Ignite Creation Date:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2025-12-26 @ 1:06 AM
Study NCT ID:
NCT03521934
Status:
TERMINATED
Last Update Posted:
2022-10-28
First Post:
2018-04-30
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Effect of Sotagliflozin on Cardiovascular Events in Participants With Type 2 Diabetes Post Worsening Heart Failure (SOLOIST-WHF Trial)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C575681', 'term': '(2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'medical-information@lexpharma.com', 'phone': '(510) 338-6064', 'title': 'Medical Affairs', 'organization': 'Lexicon Pharmaceuticals, Inc.'}, 'certainAgreement': {'otherDetails': "Institution must provide any proposed publication or presentation to Sponsor for Sponsor's review, comment and approval at least thirty (30) days prior to the proposed submission for publication date or the proposed presentation date. Sponsor shall have the right to have deleted from the final version of the publication any confidential information, proprietary information, or patentable subject matter.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Limitations of the trial such as small numbers of participants analyzed or technical problems leading to unreliable data.\n\nThe study was terminated prematurely due to business decision.'}}, 'adverseEventsModule': {'timeFrame': 'First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)', 'description': 'Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).', 'eventGroups': [{'id': 'EG000', 'title': 'Sotagliflozin', 'description': 'Sotagliflozin 200 mg tablet once daily, with possible up-titration in the first 8 months to 400 mg, for up to 21.2 months.', 'otherNumAtRisk': 605, 'deathsNumAtRisk': 608, 'otherNumAffected': 101, 'seriousNumAtRisk': 605, 'deathsNumAffected': 65, 'seriousNumAffected': 235}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Matching placebo to sotagliflozin 200 mg once daily, with possible up-titration in the first 8 months to matching placebo to sotagliflozin 400 mg, for up to 21.6 months.', 'otherNumAtRisk': 611, 'deathsNumAtRisk': 614, 'otherNumAffected': 90, 'seriousNumAtRisk': 611, 'deathsNumAffected': 76, 'seriousNumAffected': 251}], 'otherEvents': [{'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 27}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 57}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}], 'seriousEvents': [{'term': 'Aortic rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Arteriosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Circulatory collapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Hypovolaemic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 5}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Peripheral artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Peripheral artery thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Peripheral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Shock haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Aortic valve replacement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Cardiac pacemaker insertion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Cardiac rehabilitation therapy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Cardiac resynchronisation therapy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Percutaneous coronary intervention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Therapeutic procedure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Colon adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Colon cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': "Kaposi's sarcoma", 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Lung adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Lung neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Pancreatic carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Papillary renal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Cardiac death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Generalised oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Multiple organ dysfunction syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Nodule', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Sudden cardiac death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Sudden death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Vascular stent thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Acute psychosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Drug abuse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Psychotic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Cardiac valve replacement complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Concussion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Craniocerebral injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Femoral neck fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Foot fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Foreign body in gastrointestinal tract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Hand fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Intentional overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Lower limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Pelvic fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Periprosthetic fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Post procedural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 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'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Toxicity to various agents', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Ulna fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Biopsy prostate', 'stats': [{'groupId': 'EG000', 'numAtRisk': 