Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 3:00 AM
Study NCT ID:
NCT04986202
Status:
COMPLETED
Last Update Posted:
2025-08-27
First Post:
2021-06-18
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study to Evaluate the Efficacy and Safety of AZD4831 in Participants With Heart Failure With Left Ventricular Ejection Fraction > 40%
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Israel'], 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-04-15', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000706810', 'term': 'AZD4831'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'information.center@astrazeneca.com', 'phone': '1-877-240-9479', 'title': 'Global Clinical Lead', 'organization': 'AstraZeneca'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'The on-study period (Baseline - 52 weeks). The on-study period for is calculated from the date of the first dose of IP and to the earliest date of withdrawal of consent or date of death. If withdrawal of consent or death did not occur, it is calculated from the date of the first dose of IP and to the last study visit.', 'eventGroups': [{'id': 'EG000', 'title': 'AZD4831 2.5 mg', 'description': 'Once-daily oral dosing of AZD4831 2.5 mg', 'otherNumAtRisk': 234, 'deathsNumAtRisk': 234, 'otherNumAffected': 49, 'seriousNumAtRisk': 234, 'deathsNumAffected': 10, 'seriousNumAffected': 60}, {'id': 'EG001', 'title': 'AZD4831 5 mg', 'description': 'Once-daily oral dosing of AZD4831 5 mg', 'otherNumAtRisk': 240, 'deathsNumAtRisk': 240, 'otherNumAffected': 44, 'seriousNumAtRisk': 240, 'deathsNumAffected': 3, 'seriousNumAffected': 57}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Once-daily oral dosing of placebo', 'otherNumAtRisk': 235, 'deathsNumAtRisk': 235, 'otherNumAffected': 45, 'seriousNumAtRisk': 235, 'deathsNumAffected': 10, 'seriousNumAffected': 56}], 'otherEvents': [{'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 21, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 235, 'numEvents': 15, 'numAffected': 12}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 14, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 235, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Covid-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 18, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 235, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 12, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 15, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 235, 'numEvents': 21, 'numAffected': 15}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}], 'seriousEvents': [{'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 235, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 235, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 235, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 235, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hypophosphataemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 235, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Tumour lysis syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 235, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 235, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 235, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Rheumatoid arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 235, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Adenocarcinoma of colon', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 235, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 235, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 235, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Carcinoid tumour pulmonary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 235, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Colorectal adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 235, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Intraductal proliferative breast lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 235, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Invasive ductal breast carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 235, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Lip squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 235, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Malignant melanoma in situ', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 235, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Non-small cell lung cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 235, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pancreatic carcinoma metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 235, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Plasma cell myeloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 235, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 235, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Atrial tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 235, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Salivary gland neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 235, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Squamous cell carcinoma of lung', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 235, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 235, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 235, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 235, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Dementia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 235, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 235, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Embolic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 235, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 235, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 235, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 235, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Loss of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 235, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Optic neuritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 235, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 235, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 235, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 235, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 235, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 235, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 235, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Chronic kidney disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 235, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Nephrotic syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 1, 'numAffected': 1}, {'groupId': 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'ciLowerLimit': '0.84', 'ciUpperLimit': '1.07', 'pValueComment': 'Two-sided test.', 'estimateComment': 'Geometric mean ratio in change from baseline between AZD4831 and placebo.', 'groupDescription': 'NT-proBNP change from baseline at 48 weeks', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment group, neutrophil count stratification factor and the log-transformed baseline value are included in the model as explanatory variables.'}, {'pValue': '0.205', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.93', 'ciLowerLimit': '0.83', 'ciUpperLimit': '1.04', 'pValueComment': 'Two-sided test.', 'estimateComment': 'Geometric mean ratio in change from baseline between AZD4831 and placebo.', 'groupDescription': 'NT-proBNP change from baseline at 48 weeks', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment group, 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Participants were analysed according to their randomised study medication assignment, irrespective of the treatment actually received.'