {'zip': '27408', 'city': 'Greensboro', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 36.07264, 'lon': -79.79198}}, {'zip': '58104', 'city': 'Fargo', 'state': 'North Dakota', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 46.87719, 'lon': -96.7898}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '45246', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44224', 'city': 'Stow', 'state': 'Ohio', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 41.1595, 'lon': -81.44039}}, {'zip': '29464', 'city': 'Mt. 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