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'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 16}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Calculus urinary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Chronic kidney disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 6}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 1}, 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'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Osteitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Osteonecrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Osteoporosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Polyarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Spinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Diabetes mellitus inadequate control', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Diabetic complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Diabetic ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Diabetic metabolic decompensation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Fluid overload', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Gout', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Hyperglycaemic hyperosmolar nonketotic syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Hyperinsulinaemic hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Hypovolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Lactic acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Metabolic acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Metabolic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Abdominal sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Bronchitis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Clostridium difficile infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Endocarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Erysipelas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Gangrene', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Gastroenteritis clostridial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Gastroenteritis salmonella', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Infected skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Infective exacerbation of chronic obstructive airways disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Infective thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Pharyngeal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Pharyngotonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 26}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Pneumonia bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Pulmonary sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Pyelonephritis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Respiratory syncytial virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Soft tissue infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Staphylococcal bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Tracheobronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 605, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 611, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Total Occurrences of Cardiovascular (CV) Death, Hospitalizations for Heart Failure (HHF) and Urgent Visits for Heart Failure (HF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '608', 'groupId': 'OG000'}, {'value': '614', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sotagliflozin', 'description': 'Sotagliflozin 200 mg tablet once daily, with possible up-titration in the first 8 months to 400 mg, for up to 21.2 months.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo to sotagliflozin 200 mg once daily, with possible up-titration in the first 8 months to matching placebo to sotagliflozin 400 mg, for up to 21.6 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '76.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.67', 'ciLowerLimit': '0.52', 'ciUpperLimit': '0.85', 'groupDescription': 'The estimates of the hazard ratio (HR) and corresponding 2-sided 95% confidence interval (CI) was to be provided by a marginal Cox proportional hazard model stratified by region and ejection fraction, with non-cardiovascular (non-CV) death treated as a competing event.', 'statisticalMethod': 'Cox proportional hazards model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 21.9 months', 'description': 'Combined endpoint of the total number of occurrences (first and potentially subsequent) of CV death, HHF, and urgent HF visits after randomization. Events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up.', 'unitOfMeasure': 'events per 100-person years', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population includes all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Total Number of Occurrences of HHF and Urgent HF Visits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '608', 'groupId': 'OG000'}, {'value': '614', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sotagliflozin', 'description': 'Sotagliflozin 200 mg tablet once daily, with possible up-titration in the first 8 months to 400 mg, for up to 21.2 months.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo to sotagliflozin 200 mg once daily, with possible up-titration in the first 8 months to matching placebo to sotagliflozin 400 mg, for up to 21.6 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '40.4', 'groupId': 'OG000'}, {'value': '63.