}, {'type': 'SECONDARY', 'title': 'Left Ventricular Global Longitudinal Strain (LV-GLS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}, {'value': '240', 'groupId': 'OG001'}, {'value': '235', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD4831 2.5 mg', 'description': 'Once-daily oral dosing of AZD4831 2.5 mg'}, {'id': 'OG001', 'title': 'AZD4831 5 mg', 'description': 'Once-daily oral dosing of AZD4831 5 mg'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Once-daily oral dosing of placebo'}], 'classes': [{'title': 'LV-GLS change from baseline at 16 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}, {'value': '117', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000', 'lowerLimit': '-0.5', 'upperLimit': '0.6'}, {'value': '-0.5', 'groupId': 'OG001', 'lowerLimit': '-1.0', 'upperLimit': '0.0'}, {'value': '-0.4', 'groupId': 'OG002', 'lowerLimit': '-1.0', 'upperLimit': '0.1'}]}]}, {'title': 'LV-GLS change from baseline at 24 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}, {'value': '121', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.6', 'groupId': 'OG000', 'lowerLimit': '-1.1', 'upperLimit': '0.0'}, {'value': '-0.9', 'groupId': 'OG001', 'lowerLimit': '-1.4', 'upperLimit': '-0.4'}, {'value': '-1.0', 'groupId': 'OG002', 'lowerLimit': '-1.5', 'upperLimit': '-0.4'}]}]}], 'analyses': [{'pValue': '0.183', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.5', 'ciLowerLimit': '-0.2', 'ciUpperLimit': '1.2', 'pValueComment': 'Two-sided test.', 'estimateComment': 'Difference in adjusted mean change from baseline between AZD4831 and placebo.', 'groupDescription': 'Change from baseline at 16 weeks', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.'}, {'pValue': '0.898', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-0.8', 'ciUpperLimit': '0.7', 'pValueComment': 'Two-sided test.', 'estimateComment': 'Difference in adjusted mean change from baseline between AZD4831 and placebo.', 'groupDescription': 'Change from baseline at 16 weeks', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.'}, {'pValue': '0.316', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '-0.4', 'ciUpperLimit': '1.1', 'pValueComment': 'Two-sided test.', 'estimateComment': 'Difference in adjusted mean change from baseline between AZD4831 and placebo.', 'groupDescription': 'Change from baseline at 24 weeks', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.'}, {'pValue': '0.934', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-0.7', 'ciUpperLimit': '0.8', 'pValueComment': 'Two-sided test.', 'estimateComment': 'Difference in adjusted mean change from baseline between AZD4831 and placebo.', 'groupDescription': 'Change from baseline at 24 weeks', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline - 16 and 24 weeks', 'description': 'LV-GLS change from baseline at 16 and 24 weeks compared with placebo Part A.\n\nLeft ventricular global longitudinal strain (LV-GLS) is an echocardiographic measure expressing longitudinal shortening as a percentage. A negative change from baseline indicates a better outcome.', 'unitOfMeasure': 'Percentage (%)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who have been randomised to study treatment and who have received at least one dose of investigational product were included irrespective of their protocol adherence and continued participation in the study and with non-missing data at baseline and the analysis timepoint. Participants were analysed according to their randomised study medication assignment, irrespective of the treatment actually received.'}, {'type': 'SECONDARY', 'title': 'Left Atrial Volume Index (LAVI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}, {'value': '240', 'groupId': 'OG001'}, {'value': '235', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD4831 2.5 mg', 'description': 'Once-daily oral dosing of AZD4831 2.5 mg'}, {'id': 'OG001', 'title': 'AZD4831 5 mg', 'description': 'Once-daily oral dosing of AZD4831 5 mg'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Once-daily oral dosing of placebo'}], 'classes': [{'title': 'LAVI change from baseline at 16 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}, {'value': '184', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.940', 'groupId': 'OG000', 'lowerLimit': '-2.373', 'upperLimit': '0.493'}, {'value': '-1.894', 'groupId': 'OG001', 'lowerLimit': '-3.286', 'upperLimit': '-0.502'}, {'value': '-1.300', 'groupId': 'OG002', 'lowerLimit': '-2.743', 'upperLimit': '0.144'}]}]}, {'title': 'LAVI change from baseline at 24 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'OG000'}, {'value': '201', 'groupId': 'OG001'}, {'value': '189', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.096', 'groupId': 'OG000', 'lowerLimit': '-0.626', 'upperLimit': '2.818'}, {'value': '-0.376', 'groupId': 'OG001', 'lowerLimit': '-1.986', 'upperLimit': '1.235'}, {'value': '0.439', 'groupId': 'OG002', 'lowerLimit': '-1.236', 'upperLimit': '2.114'}]}]}], 'analyses': [{'pValue': '0.725', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.360', 'ciLowerLimit': '-1.647', 'ciUpperLimit': '2.366', 'pValueComment': 'Two-sided test.', 'estimateComment': 'Difference in adjusted mean change from baseline between AZD4831 and placebo.', 'groupDescription': 'Change from baseline at 16 weeks', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.'}, {'pValue': '0.555', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.594', 'ciLowerLimit': '-2.571', 'ciUpperLimit': '1.382', 'pValueComment': 'Two-sided test.', 'estimateComment': 'Difference in adjusted mean change from baseline between AZD4831 and placebo.', 'groupDescription': 'Change from baseline at 16 weeks', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.'}, {'pValue': '0.586', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.657', 'ciLowerLimit': '-1.710', 'ciUpperLimit': '3.025', 'pValueComment': 'Two-sided test.', 'estimateComment': 'Difference in adjusted mean change from baseline between AZD4831 and placebo.', 'groupDescription': 'Change from baseline at 24 weeks', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.'}, {'pValue': '0.486', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.815', 'ciLowerLimit': '-3.108', 'ciUpperLimit': '1.478', 'pValueComment': 'Two-sided test.', 'estimateComment': 'Difference in adjusted mean change from baseline between AZD4831 and placebo.', 'groupDescription': 'Change from baseline at 24 weeks', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline - 16 and 24 weeks', 'description': 'LAVI change from baseline at 16 and 24 weeks compared with placebo Part A.\n\nLeft atrial volume index (LAVI) is an echocardiographic measure calculated by dividing LA volume by body surface area. A negative change from baseline indicates a better outcome.', 'unitOfMeasure': 'mL/m2', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who have been randomised to study treatment and who have received at least one dose of investigational product were included irrespective of their protocol adherence and continued participation in the study and with non-missing data at baseline and the analysis timepoint. Participants were analysed according to their randomised study medication assignment, irrespective of the treatment actually received.'}, {'type': 'SECONDARY', 'title': 'Left Ventricular Mass Index (LVMI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}, {'value': '240', 'groupId': 'OG001'}, {'value': '235', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD4831 2.5 mg', 'description': 'Once-daily oral dosing of AZD4831 2.5 mg'}, {'id': 'OG001', 'title': 'AZD4831 5 mg', 'description': 'Once-daily oral dosing of AZD4831 5 mg'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Once-daily oral dosing of placebo'}], 'classes': [{'title': 'LVMI change from baseline at 16 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}, {'value': '204', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000', 'lowerLimit': '-1.6', 'upperLimit': '4.2'}, {'value': '-0.9', 'groupId': 'OG001', 'lowerLimit': '-3.8', 'upperLimit': '1.9'}, {'value': '1.4', 'groupId': 'OG002', 'lowerLimit': '-1.5', 'upperLimit': '4.2'}]}]}, {'title': 'LVMI change from baseline at 24 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}, {'value': '213', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '9.8', 'groupId': 'OG000', 'lowerLimit': '6.0', 'upperLimit': '13.5'}, {'value': '8.3', 'groupId': 'OG001', 'lowerLimit': '4.6', 'upperLimit': '11.9'}, {'value': '9.4', 'groupId': 'OG002', 'lowerLimit': '5.6', 'upperLimit': '13.1'}]}]}], 'analyses': [{'pValue': '0.968', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-4.1', 'ciUpperLimit': '3.9', 'pValueComment': 'Two-sided test.', 'estimateComment': 'Difference in adjusted mean change from baseline between AZD4831 and placebo.', 'groupDescription': 'Change from baseline at 16 weeks', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.'}, {'pValue': '0.251', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.3', 'ciLowerLimit': '-6.3', 'ciUpperLimit': '1.6', 'pValueComment': 'Two-sided test.', 'estimateComment': 'Difference in adjusted mean change from baseline between AZD4831 and placebo.', 'groupDescription': 'Change from baseline at 16 weeks', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.'}, {'pValue': '0.872', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '-4.8', 'ciUpperLimit': '5.7', 'pValueComment': 'Two-sided test.', 'estimateComment': 'Difference in adjusted mean change from baseline between AZD4831 and placebo.', 'groupDescription': 'Change from baseline at 24 weeks', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.'}, {'pValue': '0.682', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.1', 'ciLowerLimit': '-6.2', 'ciUpperLimit': '4.1', 'pValueComment': 'Two-sided test.', 'estimateComment': 'No formal hypothesis testing and p-value is not adjusted for multiple comparisons.', 'groupDescription': 'Change from baseline at 24 weeks', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline - 16 and 24 weeks', 'description': 'LVMI change from baseline at 16 and 24 weeks compared with placebo Part A.\n\nLeft ventricular mass index (LVMI) is an echocardiographic measure calculated by dividing LVM by body surface area. A negative change from baseline indicates a better outcome.', 'unitOfMeasure': 'g/m2', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who have been randomised to study treatment and who have received at least one dose of investigational product were included irrespective of their protocol adherence and continued participation in the study and with non-missing data at baseline and the analysis timepoint. Participants were analysed according to their randomised study medication assignment, irrespective of the treatment actually received.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics (AZD4831 Plasma Exposure)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'OG000'}, {'value': '238', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD4831 2.5 mg', 'description': 'Once-daily oral dosing of AZD4831 2.5 mg'}, {'id': 'OG001', 'title': 'AZD4831 5 mg', 'description': 'Once-daily oral dosing of AZD4831 5 mg'}], 'classes': [{'title': 'Baseline (pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'OG000'}, {'value': '238', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.02', 'spread': '19.57', 'groupId': 'OG000'}, {'value': '1.01', 'spread': '9.38', 'groupId': 'OG001'}]}]}, {'title': '4 weeks (pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.45', 'spread': '99.26', 'groupId': 'OG000'}, {'value': '26.44', 'spread': '141.88', 'groupId': 'OG001'}]}]}, {'title': '12 weeks (pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.51', 'spread': '130.33', 'groupId': 'OG000'}, {'value': '25.45', 'spread': '161.09', 'groupId': 'OG001'}]}]}, {'title': '16 weeks (pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}, {'value': '213', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.59', 'spread': '126.71', 'groupId': 'OG000'}, {'value': '25.31', 'spread': '159.79', 'groupId': 'OG001'}]}]}, {'title': '24 weeks (pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '206', 'groupId': 'OG000'}, {'value': '216', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.87', 'spread': '146.45', 'groupId': 'OG000'}, {'value': '23.08', 'spread': '199.18', 'groupId': 'OG001'}]}]}, {'title': '48 weeks (pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.36', 'spread': '188.55', 'groupId': 'OG000'}, {'value': '21.18', 'spread': '229.28', 'groupId': 'OG001'}]}]}, {'title': '52 weeks (pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.14', 'spread': '49.22', 'groupId': 'OG000'}, {'value': '1.27', 'spread': '74.56', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline, 4 weeks, 12 weeks, 16 weeks, 24 weeks, 48 weeks, 52 weeks', 'description': 'Plasma concentrations of AZD4831 summarised by timepoint and dose level Part A', 'unitOfMeasure': 'nmol/L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who have been randomised to study treatment and who have received at least one dose of investigational product were included irrespective of their protocol adherence and continued participation in the study and with non-missing data at baseline and the analysis timepoint. Participants were analysed according to their randomised study medication assignment, irrespective of the treatment actually received.'}, {'type': 'SECONDARY', 'title': 'High Sensitivity CRP (hsCRP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}, {'value': '240', 'groupId': 'OG001'}, {'value': '235', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD4831 2.5 mg', 'description': 'Once-daily oral dosing of AZD4831 2.5 mg'}, {'id': 'OG001', 'title': 'AZD4831 5 mg', 'description': 'Once-daily oral dosing of AZD4831 5 mg'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Once-daily oral dosing of placebo'}], 'classes': [{'title': 'hsCRP change from baseline at 16 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '210', 'groupId': 'OG000'}, {'value': '224', 'groupId': 'OG001'}, {'value': '218', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.940', 'groupId': 'OG000', 'lowerLimit': '0.824', 'upperLimit': '1.073'}, {'value': '1.105', 'groupId': 'OG001', 'lowerLimit': '0.971', 'upperLimit': '1.257'}, {'value': '0.914', 'groupId': 'OG002', 'lowerLimit': '0.802', 'upperLimit': '1.041'}]}]}, {'title': 'hsCRP change from baseline at 24 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}, {'value': '229', 'groupId': 'OG001'}, {'value': '210', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.029', 'groupId': 'OG000', 'lowerLimit': '0.907', 'upperLimit': '1.168'}, {'value': '1.101', 'groupId': 'OG001', 'lowerLimit': '0.976', 'upperLimit': '1.243'}, {'value': '0.926', 'groupId': 'OG002', 'lowerLimit': '0.816', 'upperLimit': '1.051'}]}]}, {'title': 'hsCRP change from baseline at 48 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'OG000'}, {'value': '215', 'groupId': 'OG001'}, {'value': '197', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.120', 'groupId': 'OG000', 'lowerLimit': '0.973', 'upperLimit': '1.288'}, {'value': '1.127', 'groupId': 'OG001', 'lowerLimit': '0.985', 'upperLimit': '1.290'}, {'value': '0.972', 'groupId': 'OG002', 'lowerLimit': '0.845', 'upperLimit': '1.119'}]}]}], 'analyses': [{'pValue': '0.760', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.029', 'ciLowerLimit': '0.857', 'ciUpperLimit': '1.236', 'pValueComment': 'Two-sided test.', 'estimateComment': 'Geometric mean ratio in change from baseline between AZD4831 and placebo.', 'groupDescription': 'Change from baseline at 16 weeks', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment group, neutrophil count stratification factor and the log-transformed baseline value are included in the model as explanatory variables.'}, {'pValue': '0.039', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.209', 'ciLowerLimit': '1.010', 'ciUpperLimit': '1.448', 'pValueComment': 'Two-sided test.', 'estimateComment': 'Treatment group, neutrophil count stratification factor and the log-transformed baseline value are included in the model as explanatory variables.', 'groupDescription': 'Change from baseline at 16 weeks', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.'}, {'pValue': '0.241', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.111', 'ciLowerLimit': '0.931', 'ciUpperLimit': '1.326', 'pValueComment': 'Two-sided test.', 'estimateComment': 'Geometric mean ratio in change from baseline between AZD4831 and placebo.', 'groupDescription': 'Change from baseline at 24 weeks', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment group, neutrophil count stratification factor and the log-transformed baseline value are included in the model as explanatory variables.'