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.64', 'ciLowerLimit': '0.49', 'ciUpperLimit': '0.83', 'groupDescription': 'The estimates of the HR and corresponding 2-sided 95% CI was to be provided by a marginal Cox proportional hazard model stratified by region and ejection fraction, with non-CV death treated as a competing event.', 'statisticalMethod': 'Cox proportional hazards model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 21.9 months', 'description': 'Combined endpoint of the total occurrences (first and potentially subsequent) of HHF and urgent HF visits after randomization. Events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up.', 'unitOfMeasure': 'events per 100-person years', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population includes all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Total Number of Deaths From Cardiovascular Causes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '608', 'groupId': 'OG000'}, {'value': '614', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sotagliflozin', 'description': 'Sotagliflozin 200 mg tablet once daily, with possible up-titration in the first 8 months to 400 mg, for up to 21.2 months.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo to sotagliflozin 200 mg once daily, with possible up-titration in the first 8 months to matching placebo to sotagliflozin 400 mg, for up to 21.6 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.6', 'groupId': 'OG000'}, {'value': '12.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '= 0.36', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.84', 'ciLowerLimit': '0.58', 'ciUpperLimit': '1.22', 'groupDescription': 'The estimates of the HR and corresponding 2-sided 95% CI was to be provided by a marginal Cox proportional hazard model stratified by region and ejection fraction, with non-CV death treated as a competing event.', 'statisticalMethod': 'Cox proportional hazards model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 21.9 months', 'description': 'Number of events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up.', 'unitOfMeasure': 'events per 100-person years', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population includes all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Total Number of Occurrences of CV Death, HHF, Non-fatal Myocardial Infarction and Non-fatal Stroke', 'denoms': [{'units': 'Participants', 'counts': [{'value': '608', 'groupId': 'OG000'}, {'value': '614', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sotagliflozin', 'description': 'Sotagliflozin 200 mg tablet once daily, with possible up-titration in the first 8 months to 400 mg, for up to 21.2 months.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo to sotagliflozin 200 mg once daily, with possible up-titration in the first 8 months to matching placebo to sotagliflozin 400 mg, for up to 21.6 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '51.4', 'groupId': 'OG000'}, {'value': '71.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.72', 'ciLowerLimit': '0.56', 'ciUpperLimit': '0.92', 'groupDescription': 'The estimates of the HR and corresponding 2-sided 95% CI was to be provided by a marginal Cox proportional hazard model stratified by region and ejection fraction, with non-CV death treated as a competing event.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 21.9 months', 'description': 'Combined endpoint of the total number of occurrences (first and potentially subsequent) of CV death, HHF, non-fatal stroke, and non-fatal myocardial infarction after randomisation. Events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up.', 'unitOfMeasure': 'events per 100-person years', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population includes all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Total Number of Occurrences of HHF, Urgent HF Visit, CV Death, and HF While Hospitalized', 'denoms': [{'units': 'Participants', 'counts': [{'value': '608', 'groupId': 'OG000'}, {'value': '614', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sotagliflozin', 'description': 'Sotagliflozin 200 mg tablet once daily, with possible up-titration in the first 8 months to 400 mg, for up to 21.2 months.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo to sotagliflozin 200 mg once daily, with possible up-titration in the first 8 months to matching placebo to sotagliflozin 400 mg, for up to 21.6 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '54.7', 'groupId': 'OG000'}, {'value': '80.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.68', 'ciLowerLimit': '0.54', 'ciUpperLimit': '0.86', 'groupDescription': 'The estimates of the HR and corresponding 2-sided 95% CI was to be provided by a marginal Cox proportional hazard model stratified by region and ejection fraction, with non-CV death treated as a competing event.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 21.9 months', 'description': 'Combined endpoint of the total number of occurrences (first and potentially subsequent) after randomisation of HHF, urgent HF visits, CV Death and HF while hospitalised. Events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up.', 'unitOfMeasure': 'events per 100-person years', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population includes all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Total Number of Deaths From Any Cause', 'denoms': [{'units': 'Participants', 'counts': [{'value': '608', 'groupId': 'OG000'}, {'value': '614', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sotagliflozin', 'description': 'Sotagliflozin 200 mg tablet once daily, with possible up-titration in the first 8 months to 400 mg, for up to 21.2 months.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo to sotagliflozin 200 mg once daily, with possible up-titration in the first 8 months to matching placebo to sotagliflozin 400 mg, for up to 21.6 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.5', 'groupId': 'OG000'}, {'value': '16.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.82', 'ciLowerLimit': '0.59', 'ciUpperLimit': '1.14', 'groupDescription': 'The estimates of the HR and corresponding 2-sided 95% CI was to be provided by a marginal Cox proportional hazard model stratified by region and ejection fraction.