}, {'pValue': '0.049', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.190', 'ciLowerLimit': '1.001', 'ciUpperLimit': '1.414', 'pValueComment': 'Two-sided test.', 'estimateComment': 'Geometric mean ratio in change from baseline between AZD4831 and placebo.', 'groupDescription': 'Change from baseline at 24 weeks', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment group, neutrophil count stratification factor and the log-transformed baseline value are included in the model as explanatory variables.'}, {'pValue': '0.158', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.151', 'ciLowerLimit': '0.946', 'ciUpperLimit': '1.401', 'pValueComment': 'Two-sided test.', 'estimateComment': 'Geometric mean ratio in change from baseline between AZD4831 and placebo.', 'groupDescription': 'Change from baseline at 48 weeks', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment group, neutrophil count stratification factor and the log-transformed baseline value are included in the model as explanatory variables.'}, {'pValue': '0.131', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.159', 'ciLowerLimit': '0.957', 'ciUpperLimit': '1.404', 'pValueComment': 'Two-sided test.', 'estimateComment': 'Geometric mean ratio in change from baseline between AZD4831 and placebo.', 'groupDescription': 'Change from baseline at 48 weeks', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment group, neutrophil count stratification factor and the log-transformed baseline value are included in the model as explanatory variables.'}], 'paramType': 'GEOMETRIC_LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline - 16, 24 and 48 weeks', 'description': 'hsCRP change from baseline at 16, 24, and 48 weeks compared with placebo Part A', 'unitOfMeasure': 'mg/dL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who have been randomised to study treatment and who have received at least one dose of investigational product were included irrespective of their protocol adherence and continued participation in the study and with non-missing data at baseline and the analysis timepoint. Participants were analysed according to their randomised study medication assignment, irrespective of the treatment actually received.'}, {'type': 'SECONDARY', 'title': 'Interleukin 6 (IL-6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}, {'value': '240', 'groupId': 'OG001'}, {'value': '235', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD4831 2.5 mg', 'description': 'Once-daily oral dosing of AZD4831 2.5 mg'}, {'id': 'OG001', 'title': 'AZD4831 5 mg', 'description': 'Once-daily oral dosing of AZD4831 5 mg'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Once-daily oral dosing of placebo'}], 'classes': [{'title': 'IL-6 change from baseline at 16 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '201', 'groupId': 'OG001'}, {'value': '199', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.1326', 'groupId': 'OG000', 'lowerLimit': '1.0261', 'upperLimit': '1.2502'}, {'value': '1.0258', 'groupId': 'OG001', 'lowerLimit': '0.9316', 'upperLimit': '1.1295'}, {'value': '1.1202', 'groupId': 'OG002', 'lowerLimit': '1.0170', 'upperLimit': '1.2339'}]}]}, {'title': 'IL-6 change from baseline at 24 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}, {'value': '188', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.0918', 'groupId': 'OG000', 'lowerLimit': '0.9934', 'upperLimit': '1.2000'}, {'value': '1.0700', 'groupId': 'OG001', 'lowerLimit': '0.9777', 'upperLimit': '1.1711'}, {'value': '0.9869', 'groupId': 'OG002', 'lowerLimit': '0.8975', 'upperLimit': '1.0852'}]}]}, {'title': 'IL-6 change from baseline at 48 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}, {'value': '177', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.3328', 'groupId': 'OG000', 'lowerLimit': '1.2134', 'upperLimit': '1.4639'}, {'value': '1.3094', 'groupId': 'OG001', 'lowerLimit': '1.1972', 'upperLimit': '1.4321'}, {'value': '1.2698', 'groupId': 'OG002', 'lowerLimit': '1.1574', 'upperLimit': '1.3931'}]}]}], 'analyses': [{'pValue': '0.874', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.0111', 'ciLowerLimit': '0.8819', 'ciUpperLimit': '1.1592', 'pValueComment': 'Two-sided test.', 'estimateComment': 'Geometric mean ratio in change from baseline between AZD4831 and placebo.', 'groupDescription': 'Change from baseline at 16 weeks', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment group, neutrophil count stratification factor and the log-transformed baseline value are included in the model as explanatory variables.'}, {'pValue': '0.200', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.9157', 'ciLowerLimit': '0.8002', 'ciUpperLimit': '1.0479', 'pValueComment': 'Two-sided test.', 'estimateComment': 'Geometric mean ratio in change from baseline between AZD4831 and placebo.', 'groupDescription': 'Change from baseline at 16 weeks', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment group, neutrophil count stratification factor and the log-transformed baseline value are included in the model as explanatory variables.'}, {'pValue': '0.135', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.1063', 'ciLowerLimit': '0.9690', 'ciUpperLimit': '1.2631', 'pValueComment': 'Two-sided test.', 'estimateComment': 'Geometric mean ratio in change from baseline between AZD4831 and placebo.', 'groupDescription': 'Change from baseline at 24 weeks', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment group, neutrophil count stratification factor and the log-transformed baseline value are included in the model as explanatory variables.'}, {'pValue': '0.220', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.0842', 'ciLowerLimit': '0.9527', 'ciUpperLimit': '1.2339', 'pValueComment': 'Two-sided test.', 'estimateComment': 'Geometric mean ratio in change from baseline between AZD4831 and placebo.', 'groupDescription': 'Change from baseline at 24 weeks', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment group, neutrophil count stratification factor and the log-transformed baseline value are included in the model as explanatory variables.'}, {'pValue': '0.467', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.0496', 'ciLowerLimit': '0.9211', 'ciUpperLimit': '1.1960', 'pValueComment': 'Two-sided test.', 'estimateComment': 'Geometric mean ratio in change from baseline between AZD4831 and placebo.', 'groupDescription': 'Change from baseline at 48 weeks', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment group, neutrophil count stratification factor and the log-transformed baseline value are included in the model as explanatory variables.'}, {'pValue': '0.636', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.0312', 'ciLowerLimit': '0.9080', 'ciUpperLimit': '1.1711', 'pValueComment': 'Two-sided test.', 'estimateComment': 'Geometric mean ratio in change from baseline between AZD4831 and placebo.', 'groupDescription': 'Change from baseline at 48 weeks', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment group, neutrophil count stratification factor and the log-transformed baseline value are included in the model as explanatory variables.'}], 'paramType': 'GEOMETRIC_LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline - 16, 24 and 48 weeks', 'description': 'IL-6 change from baseline at 16, 24, and 48 weeks compared with placebo Part A', 'unitOfMeasure': 'ng/L', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who have been randomised to study treatment and who have received at least one dose of investigational product were included irrespective of their protocol adherence and continued participation in the study and with non-missing data at baseline and the analysis timepoint. Participants were analysed according to their randomised study medication assignment, irrespective of the treatment actually received.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}, {'value': '240', 'groupId': 'OG001'}, {'value': '235', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD4831 2.5 mg', 'description': 'Once-daily oral dosing of AZD4831 2.5 mg'}, {'id': 'OG001', 'title': 'AZD4831 5 mg', 'description': 'Once-daily oral dosing of AZD4831 5 mg'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Once-daily oral dosing of placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '173', 'groupId': 'OG000'}, {'value': '180', 'groupId': 'OG001'}, {'value': '173', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline - 52 weeks', 'description': 'Number of participants with Adverse Events Part A', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of IP. Participants treated in error were accounted for in the treatment group of the treatment actually received. A participant who received any dose of the active IP was classified as in the active IP treatment group. A participant who received both doses of active IP was classified as in the highest dose treatment group.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Vital Signs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'OG000'}, {'value': '240', 'groupId': 'OG001'}, {'value': '234', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD4831 2.5 mg', 'description': 'Once-daily oral dosing of AZD4831 2.5 mg'}, {'id': 'OG001', 'title': 'AZD4831 5 mg', 'description': 'Once-daily oral dosing of AZD4831 5 mg'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Once-daily oral dosing of placebo'}], 'classes': [{'title': 'Diastolic blood pressure >= 90 and increase from baseline >= 10 (mmHg)', 'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}]}]}, {'title': 'Diastolic blood pressure < 60 and decrease from baseline >= 10 (mmHg)', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}]}, {'title': 'Pulse rate >= 100 and increase from baseline >= 20 (beats/min)', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}, {'title': 'Pulse rate < 50 and decrease from baseline >= 20 (beats/min)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}, {'title': 'Systolic blood pressure >= 140 and increase from baseline >= 20 (mmHg)', 'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}]}, {'title': 'Systolic blood pressure < 90 and decrease from baseline >= 20 (mmHg)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline - 52 weeks', 'description': 'Number of participants with treatment emergent vital sign abnormalities Part A', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of IP. Participants treated in error were accounted for in the treatment group of the treatment actually received. A participant who received any dose of the active IP was classified as in the active IP treatment group. A participant who received both doses of active IP was classified as in the highest dose treatment group. Number analyzed is the number of participants per treatment group with a baseline value and at least one post-baseline value.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Clinical Laboratory (Haematology)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '227', 'groupId': 'OG000'}, {'value': '238', 'groupId': 'OG001'}, {'value': '232', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD4831 2.5 mg', 'description': 'Once-daily oral dosing of AZD4831 2.5 mg'}, {'id': 'OG001', 'title': 'AZD4831 5 mg', 'description': 'Once-daily oral dosing of AZD4831 5 mg'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Once-daily oral dosing of placebo'}], 'classes': [{'title': 'Eosinophils >= 0.7 (10^9/L)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}, {'title': 'Eosinophils >= 1.5 (10^9/L)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hemoglobin < 100 (g/L)', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'Hemoglobin < 80 (g/L)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Neutrophil count < 1.5 (10^9/L)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Neutrophil count < 1.0 (10^9/L)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Leukocytes < 3.0 (10^9/L)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'Leukocytes < 2.0 (10^9/L)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline - 52 weeks', 'description': 'Number of participants with outliers for clinical laboratory (chemistry) measurements Part A', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of IP. Participants treated in error were accounted for in the treatment group of the treatment actually received. A participant who received any dose of the active IP was classified as in the active IP treatment group. A participant who received both doses of active IP was classified as in the highest dose treatment group. Number analyzed is the number of participants per treatment group with a baseline value and at least one post-baseline value.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Clinical Laboratory (Chemistry)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '227', 'groupId': 'OG000'}, {'value': '239', 'groupId': 'OG001'}, {'value': '232', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD4831 2.5 mg', 'description': 'Once-daily oral dosing of AZD4831 2.5 mg'}, {'id': 'OG001', 'title': 'AZD4831 5 mg', 'description': 'Once-daily oral dosing of AZD4831 5 mg'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Once-daily oral dosing of placebo'}], 'classes': [{'title': 'ALP > 1.5x ULN', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}]}, {'title': 'ALP > 3x ULN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'ALT > 3x ULN', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'ALT > 5x ULN', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'ALT > 10x ULN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'AST > 3x ULN', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'AST > 5x ULN', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'AST > 10x ULN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Creatinine >= 1.5x baseline creatinine', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}]}, {'title': 'Creatinine >= 2x baseline creatinine', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'TB > 1.5x ULN', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}]}, {'title': 'TB > 2x ULN', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'AST or ALT > 3x ULN', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'AST or ALT > 3x ULN and TB > 2x ULN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'TSH >6 (mIU/L)', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}]}, {'title': 'TSH >=10 (mIU/L)', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'TSH > 6 and free T4 < LLN (mIU/L)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'TSH >= 10 and free T4 < LLN (mIU/L)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline - 52 weeks', 'description': 'Number of participants with outliers for clinical laboratory (chemistry) measurements Part A', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of IP. Participants treated in error were accounted for in the treatment group of the treatment actually received. A participant who received any dose of the active IP was classified as in the active IP treatment group. A participant who received both doses of active IP was classified as in the highest dose treatment group. Number analyzed is the number of participants per treatment group with a baseline value and at least one post-baseline value.