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 21.9 months', 'description': 'Number of events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up.', 'unitOfMeasure': 'events per 100-person years', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population includes all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) Scores at Month 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '608', 'groupId': 'OG000'}, {'value': '614', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sotagliflozin', 'description': 'Sotagliflozin 200 mg tablet once daily, with possible up-titration in the first 8 months to 400 mg, for up to 21.2 months.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo to sotagliflozin 200 mg once daily, with possible up-titration in the first 8 months to matching placebo to sotagliflozin 400 mg, for up to 21.6 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.7', 'spread': '0.41', 'groupId': 'OG000'}, {'value': '13.6', 'spread': '0.41', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.1', 'ciLowerLimit': '1.3', 'ciUpperLimit': '7', 'groupDescription': 'The change from baseline to Month 4 was analyzed using an ANCOVA model with treatment groups as factor and baseline KCCQ-12 score and randomization stratification factors as covariates.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Month 4', 'description': 'KCCQ-12 is a 12 question questionnaire, participants completed questionnaire about how heart failure affected their life over the past 2 weeks. The scale has 4 domains: symptom frequency, physical limitation, social limitations and quality of life for a total possible transformed score of 0 to 100 where 100 denotes the highest health status. A positive change from baseline indicates improvement. An analysis of covariance (ANCOVA) model was used for analysis.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population includes all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Estimated Glomerular Filtration Rate (eGFR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '608', 'groupId': 'OG000'}, {'value': '614', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sotagliflozin', 'description': 'Sotagliflozin 200 mg tablet once daily, with possible up-titration in the first 8 months to 400 mg, for up to 21.2 months.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo to sotagliflozin 200 mg once daily, with possible up-titration in the first 8 months to matching placebo to sotagliflozin 400 mg, for up to 21.6 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.34', 'spread': '1.33', 'groupId': 'OG000'}, {'value': '-0.18', 'spread': '1.33', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Least Squares Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.16', 'ciLowerLimit': '-1.3', 'ciUpperLimit': '0.98', 'groupDescription': 'Rate of decline in eGFR observed over time was analyzed by MMRM with absolute change in eGFR from baseline as the outcome, a random effect for intercept, and fixed effects for treatment, baseline value, and time.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline up to 21.9 months', 'description': 'eGFR is a test for renal function. A blood sample was collected and was sent to a central laboratory. eGFR was calculated by the Modification of Diet in Renal Disease (MDRD) equation reported as milliliters/minute/1.73 meter squared (mL/min/1.73 m\\^2). A mixed model for repeated measures (MMRM) was used for analysis.', 'unitOfMeasure': 'mL/min/1.73 m^2', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population includes all randomized participants.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sotagliflozin', 'description': 'Sotagliflozin 200 mg tablet once daily, with possible up-titration in the first 8 months to 400 mg, for up to 21.2 months.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Matching placebo to sotagliflozin 200 mg once daily, with possible up-titration in the first 8 months to matching placebo to sotagliflozin 400 mg, for up to 21.6 months.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '608'}, {'groupId': 'FG001', 'numSubjects': '614'}]}, {'type': 'Randomized and Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '605'}, {'groupId': 'FG001', 'numSubjects': '611'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '608'}, {'groupId': 'FG001', 'numSubjects': '614'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '65'}, {'groupId': 'FG001', 'numSubjects': '73'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'Site Terminated by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '35'}]}, {'type': 'Study Terminated by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '483'}, {'groupId': 'FG001', 'numSubjects': '477'}]}, {'type': 'Reason not Specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '6'}]}]}], 'recruitmentDetails': 'Participants took part in the study at 306 investigative sites in North America, Latin America, Western Europe, Eastern Europe, and the Rest of the World from 15 June 2018 to 05 June 2020.', 'preAssignmentDetails': 'Participants with a diagnosis of Type 2 Diabetes post Worsening Heart Failure were enrolled equally in 1 of 2 treatment groups, sotagliflozin or placebo.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '608', 'groupId': 'BG000'}, {'value': '614', 'groupId': 'BG001'}, {'value': '1222', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Sotagliflozin', 'description': 'Sotagliflozin 200 mg tablet once daily, with possible up-titration in the first 8 months to 400 mg, for up to 21.2 months.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Matching placebo to sotagliflozin 200 mg once daily, with possible up-titration in the first 8 months to matching placebo to sotagliflozin 400 mg, for up to 21.6 months.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '68.6', 'spread': '9.5', 'groupId': 'BG000'}, {'value': '69.3', 'spread': '8.8', 'groupId': 'BG001'}, {'value': '68.9', 'spread': '9.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '198', 'groupId': 'BG000'}, {'value': '214', 'groupId': 'BG001'}, {'value': '412', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '410', 'groupId': 'BG000'}, {'value': '400', 'groupId': 'BG001'}, {'value': '810', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '163', 'groupId': 'BG000'}, {'value': '157', 'groupId': 'BG001'}, {'value': '320', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '438', 'groupId': 'BG000'}, {'value': '455', 'groupId': 'BG001'}, {'value': '893', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '567', 'groupId': 'BG000'}, {'value': '572', 'groupId': 'BG001'}, {'value': '1139', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Intent-to-treat (ITT) population included all randomized participants.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-12-17', 'size': 3452879, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-09-30T02:27', 'hasProtocol': True}, {'date': '2020-08-09', 'size': 5801274, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-09-30T02:26', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1222}}, 'statusModule': {'whyStopped': 'Study terminated due to business decision', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'dispFirstSubmitDate': '2020-10-23', 'completionDateStruct': {'date': '2020-06-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-30', 'studyFirstSubmitDate': '2018-04-30', 'dispFirstSubmitQcDate': '2020-10-23', 'resultsFirstSubmitDate': '2022-09-30', 'studyFirstSubmitQcDate': '2018-04-30', 'dispFirstPostDateStruct': {'date': '2020-10-28', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2022-10-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-09-30', 'studyFirstPostDateStruct': {'date': '2018-05-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-10-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Total Occurrences of Cardiovascular (CV) Death, Hospitalizations for Heart Failure (HHF) and Urgent Visits for Heart Failure (HF)', 'timeFrame': 'Up to 21.9 months', 'description': 'Combined endpoint of the total number of occurrences (first and potentially subsequent) of CV death, HHF, and urgent HF visits after randomization. Events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up.'}], 'secondaryOutcomes': [{'measure': 'Total Number of Occurrences of HHF and Urgent HF Visits', 'timeFrame': 'Up to 21.9 months', 'description': 'Combined endpoint of the total occurrences (first and potentially subsequent) of HHF and urgent HF visits after randomization. Events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up.'}, {'measure': 'Total Number of Deaths From Cardiovascular Causes', 'timeFrame': 'Up to 21.9 months', 'description': 'Number of events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up.'}, {'measure': 'Total Number of Occurrences of CV Death, HHF, Non-fatal Myocardial Infarction and Non-fatal Stroke', 'timeFrame': 'Up to 21.9 months', 'description': 'Combined endpoint of the total number of occurrences (first and potentially subsequent) of CV death, HHF, non-fatal stroke, and non-fatal myocardial infarction after randomisation. Events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up.'}, {'measure': 'Total Number of Occurrences of HHF, Urgent HF Visit, CV Death, and HF While Hospitalized', 'timeFrame': 'Up to 21.9 months', 'description': 'Combined endpoint of the total number of occurrences (first and potentially subsequent) after randomisation of HHF, urgent HF visits, CV Death and HF while hospitalised. Events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up.'}, {'measure': 'Total Number of Deaths From Any Cause', 'timeFrame': 'Up to 21.9 months', 'description': 'Number of events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up.'}, {'measure': 'Change From Baseline in Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) Scores at Month 4', 'timeFrame': 'Baseline to Month 4', 'description': 'KCCQ-12 is a 12 question questionnaire, participants completed questionnaire about how heart failure affected their life over the past 2 weeks. The scale has 4 domains: symptom frequency, physical limitation, social limitations and quality of life for a total possible transformed score of 0 to 100 where 100 denotes the highest health status. A positive change from baseline indicates improvement. An analysis of covariance (ANCOVA) model was used for analysis.'}, {'measure': 'Change From Baseline in Estimated Glomerular Filtration Rate (eGFR)', 'timeFrame': 'Baseline up to 21.9 months', 'description': 'eGFR is a test for renal function. A blood sample was collected and was sent to a central laboratory. eGFR was calculated by the Modification of Diet in Renal Disease (MDRD) equation reported as milliliters/minute/1.73 meter squared (mL/min/1.73 m\\^2). A mixed model for repeated measures (MMRM) was used for analysis.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Heart Failure', 'Type 2 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '39260929', 'type': 'DERIVED', 'citation': 'Bhatt AS, Bhatt DL, Steg PG, Szarek M, Cannon CP, Leiter LA, McGuire DK, Lewis JB, Riddle MC, Voors AA, Metra M, Lund LH, Testani JM, Wilcox CS, Davies M, Pitt B, Kosiborod MN. Effects of Sotagliflozin on Health Status in Patients With Worsening Heart Failure: Results From SOLOIST-WHF. J Am Coll Cardiol. 2024 Sep 17;84(12):1078-1088. doi: 10.1016/j.jacc.2024.06.036.'