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Electrocardiogram (ECG)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '226', 'groupId': 'OG000'}, {'value': '239', 'groupId': 'OG001'}, {'value': '232', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD4831 2.5 mg', 'description': 'Once-daily oral dosing of AZD4831 2.5 mg'}, {'id': 'OG001', 'title': 'AZD4831 5 mg', 'description': 'Once-daily oral dosing of AZD4831 5 mg'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Once-daily oral dosing of placebo'}], 'classes': [{'title': 'Normal with Normal at baseline', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}]}, {'title': 'Abnormal, not clinically significant with Normal at baseline', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}]}, {'title': 'Abnormal, clinically significant last on-study value with Normal at baseline', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Normal with Abnormal, not clinically significant at baseline', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'Abnormal, not clinically significant with Abnormal, not clinically significant at baseline', 'categories': [{'measurements': [{'value': '132', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}, {'value': '137', 'groupId': 'OG002'}]}]}, {'title': 'Abnormal, clinically significant with Abnormal, not clinically significant at baseline', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Normal with Abnormal, clinically significant at baseline', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Abnormal, not clinically significant with Abnormal, clinically significant at baseline', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}]}, {'title': 'Abnormal, clinically significant with Abnormal, clinically significant at baseline', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline - 52 weeks', 'description': 'Number of Participants With Abnormal ECG Last On-Study Value Part A', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of IP. Participants treated in error were accounted for in the treatment group of the treatment actually received. A participant who received any dose of the active IP was classified as in the active IP treatment group. A participant who received both doses of active IP was classified as in the highest dose treatment group. Number analyzed is the number of participants per treatment group with a baseline value and at least one post-baseline value.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'AZD4831 2.5 mg', 'description': 'Once-daily oral dosing of AZD4831 2.5 mg'}, {'id': 'FG001', 'title': 'AZD4831 5 mg', 'description': 'Once-daily oral dosing of AZD4831 5 mg'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Once-daily oral dosing of placebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Participants randomised', 'achievements': [{'groupId': 'FG000', 'numSubjects': '235'}, {'groupId': 'FG001', 'numSubjects': '240'}, {'groupId': 'FG002', 'numSubjects': '236'}]}, {'type': 'COMPLETED', 'comment': 'Participants completed study', 'achievements': [{'groupId': 'FG000', 'numSubjects': '218'}, {'groupId': 'FG001', 'numSubjects': '234'}, {'groupId': 'FG002', 'numSubjects': '220'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '16'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '10'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '4'}]}]}], 'recruitmentDetails': 'A total of 142 study centres in 18 countries randomised participants.', 'preAssignmentDetails': 'Part B of the study was never started, results are only presented for Part A of the study.\n\nThe discrepancy between the number of randomised participants and the number of participants in the full analysis set and the safety analysis set is because only randomized participants who have taken at least one dose of the investigational product (IP) were included in the analysis sets.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'BG000'}, {'value': '240', 'groupId': 'BG001'}, {'value': '235', 'groupId': 'BG002'}, {'value': '709', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'AZD4831 2.5 mg', 'description': 'Once-daily oral dosing of AZD4831 2.5 mg'}, {'id': 'BG001', 'title': 'AZD4831 5 mg', 'description': 'Once-daily oral dosing of AZD4831 5 mg'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Once-daily oral dosing of placebo'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '72.5', 'spread': '7.3', 'groupId': 'BG000'}, {'value': '72.1', 'spread': '7.1', 'groupId': 'BG001'}, {'value': '72.5', 'spread': '7.8', 'groupId': 'BG002'}, {'value': '72.4', 'spread': '7.4', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '< 65 Years', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '106', 'groupId': 'BG003'}]}]}, {'title': '65 - 75 Years', 'categories': [{'measurements': [{'value': '120', 'groupId': 'BG000'}, {'value': '108', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}, {'value': '343', 'groupId': 'BG003'}]}]}, {'title': '> 75 Years', 'categories': [{'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}, {'value': '260', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '107', 'groupId': 'BG000'}, {'value': '119', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}, {'value': '322', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '127', 'groupId': 'BG000'}, {'value': '121', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}, {'value': '387', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '51', 'groupId': 'BG003'}]}]}, {'title': 'Not Hispanic or Latino', 'categories': [{'measurements': [{'value': '218', 'groupId': 'BG000'}, {'value': '226', 'groupId': 'BG001'}, {'value': '214', 'groupId': 'BG002'}, {'value': '658', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '107', 'groupId': 'BG003'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '193', 'groupId': 'BG000'}, {'value': '194', 'groupId': 'BG001'}, {'value': '192', 'groupId': 'BG002'}, {'value': '579', 'groupId': 'BG003'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}, {'title': 'Not Reported', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Australia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}, {'title': 'Belgium', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}]}, {'title': 'Brazil', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}]}]}, {'title': 'Bulgaria', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '96', 'groupId': 'BG003'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}]}]}, {'title': 'Czech Republic', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '67', 'groupId': 'BG003'}]}]}, {'title': 'Denmark', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}]}]}, {'title': 'France', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}]}]}, {'title': 'Hungary', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '56', 'groupId': 'BG003'}]}]}, {'title': 'Japan', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '75', 'groupId': 'BG003'}]}]}, {'title': 'Netherlands', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '69', 'groupId': 'BG003'}]}]}, {'title': 'Russian Federation', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}]}]}, {'title': 'Slovakia', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '76', 'groupId': 'BG003'}]}]}, {'title': 'Sweden', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}]}]}, {'title': 'Taiwan', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}]}]}, {'title': 'Turkey', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}, {'title': 'United States of America', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '50', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All participants who have been randomised to study treatment and who have received at least one dose of investigational product were included irrespective of their protocol adherence and continued participation in the study and with non-missing data at baseline and the analysis timepoint. Participants were analysed according to their randomised study medication assignment, irrespective of the treatment actually received.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-09-23', 'size': 4164627, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-03-26T12:02', 'hasProtocol': True}, {'date': '2024-03-08', 'size': 13520451, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_003.