}, {'pmid': '38878007', 'type': 'DERIVED', 'citation': 'Weintraub WS, Kolm P, Dolman S, Alva M, Bhatt DL, Zhang Z. Cost-Effectiveness of Sotagliflozin in SOLOIST-WHF. JACC Heart Fail. 2024 Sep;12(9):1600-1610. doi: 10.1016/j.jchf.2024.04.018. Epub 2024 Jun 12.'}, {'pmid': '38771012', 'type': 'DERIVED', 'citation': 'Kim J, Wang S, Sikirica S, Shafrin J. Cost-effectiveness of sotagliflozin for the treatment of patients with diabetes and recent worsening heart failure. J Comp Eff Res. 2024 Jun;13(6):e230190. doi: 10.57264/cer-2023-0190. Epub 2024 May 21.'}, {'pmid': '38770818', 'type': 'DERIVED', 'citation': 'Natale P, Tunnicliffe DJ, Toyama T, Palmer SC, Saglimbene VM, Ruospo M, Gargano L, Stallone G, Gesualdo L, Strippoli GF. Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 May 21;5(5):CD015588. doi: 10.1002/14651858.CD015588.pub2.'}, {'pmid': '34152828', 'type': 'DERIVED', 'citation': 'Szarek M, Bhatt DL, Steg PG, Cannon CP, Leiter LA, McGuire DK, Lewis JB, Riddle MC, Voors AA, Metra M, Lund LH, Komajda M, Testani JM, Wilcox CS, Ponikowski P, Lopes RD, Banks P, Tesfaye E, Ezekowitz JA, Verma S, Pitt B; SOLOIST-WHF committees and investigators. Effect of Sotagliflozin on Total Hospitalizations in Patients With Type 2 Diabetes and Worsening Heart Failure : A Randomized Trial. Ann Intern Med. 2021 Aug;174(8):1065-1072. doi: 10.7326/M21-0651. Epub 2021 Jun 22.'}, {'pmid': '33200892', 'type': 'DERIVED', 'citation': 'Bhatt DL, Szarek M, Steg PG, Cannon CP, Leiter LA, McGuire DK, Lewis JB, Riddle MC, Voors AA, Metra M, Lund LH, Komajda M, Testani JM, Wilcox CS, Ponikowski P, Lopes RD, Verma S, Lapuerta P, Pitt B; SOLOIST-WHF Trial Investigators. Sotagliflozin in Patients with Diabetes and Recent Worsening Heart Failure. N Engl J Med. 2021 Jan 14;384(2):117-128. doi: 10.1056/NEJMoa2030183. Epub 2020 Nov 16.'}]}, 'descriptionModule': {'briefSummary': 'Primary Objective:\n\nTo compare the effect of sotagliflozin to placebo on the total occurrences of cardiovascular (CV) death, hospitalization for heart failure (HHF), and urgent visit for heart failure (HF) in hemodynamically stable participants after admission for worsening heart failure (WHF)\n\nSecondary Objectives:\n\nTo compare the effects of sotagliflozin to placebo on:\n\n* The total occurrences of HHF and urgent visit for HF\n* The occurrence of CV death\n* The occurrence of all-cause mortality\n* The total occurrences of CV death, HHF, urgent visit for HF, non-fatal myocardial infarction (MI), and non-fatal stroke\n* Change in Kansas City Cardiomyopathy Questionnaire-12(KCCQ-12) score\n* Change in estimated glomerular filtration rate (eGFR)', 'detailedDescription': 'The estimated study duration for a given participants will be approximately 3 to 24 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n* Type 2 Diabetes Mellitus.\n* Admitted to the hospital, or urgent heart failure visit for worsening heart failure.\n* Prior diagnosis of heart failure (\\> 3 months).\n* Prior chronic treatment for heart failure with a loop diuretic (eg furosemide, torsemide, bumetanide) for \\> 30 days.\n* Randomized when hemodynamically stable, prior to hospital discharge or within 3 days of discharge.\n* Brain natriuretic peptide (BNP) ≥150 picograms per milliliter (pg/mL) (≥450 pg/mL for participants with atrial fibrillation) or N-terminal B-type natriuretic peptide ≥600 pg/mL (≥1800 pg/mL for participants with atrial fibrillation).\n* Participants with Left Ventricular Ejection Fraction \\<40% should be on beta-blockers and renin-angiotensin-aldosterone system (RAAS) inhibitors as per local guidelines unless contraindicated.\n* Signed written informed consent.\n\nExclusion criteria:\n\n* Age \\< 18 years or \\> 85 years.\n* Worsening heart failure attributed to other causes such as pulmonary embolism, stroke, heart attack.\n* Cardiac surgery or coronary procedure within 1 month or planned during study.\n* Lower extremity complications (such as skin ulcer, infection, osteomyelitis, and gangrene) identified during screening and requiring treatment at randomization.\n* Planning to start a sodium-glucose linked transporter-2 (SGLT2) inhibitor during the study.\n* Acute coronary syndromes within 3 months prior to Randomization.\n* Hemodynamically significant uncorrected primary valvular disease.\n* Significant pulmonary disease contributing substantially to the participant's dyspnea.\n* End stage Heart Failure.\n* History of diabetic ketoacidosis (DKA) or nonketotic hyperosmolar coma within 3 months prior to screening.\n* History of stroke within 3 months prior to randomization.\n* History of dialysis within 1 year prior to randomization.\n* History of solid organ transplant or on a transplant list (if heart transplant, defined as status 1 transplant).\n* Severe kidney disease as defined by glomerular filtration rate (eGFR) \\<30 milliliter per minute per 1.72 meter square (mL/min/1.73 m\\^2).\n* Pregnancy.\n\nThe above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT03521934', 'briefTitle': 'Effect of Sotagliflozin on Cardiovascular Events in Participants With Type 2 Diabetes Post Worsening Heart Failure (SOLOIST-WHF Trial)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Lexicon Pharmaceuticals'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Effects of Sotagliflozin on Clinical Outcomes in Hemodynamically Stable Patients With Type 2 Diabetes POST Worsening Heart Failure', 'orgStudyIdInfo': {'id': 'EFC15156'}, 'secondaryIdInfos': [{'id': '2017-003510-16', 'type': 'EUDRACT_NUMBER'}, {'id': 'U1111-1190-7891', 'type': 'OTHER', 'domain': 'UTN'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sotagliflozin', 'description': 'Sotagliflozin 200 mg tablet once daily, with possible up-titration in the first 8 months to 400 mg, for up to 21.2 months.', 'interventionNames': ['Drug: Sotagliflozin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Matching placebo to sotagliflozin 200 mg once daily, with possible up-titration in the first 8 months to matching placebo to sotagliflozin 400 mg, for up to 21.6 months.