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-08-08T09:45', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 711}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2024-03-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-08', 'studyFirstSubmitDate': '2021-06-18', 'resultsFirstSubmitDate': '2025-03-26', 'studyFirstSubmitQcDate': '2021-07-29', 'lastUpdatePostDateStruct': {'date': '2025-08-27', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-08-08', 'studyFirstPostDateStruct': {'date': '2021-08-02', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-08-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-03-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Adverse Events', 'timeFrame': 'Baseline - 52 weeks', 'description': 'Number of participants with Adverse Events Part A'}, {'measure': 'Vital Signs', 'timeFrame': 'Baseline - 52 weeks', 'description': 'Number of participants with treatment emergent vital sign abnormalities Part A'}, {'measure': 'Clinical Laboratory (Haematology)', 'timeFrame': 'Baseline - 52 weeks', 'description': 'Number of participants with outliers for clinical laboratory (chemistry) measurements Part A'}, {'measure': 'Clinical Laboratory (Chemistry)', 'timeFrame': 'Baseline - 52 weeks', 'description': 'Number of participants with outliers for clinical laboratory (chemistry) measurements Part A'}, {'measure': 'Electrocardiogram (ECG)', 'timeFrame': 'Baseline - 52 weeks', 'description': 'Number of Participants With Abnormal ECG Last On-Study Value Part A'}], 'primaryOutcomes': [{'measure': 'Kansas City Cardiomyopathy Questionnaire -Total Symptom Score', 'timeFrame': 'Baseline - 16 weeks', 'description': 'Kansas City Cardiomyopathy Questionnaire -Total Symptom Score change from baseline at 16 weeks compared with placebo Part A. The score ranges from 0 to 100, where a higher score represents a better patient outcome'}, {'measure': 'Six Minute Walk Distance', 'timeFrame': 'Baseline - 16 weeks', 'description': 'Six Minute Walk Distance change from baseline at 16 weeks compared with placebo Part A'}], 'secondaryOutcomes': [{'measure': 'Kansas City Cardiomyopathy Questionnaire-Total Symptom Score', 'timeFrame': 'Baseline - 24 and 48 weeks', 'description': 'Kansas City Cardiomyopathy Questionnaire -Total Symptom Score change from baseline at 24 and 48 weeks compared with placebo Part A. The score ranges from 0 to 100, where a higher score represents a better patient outcome.'}, {'measure': 'Six Minute Walk Distance', 'timeFrame': 'Baseline - 24 and 48 weeks', 'description': 'Six Minute Walk Distance change from baseline at 24 and 48 weeks compared with placebo Part A'}, {'measure': 'N-terminal Pro-brain Natriuretic Peptide (NT-proBNP)', 'timeFrame': 'Baseline - 16, 24 and 48 weeks', 'description': 'NT-proBNP change from baseline at 16, 24, and 48 weeks compared with placebo Part A'}, {'measure': 'Left Ventricular Global Longitudinal Strain (LV-GLS)', 'timeFrame': 'Baseline - 16 and 24 weeks', 'description': 'LV-GLS change from baseline at 16 and 24 weeks compared with placebo Part A.\n\nLeft ventricular global longitudinal strain (LV-GLS) is an echocardiographic measure expressing longitudinal shortening as a percentage. A negative change from baseline indicates a better outcome.'}, {'measure': 'Left Atrial Volume Index (LAVI)', 'timeFrame': 'Baseline - 16 and 24 weeks', 'description': 'LAVI change from baseline at 16 and 24 weeks compared with placebo Part A.\n\nLeft atrial volume index (LAVI) is an echocardiographic measure calculated by dividing LA volume by body surface area. A negative change from baseline indicates a better outcome.'}, {'measure': 'Left Ventricular Mass Index (LVMI)', 'timeFrame': 'Baseline - 16 and 24 weeks', 'description': 'LVMI change from baseline at 16 and 24 weeks compared with placebo Part A.\n\nLeft ventricular mass index (LVMI) is an echocardiographic measure calculated by dividing LVM by body surface area. A negative change from baseline indicates a better outcome.'}, {'measure': 'Pharmacokinetics (AZD4831 Plasma Exposure)', 'timeFrame': 'Baseline, 4 weeks, 12 weeks, 16 weeks, 24 weeks, 48 weeks, 52 weeks', 'description': 'Plasma concentrations of AZD4831 summarised by timepoint and dose level Part A'}, {'measure': 'High Sensitivity CRP (hsCRP)', 'timeFrame': 'Baseline - 16, 24 and 48 weeks', 'description': 'hsCRP change from baseline at 16, 24, and 48 weeks compared with placebo Part A'}, {'measure': 'Interleukin 6 (IL-6)', 'timeFrame': 'Baseline - 16, 24 and 48 weeks', 'description': 'IL-6 change from baseline at 16, 24, and 48 weeks compared with placebo Part A'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Heart failure', 'Heart failure with preserved ejection fraction', 'HFpEF'], 'conditions': ['Heart Failure With Preserved Ejection Fraction']}, 'referencesModule': {'references': [{'pmid': '37470101', 'type': 'DERIVED', 'citation': 'Lund LH, Lam CSP, Pizzato PE, Gabrielsen A, Michaelsson E, Nelander K, Ericsson H, Holden J, Folkvaljon F, Mattsson A, Collen A, Aurell M, Whatling C, Baldus S, Drelich G, Goudev A, Merkely B, Bergh N, Shah SJ. Rationale and design of ENDEAVOR: A sequential phase 2b-3 randomized clinical trial to evaluate the effect of myeloperoxidase inhibition on symptoms and exercise capacity in heart failure with preserved or mildly reduced ejection fraction. Eur J Heart Fail. 2023 Sep;25(9):1696-1707. doi: 10.1002/ejhf.2977. Epub 2023 Aug 22.'}], 'seeAlsoLinks': [{'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D6580C00010&attachmentIdentifier=d0341baa-e973-48d0-95d4-91c806b29fca&fileName=D6580C00010_Redacted_CSP.pdf&versionIdentifier=', 'label': 'Redacted\\_CSP'}, {'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D6580C00010&attachmentIdentifier=ac832783-a7d5-46b3-8823-8d5a77d1fa45&fileName=D6580C00010-Redacted_CSR_synopsis.pdf&versionIdentifier=', 'label': 'Redacted CSR synopsis'}, {'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D6580C00010&attachmentIdentifier=c7691e40-e2a4-4c14-826f-c6b7fe018451&fileName=D6580C00010_Redacted_SAP.pdf&versionIdentifier=', 'label': 'D6580C00010\\_Redacted\\_SAP'}]}, 'descriptionModule': {'briefSummary': 'This is a randomised, double-blind, placebo-controlled, multi-center sequential phase 2b and Phase 3 study to evaluate the efficacy and safety of AZD4831 administered for up to 48 Weeks in participants with heart failure with left ventricular ejection fraction \\> 40%. The study will consist of 2 separate parts, Part A and Part B, approximately 660 participants will be randomised in Part A, 820 in Part B.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nPart A\n\n1. ≥ 40 to ≤ 85 years of age, at the time of signing the informed consent.\n2. Documented stable symptomatic HF (New York Heart Association Class II-IV) for at least 1 month at Screening (Visit 1) (transient HF in the setting of an MI does not qualify), with a medical history of typical symptoms of HF and receiving optimal therapy for HF as determined by the health-care physician.\n3. LVEF \\> 40% at Screening (Visit 1). All participants will undergo a local echocardiogram at the Screening (Visit 1) with central reading to confirm the LVEF \\> 40% eligibility criteria before randomisation.\n4. 6MWD ≥ 30 meters and ≤ 400 meters at Screening (Visit 1) and Randomisation (Visit 3). Difference in 6MWD between Screening and Randomisation must be \\< 50 meters.\n5. KCCQ-TSS ≤ 90 points at Screening (Visit 1) and Randomisation (Visit 3)\n6. NT-proBNP ≥ 250 pg/mL (sinus rhythm) or ≥ 500 pg/mL (atrial fibrillation/flutter) at Screening (Visit 1) for patients with BMI ≤30 kg/m2.\n\nNT-proBNP ≥ 200 pg/mL (sinus rhythm) or ≥ 400 pg/mL (atrial fibrillation/flutter) at Screening (Visit 1) for patients with BMI \\> 30 kg/m2.\n\nThe ECG performed at Screening should be used for heart rhythm evaluation.\n\n7.At least one of the following:\n\n1. Structural heart disease, ie, LA enlargement and/or left ventricular hypertrophy at the echocardiogram performed at Screening (Visit 1). Left atrial enlargement is defined by at least 1 of the following: LA width (diameter) ≥ 3.8 cm or LA length ≥ 5.0 cm, or LA area ≥ 20 cm2 or LA volume ≥ 55 mL or LAVI \\> 34 mL/m2. Left ventricular hypertrophy is defined by septal thickness or posterior wall thickness ≥ 1.1 cm or LVMI \\> 95 g/m2 in women and \\> 115 g/m2 in men.\n2. Spectral tissue Doppler echocardiography - E/e' ratio (average of septal and lateral) ≥ 13 at rest at the echocardiogram performed at Screening (Visit 1).\n3. Indirectly estimated elevation of PASP by TRmax velocity \\> 2.8 m/s (280 cm/s) (PASP \\> 35 mmHg) at the echocardiogram performed at Screening (Visit 1) OR directly measured pulmonary capillary wedge pressure \\> 15 mmHg at rest within the past 12 months or \\> 25 mmHg at exercise documented by right heart catheterisation within 12 months prior to Screening (Visit 1).