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Sotagliflozin', 'type': 'DRUG', 'otherNames': ['SAR439954'], 'description': 'Pharmaceutical form: tablet\n\nRoute of administration: oral', 'armGroupLabels': ['Sotagliflozin']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Pharmaceutical form: tablet\n\nRoute of administration: oral', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35010', 'city': 'Alexander City', 'state': 'Alabama', 'country': 'United States', 'facility': 'Investigational Site Number 8400128', 'geoPoint': {'lat': 32.94401, 'lon': -85.95385}}, {'zip': '86326', 'city': 'Cottonwood', 'state': 'Arizona', 'country': 'United States', 'facility': 'Investigational Site Number 8400109', 'geoPoint': {'lat': 34.73919, 'lon': -112.00988}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Investigational Site Number 8400032', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Investigational Site Number 8400080', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '93309', 'city': 'Bakersfield', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 8400075', 'geoPoint': {'lat': 35.37329, 'lon': -119.01871}}, {'zip': '93701', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 8400069', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '90024', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 8400008', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90073', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 8400063', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '91950', 'city': 'National City', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 8400127', 'geoPoint': {'lat': 32.67811, 'lon': -117.0992}}, {'zip': '90277', 'city': 'Redondo Beach', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 8400007', 'geoPoint': {'lat': 33.84918, 'lon': -118.38841}}, {'zip': '95204', 'city': 'Stockton', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 8400036', 'geoPoint': {'lat': 37.9577, 'lon': -121.29078}}, {'zip': '91342', 'city': 'Sylmar', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 8400033', 'geoPoint': {'lat': 34.30778, 'lon': -118.44925}}, {'zip': '90502', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 8400049', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '94598', 'city': 'Walnut Creek', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 8400028', 'geoPoint': {'lat': 37.90631, 'lon': -122.06496}}, {'zip': '06606', 'city': 'Bridgeport', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Investigational Site Number 8400029', 'geoPoint': {'lat': 41.17923, 'lon': -73.18945}}, {'zip': 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Site Number 8400057', 'geoPoint': {'lat': 26.97617, 'lon': -82.09064}}, {'zip': '34239', 'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number 8400006', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '33609', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number 8400035', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number 8400042', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '33449', 'city': 'Wellington', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number 8400004', 'geoPoint': {'lat': 26.65868, 'lon': -80.24144}}, {'zip': '30322-1020', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Investigational Site Number 8400073', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30084', 'city': 'Tucker', 'state': 'Georgia', 'country': 'United States', 'facility': 'Investigational Site Number 8400118', 'geoPoint': {'lat': 33.85455, 'lon': -84.21714}}, {'zip': '60005', 'city': 'Arlington Heights', 'state': 'Illinois', 'country': 'United States', 'facility': 'Investigational Site Number 8400067', 'geoPoint': {'lat': 42.08836, 'lon': -87.98063}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Investigational Site Number 8400043', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60007', 'city': 'Elk Grove Village', 'state': 'Illinois', 'country': 'United States', 'facility': 'Investigational Site Number 8400072', 'geoPoint': {'lat': 42.00392, 'lon': -87.97035}}, {'zip': '46060', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Investigational Site Number 8400055', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '47303-3400', 'city': 'Muncie', 'state': 'Indiana', 'country': 'United States', 'facility': 'Investigational Site Number 8400020', 'geoPoint': {'lat': 40.19338, 'lon': -85.38636}}, {'zip': '47374', 'city': 'Richmond', 'state': 'Indiana', 'country': 'United States', 'facility': 'Investigational Site Number 8400122', 'geoPoint': {'lat': 39.82894, 'lon': -84.89024}}, {'zip': '50702', 'city': 'Waterloo', 'state': 'Iowa', 'country': 'United States', 'facility': 'Investigational Site Number 8400091', 'geoPoint': {'lat': 42.49276, 'lon': -92.34296}}, {'zip': '70433', 'city': 'Covington', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Investigational Site Number 8400030', 'geoPoint': {'lat': 30.47549, 'lon': -90.10042}}, {'zip': '21401', 'city': 'Annapolis', 'state': 'Maryland', 'country': 'United States', 'facility': 'Investigational Site Number 8400065', 'geoPoint': {'lat': 38.97859, 'lon': -76.49184}}, {'zip': '02118', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Investigational Site Number 8400012', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02135', 'city': 'Cambridge', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Investigational Site Number 8400001', 'geoPoint': {'lat': 42.3751, 'lon': -71.10561}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Investigational Site Number 8400077', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '49009', 'city': 'Kalamazoo', 'state': 'Michigan', 'country': 