\n4. HF decompensation within 6 months before Randomisation (Visit 3), defined as hospitalisation for HF or IV diuretic treatment for HF during an urgent, unscheduled visit without hospitalisation.\n\n 8.Body mass index ≥ 18.0 kg/m2 and ≤ 45.0 kg/m2\n\n 9.Male or female of non-childbearing potential.\n\n Part B\n 1. Participant must be ≥ 40 to ≤ 85 years of age, at the time of signing the informed consent.\n 2. Documented diagnosis of symptomatic HF (NYHA class II-IV) at Screening (Visit 1), and a medical history of typical symptoms/signs of heart failure ≥ 6 weeks before Screening (Visit 1), and receiving optimal therapy for HF as determined by the health-care physician, with at least intermittent need for diuretic treatment.\n 3. LVEF \\>40% and evidence of structural heart disease (ie, left ventricular hypertrophy or\n\n left atrial enlargement \\[defined by at least one of the following:LA enlargement and/or left ventricular hypertrophy at the echocardiogram\n\n performed at Screening (Visit 1). Left atrial enlargement is defined by at least 1 of the following: LA width\n\n (diameter) ≥ 3.8 cm or LA length ≥ 5.0 cm, or LA area ≥ 20 cm2 or LA volume ≥ 55 mL or LAVI \\> 34\n\n mL/m2. Left ventricular hypertrophy is defined by septal thickness or posterior wall thickness ≥ 1.1 cm or\n\n LVMI \\> 95 g/m2 in women and \\> 115 g/m2 in men.\\]) documented by the most recent echocardiogram, or cardiac\n\n magnetic resonance imaging within the last 12 months prior to Screening (Visit 1). If no\n\n echocardiogram is available, it can be performed at Screening (Visit 1).\n 4. 6MWD ≥ 30 meters and ≤ 400 meters at Screening (Visit 1) and Randomisation (Visit 2). Difference in 6MWD between Screening and Randomisation must be \\< 50 meters\n 5. KCCQ-TSS ≤ 90 points at Screening (Visit 1) and Randomisation (Visit 2).\n 6. NT-proBNP ≥ 250 pg/mL (sinus rhythm) or ≥ 500 pg/mL (atrial fibrillation/flutter) at Screening (Visit 1) for patients with BMI ≤ 30 kg/m2. NT-proBNP ≥ 200 pg/mL (sinus rhythm) or ≥ 400 pg/mL (atrial fibrillation/flutter) at Screening (Visit 1) for patients with BMI \\> 30 kg/m2. The ECG performed at Screening should be used for heart rhythm evaluation\n 7. Body mass index ≥ 18.0 kg/m2 and ≤ 45.0 kg/m2\n 8. Male or female of non-childbearing potential.\n\n Exclusion Criteria:\n\n Part A\n\n 1 eGFR \\< 30 mL/min/1.73m2 (Chronic Kidney Disease-Epidemiology Collaboration formula) at Screening (Visit 1).\n\n 2\\. Systolic blood pressure \\< 90 mmHg or ≥ 160 mmHg if not on treatment with ≥ 3 blood pressure lowering medications or ≥ 180 mmHg irrespective of treatments at Randomisation\n\n 3\\. Heart rate \\> 110 bpm or \\< 50 bpm at Randomisation\n\n 4\\. Life expectancy \\< 3 years due to other reasons than cardiovascular disease.\n\n 5\\. History or ongoing allergy/hypersensitivity reactions to drugs (including but not limited to rash, angioedema, acute urticaria).\n\n 6\\. Presence of any disease or condition rather than HF constituting the main reason for limiting the ability to exercise/reduced exercise capacity.\n\n 7\\. Current decompensated HF and/or NT-proBNP \\> 5000 pg/mL at Screening (Visit 1)\n\n 8\\. Documented history of ejection fraction ≤ 40%.i.e. HF with recovered ejection fraction. Transient ejection fraction decrease e.g. in the setting of an MI does not apply\n\n 9\\. Any planned cardiovascular procedure (eg, coronary revascularisation, ablation of atrial fibrillation/flutter, valve repair/replacement, aortic aneurysm surgery, etc).\n\n 10\\. Any cardiac event (eg, myocardial infarction, unstable angina), coronary revascularisation (percutaneous coronary intervention or coronary artery bypass grafting), ablation of atrial fibrillation/flutter, valve repair/replacement, implantation of a cardiac resynchronisation therapy device within 12 weeks prior to Screening (Visit 1) or between Screening and Randomisation. Patients who underwent a successful atrial fibrillation/flutter cardioversion, can be enrolled in the study after 4 weeks.\n\n 14\\. Hb \\< 110 g/L (male) and \\< 100 g/L (female) or iron-deficiency with/without anaemia requiring ongoing or planned IV iron treatment.\n\n 15\\. Participants with hyperthyroidism, uncontrolled hypothyroidism (including but not limited to TSH ≥10 mIU/mL), or any clinically significant thyroid disease as judged by the investigator.\n\n 18\\. ALT or AST ≥ 2 × ULN at Screening (Visit 1).\n\n 19\\. Pulmonary arterial hypertension, chronic pulmonary embolism, severe pulmonary disease including COPD (ie, requiring home oxygen, chronic nebulizer therapy or chronic oral steroid therapy, or hospitalization for exacerbation of COPD requiring ventilatory support within 12 months prior to Screening (Visit 1).\n\n 20\\. Any active infection requiring oral, intravenous or intramuscular treatment at Screening (Visit 1) and/or at Randomisation.\n\n 23 Any signs or confirmation of COVID-19 infection:\n * Suspected (as judged by PI) or confirmed COVID-19 within the last 2 weeks prior to Screening (Visit 1) or at Randomisation.\n * Hospitalisation for COVID-19 within the last 12 weeks prior to Screening (Visit 1).\n\n 24\\. Any concomitant medications known to be a potent CYP3A4 inducers or inhibitors, eg, itraconazole, rifampicin, clarithromycin, or propylthiouracil\n\n 29\\. Previous enrolment and randomisation in the present study. (Participants who where screened and screen failed and not randomised in Part A can be screened for possible entry to Part B).\n\n All exclusion criteria in Part A are applicable to Part B with the following exceptions:\n\n Exclusion criteria 4; 19\n\n Exclusion Criteria specific for Part B only \\[criteria numeration for Part B\\]\n\n 4\\. Life expectancy \\< 2 years due to other reasons than cardiovascular disease.\n\n 11\\. HF due to any of the following: known infiltrative cardiomyopathy (eg, amyloid, sarcoid, lymphoma, endomyocardial fibrosis), active myocarditis, constrictive pericarditis, cardiac tamponade, known genetic hypertrophic cardiomyopathy or obstructive hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy/dysplasia (ARVC/D), or uncorrected primary valvular disease.\n\n 18\\. Primary pulmonary hypertension, chronic pulmonary embolism, severe pulmonary disease including COPD (ie, requiring home oxygen, chronic nebulizer therapy or chronic oral steroid therapy, or hospitalization for exacerbation of COPD requiring ventilatory support within 12 months prior to Screening \\[Visit 1\\])."}, 'identificationModule': {'nctId': 'NCT04986202', 'acronym': 'ENDEAVOR', 'briefTitle': 'Study to Evaluate the Efficacy and Safety of AZD4831 in Participants With Heart Failure With Left Ventricular Ejection Fraction > 40%', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Randomised, Double-blind, Placebo-controlled, Multi-center Sequential Phase 2b and Phase 3 Study to Evaluate the Efficacy and Safety of AZD4831 Administered for Up to 48 Weeks in Participants With Heart Failure With Left Ventricular Ejection Fraction > 40%', 'orgStudyIdInfo': {'id': 'D6580C00010'}, 'secondaryIdInfos': [{'id': '2020-005844-47', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part A 2.5 mg', 'description': 'AZD4831 2.5 mg', 'interventionNames': ['Drug: AZD4831']}, {'type': 'EXPERIMENTAL', 'label': 'Part A 5 mg', 'description': 'AZD4831 5 mg', 'interventionNames': ['Drug: AZD4831']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Part A Placebo', 'description': 'Placebo', 'interventionNames': ['Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part B Dose based on Part A', 'description': 'AZD4831 Dose based on Part A', 'interventionNames': ['Drug: AZD4831']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Part B Placebo', 'description': 'Placebo', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'AZD4831', 'type': 'DRUG', 'description': 'AZD4831', 'armGroupLabels': ['Part A 2.5 mg', 'Part A 5 mg', 'Part B Dose based on Part A']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo', 'armGroupLabels': ['Part A Placebo', 'Part B Placebo']}]}, 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