'United States', 'facility': 'Investigational Site Number 8400062', 'geoPoint': {'lat': 42.29171, 'lon': -85.58723}}, {'zip': '49048', 'city': 'Kalamazoo', 'state': 'Michigan', 'country': 'United States', 'facility': 'Investigational Site Number 8400017', 'geoPoint': {'lat': 42.29171, 'lon': -85.58723}}, {'zip': '55805', 'city': 'Duluth', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Investigational Site Number 8400107', 'geoPoint': {'lat': 46.78327, 'lon': -92.10658}}, {'zip': '39216', 'city': 'Jackson', 'state': 'Mississippi', 'country': 'United States', 'facility': 'Investigational Site Number 8400056', 'geoPoint': {'lat': 32.29876, 'lon': -90.18481}}, {'zip': '65201', 'city': 'Columbia', 'state': 'Missouri', 'country': 'United States', 'facility': 'Investigational Site Number 8400019', 'geoPoint': {'lat': 38.95171, 'lon': -92.33407}}, {'zip': '64064', 'city': "Lee's Summit", 'state': 'Missouri', 'country': 'United States', 'facility': 'Investigational Site Number 8400103', 'geoPoint': {'lat': 38.91084, 'lon': -94.38217}}, {'zip': '68803', 'city': 'Grand Island', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Investigational Site Number 8400132', 'geoPoint': {'lat': 40.92501, 'lon': -98.34201}}, {'zip': '68506', 'city': 'Lincoln', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Investigational Site Number 8400130', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}, {'zip': '68124', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Investigational Site Number 8400083', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '68198', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Investigational Site Number 8400071', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '07450-2736', 'city': 'Ridgewood', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Investigational Site Number 8400015', 'geoPoint': {'lat': 40.97926, 'lon': -74.11653}}, {'zip': '08043', 'city': 'Voorhees Township', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Investigational Site Number 8400050', 'geoPoint': {'lat': 40.4795, 'lon': -74.49062}}, {'zip': '87131', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'Investigational Site Number 8400131', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '11203', 'city': 'Brooklyn', 'state': 'New York', 'country': 'United States', 'facility': 'Investigational Site Number 8400051', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}, {'zip': '14215', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Investigational Site Number 8400111', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '10457', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Investigational Site Number 8400097', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '10468-3904', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Investigational Site Number 8400061', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '27401', 'city': 'Greensboro', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Investigational Site Number 8400045', 'geoPoint': {'lat': 36.07264, 'lon': -79.79198}}, {'zip': '27610', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Investigational Site Number 8400085', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Investigational Site Number 8400078', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '45220', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Investigational Site Number 8400087', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '45267', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Investigational Site Number 8400047', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '43537', 'city': 'Maumee', 'state': 'Ohio', 'country': 'United States', 'facility': 'Investigational Site Number 8400095', 'geoPoint': {'lat': 41.56283, 'lon': -83.65382}}, {'zip': '43699', 'city': 'Toledo', 'state': 'Ohio', 'country': 'United States', 'facility': 'Investigational Site Number 8400099', 'geoPoint': {'lat': 41.66394, 'lon': -83.55521}}, {'zip': '43701', 'city': 'Zanesville', 'state': 'Ohio', 'country': 'United States', 'facility': 'Investigational Site Number 8400121', 'geoPoint': {'lat': 39.94035, 'lon': -82.01319}}, {'zip': '19001', 'city': 'Arlington', 'state': 'Oregon', 'country': 'United States', 'facility': 'Investigational Site Number 8400054', 'geoPoint': {'lat': 45.7168, 'lon': -120.20088}}, {'zip': '18901', 'city': 'Doylestown', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Investigational Site Number 8400134', 'geoPoint': {'lat': 40.31011, 'lon': -75.12989}}, {'zip': '15065', 'city': 'Natrona Heights', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Investigational Site Number 8400044', 'geoPoint': {'lat': 40.6234, 'lon': -79.72977}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Investigational Site Number 8400115', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '18840', 'city': 'Sayre', 'state': 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'city': 'Swansea', 'country': 'United Kingdom', 'facility': 'Investigational Site Number 8260003', 'geoPoint': {'lat': 51.62079, 'lon': -3.94323}}, {'zip': 'SN3 6BB', 'city': 'Swindon', 'country': 'United Kingdom', 'facility': 'Investigational Site Number 8260006', 'geoPoint': {'lat': 51.55797, 'lon': -1.78116}}, {'zip': 'TQ2 7AA', 'city': 'Torquay', 'country': 'United Kingdom', 'facility': 'Investigational Site Number 8260004', 'geoPoint': {'lat': 50.46198, 'lon': -3.52522}}, {'zip': 'YO31 8HE', 'city': 'York', 'country': 'United Kingdom', 'facility': 'Investigational Site Number 8260007', 'geoPoint': {'lat': 53.95763, 'lon': -1.08271}}], 'overallOfficials': [{'name': 'Suman Wason, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Lexicon Pharmaceuticals, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any 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